The World Generic Market Report 2012

NEW YORK, May 29, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

The World Generic Market Report 2012

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Generics, Pharmaceuticals, Healthcare

A complete global analysis of the prospects for markets and companies in this dynamic industry sector

Features and benefits of this thoroughly-researched and highly-regarded management report:

High quality: Original research, novel 5-year market forecasts and informed commentary from our experienced editors are allied with unrivalled primary source data Global coverage: Covers leading economies as well as key emerging markets such as Russia and Brazil Issue driven: Understand the latest company, product, and regulatory developments Company Focus: Who's working with whom? Who's suing whom? Who's up, who's down? Detailed and frank appraisals of 27 leading companies in the field Flexible formats: Available in pdf or print with Espicom Interactive access included in the price. Cost-effective distribution licences can ensure you get the best from your investmentEasily understand the threats and opportunities that are shaping this rapidly evolving sector!

Industry consolidation, new market opportunities, the latest on biosimilars plus much, much more! This leading report, now in its 10th year of publication, draws on primary research with companies, statistics offices, health ministries and trade associations worldwide and provides standard, comparative data and discussion on key issues. This extensive data set is interpreted and evaluated by the editors to provide a complete and compelling review of the whole sector.

Key facts, issues and questions What branded companies are taking an interest in generics – we identify and assess the latest developments

What has Teva been up to in Japan in 2011?

Biosimilars get ever closer – latest regulatory data update

Which Mediterranean country might expect a generic sector average growth rate of 14.8% a year to 2016?

The political, regulatory and funding background in key markets

What pricing and production issue must generic companies overcome in Brazil?

Low market penetration of generics makes Italy an attractive proposition for generic manufacturers but what are the challenges?

How generic companies are faring in the recession

Who is involved in the latest legal challenges and litigation?

The generic sector is fast growing, driven by demand for cost-effective medicines and new availability of high value products

World Generics per capita spend (US$) forecast to 2016

Industry Issues If the branded pharmaceutical industry was facing a patent cliff it is now teetering on the edge of it. Ironically, it is the world's best selling drug, Lipitor, which exemplifies the trend. Despite still having patent protection, Pfizer has been unable to stem the tide of interest and pressure from a number of companies, Ranbaxy being chief amongst them. Despite pressure on prices in many markets, the generic sector continues to thrive with increased sales across the board in 2011. The maturity of the sector can also be seen in the size of the businesses: there are now 17 generic companies with revenues in excess of US$1 billion, 5 more than in 2008/09.

Company Assessments

Consolidation and collaboration continues to be the game plan for many in the sector. The rationalisation of the industry continues, but it is driven by different motivations. Certainly Teva's acquisition of ratiopharm was of the traditional model of adding market and value, but the 2011 acquistion of Cephalon is altogether more interesting as it supports Teva's long term movement to the development of branded drugs. But adding capability is equally important. Watson's acquisition of Arrow group also provided a stake in Eden Biodesign which gives the company a platform for the biosimilars market.

Market Analysis The generic market is experiencing two opposing trends driven by the global downturn. On one hand, the use of generics is increasing due to their cost-effectiveness and adoption has accelerated in markets where branded prescribing was dominant. On the other hand, the squeeze on government spending has not left generics untouched with many countries lowering generic prices through cuts in reimbursement rates or contract tendering with a resultant squeeze on margins.

All customers get the practical power of Espicom Interactive and at no additional cost! The interactive web-based version of The World Generic Market Report will rapidly identify the information you are looking for.

More Information...VOLUME I: COMPANY PROFILESIndustry IssuesIndustry consolidationThe impact of the economic downturnRegulation & confusion in the USAEuropean generic opportunitiesProgress with biosimilarsProspects for growth in key markets

Extensive company profiles covering

Financial performance

ANDAs and launched products

M&A activity and litigation

Companies coveredActavisApotexAspen PharmacareAurobindoCiplaDr Reddy's LaboratoriesEgisHospiraImpax LaboratoriesKrkaLannettLupinMylanPar Pharmaceutical CompaniesPerrigoRanbaxy LaboratoriesGedeon RichterSandozSanofiSawai PharmaceuticalsSimcere PharmaceuticalsStada ArzneimittelSun Pharmaceutical IndustriesTeva Pharmaceutical IndustriesWatson PharmaceuticalsWockhardtZydus Cadila

VOLUME II: COUNTRY PROFILES

Country market data covering

Key facts

Generic market value & 5-year forecast

SWOT analysis of each market

Patent protection/IP Issues

Pricing/reimbursement

The manufacturing sector

Markets coveredAustralia Brazil Canada France Germany Italy JapanRussiaSpainSwitzerlandUKUSA

