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World Leaders in Health Industry Analysis

The World Generic Market Report 2012

Volume I: Global Overview and Company Profiles


ISBN: 978-1-85822-441-1

© Copyright 2012 Espicom Business Intelligence Publications Limited

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World Generic Market Report 2012 Vol I: Company Profiles

March 2012 i

© Espicom Business Intelligence

TABLE OF CONTENTS

FOREWORD ...................................................................................................... xvii

The state of the Industry ...................................................................................... 1

Generic Consolidations, Mergers and Acquisitions ........................................................................................... 1

Generic and Branded Acquisitions and Agreements.......................................................................................... 3

The branded industry's 'patent cliff' ..................................................................................................................... 4

Major Generic Manufacturers .............................................................................. 5

Biosimilars ............................................................................................................ 8

In the USA ................................................................................................................................................................ 8 Another option: file a full BLA? ............................................................................................................................ 9

The development of a US biosimilar pathway ..................................................................................................... 9

The BCPIA ......................................................................................................................................................... 10

Implementation of the BCPIA ............................................................................................................................ 11

FDA guidance documents published ............................................................................................................................... 13

FDA sends user fee scheme to Congress .......................................................................................................... 14

In Europe ............................................................................................................................................................... 14

EMA Guideline Documents ................................................................................................................................ 15

Regulation of Monoclonal Antibodies ................................................................................................................ 17

Elsewhere .............................................................................................................................................................. 17

Market acceptance................................................................................................................................................ 17 Positive drivers for biosimilar acceptance .......................................................................................................... 18

Potential barriers to entry for biosimilars ........................................................................................................... 18

Who will the developers be? ............................................................................................................................... 18

Current Issues in the USA .................................................................................. 19

Authorised generics ............................................................................................................................................. 19 FDA issues direct final rule regarding listing of authorised generics ................................................................. 20

Reverse Payments ................................................................................................................................................ 21

Shared exclusivity ................................................................................................................................................ 21

GDUFA ................................................................................................................................................................... 25

FDA Inspections and Warning Letters................................................................................................................ 25 Impax Laboratories ............................................................................................................................................ 26

Aurobindo Pharma ............................................................................................................................................. 26

Dr Reddy's Laboratories .................................................................................................................................... 26

Ranbaxy Laboratories consent decree .............................................................................................................. 27

Current Issues in the European Union .............................................................. 28

EC releases final report into pharmaceutical sector ......................................................................................... 28

Monitoring of patent settlements ........................................................................................................................ 30


ii March 2012


EC carries out surprise inspections at pharmaceutical firms .......................................................................... 31

Generic drug shipments seized in the EU .......................................................................................................... 32

Canada – EU Comprehensive Economic and Trade Agreement ...................................................................... 33

The WTO and access to generics ..................................................................... 35

TRIPS patent ruling on least-developed countries, 2002 .................................................................................. 35

2003 Agreement .................................................................................................................................................... 36

Original decision turns ten ................................................................................................................................. 39

Actavis................................................................................................................. 41

Introduction ........................................................................................................................................................... 41

Company Details ................................................................................................................................................... 41 Organisational Structure .................................................................................................................................... 41

Products................................................................................................................................................................. 42 Own-Label Sales ................................................................................................................................................ 42

Third-Party Sales ............................................................................................................................................... 42

Hospital Products ............................................................................................................................................... 42

Recent Developments .......................................................................................................................................... 44 Recent Acquisitions............................................................................................................................................ 44

Actavis acquires PharmaPack International ....................................................................................................................44

Recent Company News ..................................................................................................................................... 44

Actavis plans to launch oncology products in Turkey in the coming year .......................................................................44

Actavis chief become EGA President; sets out viewpoint ...............................................................................................45

Actavis plans Latin America expansion ...........................................................................................................................45

Actavis formally opens Zug headquarters; details market strategy .................................................................................45

Actavis opens expansion to Iceland manufacturing plant ................................................................................................46

EC clears acquisition of control of Actavis by Deutsche Bank.........................................................................................46

Actavis plans biosimilars entry with help from Biopartners acquisition ............................................................................46

Recent Litigation ................................................................................................................................................ 47

Avanir Pharmaceuticals files dextromethorphan + quinidine lawsuit against Actavis and others....................................47

Eli Lilly gains appellate court ruling on atomoxetine patent validity .................................................................................47

Generics industry welcomes Supreme Court ruling regarding labelling ..........................................................................48

Pfizer settles gabapentin litigation with Teva and Actavis ...............................................................................................48

Texas jury orders Actavis to pay US$170 million in damages .........................................................................................49

Shire gains lisdexamphetamine exclusivity victory ..........................................................................................................49

Actavis challenges Labopharm's US trazodone patents ..................................................................................................49

Apotex ................................................................................................................. 50

Introduction ........................................................................................................................................................... 50

Company Details ................................................................................................................................................... 50

Products................................................................................................................................................................. 51

ApoTriavir ........................................................................................................................................................... 54

Financials .............................................................................................................................................................. 55

Recent Developments .......................................................................................................................................... 55


March 2012 iii



Apotex resumes shipments to the US ............................................................................................................................. 55

Apotex plans the construction of a new plant in Mexico .................................................................................................. 55

Apotex sells group of products to AA Pharma ................................................................................................................. 55


Path cleared for Apotex to launch clopidogrel in Canada ................................................................................................ 56

Apotex secures Canadian latanoprost litigation victory ................................................................................................... 56

Acorda Therapeutics loses tizanidine litigation ................................................................................................................ 56

CGPA and Apotex lose data protection challenge ........................................................................................................... 56

Apotex loses in olopatadine lawsuit ................................................................................................................................. 57

Pronova BioPharma reaches patent litigation settlement with Apotex ............................................................................ 57

Appellate court upholds budesonide injunction against Apotex ...................................................................................... 58

Mylan to appeal court paroxetine decision ...................................................................................................................... 58

Daiichi Sankyo settles cevimeline patent litigation with Apotex....................................................................................... 59

Aspen Pharmacare.............................................................................................. 60

Introduction ........................................................................................................................................................... 60

Company Details................................................................................................................................................... 60

Products ................................................................................................................................................................ 61

HIV/AIDS drugs ................................................................................................................................................. 61

Tenofovir-based ARVs ..................................................................................................................................................... 62

Efavirenz .......................................................................................................................................................................... 63

Abacavir ........................................................................................................................................................................... 63

South African government ARV tender ............................................................................................................................ 63

Financials .............................................................................................................................................................. 63



Prasco to become US distributor for Aspen branded products ........................................................................................ 64

Aspen acquires Australia's Sigma Pharmaceuticals ........................................................................................................ 64

Aurobindo ............................................................................................................ 66

Introduction ........................................................................................................................................................... 66

Company Details................................................................................................................................................... 66

Products ................................................................................................................................................................ 66

Financials .............................................................................................................................................................. 70

Recent Developments .......................................................................................................................................... 71 Recent Company News ..................................................................................................................................... 71

Aurobindo joins the Medicines Patent Pool ..................................................................................................................... 71

Aurobindo Pharma establishes JV with Russia's Diod .................................................................................................... 71

Aurobindo receives FDA Warning Letter ......................................................................................................................... 72

Aurobindo to divest Chinese subsidiary ........................................................................................................................... 72

