2014

The World Generic Market Report 2012

NEW YORK, Dec. 13, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:



The World Generic Market Report 2012
http://www.reportlinker.com/p0192416/The-World-Generic-Market-Report-2012.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Drug_and_Medication



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 28 leading companies in the field
Flexible formats: Available in pdf or print with web access included in the price. Cost-effective distribution licences can ensure you get the best from your investment
Easily 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 9th 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

Industry collaboration - more and more branded companies are taking an interest in generics - we identify and assess the companies involved
US biosimilar regulatory progress - on the statute book but a long way from the market
Unblocking the US ANDA approval delays - action by the FDA and what it will mean
The EU's anti-competitive investigation: more of the same - what are the issues?
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 2015
Industry Issues | Company Assessments | Market Analysis | Free Web Edition







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

__________________________
Contact Nicolas: nicolasbombourg@reportlinker.com
US: (805)-652-2626
Intl: +1 805-652-2626

 

SOURCE Reportlinker



RELATED LINKS
http://www.reportlinker.com

More by this Source


Custom Packages

Browse our custom packages or build your own to meet your unique communications needs.

Start today.

 

PR Newswire Membership

Fill out a PR Newswire membership form or contact us at (888) 776-0942.

Learn about PR Newswire services

Request more information about PR Newswire products and services or call us at (888) 776-0942.