The World Generic Market Report 2013 (Volume 1 & 2)

Published: June 2013
No. of Pages: 492
   

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

  • High quality research and forecasts: Independent research, combined with detailed 5-year forecasts, informed commentary and unrivalled primary source data will aid your business planning and decision-making process
  • Global coverage - with 74 country markets profiles: Scope opportunities for new investment or sales growth, with detailed historical data and forecasts on the leading developed economies as well as key emerging markets from Africa, the Americas, Asia, Emerging Europe, and the Middle East
  • Issue driven: Understand the latest company, product, and regulatory developments
  • Company Insight - with the 26 leading companies reviewed: Who’s working with whom? Who’s suing whom? Who’s up, who’s down? Assess the activities, strategies and market position of your competitors, partners and clients
  • Flexible formats: Available in pdf format with online access included in the price. Cost-effective distribution licences can ensure you get the best from your investment
  • Biosimilars: Coverage of the fast developing biosimilars market

Easily understand the threats and opportunities that are shaping this rapidly evolving sector!

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 2012. The maturity of the sector can also be seen in the size of the businesses: there are now 18 generic companies with revenues in excess of US$1,000 million, 6 more than in 2008/09.

Company Assessments

In recent years there has been a trend towards consolidation, both within the generics industry itself, and between the generics industry and the branded industry. This has been a trend born of necessity, reflecting both the difficult economic environment and the slowdown in development of innovative drugs. Without doubt, the most important and largest acquisition to have taken place over the last year has been the merger between Watson Pharmaceuticals and Actavis. The merger has created a company with revenues for the year ended 31st December 2012 of just over US$5.9 billion.

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.

Industry consolidation, new market opportunities, the latest on biosimilars plus much, much more!

This leading report, now in its 11th 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

  • Which branded companies are taking an increased interest in the dynamic generics market?
  • How are generics companies faring in the recession?
  • Which companies are involved in the latest legal challenges and litigation?
  • Biosimilars get ever closer – what are the latest regulatory updates?
  • Which country markets have experienced the largest growth in 2012 and which are forecast to be the fastest growers?
  • Negative perceptions of generic drug quality – which markets are most exposed?
  • Pricing pressures – which markets are facing the greatest pressures on pricing from the government?
  • State support for local production – which markets are set to benefit from increased government support?

The interactive web-based version of The World Generic Market Report will rapidly identify the information you are looking for.

  • Export data and charts for inclusion in presentations
  • Address all questions across the product in your library
  • Share access with colleagues near and far with a flexible and cost-effective distribution licence

The World Generic Market Report 2013 (Volume 1 & 2)

Table of Contents

Foreword 1

The State of the Industry 2
Generic Consolidations, Mergers and Acquisitions 2
Generic and Branded Acquisitions and Agreements 4
The branded industry’s ‘patent cliff’ 6

Major Generic Manufacturers 7

Biosimilars 11
In the USA 11
Another option: file a full BLA ? 11
The development of a US biosimilar pathway 12
The BCPIA 13
Implementation of the BCPIA 13
FDA guidance documents published 15
Innovators make their case to the FDA 16
Biosimilar User Fee Programme 18
Virginia passes biosimilar legislation 18
GPhA: Grant Thornton study shows need for biosimilar competition 20
In Europe 21
EMA Guideline Documents 21
EMA to accept biosimilar reference medicines from outside the EEA 22
Sandoz: new study shows biosimilars can save EU healthcare systems up to 33 billion euros by 2020 23
Elsewhere 24

Current Issues in the USA 25
Authorised generics 25
FDA issues direct final rule regarding listing of authorised generics 26
Pay for delay agreements 27
Shared exclusivity 27
GDUFA 31
Drug shortages 32
Generic drug labelling 33
Study finds majority of generics’ warning labels differ from branded equivalents 34

Current Issues in the European Union 36
EC releases final report into pharmaceutical sector 36
Monitoring of patent settlements 37
EC Statement of Objections 38
European Parliament votes in favour of European unitary patent 42
EU committee votes on Transparency Directive 42
Free Trade Agreements 43

