This new 2 volume, 714-page edition is packed with facts, figures, analysis and statistics, that provides the most thorough analysis available on generic markets, products and companies and the issues they face. The changing face of the generics industryCorporate consolidation continues to change the operating landscape, most notably with the acquisition of Barr Pharma by Teva which has created by far the largest generics company and a major player on the global pharmaceutical stage. Big though the deal may be, it is just one of a number of events which are seeing the rationalisation of the industry. In a separate and interesting company development, Merck & Co has announced the development of a biosimilar division in the US.Is the credit crunch taking its toll'For some generic players, tighter healthcare budgets may prove an opportunity to boost sales. In contrast, those with high debt levels and restricted access to credit may struggle to survive in their current form.Key company, market and product information To understand the generic market, Espicom, the publisher of the respected twice-monthly business publication World Generic Markets, has published The World Generic Market Report 2009. Packed with facts, figures, analysis and statistics, the new 2 volume 714-page edition provides the most thorough analysis available on generic markets, products and companies and the issues they face.Industry consolidation, company survival, new market opportunities, the latest on biosimilars plus much more!Published in January 2009, this report draws on primary research with companies, statistics offices, health ministries and trade associations worldwide and provides standard, comparative data and discussion on key issues such as:Industry consolidation and the emergence of 'super' generic companiesGeneric market growth ' but where'Biosimilars: continued development in Europe but no action in US ' will the new Obama government break the deadlock'Are changes afoot in EU generic regulationKey legal challengesThe political and funding backgroundIntellectual property issuesUnderstand the corporate threats and market opportunities that are shaping this rapidly evolving sector VOLUME I: GLOBAL & COMPANY OVERVIEWIndustry issuesAuthorised genericsIndustry consolidationBiosimilarsAccess to Drugs in Developing CountriesCurrent Issues in the EUWidening Influence of Indian Companies Prospects for Future GrowthCompany profiles coveringFinancial PerformanceANDAs and launched productsM&A activity and litigationCompanies covered- Actavis- Apotex- Aspen Pharmacare- Barr Pharmaceuticals- Cipla- Dr Reddy's Laboratories- Egis- Hospira- Krka- Lannett- Mylan- Par Pharmaceutical Companies- Perrigo- Pliva- Ranbaxy Laboratories- ratiopharm- Gedeon Richter- Sandoz- Sawai Pharmaceutical- Stada Arzneimittel- Teva Pharmaceutical Industries- Towa Pharmaceuticals- Watson Pharmaceuticals- Winthrop Pharmaceuticals- Wockhardt- Zentiva- Zydus Cadila VOLUME II: COUNTRY PROFILESCountry market data coveringInternational OverviewGeneric market value & 5-year forecastPatent protection/IPPricing/reimbursementThe manufacturing sectorMarlets covered- Australia - Brazil - Canada - France - Germany - Italy - Japan- Netherlands- Russia- Spain- Switzerland- UK- USA

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World Generic Market Report 2009
Published on January 2009
Report Summary
This new 2 volume, 714-page edition is packed with facts, figures, analysis and statistics, that provides the most thorough analysis
available on generic markets, products and companies and the issues they face. The changing face of the generics industry
Corporate consolidation continues to change the operating landscape, most notably with the acquisition of Barr Pharma by Teva
which has created by far the largest generics company and a major player on the global pharmaceutical stage. Big though the deal
may be, it is just one of a number of events which are seeing the rationalisation of the industry. In a separate and interesting
company development, Merck & Co has announced the development of a biosimilar division in the US.
Is the credit crunch taking its toll'
For some generic players, tighter healthcare budgets may prove an opportunity to boost sales. In contrast, those with high debt levels
and restricted access to credit may struggle to survive in their current form.
Key company, market and product information
To understand the generic market, Espicom, the publisher of the respected twice-monthly business publication World Generic
Markets, has published The World Generic Market Report 2009. Packed with facts, figures, analysis and statistics, the new 2 volume
714-page edition provides the most thorough analysis available on generic markets, products and companies and the issues they
face.
Industry consolidation, company survival, new market opportunities, the latest on biosimilars plus much more!
Published in January 2009, this report draws on primary research with companies, statistics offices, health ministries and trade
associations worldwide and provides standard, comparative data and discussion on key issues such as:
Industry consolidation and the emergence of 'super' generic companies
Generic market growth ' but where'
Biosimilars: continued development in Europe but no action in US ' will the new Obama government break the deadlock'
Are changes afoot in EU generic regulation
Key legal challenges
The political and funding background
Intellectual property issues
Understand the corporate threats and market opportunities that are shaping this rapidly evolving sector
VOLUME I: GLOBAL & COMPANY OVERVIEW
Industry issues
Authorised generics
World Generic Market Report 2009 Page 1/18