Aurobindo enters licensing and supply agreements with AstraZeneca ........................................................................... 73


Takeda settles pioglitazone lawsuits ............................................................................................................................... 73

Rosuvastatin patent upheld in court ................................................................................................................................ 74


iv March 2012


Cipla .................................................................................................................... 75

Introduction ........................................................................................................................................................... 75

Company Details ................................................................................................................................................... 75 Manufacturing facilities ...................................................................................................................................... 75

Products................................................................................................................................................................. 76

Financials .............................................................................................................................................................. 77


Dr Reddy's enters agreements with Cipla for Russia and Ukraine ..................................................................................78


Abbott lopinavir / ritonavir patent rejected in India ...........................................................................................................78

Dr Reddy's Laboratories .................................................................................... 79

Introduction ........................................................................................................................................................... 79

Company Details ................................................................................................................................................... 79

Products................................................................................................................................................................. 80

Financials .............................................................................................................................................................. 82 Segment Data .................................................................................................................................................... 83


Recent Acquisitions............................................................................................................................................ 84

Dr Reddy's and GlaxoSmithKline enter US penicillin facility sale ....................................................................................84


Dr Reddy's and Fujifilm to establish Japanese generic joint venture ..............................................................................84

Dr Reddy's and JBCP enter into, then terminate, Russian prescription business deal ...................................................84

Dr Reddy's Cuernavaca facility received FDA Warning Letter ........................................................................................84

Dr Reddy's affiliate and Valeant form clocortolone collaboration in US ...........................................................................85

Dr Reddy's expands R&D centre in Cambridge ...............................................................................................................85

Dr Reddy's signs agreement with Russia's R-Pharm ......................................................................................................86

Dr Reddy's enters agreements with Cipla, Vitabiotics, for Russia and Ukraine ...............................................................86

Alchemia and Dr Reddy's expand fondaparinux marketing collaboration ........................................................................86


Dr Reddy's settles atorvastatin ANDA litigation with Pfizer .............................................................................................87

Pozen claims win in sumatriptan / naproxen sodium litigation cases ..............................................................................87

AstraZeneca and Pozen file naproxen / esomeprazole patent infringement lawsuit against Dr Reddy's ........................87

Dr Reddy's overturns fexofenadine / pseudoephedrine preliminary injunction ................................................................88

Takeda settles pioglitazone lawsuits ...............................................................................................................................89

Forest / Merz settle memantine litigation .........................................................................................................................90

Egis ...................................................................................................................... 91

Introduction ........................................................................................................................................................... 91

Company Details ................................................................................................................................................... 91

Products................................................................................................................................................................. 92

Financials .............................................................................................................................................................. 93 Regional sales breakdown ................................................................................................................................. 94


March 2012 v


Hungary ........................................................................................................................................................................... 94

Russia and the CIS .......................................................................................................................................................... 94

Central and Eastern Europe ............................................................................................................................................ 94

Western Europe ............................................................................................................................................................... 94


Egis enters collaboration agreement with Celltrion .......................................................................................................... 95

Hospira ................................................................................................................ 96

Introduction ........................................................................................................................................................... 96

Company Details................................................................................................................................................... 96

Project Fuel ....................................................................................................................................................... 97

Shareholders attempt to sue Hospira over Project Fuel .................................................................................................. 97

Manufacturing facilities ...................................................................................................................................... 98

Products ................................................................................................................................................................ 98 Product Development ........................................................................................................................................ 98

Hospira completes Phase I US clinical trial of erythropoietin in renal patients; commences Phase III ........................... 99

Financials ............................................................................................................................................................ 100

Results by region ............................................................................................................................................. 101

Americas ........................................................................................................................................................................ 101

EMEA ............................................................................................................................................................................. 101

APAC ............................................................................................................................................................................. 101

Recent Developments ........................................................................................................................................ 102 Recent Company News ................................................................................................................................... 102

Hospira board authorises US$1 billion share repurchase programme .......................................................................... 102

Impax Laboratories ........................................................................................... 103

Introduction ......................................................................................................................................................... 103

Company Details................................................................................................................................................. 103 Alliance and collaboration agreements ............................................................................................................ 103

Global Division: alliance and collaboration agreements ................................................................................................ 104

Teva Agreement ............................................................................................................................................................ 104

OTC Partner Alliance Agreements ................................................................................................................................ 104

Impax Division: alliance and collaboration agreements ................................................................................................. 105

Products .............................................................................................................................................................. 105

Financials ............................................................................................................................................................ 107 Sales by division .............................................................................................................................................. 107


Impax receives FDA warning letter following Hayward site inspection .......................................................................... 108

Impax enters commercialisation agreement with Banner Pharmacaps ......................................................................... 108

Impax and Perrigo enter development agreement ......................................................................................................... 108

Recent Litigation .............................................................................................................................................. 108

Impax launches fentanyl patent challenge ..................................................................................................................... 108


vi March 2012


Impax and Abbott settle choline fenofibrate patent litigation .........................................................................................109

Impax confirms dutasteride+tamsulosin hydrochloride patent challenge ......................................................................109

Avanir Pharmaceuticals files dextromethorphan+quinidine lawsuits against Actavis, Par, Impax ................................109

Impax and Daiichi Sankyo, Genzyme, reach colesevelam settlement ..........................................................................110

Impax initiates tolterodine tartrate patent challenge ......................................................................................................111

Impax confirms methylphenidate patent challenge ........................................................................................................111

Impax challenges oxycodone patents ............................................................................................................................111

Impax challenges dexlansoprazole patents ...................................................................................................................111

Impax confirms niacin+simvastatin patent challenge ....................................................................................................112

Shire receives guanfacine Paragraph IV notice from Impax; pair clash over Adderall supplies ....................................113

Impax challenges ezetimibe / simvastatin patent ..........................................................................................................114

Impax and Watson challenge sevelamer patents ..........................................................................................................114

Impax and Endo settle oxymorphone litigation ..............................................................................................................115

Krka ....................................................................................................................116

Introduction ......................................................................................................................................................... 116

Company Details ................................................................................................................................................. 116

Krka Group development strategy ................................................................................................................... 116

Krka: key strategies and objectives – to 2014 ...............................................................................................................116

Krka: key strategies – to 2014 .......................................................................................................................................117

Krka: Group business objectives for 2011 .....................................................................................................................117

Products............................................................................................................................................................... 117 Marketing authorisations .................................................................................................................................. 118

Prescription pharmaceuticals ........................................................................................................................... 119

Financials ............................................................................................................................................................ 119

Results by Regions .......................................................................................................................................... 120

Slovenia .........................................................................................................................................................................120

South-Eastern Europe....................................................................................................................................................120

Eastern Europe ..............................................................................................................................................................120

Central Europe ...............................................................................................................................................................121

Western Europe and Overseas Market ..........................................................................................................................121

Product and Service Groups ............................................................................................................................ 122


Krka opens new R&D centre and manufacturing plant ..................................................................................................122

Lannett ...............................................................................................................123

Introduction ......................................................................................................................................................... 123

Company Details ................................................................................................................................................. 123

Products............................................................................................................................................................... 124

Financials ............................................................................................................................................................ 125


Lannett reaches cocaine Special Protocol Assessment agreement with the FDA ........................................................127