Current Issues in the Rest of the World 44
The WTO and access to generics 44
TRIPS patent ruling on least-developed countries, 2002 44
2003 Agreement 44
US PEPFAR Programme 47
The Medicines Patent Pool 49
Patent Laws 50
India 50

Companies 53

Actavis 53
Introduction 53
Company Details 53
Watson Pharmaceuticals 53
Actavis Group 54
Acquisition and merger 54
Operations – Watson Pharmaceuticals 55
Operations – Actavis 56
Products 57
Generics 57
Brand Products 58
Distribution 59
Financials 63
Segment Results 64
Recent Developments 65
Recent Acquisitions 65
Recent Company News 66
Recent Litigation News 71

Apotex 86
Introduction 86
Company Details 86
Products 86
ApoTriavir 90
Financials 91
Recent Developments 91
Recent Company News 91
Recent Litigation 92

Aspen Pharmacare 96
Introduction 96
Company Details 96
Products 97
HIV/AIDS drugs 97
Financials 98
Regional Financial Breakdown 98
Recent Developments 99
Recent Company News 99

Aurobindo Pharma 101
Introduction 101
Company Details 101
Products 102
Financials 105
Recent Developments 106
Recent Company News 106
Recent Litigation 107

Cipla 109
Introduction 109
Company Details 109
Manufacturing facilities 109
Products 110
Financials 112
Recent Developments 113
Recent Company News 113
Recent Litigation 114

Dr Reddy’s Laboratories 116
Introduction 116
Company Details 116
Products 117
Financials 119
Segment Data 120
Recent Developments 121
Recent Acquisitions 121
Recent Company News 121
Recent Litigation 123

Egis 125
Introduction 125
Company Details 125
Products 126
Financials 127
Regional sales breakdown 128
Recent Developments 129
Recent Litigation 129

Hospira 130
Introduction 130
Company Details 130
Project Fuel 130
Manufacturing facilities 131
Products 131
Product Development 131
Financials 133
Results by region 134
Recent Developments 135
Recent Agreements 135
Recent Company News 135

Impax Laboratories 136
Introduction 136
Company Details 136
Alliance and collaboration agreements 137
Products 139
Financials 140
Sales by division 140
Recent Developments 141
Recent Company News 141
Recent Litigation 142

KRKA 147
Introduction 147
Company Details 147
Krka Group development strategy 147
Products 148
Marketing authorisations 150
Prescription pharmaceuticals 150
Financials 150
Results by Regions 151
Product and Service Groups 153
Recent Developments 154
Recent Company News 154

Lannett 155
Introduction 155
Company Details 155
Products 156
Financials 158
Recent Developments 159
Recent Company News 159
Recent Litigation News 160

Lupin 161
Introduction 161
Company Details 161
Products 162
Financials 164
Recent Developments 165
Recent Acquisitions 165
Recent Company News 165
Recent Litigation 166

Mylan 168
Introduction 168
Company Details 168
Products 171
Financials 178
Segment Data 179
Recent Developments 180
Recent Acquisitions 180
Recent Company News 181
Recent Litigation News 183

PAR  Pharmaceutical Companies 193
Introduction 193
Company Details 193
Products 193
Financials 195
Segment Data 195
Recent Developments 196
Recent Acquisitions 196
Recent Company News 197
Recent Agreements 198
Recent Litigation News 199

Perrigo 202
Introduction 202
Company Details 202
Products 204
Financials 207
Segment Sales 207
Recent Developments 208
Recent Acquisitions 208
Recent Company News 209
Recent Litigation 209

Ranbaxy Laboratories 212
Introduction 212
Company Details 212
Acquisition by Daiichi Sankyo 212
Products 213
Financials 216
Recent Developments 217
Recent Company News 217

Gedeon Richter 222
Introduction 222
Company Details 222
Products 222
Research and development 223
Female healthcare 224
Financials 227
Markets – pharmaceutical segment 228
Recent Developments 231
Recent Company News 231
Recent Agreements 231
Recent Litigation 232