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Industry consolidation
Biosimilars
Access to Drugs in Developing Countries
Current Issues in the EU
Widening Influence of Indian Companies
Prospects for Future Growth
Company profiles covering
Financial Performance
ANDAs and launched products
M&A activity and litigation
Companies covered
- Actavis
- Apotex
- Aspen Pharmacare
- Barr Pharmaceuticals
- Cipla
- Dr Reddy's Laboratories
- Egis
- Hospira
- Krka
- Lannett
- Mylan
- Par Pharmaceutical Companies
- Perrigo
- Pliva
- Ranbaxy Laboratories
- ratiopharm
- Gedeon Richter
- Sandoz
- Sawai Pharmaceutical
- Stada Arzneimittel
- Teva Pharmaceutical Industries
- Towa Pharmaceuticals
- Watson Pharmaceuticals
- Winthrop Pharmaceuticals
- Wockhardt
- Zentiva
- Zydus Cadila
VOLUME II: COUNTRY PROFILES
Country market data covering
International Overview
Generic market value & 5-year forecast
Patent protection/IP
Pricing/reimbursement
The manufacturing sector
Marlets covered
- Australia
- Brazil
- Canada
World Generic Market Report 2009 Page 2/18

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- France
- Germany
- Italy
- Japan
- Netherlands
- Russia
- Spain
- Switzerland
- UK
- USA
Table of Content
FOREWORD ....................xx
Current Issues in the USA 1
Authorised generics ................... 1
FTC investigation 3
FDA issues direct final rule regarding listing of authorised generics....... 4
FTC study finds increase in 'reverse payments'................ 5
Moves in Congress.................. 5
PhRMA responds 6
GPhA responds.. 7
More studies, more arguments. 7
Shared exclusivity. 8
Industry consolidation ...12
Where next in the USA' ........... 14
Where next in Europe' ............. 15
Biosimilars 16
In the USA............ 16
In Europe.............. 17
Elsewhere ............ 18
Market acceptance................... 19
Who will the developers be'.... 19
Access to Generic Drugs in the Developing World: WTO Agreement............20
2003 Agreement .. 20
TRIPS patent ruling on least-developed countries, 2002 ..................... 22
Canada ................. 22
Apotex uses the law ............... 23
Apotex awarded ApoTriavir tender from Rwandan Government .24
European Union .. 24
European Parliament pushes for greater access to generic drugs..... 25
European patent rules streamlined .............. 26
EGA claims WTO compulsory licence system is unworkable............... 26
Thailand ............... 27
World Generic Market Report 2009 Vol I: Company Profiles
Thai government issues further compulsory licences, reaches imatinib deal with Novartis..............34
World Generic Market Report 2009 Page 3/18

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Brazil .....................35
PEPFAR ................37
Current Issues in the European Union .................. 42
European Union Regulatory Reforms Take Effect, November 2005 ....42
Product definition ....................42
Data exclusivity .42
European Commission regulations for paediatric medicines introduced in 2007 ..43
Enlargement of the European Union..............43
Parallel Trade in the enlarged EU...................45
EC publishes preliminary report into competition in the pharmaceutical sector ....46
The widening influence of Indian companies ....... 48
Prospects for Future Growth............ 50
Relative strength of intellectual property laws ................50
Pricing/reimbursement regimes .....................51
Prescriber/patient habits...........53
Major Generic Manufacturers........... 53
Actavis....... 60
Executive Summary..................60
Background..........60
Products ............61
Financials .............63
Major developments ..................64
Actavis to restructure manufacturing operations in Bulgaria..................64
Actavis opens R&D laboratories in Florida....65
Congressional Committee turns attention to Actavis recall....................65
Keri Pharma rebranded as Actavis Hungary .66
Actavis opens new offices, commences branded sales in Italy .............66
Actavis opens Albania office ...66
Mergers, acquisitions and agreements .........67
LPA to distribute Actavis' generic products in Algeria ......67
ASKA Pharmaceutical and Actavis enter alliance and joint venture in Japan.............67
Actavis expands presence in India................67
World Generic Market Report 2009 Vol I: Company Profiles
Actavis formally launches in France............. 67
Actavis signs distribution agreement with J&M Pharma.. 68
Actavis divests Polish products to Glenmark .................. 68
Actavis signs distribution agreement with Generic Health in Australia.. 68
Actavis acquires API manufacturing company in China.. 68
Actavis acquires Italian manufacturing site from Pfizer... 68
Litigation .............. 69
Justice Department seeks permanent injunction against Actavis ......... 69
Endo and Penwest file oxymorphone suit against Actavis .................... 70
Apotex........ 71
Introduction ......... 71
Background......... 71
Products............... 72
Apotex awarded tender from Rwandan Government for ApoTriavir... 75
Apotex to develop biosimilar G-CSF with IBP................. 77
Plavix (clopidogrel) ................... 77
sanofi-aventis and Bristol-Myers Squibb win US clopidogrel court action.................. 78
World Generic Market Report 2009 Page 4/18