Lannett reports positive facilities inspections .................................................................................................................127


March 2012 vii


Lupin .................................................................................................................. 128

Introduction ......................................................................................................................................................... 128

Company Details................................................................................................................................................. 128

Products .............................................................................................................................................................. 129

Financials ............................................................................................................................................................ 131

Recent Developments ........................................................................................................................................ 132

Recent Acquisitions ......................................................................................................................................... 132

Lupin acquires I'rom Pharmaceuticals through Japanese subsidiary ............................................................................ 132

Recent Company News ................................................................................................................................... 132

Eli Lilly and Lupin enter diabetes strategic collaboration ............................................................................................... 132

Lupin and Medicis enter into joint development agreement .......................................................................................... 132

Lupin and Natco join forces to commercialise lapatinib product .................................................................................... 132

Lupin enters licensing agreement with NeuClone ......................................................................................................... 133

Salix expands rifaximin collaboration with Lupin ........................................................................................................... 133

Lupin signs agreement with Brazil's Farmanguinhos .................................................................................................... 133


Shionogi sees success in metformin litigation ............................................................................................................... 134

Lupin and Medicis settle minocycline litigation .............................................................................................................. 134

Flamel files carvedilol lawsuit against Lupin .................................................................................................................. 134

Lupin and Dainippon settle eszopiclone lawsuit ............................................................................................................ 135

Lupin loses levofloxacin patent challenge ..................................................................................................................... 135

Warner Chilcott settles oral contraceptive litigation with Lupin ...................................................................................... 136

Forest / Merz settle memantine litigation ....................................................................................................................... 136

Gilead files ranolazine patent lawsuit against Lupin ...................................................................................................... 136

Mylan .................................................................................................................. 137

Introduction ......................................................................................................................................................... 137

Company Details................................................................................................................................................. 137

Products .............................................................................................................................................................. 138

Financials ............................................................................................................................................................ 144

Segment Data .................................................................................................................................................. 145

Generics Segment ......................................................................................................................................................... 145

Specialty Segment ......................................................................................................................................................... 145



Mylan to acquire Pfizer's respiratory delivery platform .................................................................................................. 146

Mylan acquires Bioniche injectable business ................................................................................................................ 147


Gilead announces new HIV product licensing rights with four Indian firms ................................................................... 147

Bristol-Myers Squibb signs new agreement to expand access to atazanavir in sub-Saharan Africa and India ............ 148

Dey Pharma enters epinephrine deal with Meda ........................................................................................................... 148

Mylan to invest 67 million euros in Hungary .................................................................................................................. 148

Recent Litigation News .................................................................................................................................... 148

Mylan launches oral contraceptive patent challenge ..................................................................................................... 148


viii March 2012


Warner Chilcott sees setback in doxycycline hyclate litigation ......................................................................................149

Mylan and Novartis settle oestradiol litigation ................................................................................................................149

Mylan enters oral contraceptive settlement agreement .................................................................................................150

Mylan announces capecitabine settlement and licence agreement ..............................................................................150

Mylan initiates frovatriptan patent challenge ..................................................................................................................150

Teva gains favourable claim construction rulings in glatiramer patent litigation ............................................................151

Mylan initiates oestradiol transdermal system patent challenge ....................................................................................151

Endo receives lidocaine patch challenge .......................................................................................................................152

Orion files entacapone patent infringement lawsuit against Mylan ................................................................................152

Mylan and Pfizer enter atorvastatin settlements ............................................................................................................153

Mylan confirms prednisolone patent challenge ..............................................................................................................153

Mylan to appeal court paroxetine decision.....................................................................................................................153

Daiichi Sankyo claims court victor against Mylan in olmesartan medoxomil patent litigation........................................154

Forest / Merz settle memantine litigation .......................................................................................................................154

Par Pharmaceutical Companies .......................................................................155

Introduction ......................................................................................................................................................... 155

Company Details ................................................................................................................................................. 155

Products............................................................................................................................................................... 155

Financials ............................................................................................................................................................ 158 Segment Data .................................................................................................................................................. 158


Recent Acquisitions.......................................................................................................................................... 159

Par acquires Anchen Pharmaceuticals ..........................................................................................................................159

Par to acquire Edict Pharmaceuticals ............................................................................................................................160


IntelGenx enters development and commercialisation agreement with Par ..................................................................160

Intellipharmaceutics and Par expand agreement ...........................................................................................................160

Par restructures its branded division ..............................................................................................................................160

Par enters ezetimibe agreement with Glenmark; Glenmark settles litigation with Merck ..............................................161


Par files declaratory judgement to protect right to provide drug information ..................................................................161

Pozen claims win in sumatriptan / naproxen sodium litigation cases ............................................................................161

Par reaches settlement in principle over drug pricing lawsuits ......................................................................................162

Pronova files suits against Par and Teva regarding omega-3-acid ethyl esters ............................................................162

Par challenges mesalamine patents ..............................................................................................................................162

Rosuvastatin patent upheld in court ...............................................................................................................................162

Appellate court upholds tramadol decision in Par's favour ............................................................................................163

Perrigo ................................................................................................................164

Introduction ......................................................................................................................................................... 164

Company Details ................................................................................................................................................. 164

Products............................................................................................................................................................... 166

Financials ............................................................................................................................................................ 168

Segment Sales ................................................................................................................................................. 169


March 2012 ix


Consumer Healthcare .................................................................................................................................................... 169

Nutritionals ..................................................................................................................................................................... 169

Rx Pharmaceuticals ....................................................................................................................................................... 169

API ................................................................................................................................................................................. 169

Recent Developments ........................................................................................................................................ 170 Recent Acquisitions ......................................................................................................................................... 170

Perrigo acquires Paddock Laboratories ......................................................................................................................... 170


Perrigo facility successfully re-inspected ....................................................................................................................... 171

Perrigo acquires OTC fexofenadine / pseudoephedrine rights from Teva ..................................................................... 172


Perrigo challenges testosterone gel patent ................................................................................................................... 172

Perrigo launches olopatadine nasal spray patent challenge ......................................................................................... 172

Perrigo enters fluticasone litigation settlements ............................................................................................................ 172

Perrigo initiates calcipotriene and betamethasone patent challenge............................................................................. 172

Perrigo settles minoxidil foam litigation.......................................................................................................................... 173

Perrigo confirms filing of omeprazole / sodium bicarbonate ANDA, leading to lawsuit ................................................. 173

Perrigo submits butoconazole nitrate ANDA to FDA; KV files suit ................................................................................ 173

Perrigo challenges clobetasol patents ........................................................................................................................... 174

Ranbaxy Laboratories ...................................................................................... 175

Introduction ......................................................................................................................................................... 175

Company Details................................................................................................................................................. 175

Acquisition by Daiichi Sankyo .......................................................................................................................... 175

Products .............................................................................................................................................................. 176

New Drug Discovery research ......................................................................................................................... 176

Pharmaceutical Research (drug products) ...................................................................................................... 177

Chemical Research (active pharmaceutical ingredients) ................................................................................. 177

Antiretrovirals ................................................................................................................................................... 180

Financials ............................................................................................................................................................ 180



Ranbaxy signs consent decree with FDA; document filed in court ................................................................................ 181