Sandoz 233
Introduction 233
Company Details 233
Products 234
Financials 238
Recent Developments 239
Recent Acquisitions 239
Recent Company News 240
Recent Litigation 241

Sanofi 244
Introduction 244
Company Details 244
Zentiva 244
Medley 245
Kendrick 245
Products 245
Financials 245
Recent Developments 246
Recent Company News 246

Sawai Pharmaceutical 247
Introduction 247
Company Details 247
Medium-term Business Plan M1 TRUST 247
M1 TRUST 2015 248
Sawai reviews Japanese generic drug market 248
Products 248
New government supply rules, 2006 250
Financials 251
Recent Developments 252
Recent Company News 252

Simcere Pharmaceutical 253
Introduction 253
Company Details 253
Products 254
Financials 254
Recent Developments 255
Recent Company News 255
Recent Litigation 256

Stada Arzneimittel 257
Introduction 257
Company Details 257
Build the future 257
Products 258
Biosimilars 259
Financials 259
Segment Data 260
Geographic Segment Data 261
Recent Developments 262
Recent Acquisitions 262
Recent Company News 263

Sun Pharmaceutical Industries 268
Introduction 268
Company Details 268
Group Companies 268
Products 271
Financials 274
Recent Developments 275
Recent Company News 275
Recent Litigation News 276

Teva Pharmaceutical Industries 278
Introduction 278
Company Details 278
Business strategy 278
Organisational structure 279
Products 280
Pharmaceutical Production 280
Raw materials for pharmaceutical production 281
Research and development 281
Generic Products 281
United States 282
Europe 282
Rest of the World 282
Branded products 283
Copaxone 283
Azilect 283
Biosimilars 284
Financials 288
Geographical breakdown 288
Recent Developments 290
Recent Acquisitions 290
Recent Company News 292
Recent Litigation 293

Wockhardt 299
Introduction 299
Company Details 299
Products 300
Financials 302
Recent Developments 304
Recent Company News 304
Recent Litigation 304

Zydus Cadila 305
Introduction 305
Company Details 305
Products 306
Products updates for FY2011/12 306
Financials 308
Recent Developments 309
Recent Acquisitions 309
Recent Company News 309
Recent Litigation News 310