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sanofi-aventis wins Canadian clopidogrel patent case against Apotex . 79
Financials............. 79
Cangene............... 79
Major developments ................. 80
Mergers, acquisitions and agreements......... 80
BMP Sunstone launches Ferriprox in China. 80
Apotex acquires Lareq Pharma.................... 80
Topgen ............. 80
Beijing Med-Pharm................ 80
Litigation .............. 81
Apotex prohibited from marketing generic Fortical under Unigene injunction ............ 81
Apotex gains UK damages in perindopril case................ 81
US Federal Court affirms omeprazole ruling 82
Sanofi-aventis sues Apotex over docetaxel . 82
Pfizer enters settlement agreement with Apotex over atorvastatin ....... 82
Apotex loses ketorolac appeal ..................... 82
Meda and Apotex settle azelastine dispute.. 83
Apotex and GSK win pre-emption case........ 83
Pfizer to appeal Federal Court ruling on atorvastatin patent................. 84
World Generic Market Report 2009 Vol I: Company Profiles
AstraZeneca files patent infringement actions in response to rosuvastatin ANDAs ...84
Merck & Co .......84
Abbott................85
Acorda ...............85
Pfizer .................85
Teva Pharmaceutical Industries....................86
Perindopril .........86
Aspen Pharmacare......... 87
Introduction ..........87
Background..........87
Products ...............88
HIV/AIDS drugs .89
Tenofovir-based ARVs ............90
Efavirenz ...........90
South African government ARV tender .........90
PEPFAR............91
Other Antiretrovirals ................91
Financials .............91
Major developments ..................94
Mergers, acquisitions and agreements .........94
Aspen and Matrix end joint venture...............94
Aspen and Strides revise Latin America terms ................94
GSK, Aspen, and Strides Arcolab announce tie-up .........95
Shelys Africa .....96
GSK to sell four products to Aspen...............96
Aspen Australia and Teva enter distribution agreement ..96
Barr Pharmaceuticals..... 97
Introduction ..........97
Background..........97
Products ...............98
World Generic Market Report 2009 Page 5/18

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Duramed's BLA for Ad Type 4 and 7 vaccines accepted by FDA..........99
Financials ...........101
Major developments ................103
Mergers, acquisitions and agreements .......103
Teva to acquire Barr..............103
World Generic Market Report 2009 Vol I: Company Profiles
Barr successfully acquires Pliva................. 105
Litigation ............ 107
Cephalon/Eurand file patent infringement lawsuit against Mylan and Barr over generic Amrix ..... 107
sanofi-aventis settles Nasacort AQ and certain Allegra/Allegra D-12 US patent litigations ........... 108
Barr initiates oxybutynin transdermal system patent challenge .......... 109
Barr confirms patent challenge of Opana ER................ 109
Court of Appeals upholds 1997 Cipro settlement.......... 110
Court favours Barr and Mylan in galantamine case ...... 110
Barr initiates clozapine patent challenge.... 111
Barr enters agreement to settle Aggrenox patent challenge............... 111
Texas AG pursues generic manufacturers over false prices............... 112
Barr challenges cinacalcet patents............. 112
Barr launches levocetirizine challenge....... 112
Barr confirms fentanyl challenge................ 113
Barr receives favourable ruling in Mirapex patent challenge............... 113
Barr challenges patents related to Prevacid SoluTab ... 113
Barr initiates patent challenge relating to AstraZeneca's Entocort EC 114
Bayer appeals invalidity ruling on Yasmin patent.......... 114
Watson launches Seasonique patent challenge ........... 115
Barr challenges dutasteride patent............. 115
Barr to pay states US$6 million in Ovcon settlement .... 115
FTC files complaint against Cephalon charging unlawful blockage of generic modafinil ............... 115
Barr and Ortho to settle contraceptive drug patent litigation............... 116
Forest and Merz file lawsuits for memantine patent infringement....... 116
Barr initiates US oxaliplatin patent challenge................ 116
Encysive files argatroban lawsuit against Barr.............. 117
Barr sues Watson and Sandoz over oral contraceptive 117
Barr initiates dexmethylphenidate patent challenge...... 117
Novartis sues Barr over methylphenidate patent challenge ................ 118
Barr challenges Alcon's olopatadine patents................. 118
Barr and Par settle diazepam patent challenge with Valeant.............. 118
Warner Chilcott sues Barr and Watson over chewable contraceptive. 119
sanofi-aventis commences litigation over alfuzosin ...... 119
Cipla .........120
Introduction ....... 120
Background....... 120
World Generic Market Report 2009 Vol I: Company Profiles
Cipla planning Rs 9,500 million expansion .120
Products .............121
Financials ...........121
Segment Results..................123
Major developments ................124
HIV/AIDS.........124
Thai government in talks with Cipla over antiretroviral ingredients...............124
World Generic Market Report 2009 Page 6/18