Ranbaxy to market Daiichi Sankyo's products in Malaysia ........................................................................................... 182

Ranbaxy extends Daiichi Sankyo's product reach in Italy ............................................................................................. 182

Daiichi Sankyo and Ranbaxy to expand Hybrid Business Model in Mexico .................................................................. 183

Ranbaxy to decommission New York facility ................................................................................................................. 183

Gilead announces new HIV product licensing rights with four Indian firms ................................................................... 183

Daiichi Sankyo to use Ranbaxy's market in Singapore ................................................................................................. 183

Ranbaxy enters MoU with Yaroslavl government .......................................................................................................... 184

Sonke reports success in South African antiretroviral tenders ...................................................................................... 184

Ranbaxy sets up South African manufacturing facility................................................................................................... 184

Daiichi Sankyo to use Ranbaxy to market levofloxacin product in Romania, South Africa ........................................... 184

Ranbaxy's New Drug Discovery Research arm transferred to Daiichi Sankyo.............................................................. 185


x March 2012



Takeda settles pioglitazone lawsuits .............................................................................................................................185

Gedeon Richter ..................................................................................................186

Introduction ......................................................................................................................................................... 186

Company Details ................................................................................................................................................. 186

Products............................................................................................................................................................... 187 Research and development ............................................................................................................................. 187

Female healthcare ........................................................................................................................................... 187

Financials ............................................................................................................................................................ 191

Markets – pharmaceutical segment ................................................................................................................. 191

Hungary..........................................................................................................................................................................192

International sales ..........................................................................................................................................................192

European Union .............................................................................................................................................................193

CIS .................................................................................................................................................................................193

United States .................................................................................................................................................................193

Recent Developments ........................................................................................................................................ 194 Recent Acquisitions.......................................................................................................................................... 194

Gedeon Richter acquires Switzerland's PregLem .........................................................................................................194


Stada and Gedeon Richter enter biosimilars co-operation agreement ..........................................................................194

Gedeon Richter and European Investment Bank sign credit line contract ....................................................................195

Gedeon Richter and Watson enter ulipristal agreement ................................................................................................195

Gedeon Richter signs biosimilars agreement with Mochida Pharmaceutical ................................................................195

Gedeon Richter forms Chinese joint venture .................................................................................................................196

Gedeon Richter acquires Grünenthal's oral contraceptive portfolio ...............................................................................196


Gedeon Richter awarded US$40 million for failed Polpharma bid .................................................................................196

Sandoz ...............................................................................................................198

Introduction ......................................................................................................................................................... 198

Company Details ................................................................................................................................................. 198

Products............................................................................................................................................................... 199 Omnitrope gains new US indications .............................................................................................................................203

Sandoz begins phase II trial for rituximab biosimilar .....................................................................................................204

Sandoz initiates two Phase III biosimilar trials ...............................................................................................................204

Financials ............................................................................................................................................................ 204



EC opens antitrust proceedings against Johnson & Johnson and Sandoz ...................................................................205

Sandoz expands US portfolio to include Alcon ophthalmic generics .............................................................................205

Congress sends letters to firms over 2007/08 contaminated heparin incidents ............................................................205

Sandoz opens new development centre in New Jersey ................................................................................................206



March 2012 xi


Momenta reports enoxaparin preliminary injunction, change in collaboration terms with Sandoz ................................ 206

Astellas files Canadian tacrolimus patent lawsuit against Sandoz ................................................................................ 207

Shire files lisdexamphetamine patent infringement lawsuits ......................................................................................... 207

InSite, Merck & Co and Pfizer file patent litigation against Sandoz over azithromycin filing ......................................... 208

Takeda settles pioglitazone lawsuits ............................................................................................................................. 208

Teva enters litigation against Momenta/Sandoz over generic glatiramer ...................................................................... 209

Sanofi ................................................................................................................. 210

Introduction ......................................................................................................................................................... 210

Company Details................................................................................................................................................. 210 Winthrop Pharmaceuticals ............................................................................................................................... 210

France ............................................................................................................................................................................ 210

Germany ........................................................................................................................................................................ 210

Portugal .......................................................................................................................................................................... 211

United Kingdom ............................................................................................................................................................. 211

Zentiva ............................................................................................................................................................. 211

Slovakofarma ................................................................................................................................................................. 211

Léciva............................................................................................................................................................................. 212

Products .............................................................................................................................................................. 212

Financials ............................................................................................................................................................ 212



All European Sanofi generics to be marketed under Zentiva brand name .................................................................... 213

Zentiva plans to enter the generic respiratory medicines segment ............................................................................... 213

Sawai Pharmaceutical ...................................................................................... 214

Introduction ......................................................................................................................................................... 214

Company Details................................................................................................................................................. 214 Medium-term Business Plan M1 TRUST ......................................................................................................... 214

Products .............................................................................................................................................................. 215 New government supply rules, 2006 ............................................................................................................... 216

Financials ............................................................................................................................................................ 216



Acino and Sawai sign collaboration agreement for Japanese market ........................................................................... 217

Simcere Pharmaceutical ................................................................................... 218

Introduction ......................................................................................................................................................... 218

Company Details................................................................................................................................................. 218

Products .............................................................................................................................................................. 219

Financials ............................................................................................................................................................ 220



Simcere's branded generic diosmectite product passes EU-GMP inspection ............................................................... 221


xii March 2012


Merck/Simcere to establish Chinese JV ........................................................................................................................221

Simcere interest gains Chinese drug approval; Simcere also plans to establish R&D centre .......................................222

Simcere to gain 90% stake in Boda ...............................................................................................................................222


Simcere reaches agreement with former Jiangsu Quanyi shareholders .......................................................................222

Stada Arzneimittel .............................................................................................223

Introduction ......................................................................................................................................................... 223

Company Details ................................................................................................................................................. 223 Build the future ................................................................................................................................................. 223

Products............................................................................................................................................................... 224

Biosimilars ........................................................................................................................................................ 225

Financials ............................................................................................................................................................ 225 Segment Data .................................................................................................................................................. 226

Geographic Segment Data .............................................................................................................................. 227

Germany ........................................................................................................................................................................227

Russia ............................................................................................................................................................................227

Belgium ..........................................................................................................................................................................227

Serbia .............................................................................................................................................................................227

Italy ................................................................................................................................................................................227


Stada to acquire Spirig's generics business ..................................................................................................................229

Stada acquires branded product portfolio from Grünenthal ...........................................................................................229

Stada acquires UK branded product ..............................................................................................................................229


Stada secures 400 million euros of promissory notes ...................................................................................................230

Stada welcomes efforts to stabilise Serbian healthcare market ....................................................................................230

Stada and Gedeon Richter enter biosimilars co-operation agreement ..........................................................................231

Stada gains successes in German tenders ...................................................................................................................231

Sun Pharmaceutical Industries ........................................................................233

Introduction ......................................................................................................................................................... 233

Company Details ................................................................................................................................................. 233

Group Companies ............................................................................................................................................ 233

Caraco Pharmaceutical Laboratories .............................................................................................................................233

Sun Pharmaceutical Industries (SPI) .............................................................................................................................234

Sun Pharmaceutical (Bangladesh) ................................................................................................................................234

Alkaloida Chemical Company Exclusive Group Ltd .......................................................................................................234