List of Tables

Fiscal Year Results, Listed by Sales 9
Fiscal Year Results for the last Five Years, Listed by Sales 10
EU-Approved Biosimilars, 2006-12 21
Major Shared Exclusivities, 2009-12 28
Least-Developed Countries 44
Members and dates of acceptance 46
Actavis: owned properties 56
Actavis: leased properties 57
Actavis: selected generic product portfolio, 2012 58
Actavis: selected brand product portfolio, 2012 58
Watson ANDA Approvals, January 2002 – December 2012 59
Actavis, ANDA Approvals January 2006 – December 2012 62
Actavis: fiscal year results, in US$ millions 63
Actavis: sales by region, in US$ millions 64
Actavis: sales by therapy area, in US$ millions 64
Actavis: product sales by segment, in US$ millions 65
Apotex ANDA Approvals, January 2002 – December 2012 87
Aspen Pharmacare Group at a glance 96
Aspen Pharmacare: fiscal year results, in R millions 98
Aspen Pharmacare: fiscal year results, in US$ millions 98
Aurobindo: regulatory filings as at 31st March 2012 102
Aurobindo ANDA Approvals, January 2002 - December 2012 102
Aurobindo: standalone fiscal year results, in Rs millions 105
Aurobindo: standalone fiscal year results, in US$ millions 105
Aurobindo: consolidated fiscal year results, in Rs millions 106
Aurobindo: consolidated fiscal year results, in US$ millions 106
Cipla ANDA Approvals, January 2002 – December 2012 111
Cipla: fiscal year results to 31st March in Rs millions 112
Cipla: fiscal year results to 31st March in US$ millions 113
Dr Reddy’s ANDA Approvals, January 2002 – December 2012 117
Dr Reddy’s Laboratories: Consolidated Fiscal Year Results, in Rs millions 120
Dr Reddy’s Laboratories: Consolidated Fiscal Year Results, in US$ millions 120
Dr Reddy’s Laboratories: Consolidated Fiscal Year Segment Results, in Rs millions 121
Dr Reddy’s Laboratories: Consolidated Fiscal Year Results, in US$ millions 121
Egis: Sales of Pharmaceuticals by Therapy, in HUF millions 126
Egis: Sales of Pharmaceuticals by Therapy, in US$ millions 126
Egis: Leading Product Lines, 2011/12, in HUF millions and US$ millions 126
Egis ANDA approvals, January 2002 – December 2012 126
Egis: Fiscal Year Results, in HUF millions 127
Egis: Fiscal Year Results, in US$ millions 127
Egis: Fiscal Year Regional Sales Breakdown, in HUF millions 128
Egis: Fiscal Year Regional Sales Breakdown, in US$ millions 128
Hospira ANDA Approvals January 2004 – December 2012 132
Hospira: consolidated full year results, fiscal years ended 31st December, in US$ millions 133
Hospira: results by region, fiscal years ended 31st December, in US$ millions 134
Impax Laboratories ANDA Approvals, January 2002 – December 2012 139
Impax Laboratories: consolidated fiscal year results, in US$000s 140
Impax Laboratories: consolidated sales by division, in US$000s 141
Krka Group: number of Marketing Authorisations by region, 2007 – 2011 150
Krka Group: fiscal year results, in EUR 000s 150
Krka Group: fiscal year results, in US$000s 151
Krka Group: fiscal year results by region, in EUR 000s 152
Krka Group: fiscal year results by region, in US$000s 153
Krka Group: fiscal year results by product and service group, in EUR 000s 153
Krka Group: fiscal year results by product and service group, in US$000s 153
Lannett ANDA Approvals, January 2002 – December 2012 157
Lannett: Fiscal Year Results, in US$000s 158
Lannett: Fiscal Year Results by Therapy Area, in US$000s 159
Lannett: Fiscal Year Sales by Customer Category, in US$ millions 159
Lupin ANDA Approvals, January 2002 – December 2012 162
Lupin: Consolidated Fiscal Year Results, in Rs millions 164
Lupin: Consolidated Fiscal Year Results, in US$ millions 164
Mylan: global properties 169
Mylan: product sales by therapeutic category, in US$000s 172
Mylan ANDA Approvals, January 2002 – December 2012 173
Matrix Laboratories ANDA Approvals, January 2002 – December 2012 177
Bioniche Pharma ANDA Approvals, January 2002 – December 2012 177
Mylan: fiscal year results, in US$ millions 179
Mylan: fiscal year results by region, in US$000s 179
Mylan: segment results, in US$000s 180
Featured Products 193
Par Pharmaceutical ANDA Approvals, January 2002 – December 2012 194
Par Pharmaceutical Companies: Fiscal Year Results, in US$000s 195
Par Pharmaceutical Companies: Fiscal Year Results by Segment, in US$000s 195
Par Pharmaceutical Companies: Top Selling Products, in US$000s 196
Perrigo ANDA approvals, January 2002 – December 2012 206