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AHF and Cipla quarrel over AIDS drugs prices ...124
Clinton Foundation and UNITAID announce agreements to reduce ARV prices................125
Mergers, acquisitions and agreements .......126
Akorn ...............126
Avesthagen/Cipla acquires Siegfried ..........127
Litigation .............127
Interim Court order favours Cipla over generic Tarceva 127
Dr Reddy's Laboratories..................128
Introduction ........128
Background........128
Dr Reddy's launches US Specialty Business .................129
Products .............130
Financials ...........131
Segment Data .....132
Branded Formulations..........132
Active Pharmaceutical Ingredients and Intermediates ...133
Generics..........134
Custom Pharmaceutical Services (CPS).....134
Major developments ................135
Mergers, acquisitions & agreements ...........135
Dr Reddy's makes dermatology product advances........135
TMH/Dr Reddy's sign agreement to create self-injectable product......136
Dr Reddy's and Albemarle sign ibuprofen API deal .......136
Aquapharm signs new agreement and extends R&D licence with Dr Reddy's .........137
Dr Reddy's to buy BASF contract manufacturing operations ...............137
Dowpharma's UK Small Molecules business sold to Dr Reddy's.........137
Dr Reddy's acquires Jet Generici................137
7TM/Dr Reddy's enter drug-discovery collaboration ......138
Dr Reddy's/SkyePharma collaborate on feasibility study .....................138
Sygnis .............138
World Generic Market Report 2009 Vol I: Company Profiles
Argenta Discovery............... 138
Ceragenix....... 139
Litigation ............ 139
Teva and Dr Reddy's settle carvedilol suit . 139
AstraZeneca sues Dr Reddy's over generic zafirlukast. 139
US court affirms that Eisai's Aciphex patent is valid and enforceable. 139
Dr Reddy's and Novartis settle rivastigmine litigation.... 140
Forest and Merz file additional lawsuit for Namenda patent infringement................ 140
Moxifloxacin.... 140
Levetiracetam. 141
Sertraline action ................... 141
Egis .......... 142
Introduction ....... 142
Background....... 142
Products............. 142
Financials........... 143
Major developments ............... 145
Mergers, acquisitions and agreements....... 145
Egis and Gedeon Richter divest Medimpex .................. 145
World Generic Market Report 2009 Page 7/18