Chattem Chemicals ........................................................................................................................................................235

Taro Pharmaceutical Industries .....................................................................................................................................235

Products............................................................................................................................................................... 236

Financials ............................................................................................................................................................ 239



March 2012 xiii



MSD and Sun enter strategic partnership in India ......................................................................................................... 240


Sun receives oxaliplatin blow ......................................................................................................................................... 240

Depomed files metformin ER patent lawsuit against Sun .............................................................................................. 241

Sun sees gemcitabine patent victory against Eli Lilly .................................................................................................... 241

Nycomed and Pfizer see pantoprazole litigation success ............................................................................................. 242


Teva Pharmaceutical Industries ...................................................................... 243

Introduction ......................................................................................................................................................... 243

Company Details................................................................................................................................................. 243 Teva outlines respiratory business growth strategy ....................................................................................................... 244

Organisational structure .................................................................................................................................. 244

Products .............................................................................................................................................................. 245

Pharmaceutical Production .............................................................................................................................. 245

Raw materials for pharmaceutical production.................................................................................................. 246

Research and development ............................................................................................................................. 246

Generic Products ............................................................................................................................................. 246

North America .................................................................................................................................................. 247

Europe ............................................................................................................................................................. 248

International ..................................................................................................................................................... 248

Branded products ............................................................................................................................................... 248

Copaxone ........................................................................................................................................................ 249

Peptimmune files glatiramer Citizen Petition ................................................................................................................. 249

Azilect .............................................................................................................................................................. 250

Biopharmaceuticals and biosimilars ................................................................................................................ 250

Teva plans further study with rituximab biosimilar ......................................................................................................... 251

Financials ............................................................................................................................................................ 255

Geographical breakdown ................................................................................................................................. 255

North America ................................................................................................................................................................ 255

Europe ........................................................................................................................................................................... 256

International Markets ..................................................................................................................................................... 256

Sales by product line ....................................................................................................................................... 256

Generics and Other Products ........................................................................................................................................ 256

Innovative Products ....................................................................................................................................................... 256

Biosimilars ..................................................................................................................................................................... 257

Recent Developments ........................................................................................................................................ 257 Recent Acquisitions ......................................................................................................................................... 257

Acino and Teva sign deal to complete acquisition of Mepha businesses...................................................................... 257

Teva completes Cephalon acquisition ........................................................................................................................... 258

Teva buys out Kowa's stake in Japanese joint venture ................................................................................................. 259

Teva completes acquisition of Taiyo ............................................................................................................................. 259


xiv March 2012


Corporación Infarmasa...................................................................................................................................................259

Laboratoire Théramex ....................................................................................................................................................259

ratiopharm ......................................................................................................................................................................260


Teva announces US$3 billion share repurchase programme ........................................................................................260

Teva announces pricing of US$5 billion of Senior Notes ...............................................................................................261

Teva to construct manufacturing facility in Russia .........................................................................................................261

Teva and Procter & Gamble form consumer healthcare partnership .............................................................................261

APP and Teva enter gemcitabine agreement ................................................................................................................262

Teva enters into US$1.5 billion syndicated credit facility ...............................................................................................262

Teva enters agreement for AMD treatment....................................................................................................................262

Teva opens a new pharmaceutical packaging plant in Hungary ...................................................................................263


The Medicines Company settles bivalirudin patent litigation with Teva .........................................................................263

Teva gains favourable claim construction rulings in glatiramer patent litigation ............................................................263

Pfizer claims sildenafil citrate patent victory against Teva ............................................................................................264

Pronova BioPharma provides litigation update ..............................................................................................................264

Amgen and Teva settle G-CSF patent litigation ............................................................................................................264

Teva and Pfizer battle in UK courts over atorvastatin; reach settlement .......................................................................265

Pfizer settles gabapentin litigation with Teva .................................................................................................................266

Cubist settles daptomycin litigation with Teva ...............................................................................................................266

Watson gains success in oral contraceptive litigation brought by Teva ........................................................................267

Teva loses cinacalcet patent challenge .........................................................................................................................267


Companies issue aripiprazole appeal ............................................................................................................................268

Momenta files enoxaparin litigation against Teva ..........................................................................................................269

Merck claims temozolomide patent lawsuit victory ........................................................................................................269

Nycomed and Pfizer see pantoprazole litigation success ..............................................................................................270

Watson Pharmaceuticals ..................................................................................271

Introduction ......................................................................................................................................................... 271

Company Details ................................................................................................................................................. 271 Watson designates Parsippany, New Jersey, as corporate headquarters ....................................................................271

Arrow ................................................................................................................................................................ 271

Andrx ................................................................................................................................................................ 272

Operations ....................................................................................................................................................... 272

Products............................................................................................................................................................... 273 Generics ........................................................................................................................................................... 274

Brand Products ................................................................................................................................................ 275

Watson suffers setback as FDA advisory committee declines to approve novel progesterone product .......................275

Distribution ....................................................................................................................................................... 275

Financials ............................................................................................................................................................ 278 Segment Results .............................................................................................................................................. 278

Global Generic Segment ................................................................................................................................................279

Global Brand Segment ...................................................................................................................................................279


March 2012 xv


Distribution Segment...................................................................................................................................................... 279



Watson acquires Ascent Pharmahealth ......................................................................................................................... 279

Watson acquires the Greek firm, Specifar Pharmaceuticals ......................................................................................... 280


Amgen and Watson to collaborate on oncology biosimilars .......................................................................................... 281

Watson subsidiary to build new warehouse and distribution facility .............................................................................. 281

Watson and Antares enter into oxybutynin gel product agreement ............................................................................... 281

Watson expands Salt Lake City facility .......................................................................................................................... 282

FTC claims sanofi-aventis, Watson and Synthon failed to report drug patent agreements ........................................... 282

Watson and Natco enter lenalidomide agreement ......................................................................................................... 283

Gedeon Richter and Watson enter ulipristal agreement ................................................................................................ 283

Watson signs authorised generic agreement with Ortho-McNeil-Janssen Pharmaceuticals ........................................ 283

Watson and Moksha8 form marketing partnership for Brazil and Mexico ..................................................................... 284

Watson enters biosimilar product development agreement with Itero ........................................................................... 284

Watson completes acquisition of Crinone/Prochieve and Columbia shares ................................................................. 284


Mylan confirms pioglitazone + metformin patent challenge ........................................................................................... 285

Watson confirms rivastigmine patent challenge ............................................................................................................ 285

Watson claims victory in oral contraceptive litigation .................................................................................................... 286

Watson confirms risedronate patent challenge .............................................................................................................. 286

Noven files methylphenidate litigation ........................................................................................................................... 286

Watson initiates morphine / naltrexone patent challenge .............................................................................................. 287

Watson confirms dutasteride and tamsulosin patent challenge..................................................................................... 287

Watson claims victory in guaifenesin patent battle ........................................................................................................ 288

Shire files lisdexamphetamine patent infringement lawsuits ......................................................................................... 288

Watson confirms dutasteride patent challenge .............................................................................................................. 288

Watson challenges olopatadine patents ........................................................................................................................ 289

Watson initiates sildenafil patent challenge ................................................................................................................... 289

Watson initiates second colesevelam patent challenge ................................................................................................ 289

