Top Viewed Report: World generic market report 2013 by marketresearchreports.biz

World Generic Market Report 2013
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 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?
table Of Content
foreword 1
the State Ofthe 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 Issuesin 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 Issuesin 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 Issuesin The Rest Ofthe 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 Litigation .92
aspen Pharmacare .96
introduction .96
company Details .96
products .97
hiv/aids Drugs .97
financials 98
regional Financial Breakdown 98
aurobindo Pharma .101

introduction .101
company Details .101
products .102
financials 105
cipla 109
introduction .109
manufacturing Facilities .109
products 110
financials .112
recent Developments .113
dr Reddy’slaboratories 116
introduction 116
company Details 116
products 117
financials .119
segment Data 120
egis .125
introduction 125
company Details 125
products 126
financials .127
regional Sales Breakdown 128
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 Agreements .135
impax Laboratories 136

introduction 136
company Details 136
alliance And Collaboration Agreements 137
products 139
financials 140
sales By Division 140
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
lannett .155
introduction .155
products .156
financials 158
lupin .161
introduction .161
products .162
financials 164
mylan .168
introduction .168
products .171
financials 178
segment Data 179

par Pharmaceutical Companies .193
introduction .193
products .193
financials 195
segment Data 195
perrigo .202
introduction .202
products .204
financials 207
segment Sales 207
recent Acquisitions 208
recent Company News .209
recent Litigation 209
ranbaxy Laboratories 212
introduction .212
acquisition By Daiichi Sankyo 212
products .213
financials 216
gedeon Richter .222
introduction .222
products .222
research And Development 223
female Healthcare 224
financials 227
markets – Pharmaceutical Segment .228
sandoz .233
introduction .233
products .234
financials 238

sanofi .244
introduction .244
zentiva .244
medley . 245
kendrick 245
products .245
financials 245
sawai Pharmaceutical .247
introduction .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
simcere Pharmaceutical .253
introduction .253
products .254
financials 254
stada Arzneimittel 257
introduction .257
build The Future .257
products .258
biosimilars . 259
financials 259
segment Data .260
geographic Segment Data .261
recent Company News . 263
sun Pharmaceutical Industries .268
introduction .268

group Companies .268
products .271
financials 274
teva Pharmaceutical Industries 278
introduction .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
wockhardt .299
introduction .299
products .300
financials 302
zyduscadila 305
introduction .305
products .306
products Updates For Fy2011/12 .306
financials 308

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Top Viewed Report: World generic market report 2013 by marketresearchreports.biz

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Top Viewed Report: World generic market report 2013 by marketresearchreports.biz