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Serdix ............. 145
Hospira .... 146
Introduction ....... 146
Background....... 146
Manufacturing facilities .......... 147
Products............. 148
Product Development ............. 148
Financials........... 150
Segment Results................. 151
Segment Data ......151
Major Developments ............... 153
Mergers, acquisitions and agreements....... 153
HGS to manufacture biopharmaceuticals for Hospira... 153
Altea and Hospira enter deal for transdermal product... 153
Hospira agrees further contract with HealthTrust.......... 153
Hospira to distribute Orexo's Rapinyl in Asia Pacific..... 153
World Generic Market Report 2009 Vol I: Company Profiles
Mayne Pharma154
KRKA........156
Introduction ........156
Background........156
Key strategic objectives and strategies to 2012.............157
Products .............157
Financials ...........158
Results by Regions ...............159
Slovenia159
South-Eastern Europe....................159
Eastern Europe........160
Central Europe.........160
Western Europe and Overseas Market...............160
Product and Service Groups .162
Major developments ................164
Mergers, acquisitions and agreements .......164
Krka acquires Alternova AT ..164
Krka purchases shares in Zhejiang and Anhui...............164
TAD Pharma GmbH..............164
Facilities .............165
Macedonia.......165
Slovenia ..........165
Krka opens new chemical development laboratories.................165
Krka completes the construction of a new injection plant ..........165
Sinteza 4..................165
Litigation .............166
Eli Lilly .............166
Merck Frosst Canada ............166
Lannett .....167
Introduction ........167
Background........167
Products .............167
Financial .............169
World Generic Market Report 2009 Page 8/18

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Major developments ................170
Lannett to enter pain management market .170
Litigation .............170
Lannett files lawsuit against KV ..................170
World Generic Market Report 2009 Vol I: Company Profiles
Mylan........ 171
Introduction ....... 171
Background....... 171
Mylan to retain Dey subsidiary ................... 173
Products............. 174
Mylan and Matrix ANDA Approvals ............ 175
Merck Generics subsidiary ANDA Approvals ................ 177
Financials........... 178
Segment Data. 179
Geographic Information........ 180
Sales by Therapy ................. 181
Major developments ............... 181
Mylan downsizes Puerto Rico facility ......... 181
Mergers, acquisitions and agreements....... 181
Mylan signs OC agreement with Famy Care................. 181
Forest Laboratories .............. 182
Merck Generics .................... 182
Litigation ............ 184
US Federal Court upholds decision in favour of Takeda in Actos patent case ........ 184
Mylan/Novartis enter agreement to settle Femara patent challenge... 184
Cephalon/Eurand file patent infringement lawsuit against Mylan and Barr over generic Amrix ..... 184
Court favours Barr and Mylan in galantamine case ...... 185
Daiichi Sankyo sues Matrix for Azor patent infringement.................... 185
FTC files complaint against Cephalon charging unlawful blockage of generic modafinil ............... 186
Forest and Merz file second suit against memantine challengers....... 186
Mylan to appeal latest lorazepam and clorazepate ruling................... 187
AstraZeneca files patent infringement actions in response to rosuvastatin ANDAs. 187
Mylan and GSK settle generic Paxil dispute ................. 188
UCB settles levetiracetam patent litigation. 188
Par Pharmaceuticals..... 189
Introduction ....... 189
Background....... 189
Par resizes generic unit........ 190
Products............. 190
Financial............. 193
World Generic Market Report 2009 Vol I: Company Profiles
Segment Data .193
Major Developments...............195
Mergers, acquisitions and agreements .......195
MonoSolRx licenses thin film formulation of ondansetron to Strativa ..195
Par acquires Spectrum's interest in sumatriptan injection....................196
Litigation .............196
Santarus makes gains against Par in Markman hearing196
Texas AG pursues generic manufacturers over false prices ...............197
AstraZeneca files patent infringement actions in response to rosuvastatin ANDAs .197
World Generic Market Report 2009 Page 9/18

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Federal Circuit affirms invalidity of Par's megestrol patents ................198
Barr and Par settle diazepam patent challenge with Valeant...............198
Santarus commences Zegerid patent litigation against Par .................198
Perrigo......200
Introduction ........200
Background........200
Products .............201
Financials ...........203
Segment Sales204
Consumer Healthcare....................204
Rx Pharmaceuticals.205
API ........205
Other.....205
Major developments ................206
Perrigo to expand operations in Michigan ...206
Mergers, acquisitions and agreements .......206
Perrigo acquires Unico Holdings.................206
Perrigo licenses dermatologicals to Medimetriks...........207
Perrigo acquires Mexico's Laboratorios Diba.................207
Perrigo acquires exclusive US rights to generic levocetirizine.............207
Perrigo purchases JB Laboratories.............207
NeutraHealth purchases Perrigo UK...........207
Perrigo collaborates with Cobrek for generic topical products .............208
Perrigo acquires Galpharm Healthcare .......208
Litigation .............208
Perrigo dismissed from miconazole patent litigation ......208
Perrigo files ANDA for generic Vanos; Medicis files suit209
World Generic Market Report 2009 Vol I: Company Profiles
Pliva .........210
Introduction ....... 210
Background....... 210
Pliva delists from London Stock Exchange 211
Products............. 212
Biosimilars ...... 212
Financials........... 213
Geographical Data ............... 214
Major developments ............... 215
Mergers, acquisitions and agreements....... 215
Pliva divests Spanish operations................ 215
Pliva divests Italian operations to Biomedica................ 215
Pliva to acquire ORCApharm ..................... 216
Barr successfully acquires Pliva................. 216
Litigation ............ 218
California court rules branded firms can be liable for generics ........... 218
Barr confirms patent challenge regarding UCB's Xyzal. 219
Ranbaxy... 220
Introduction ....... 220
Background....... 220
Ranbaxy to be acquired by Daiichi Sankyo 226
Products............. 226
World Generic Market Report 2009 Page 10/18