Watson confirms moxifloxacin hydrochloride patent challenge ..................................................................................... 290

Shire files Adderall patent infringement and breach of contract lawsuit against Watson .............................................. 290

Watson receives blow in fentanyl buccal tablet litigation ............................................................................................... 291

Watson gains success in oral contraceptive litigation brought by Teva ........................................................................ 291

Watson confirms oxycodone challenge ......................................................................................................................... 292

Takeda settles pioglitazone lawsuits ............................................................................................................................. 292

Watson confirms hydromorphone hydrochloride patent challenge ................................................................................ 293

Shire files more guanfacine lawsuits ............................................................................................................................. 293

Watson challenges rosuvastatin patents ....................................................................................................................... 293

Watson confirms rasagiline patent challenge ................................................................................................................ 294

Watson settles oxymorphone litigation with Endo ......................................................................................................... 294

Watson confirms brimonidine tartrate and timolol maleate ophthalmic patent challenge .............................................. 295


Impax and Watson challenge sevelamer patents .......................................................................................................... 295


xvi March 2012


Wockhardt ..........................................................................................................297

Introduction ......................................................................................................................................................... 297

Company Details ................................................................................................................................................. 297

Products............................................................................................................................................................... 299

Financials ............................................................................................................................................................ 301



Wockhardt signs recombinant insulin agreement with Sheffield Bio-Science ...............................................................302


Eli Lilly wins duloxetine patent litigation .........................................................................................................................302


Forest / Merz settle memantine litigation .......................................................................................................................303

Zydus Cadila ......................................................................................................304

Introduction ......................................................................................................................................................... 304

Company Details ................................................................................................................................................. 304

Products............................................................................................................................................................... 305

Financials ............................................................................................................................................................ 307


Zydus Cadila acquires Biochem ....................................................................................................................................308

Zydus acquires KV's generics business ........................................................................................................................308


Microbix and Zydus Cadila reach urokinase agreement for North America...................................................................309

Bayer and Zydus create joint venture in India................................................................................................................309

Zydus Nycomed commissions newly-expanded plant ...................................................................................................310


Mesalamine lawsuit filed against Zydus Cadila .............................................................................................................310

World Leaders in Health Industry Analysis


Volume II: National Markets

The World Generic Market Report 2012, Volume II: National Markets

ISBN: 978 1 85822 441 1

© Copyright 2012 Espicom Business Intelligence Publications Limited

All rights reserved. No part of this publication may be reproduced or used in any form or by any means graphic, electronic or mechanical, including photocopying, recording, taping or storage in information retrieval systems without the express permission of the publisher.

Every care has been taken to ensure that the information contained in this report is correct. The publisher accepts no liability for decisions made on the basis of information contained

British Library Cataloguing in Publication Data.

A catalogue record for this report is available from the British Library.

World Generic Market Report 2012 Vol II: National Markets

March 2012 i © Espicom Business Intelligence

TABLE OF CONTENTS

Overview ................................................................................................................ 1

Population .............................................................................................................................................. 1

GDP per capita ...................................................................................................................................... 2

Health Expenditure ............................................................................................................................... 2

Total Pharmaceutical Expenditure ...................................................................................................... 4

Generic Pharmaceutical Expenditure .................................................................................................. 5

Generic Market Projections ................................................................................................................ 8

Australia .............................................................................................................. 13

Introduction ......................................................................................................................................... 13

Pharmaceutical Market ....................................................................................................................... 14

PBS prescription data ....................................................................................................................... 15

Generic Market .................................................................................................................................... 21

Summary Outlook ............................................................................................................................. 22

Regulation ........................................................................................................................................ 23

International harmonisation ............................................................................................................................................. 23

Intellectual Property .......................................................................................................................... 24

US Free Trade Agreement, Generic Amendments ......................................................................................................... 24

Parliament passes patent springboarding Bill ................................................................................................................. 25

Pricing & reimbursement .................................................................................................................. 25

Therapeutic Group Premiums.......................................................................................................................................... 26

US Free Trade Agreement .............................................................................................................................................. 26

Government announces new pricing measures for newly listed drugs ........................................................................... 27

Government announces further PBS reforms, 2006 ....................................................................................................... 27

Manufacturing ................................................................................................................................... 29

Alphapharm ..................................................................................................................................................................... 29

Apotex (formerly GenRx) ................................................................................................................................................. 29

Arrow Pharmaceuticals Pty .............................................................................................................................................. 29

Ascent Pharmahealth (formerly Genepharm) .................................................................................................................. 30

Aspen Australia ................................................................................................................................................................ 30

Generic Health/Bellwether Pharma ................................................................................................................................. 31

Mayne Pharma (Hospira) ................................................................................................................................................. 31

Ranbaxy Australia ............................................................................................................................................................ 32

Sandoz ............................................................................................................................................................................. 32

Sigma Pharmaceuticals (Australia).................................................................................................................................. 32

Winthrop Pharmaceuticals ............................................................................................................................................... 33

Brazil .................................................................................................................... 35

Introduction ......................................................................................................................................... 35


Generic Market .................................................................................................................................... 37

Size................................................................................................................................................... 37


ii March 2012 © Espicom Business Intelligence

Patent expiries ............................................................................................................................................................ 38

Outlook & Projections ........................................................................................................................ 39

Intellectual Property ........................................................................................................................... 40

Pricing & reimbursement ................................................................................................................... 41

Drug Price Authority ........................................................................................................................................................ 41

Drug Price Readjustments .............................................................................................................................................. 42

Drug Price Control .......................................................................................................................................................... 42

The Tax Substitution System .......................................................................................................................................... 44

REIMBURSEMENT ........................................................................................................................................................ 44

PFPB ............................................................................................................................................................................... 45

Manufacturing .................................................................................................................................... 46

Pró-Genéricos ................................................................................................................................................................. 46

Aché ................................................................................................................................................................................ 47

Cimed .............................................................................................................................................................................. 47

Cristália ........................................................................................................................................................................... 48

EMS Sigma Pharma ....................................................................................................................................................... 48

Eurofarma ....................................................................................................................................................................... 49

Hipolabor ......................................................................................................................................................................... 52

Hypermarcas ................................................................................................................................................................... 53

LAFEPE .......................................................................................................................................................................... 54

Libbs Farmaceutica......................................................................................................................................................... 55

Teuto ............................................................................................................................................................................... 55

União Química ................................................................................................................................................................ 56

Canada ................................................................................................................ 57

Introduction .......................................................................................................................................... 57

Pharmaceutical Market ........................................................................................................................ 58

Generic Market ..................................................................................................................................... 60

Size ................................................................................................................................................... 60

Outlook & Projections ........................................................................................................................ 61

Generics have saved Canadian healthcare system C$26 billion in past five years says CGPA ................................... 62

Ammunition for the CGPA's stance regarding EU trade negotiations ............................................................................ 63

Intellectual Property ........................................................................................................................... 64

Evergreening ................................................................................................................................................................... 65

Canada's Access to Medicine Regime ........................................................................................................................... 66

Pricing & reimbursement ................................................................................................................... 66

Manufacturing .................................................................................................................................... 69

Apotex ............................................................................................................................................................................. 69

Cobalt Pharma ................................................................................................................................................................ 70