Perrigo: Fiscal Year Results, in US$000s 207
Perrigo: Results by Division, in US$000s 208
Ranbaxy Laboratories: day one generic product launches in 2012 213
Ranbaxy Laboratories: leading branded products in 2012 214
Ranbaxy Laboratories: leading therapies in generic and branded markets in 2012 214
Ranbaxy ANDA Approvals, January 2002 –December 2012 214
Ohm Laboratories ANDA Approvals, January 2002 – December 2012 216
Ranbaxy Laboratories: consolidated fiscal year results, in Rs millions 217
Ranbaxy Laboratories: consolidated fiscal year results, in US$ millions 217
Gedeon Richter: main licensing partners, 2011 223
Gedeon Richter: main gynaecological products, 2011 224
Gedeon Richter: top ten products, in HUF millions 225
Gedeon Richter: top ten products in Hungary, in HUF millions 225
Gedeon Richter: own-developed compounds launched during 2011 226
Gedeon Richter: Licensed-in products launched during 2011 226
Gedeon Richter ANDA approvals, January 2002 – December 2012 226
Gedeon Richter: consolidated fiscal year results, in HUF millions 227
Gedeon Richter: consolidated fiscal year results, in US$ millions 227
Gedeon Richter: consolidated pharmaceutical segment results, in HUF millions 228
Gedeon Richter: consolidated pharmaceutical segment results, in US$ millions 228
Gedeon Richter: sales to top ten international markets, in Euro millions (Gedeon Richter figures) 230
Gedeon Richter: sales to top ten international markets, in US$ millions (Espicom figures) 230
Sandoz ANDA Approvals, January 2002 – December 2012 234
Sandoz: full year results, fiscal years ended 31st December, in US$ millions 238
Sawai Pharmaceutical: new products listed in November 2010 to June 2011 249
Sawai Pharmaceutical: new products listed in November 2011 to June 2012 249
Sawai Pharmaceutical: major products 250
Sawai Pharmaceutical: sales by therapeutic category, FY2011 250
Sawai Pharmaceutical: Fiscal Year Results, in ¥ millions 251
Sawai Pharmaceutical: Fiscal Year Results, in US$ millions 251
Simcere Pharmaceutical: Fiscal Year Results, in RMB000s 255
Simcere Pharmaceutical: Fiscal Year Results, in US$000s 255
Stada Arzneimittel: top five API sales in 2011, in EUR millions and US$ millions 258
Stada Arzneimittel: number of product launches per year 259
Stada Arzneimittel: fiscal year results, in EUR millions 260
Stada Arzneimittel: fiscal year results, in US$ millions 260
Stada Arzneimittel: fiscal year results by segment, in EUR millions 260
Stada Arzneimittel: fiscal year results by segment in US$ millions 260
Stada Arzneimittel: selected geographic segment data, in EUR millions 261
Stada Arzneimittel: selected geographic segment data, in US$ millions 262
Sun Pharmaceutical Industries ANDA Approvals, February 2006 - December 2012 272
Taro Pharmaceutical Industries ANDA Approvals, February 2010 - December 2012 274
Sun Pharmaceutical Industries: Consolidated Fiscal Year Results, in Rs millions 274
Sun Pharmaceutical Industries: Consolidated Fiscal Year Results, in US$ millions 274
Sun Pharmaceutical Industries: Consolidated Fiscal Year Results by Segment, in Rs millions and US$ millions 275
Teva Pharmaceutical Industries: principal operating subsidiaries 279
Teva Pharmaceutical Industries: principal pharmaceutical manufacturing facilities 281
Teva Pharmaceutical Industries: generics launched in the US, 2011 282
Teva ANDA Approvals January 2006 – December 2012 284
Barr Laboratories ANDA Approvals, January 2008 – December 2012 287
Pliva, Pliva Hrvatska and Pliva Lachema ANDA Approvals, January 2006 – December 2012 288
Teva Pharmaceutical Industries: fiscal year results, in US$ millions 288
Teva Pharmaceutical Industries: sales by geographical areas, in US$ millions 289
Wockhardt subsidiaries 299
Wockhardt ANDA Approvals, January 2002 – December 2012 301
Wockhardt: consolidated fiscal year results, in Rs millions 302
Wockhardt: consolidated fiscal year results, in US$ millions 303
Wockhardt: Consolidated Fiscal Year Results by Region, in Rs millions 303
Wockhardt: Consolidated Fiscal Year Results by Region, in US$ millions 303
Zydus Pharmaceuticals USA ANDA Approvals, January 2002 – December 2012 307
Zydus Cadila, consolidated fiscal year results, in Rs millions 308
Zydus Cadila, consolidated fiscal year results, in US$ millions 308

Published By: Espicom Limited
Product Code: Espicom Limited1416


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