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Antiretrovirals . 229
Financials........... 230
Results by Geography.......... 230
North America ..........230
European Union.......231
UK.........231
Germany ..................231
France ...231
Romania231
India......231
Asia Pacific ..............231
Results by Therapy .............. 232
Major developments ............... 232
FDA issues Warning Letters, blocks imports from two Ranbaxy facilities................ 232
Congressional Committee expands Ranbaxy probe to include PEPFAR programme ................... 234
World Generic Market Report 2009 Vol I: Company Profiles
Daiichi acquires Ranbaxy......235
Ranbaxy launches business operation in Yemen ..........236
Ranbaxy clears NDDR de-merger...............237
Mergers, acquisitions and agreements .......237
Ranbaxy to market Gliadel for gliomas in India..............237
Cipher / Ranbaxy enter agreement for CIP-Isoptretinoin acne treatment .................237
Ranbaxy/Merck enter anti-infective drug-discovery and -development collaboration.....................238
Ranbaxy and Orchid enter long-term strategic alliance .238
Ranbaxy/DBT collaborate to develop TB therapeutics ..238
Ranbaxy increases Zenotech stake ............238
Litigation .............239
Danish Court upholds two atorvastatin patents..............239
Ranbaxy, Goldshield win SFO cases..........239
Ranbaxy comes under fire from US Justice Department .....................240
Pfizer and Ranbaxy settle majority of worldwide atorvastatin litigations ...................240
AstraZeneca settles esomeprazole patent litigation with Ranbaxy; enters further agreements......241
Forest and Merz file second suit against memantine challengers .......242
Ranbaxy settles possible litigation with GSK over sumatriptan ...........242
Ranbaxy, Astellas and Boehringer resolve tamsulosin US patent litigation..............242
Novartis sues Ranbaxy over valsartan........243
ratiopharm244
Introduction ........244
Background........244
BioGeneriX......245
Merckle Biotec.245
Merckle............246
PulmoTec ........246
ratiopharm direct ...................246
Products .............246
BioGeneriX/Neose initiate Phase II trial for GlycoPEG-GCSF.............246
Financials ...........247
Major developments ................248
Death of Adolf Merckle ..........248
Mergers, acquisitions and agreements .......248
World Generic Market Report 2009 Page 11/18

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Neose sells assets to Novo Nordisk and BioGeneriX as first step in liquidation.......248
Litigation .............249
World Generic Market Report 2009 Vol I: Company Profiles
sanofi-aventis to appeal German generic clopidogrel marketing authorisations ...... 249
Gedeon Richter ............. 250
Introduction ....... 250
Background....... 250
Products............. 251
Financials........... 253
Markets........... 254
Hungary 254
Exports ........... 255
CIS........255
EU.........256
USA and Other Countries ..............256
Products ......... 257
Major developments ............... 258
Mergers, acquisitions and agreements....... 258
Gedeon Richter licenses DSM/Crucell's PER.C6 cell line................... 258
Richter to build biopharmaceutical plant in Debrecen... 259
Polpharma...... 259
Akrihin ............ 260
Pharmafarm.... 260
Egis and Gedeon Richter divest Medimpex .................. 260
Litigation ............ 261
Gedeon Richter and Merck settle alendronate lawsuit.. 261
Sandoz .....262
Introduction ....... 262
Background....... 262
Production Facilities ............. 263
Sandoz Canada to invest C$80 million in Boucherville facilities ..................263
Products............. 264
Major New Products Launched in 2007...... 264
Financials........... 269
Lek.................. 270
Major developments ............... 270
WHO issues Notice of Concern to Sandoz South Africa..................... 270
FDA sends Sandoz warning letter over metoprolol ....... 271
Mergers, Acquisitions and Agreements...... 271
World Generic Market Report 2009 Vol I: Company Profiles
Sandoz enters into LNK cetirizine agreement ................271
Sandoz discloses link-up with Vectura on generic asthma drugs ........271
Sandoz and Gambro form strategic alliance ..................272
Sandoz receives not approvable letter for enoxaparin ...272
Litigation .............273
Teva to file lawsuit against Momenta/Sandoz over generic glatiramer 273
Summary judgement granted for Seroquel patent litigation.................273
Wyeth sues Sandoz over pantoprazole ......274
Abbot sues Zydus and Sandoz over divalproex.............274
AstraZeneca files patent infringement actions in response to rosuvastatin ANDAs .274
World Generic Market Report 2009 Page 12/18