Mylan Pharmaceuticals ULC (formely Genpharm) ......................................................................................................... 70

Pharmascience ............................................................................................................................................................... 71

Ranbaxy .......................................................................................................................................................................... 71

Sandoz ............................................................................................................................................................................ 71

Taro Pharm ..................................................................................................................................................................... 71

Teva Canada .................................................................................................................................................................. 72

France ................................................................................................................. 73


March 2012 iii © Espicom Business Intelligence

Introduction ......................................................................................................................................... 73


Generic Market .................................................................................................................................... 75

Size................................................................................................................................................... 75

Outlook & Projections ....................................................................................................................... 78


Supplementary Protection Certificates ............................................................................................................................ 80

Pricing & Reimbursement ................................................................................................................. 80

Pricing .............................................................................................................................................................................. 80

Pricing of Reimbursable Medicines in the Retail Pharmacy Market ............................................................................ 80

Price Revisions ............................................................................................................................................................ 81

Pricing Activity .............................................................................................................................................................. 82

Pharmacy Margins ....................................................................................................................................................... 83

Reference Pricing (TFR) .............................................................................................................................................. 83

Pricing of Hospital Medicines ....................................................................................................................................... 83

Reimbursement ............................................................................................................................................................... 84

Manufacturing ................................................................................................................................... 85

Local Manufacturers & Suppliers ..................................................................................................................................... 86

Arrow Génériques ........................................................................................................................................................ 86

Biogaran ....................................................................................................................................................................... 86

EG-Labo (Stada) .......................................................................................................................................................... 86

Mylan (formerly Merck Génériques) ............................................................................................................................ 86

Ranbaxy ....................................................................................................................................................................... 87

ratiopharm .................................................................................................................................................................... 88

Sandoz ......................................................................................................................................................................... 88

Teva ............................................................................................................................................................................. 89

Winthrop ....................................................................................................................................................................... 89

Wockhardt ........................................................................................................................................................................ 89

Zydus France ............................................................................................................................................................... 90

Germany .............................................................................................................. 91

Introduction ......................................................................................................................................... 91

Pharmaceutical Market ....................................................................................................................... 92 Retail Pharmaceutical Expenditure ................................................................................................................................. 92

GKV Drug Expenditure .................................................................................................................................................... 93

Generic Market .................................................................................................................................... 94

Size................................................................................................................................................... 94

Outlook & Projections ....................................................................................................................... 97


Pricing & Reimbursement ................................................................................................................. 98

Pricing .............................................................................................................................................................................. 98

Reimbursement ............................................................................................................................................................... 98

AOK Negotiates Pharmaceutical Supplier Contracts for 2012-14 ................................................................................... 99

Generic Substitution Policies ........................................................................................................................................... 99


iv March 2012 © Espicom Business Intelligence

Compulsory Manufacturer Rebates .............................................................................................................................. 100

AVWG, 2006 ................................................................................................................................................................. 100

Manufacturing .................................................................................................................................. 100

Accedo Arzneimittel GmbH ........................................................................................................................................... 100

Actavis Deutschland ..................................................................................................................................................... 100

betapharm ..................................................................................................................................................................... 101

CT-Arzneimittel ............................................................................................................................................................. 101

Heumann Pharma Generics/Torrent Pharmaceuticals ................................................................................................. 101

Hexal ............................................................................................................................................................................. 101

Hospira Deutschland GmbH ......................................................................................................................................... 102

Mylan Dura (formerly Merck Dura) ............................................................................................................................... 102

Neuraxpharm ................................................................................................................................................................ 102

Ribosepharm ................................................................................................................................................................. 102

Sandoz .......................................................................................................................................................................... 103

Stada Arzneimittel ......................................................................................................................................................... 103

Teva .............................................................................................................................................................................. 103

Winthrop Arzneimittel .................................................................................................................................................... 103

Italy .................................................................................................................... 105

Introduction ........................................................................................................................................ 105

Pharmaceutical Market ...................................................................................................................... 106

Retail Pharmacy Sales .................................................................................................................... 107

Generic Market ................................................................................................................................... 108

Size ................................................................................................................................................. 108

Outlook & Projections ...................................................................................................................... 110

Intellectual Property ......................................................................................................................... 111

National Supplementary Protection Certificate ............................................................................................................. 111

Pricing & reimbursement ................................................................................................................. 112

Pricing ............................................................................................................................................. 112

Reimbursement ............................................................................................................................... 113

Austerity Budget Measures ........................................................................................................................................... 113

Manufacturing .................................................................................................................................. 114

ASSOGENERICI ........................................................................................................................................................... 115

Local Manufacturers ..................................................................................................................................................... 116

Angenerico ................................................................................................................................................................ 116

DOC Generici ............................................................................................................................................................ 116

Mylan ......................................................................................................................................................................... 116

Sandoz ...................................................................................................................................................................... 116

Stada Arzneimittel ..................................................................................................................................................... 116

Teva Pharma Italia .................................................................................................................................................... 116

Japan ................................................................................................................. 117

Introduction ........................................................................................................................................ 117


Generic Market ................................................................................................................................... 119


March 2012 v © Espicom Business Intelligence

Size................................................................................................................................................. 119

Outlook & Projections ..................................................................................................................... 120

Regulations ..................................................................................................................................... 121

Generic regulation, 2005 ...............................................................................................................................................122

Intellectual Property ........................................................................................................................ 122

Data Exclusivity .............................................................................................................................................................123

Exclusion of Use ............................................................................................................................................................123

Patent term extensions ..................................................................................................................................................123

Pricing & Reimbursement ............................................................................................................... 123

Generic drug pricing ......................................................................................................................................................123

Manufacturing ................................................................................................................................. 124

MHLW Stable Supply Requirements, 2006 ...................................................................................................................124

Actavis ASKA .............................................................................................................................................................125

Daiichi Sankyo Espha ................................................................................................................................................125

Lupin ..........................................................................................................................................................................126

Mylan Seiyaku ............................................................................................................................................................126

Nichi-iko .....................................................................................................................................................................126

Pfizer ..........................................................................................................................................................................126

Sanofi .........................................................................................................................................................................127

Sawai .........................................................................................................................................................................127

Taiyo ..........................................................................................................................................................................127

Teva ...........................................................................................................................................................................127

Towa ..........................................................................................................................................................................127

Russia ................................................................................................................ 129

Introduction ....................................................................................................................................... 129

Pharmaceutical Market ..................................................................................................................... 130 Pharmacy Market ...........................................................................................................................................................130

Hospital Market ..............................................................................................................................................................131

APS Market ....................................................................................................................................................................131

Generic Market .................................................................................................................................. 132

Size................................................................................................................................................. 132




Pricing ............................................................................................................................................................................135

Registration of Maximum Prices ................................................................................................................................136

Price Freezes .............................................................................................................................................................136

List of Vitally Important Drugs for 2011 ......................................................................................................................136

Reimbursement .............................................................................................................................................................137

DLO Budget ...............................................................................................................................................................137

Procurement of Pharmaceuticals for the DLO ...........................................................................................................138

Future of the DLO ......................................................................................................................................................138

Subsidising of Prescription Medicines .......................................................................................................................138


vi March 2012 © Espicom Business Intelligence

Manufacturing .................................................................................................................................. 139