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

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 others47

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

Recent Company News . 55

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

Recent Litigation 56

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

Recent Developments 64

Recent Company News . 64

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

Recent Litigation 73

Takeda settles pioglitazone lawsuits . 73

Rosuvastatin patent upheld in court .. 74

Cipla .. 75

Introduction .. 75

Company Details 75

Manufacturing facilities .. 75

Products.. 76

Financials .. 77

Recent Developments 78

Recent Company News . 78

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

Recent Litigation 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 Developments 84

Recent Acquisitions.. 84

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

Recent Company News . 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

Recent Litigation 87

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

Hungary 94

Russia and the CIS . 94

Central and Eastern Europe .. 94

Western Europe 94

Recent Developments 95

Recent Company News . 95

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

Recent Developments . 108

Recent Company News .. 108

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

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

Recent Developments . 122

Recent Company News .. 122

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

Lannett 123

Introduction 123

Company Details . 123

Products 124

Financials 125

Recent Developments . 127

Recent Company News .. 127

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

Lannett reports positive facilities inspections ..127

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

Recent Litigation . 134

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

Recent Developments . 146

Recent Acquisitions .. 146

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

Mylan acquires Bioniche injectable business . 147

Recent Company News .. 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

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 decision153

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 Developments . 159

Recent Acquisitions 159

Par acquires Anchen Pharmaceuticals ..159

Par to acquire Edict Pharmaceuticals .160

Recent Company News .. 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

Recent Litigation News 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

Consumer Healthcare . 169

Nutritionals 169

Rx Pharmaceuticals . 169

API 169

Recent Developments . 170

Recent Acquisitions .. 170

Perrigo acquires Paddock Laboratories . 170

Recent Company News .. 171

Perrigo facility successfully re-inspected .. 171

Perrigo acquires OTC fexofenadine / pseudoephedrine rights from Teva 172

Recent Litigation News 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

Recent Developments . 181

Recent Company News .. 181

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

Recent Litigation . 185

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

Recent Company News .. 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

Recent Litigation . 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

Recent Developments . 205

Recent Company News .. 205

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

Recent Litigation . 206

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

Recent Developments . 213

Recent Company News .. 213

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

Recent Developments . 217

Recent Company News .. 217

Acino and Sawai sign collaboration agreement for Japanese market 217

Simcere Pharmaceutical .. 218

Introduction 218

Company Details. 218

Products .. 219

Financials 220

Recent Developments . 221

Recent Company News .. 221

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

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

Recent Litigation . 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

Recent Developments . 229

Recent Acquisitions 229

Stada to acquire Spirig's generics business 229

Stada acquires branded product portfolio from Grünenthal .229

Stada acquires UK branded product 229

Recent Company News .. 230

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

Recent Developments . 240

Recent Company News .. 240

MSD and Sun enter strategic partnership in India 240

Recent Litigation News 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

Forest / Merz settle memantine litigation .. 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 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

Corporación Infarmasa259

Laboratoire Théramex .259

ratiopharm .260

Recent Company News .. 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

Recent Litigation . 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

Takeda settles pioglitazone lawsuits ..268

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

Distribution Segment 279

Recent Developments . 279

Recent Acquisitions .. 279

Watson acquires Ascent Pharmahealth . 279

Watson acquires the Greek firm, Specifar Pharmaceuticals .. 280

Recent Company News .. 281

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

Recent Litigation News 285

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

Forest / Merz settle memantine litigation .. 295

Impax and Watson challenge sevelamer patents . 295

Wockhardt .297

Introduction 297

Company Details . 297

Products 299

Financials 301

Recent Developments . 302

Recent Company News .. 302

Wockhardt signs recombinant insulin agreement with Sheffield Bio-Science 302

Recent Litigation News 302

Eli Lilly wins duloxetine patent litigation .302

Takeda settles pioglitazone lawsuits ..303

Forest / Merz settle memantine litigation ..303

Zydus Cadila 304

Introduction 304

Company Details . 304

Products 305

Financials 307

Recent Developments . 308

Recent Acquisitions 308

Zydus Cadila acquires Biochem 308

Zydus acquires KV's generics business 308

Recent Company News .. 309

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

Recent Litigation News 310

Mesalamine lawsuit filed against Zydus Cadila .310

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

Pharmaceutical Market .. 36

Generic Market 37

Size 37

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

Introduction .. 73

Pharmaceutical Market .. 74

Generic Market 75

Size 75

Outlook & Projections .. 78

Intellectual Property .. 80

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

Intellectual Property .. 98

Pricing & Reimbursement .. 98

Pricing 98

Reimbursement 98

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

Generic Substitution Policies . 99

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 <br

To order this report:Drug and Medication Industry: The World Generic Market Report 2012

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Industry Analysis and Insights

Nicolas Bombourg
Reportlinker
Email: nbo@reportlinker.com
US: (805)652-2626
Intl: +1 805-652-2626

SOURCE Reportlinker



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