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Barr sues Watson and Sandoz over oral contraceptive .275
Spanish Appellate Court upholds atorvastatin patent ....275
Atomoxetine patent litigations launched......275
Sawai Pharmaceutical...276
Introduction ........276
Background........276
Products .............276
Leading Sawai Generics, 2002-07...................277
New government supply rules, 2006...........277
Heparin calcium, flutazolam, biperiden hydrochloride....278
Synthetic penicillin................278
Financials ...........278
Major developments ................279
Mergers, acquisitions and agreements .......279
Towa, Sawai and Nichi-iko sign agreement for stable supply of generic products ...279
Medisa Shinyaku..................280
Nihon Schering's Mobara factory ................280
Litigation .............280
Eisai's lawsuit against manufacturers/distributors of generic Selbex dismissed .......280
Stada Arzneimittel .........281
Introduction ........281
Background........281
Teva 'in talks' to buy Stada' ....................Error! Bookmark not defined.
Products .............282
Refusal of marketing approval confirmed by CHMP for Stada's fentanyl patches....283
World Generic Market Report 2009 Vol I: Company Profiles
Financial............. 283
Segment Data. 284
Segment Results, 2005 - 2007 ..285
Stada's top-five APIs, 2007........286
Geographic Segment Data... 286
Major developments ............... 288
Stada opens Vietnam plant with EU approval ............... 288
Stada restructures its sales division........... 288
Stada confirms product deal with German insurer ........ 289
Mergers, acquisitions and agreements....... 289
Eisai China signs licence agreement for Alpha-Lipon 300 Stada........ 289
Stada to acquire Forum Bioscience ........... 289
Litigation ............ 289
Court favours Stada over Merck in losartan case ......... 289
Teva Pharmaceutical Industries .....290
Introduction ....... 290
Background....... 290
Products............. 292
Antares/Teva file sNDA for needlefree injector for HGH product ........ 293
Financials........... 299
Pharmaceutical Sales........... 299
North America ..........299
Europe ..300
International .............300
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Animal Health...........300
Innovative Products .300
Specialty Products ...301
Active Pharmaceutical Ingredients Sales ............301
Major developments ............... 302
Mergers, acquisitions and agreements....... 302
Jexys enters R&D collaboration with Teva. 302
Indevus/Teva enter deal to develop pagoclone for stuttering.............. 302
Teva to acquire Barr............. 303
Teva and Kowa form strategic partnership to dominate Japanese generic market . 304
Teva and Proteologics extend anticancer collaboration 305
Consortium acquires Teva's controlling stake in IVAX Diagnostics .... 305
Teva to market CEL-SCI's Multikine in Israel and Turkey ................... 305
Teva signs agreement for Capricorn's Korkoat technology platform... 306
World Generic Market Report 2009 Vol I: Company Profiles
Teva acquires Bentley Pharmaceuticals .....306
Czech expansion..................307
Irish expansion307
Hungarian expansion ............307
CoGenesys acquisition .........307
UCB.................308
UK expansion..308
Litigation .............308
Gilead files emtricitabine patent infringement lawsuit against Teva.....308
Teva loses lansoprazole litigation ...............309
California court rules branded firms can be liable for generics ............309
sanofi-aventis settles Nasacort AQ and certain Allegra/Allegra D-12 US patent litigations ............310
Appeals court rules against Teva in generic Prevacid litigation ...........311
Teva gains budesonide approval, flurry of activity results....................311
Appellate court reverses generic risperidone exclusivity decision .......312
Teva and Dr Reddy's settle carvedilol suit ..313
Appeals Court favours Eisai in rabeprazole judgement .313
FDA review of generic Copaxone prompts lawsuit from Teva .............314
Summary judgement granted for Seroquel patent litigation .................314
Enoxaparin......314
Escitalopram (UK) .................314
Brussels court revokes MSD's European alendronate patent..............315
Depomed enters deal to settle patent litigation against IVAX ..............315
Quetiapine.......315
Celecoxib ........315
Solvay subsidiaries file fenofibrate suits against Teva...316
Forest and Merz file lawsuits for memantine patent infringement........316
AstraZeneca files patent infringement actions in response to rosuvastatin ANDAs .316
Pfizer's quinapril patent upheld...................317
Teva finalises adenosine settlement with Astellas, King and Item.......317
Teva wins Appeal Court ruling concerning cyclosporine317
GlaxoSmithKline and Teva settle rosiglitazone suit .......317
Novartis' famciclovir motion denied; Teva recommences sales...........318
Teva sues Apotex over carvedilol ...............318
Appeals court favours Pfizer over Teva in gabapentin case................318
World Generic Market Report 2009 Page 14/18