Government Programme for the Development of the Pharmaceutical Industry ........................................................... 140

Trade Associations .......................................................................................................................... 141

AIPM ............................................................................................................................................................................. 141

Manufacturers ................................................................................................................................. 141

Akrikhin ......................................................................................................................................................................... 141

JSC Farmacon .............................................................................................................................................................. 142

KRKA ............................................................................................................................................................................ 142

Pharmstandard ............................................................................................................................................................. 143

Ranbaxy ........................................................................................................................................................................ 143

STADA CIS ................................................................................................................................................................... 143

Teva .............................................................................................................................................................................. 144

Valenta .......................................................................................................................................................................... 144

Veropharm .................................................................................................................................................................... 144

Yugrafarm ..................................................................................................................................................................... 144

Spain ................................................................................................................. 145

Introduction ........................................................................................................................................ 145

Pharmaceutical Market ...................................................................................................................... 146 Pharmacy Sales ............................................................................................................................................................ 148

Generic Market ................................................................................................................................... 150

Size ................................................................................................................................................. 150


Spain rules to prevent biosimilar subsititution............................................................................................................... 152

Regional INN Prescribing.............................................................................................................................................. 152


Pricing & Reimbursement ................................................................................................................ 155

COST-CONTAINMENT MEASURES IMPLEMENTED IN 2011 .................................................................................. 156

Prescription by Active Ingredient .............................................................................................................................. 156

Reference Prices ...................................................................................................................................................... 157

Price Reduction of 15.0% for Generic Medicaments ................................................................................................ 157

Manufacturing .................................................................................................................................. 158

AESEG .......................................................................................................................................................................... 158

Local Manufacturers ........................................................................................................................ 159

Adamed ......................................................................................................................................................................... 160

Alter ............................................................................................................................................................................... 160

Barr ............................................................................................................................................................................... 161

Cantabria Pharma ......................................................................................................................................................... 161

Cinfa .............................................................................................................................................................................. 161

Combino Pharm ............................................................................................................................................................ 161

DOMAC ......................................................................................................................................................................... 162

Dr Reddy’s .................................................................................................................................................................... 162

Kern Pharma ................................................................................................................................................................. 162

Mabo-Farma ................................................................................................................................................................. 162

Mylan (Formerly Merck/Prasfarma) .............................................................................................................................. 163

Normon ......................................................................................................................................................................... 163


March 2012 vii © Espicom Business Intelligence

Pharmagenus ................................................................................................................................................................163

Ranbaxy .........................................................................................................................................................................163

Ratiopharm (now Teva) .................................................................................................................................................163

Sandoz ...........................................................................................................................................................................164

Stada..............................................................................................................................................................................164

Teva ...............................................................................................................................................................................164

Zydus Cadila ..................................................................................................................................................................164

Switzerland ........................................................................................................ 165

Introduction ....................................................................................................................................... 165

Pharmaceutical Market ..................................................................................................................... 165

Generic Market .................................................................................................................................. 166

Size................................................................................................................................................. 166



Pricing & reimbursement ................................................................................................................ 168

Generic pricing ...............................................................................................................................................................169

Generic reimbursement .................................................................................................................................................169

Manufacturing ................................................................................................................................. 169

Intergenerika ..................................................................................................................................................................170

Acino Pharma (formerly Cimex).....................................................................................................................................171

Helvepharm ...................................................................................................................................................................172

Mepha Pharma AG ........................................................................................................................................................172

Sandoz Pharmaceuticals ...............................................................................................................................................172

Spirig ..............................................................................................................................................................................173

Streuli Pharma ...............................................................................................................................................................173

United Kingdom ................................................................................................ 175

Introduction ....................................................................................................................................... 175

Pharmaceutical Market ..................................................................................................................... 176

Market Structure ............................................................................................................................. 176

NHS Prescription Medicines Market ............................................................................................... 177

Generic Market .................................................................................................................................. 179

Size................................................................................................................................................. 179

Generic Prescribing ........................................................................................................................ 179

Outlook & Projections ....................................................................................................................................................182

Regulation ...................................................................................................................................... 183


Supplementary Protection Certificates ..........................................................................................................................183


Pricing ............................................................................................................................................................................183

PPRS Reforms, 2008 ....................................................................................................................................................184

Further reforms on the way ........................................................................................................................................184

Unbranded Generic Pricing ...........................................................................................................................................185

2005 generics reimbursement scheme .........................................................................................................................185


viii March 2012 © Espicom Business Intelligence

Reimbursement ............................................................................................................................................................. 186

Manufacturing .................................................................................................................................. 186

Actavis .......................................................................................................................................................................... 190

Arrow Generics ............................................................................................................................................................. 190

Bristol Laboratories ....................................................................................................................................................... 190

Dexcel Pharma ............................................................................................................................................................. 190

Dr Reddy’s .................................................................................................................................................................... 190

Focus Pharmaceuticals................................................................................................................................................. 190

Generics (UK) – now Mylan .......................................................................................................................................... 191

Genus Pharmaceuticals ................................................................................................................................................ 191

Goldshield Pharmaceuticals ......................................................................................................................................... 191

Kent Pharmaceuticals ................................................................................................................................................... 191

Pliva Pharma (Teva) ..................................................................................................................................................... 191

Ranbaxy ........................................................................................................................................................................ 192

ratiopharm ..................................................................................................................................................................... 192

Rosemont Pharmaceuticals .......................................................................................................................................... 192

Sandoz .......................................................................................................................................................................... 192

Teva Pharmaceuticals .................................................................................................................................................. 192

Winthrop Pharmaceuticals ............................................................................................................................................ 193

Wockhardt ..................................................................................................................................................................... 193

USA .................................................................................................................... 194

Introduction ........................................................................................................................................ 194


President Obama‟s Healthcare Reforms ......................................................................................... 197

Generic Market ................................................................................................................................... 197

Size ................................................................................................................................................. 197



Hatch-Waxman ............................................................................................................................................................. 200

Hatch Waxman reform, 2003 ........................................................................................................................................ 200

Bolar Amendment ......................................................................................................................................................... 201

Biosimilar regulation - BCPIA ....................................................................................................................................... 201

Major Product Approvals ................................................................................................................. 203

Generic Initiative for Value and Efficiency (GIVE) ........................................................................................................ 205

Approvals in 2011 ......................................................................................................................................................... 206

Forthcoming Patent Expiries ......................................................................................................................................... 231

Atorvastatin ............................................................................................................................................................... 231

Clopidogrel ................................................................................................................................................................ 231

Nexium ...................................................................................................................................................................... 232

Pricing & Reimbursement ................................................................................................................ 234

Public Drug Procurement .............................................................................................................................................. 234

Medicaid .................................................................................................................................................................... 234

Average Wholesale Price (AWP) .............................................................................................................................. 235

Medicare ................................................................................................................................................................... 235

H.R.1 (Medicare Prescription Drug, Improvement, and Modernization Act of 2003)................................................ 236


March 2012 ix © Espicom Business Intelligence

State pricing/reimbursement moves ..............................................................................................................................237

Manufacturing ................................................................................................................................. 237

Sources .............................................................................................................. 239

Directory ............................................................................................................ 240

Regulators ...................................................................................................................................... 240

Industry Associations ...................................................................................................................... 241