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Dr Reddy's and Teva settle sertraline action .................318
Roche files complaint over Teva's ibandronate .............319
World Generic Market Report 2009 Vol I: Company Profiles
Court favours Teva/Sun in pantoprazole motion........... 319
Appeals court upholds escitalopram decision ............... 319
Towa Pharmaceutical ...320
Introduction ....... 320
Background....... 320
Products............. 320
Financials........... 321
Major developments ............... 321
Mergers and Agreements ....... 321
Towa, Sawai and Nichi-iko reach supply agreement..... 321
Japanese Generic companies form agreement for stable generic supply ............... 322
Litigation ............ 322
Eisai's lawsuit against manufacturers/distributors of generic Selbex dismissed ...... 322
Watson Pharmaceuticals................. 323
Introduction ....... 323
Background....... 323
Andrx .............. 323
Products............. 324
Generics......... 324
Brand Products.................... 325
Distribution ..... 325
Financials........... 327
Segment Results................. 327
Generics segment....328
Brand segment.........328
Distribution segment 328
Major developments ............... 329
Mergers, acquisitions and agreements....... 329
Watson to acquire products related to Teva's proposed acquisition of Barr ............ 329
Mylan buys out Watson's Somerset Pharma stake....... 329
Watson to distribute generic Fosamax Tablets under agreement with Merck.......... 330
Recordati licenses European rights to Kentera from Watson.............. 330
Litigation ............ 330
Watson enters lawsuit with Barr over Oxytrol system ... 330
Barr initiates oxybutynin transdermal system patent challenge .......... 331
Watson loses naproxen patent dispute ...... 331
World Generic Market Report 2009 Vol I: Company Profiles
Texas AG pursues generic manufacturers over false prices ...............332
Cephalon files patent infringement lawsuit against Watson over generic Fentora....332
Watson files ANDA for generic Yasmin; Bayer seeks to halt launch ...332
Watson challenges Lybrel patent ................333
Duramed sues Watson for Seasonique patent infringement................333
Barr sues Watson and Sandoz over oral contraceptive .333
Biovail and Watson reach settlement agreement regarding diltiazem .334
Bayer sues Watson over drosperinone and ethinyloestradiol ANDA ...334
Warner Chilcott files lawsuit against Watson for infringement of Femcon Fe patent 334
Winthrop Pharmaceuticals ..............335
World Generic Market Report 2009 Page 15/18

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Introduction ........335
Background........335
France .............336
Germany .........337
Portugal ...........337
United Kingdom....................337
Products .............338
Financials ...........338
Wockhardt339
Introduction ........339
Background........339
Products .............340
Financials ...........342
Sales by Region...................343
Major developments ................344
Wockhardt to restructure its R&D business 344
Mergers, acquisitions and agreements .......344
Sinclair Pharma....................344
IDC and Wockhardt co-develop insulin pens for Indian market ...........344
Morton Grove ..345
Litigation .............345
Orion comments on Wockhardt's carbidopa / entacapone / levodopa ANDA...........345
Forest and Merz file lawsuits for memantine patent infringement........346
Orion files lawsuit against Wockhardt to enforce entacapone patents.346
Zentiva......347
World Generic Market Report 2009 Vol I: Company Profiles
Introduction ....... 347
Background....... 347
Products............. 349
Financials........... 349
Sales by segment................ 350
Prescription Pharmaceutical Products................350
Consumer Healthcare (
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