Hospital Injectable Drugs: Future Prospects for Generics & Biosimilars (Volume I and II)

• Publication date: July 2011

The generic injectables sector exceeds US$11.2 billion and numerous high-value injectable products will face patent expiry in major markets over the next decade. This critical new report evaluates the markets, players and products in detail. As companies seek new ways to gain a competitive edge in maturing generics markets, injectables have become increasingly desirable to the major players. Companies like Teva, Sandoz, Mylan, Hospira and ...

The generic injectables sector exceeds US$11.2 billion and numerous high-value injectable products will face patent expiry in major markets over the next decade. This critical new report evaluates the markets, players and products in detail.

As companies seek new ways to gain a competitive edge in maturing generics markets, injectables have become increasingly desirable to the major players. Companies like Teva, Sandoz, Mylan, Hospira and Hikma have all increased their presence in the injectables sector through acquisitions in the last couple of years. And interest has not been limited to established generic companies, as pharmaceutical majors like Pfizer have also become attracted to the generic injectables market.

High risks, high reward
This is hardly surprising with a global injectables market in the region of US$120 billion. While the lion’s share remains with the innovative industry for the time being, the generic injectables sector already exceeds US$11.2 billion and numerous high-value injectable products will face patent expiry in major markets over the next decade. But, many of the big sellers are biological products and biosimilar approvals will only be possible for a few companies. Gaining regulatory approval in developed markets is more complex for biosimilars. For companies who are able to navigate the approval process, the sector for biosimilars is inherently different to the traditional generics market. Market acceptance remains a big challenge and the take-up of biosimilars in Europe has been relatively slow. Not only will companies need to convince healthcare providers that biosimilar drugs are as good as the originator products, they will also have to compete with the originator companies who are unlikely to exit the market as they may previously have done when faced with a flood of bioequivalent generics.

Is a biosimilar market inevitable?
The fact remains that the generic drugs sector must either respond vigorously or rely on a diminishing number of non-biological products. Progress to developing a biosimilar market to date has been patchy and slow, and few competitive therapies are beyond early-stage research. But accessing the fast-growing hospital market will be essential. Health payers, the branded industry and investment community will all be watching developments closely.

A complete analysis packed with market facts,
product forecasts to 2016 and detailed company evaluations



About the author: The report has been researched and written by Espicom’s Senior Pharmaceuticals Analyst, Karen Holmes. Karen has over 15 years pharmaceutical and healthcare market analysis experience. Her recent studies include Injectable Generic Drugs: Prospects and Opportunities, Emerging Opportunities in Inhalation and Nasal Spray Generic Drugs, and Ophthalmology Drug Futures.

Generic Drug Industry in the United States

FOREWORD ........... 1
EXECUTIVE SUMMARY ... 3
OVERVIEW ..... 4
INJECTABLE DRUGS MARKET........... 4
European Markets ....... 6
Biosimilars Approved in the EU ......... 7
Austria .. 8
Belgium ...... 8
Denmark. 9
France ... 11
Germany ... 11
Italy ...... 12
Netherlands .. 14
Spain 5
Sweden. 16
Switzerland 7
United Kingdom .. 17
US Market ....... 21
MAJOR COMPETITORS ..................... 23
CANCER .................... 27
HORMONAL THERAPIES ............... 27
Faslodex (fulvestrant)...... 27
Mode of Action ......................... 27
Approvals ....................................... 27
Lifecycle Development 28
Competition within the Marketplace ................. 28
Patents.............................. 29
Generic Company Activity ....................... 29
Market Outlook.............. 29
Zoladex (goserelin)... 31
Mode of Action............... 31
Approvals......................... 31
Competition within the Marketplace.. 32
Breast Cancer......32
Prostate Cancer..33
Patents.............................. 33
Generic Company Activity..... 33
Market Outlook ....... 34
CHEMOTHERAPY 36
Eloxatin (oxaliplatin)................................................ 37
Mode of Action.............. 37
Approvals......................... 37
Competition within the Marketplace.... 37
Patents.............................. 38
Generic Company Activity............ 38
The ‘874 Patent Litigation: At Risk Launches and Subsequent Withdrawals ....... 38
Europe.................. 40
Market Outlook.............. 41
Taxotere (docetaxel) .............. 42
Mode of Action.............. 42
Approvals........................... 42
Competition within the Marketplace ..... 43
Patents ................................. 43
Generic Company Activity ........ 44
Europe ............................ 44
US .................................... 46
Market Outlook.............. 46
Abraxane (paclitaxel protein-bound particles for injectable suspension; albumin-bound) .............. 48
Mode of Action ............................ 48
Approvals ........................... 48
Lifecycle Development 48
Competition within the Marketplace ................. 49
Patents .............................. 49
Market Outlook .............. 50
Alimta (pemetrexed) .....51
Mode of Action .............. 51
Approvals ......................... 51
Lifecycle Development 52
Competition within the Marketplace ...................................... 52
Patents .............................. 52
Generic Company Activity ..................................................... 52
Market Outlook .............. 53
Velcade (bortezomib) ....................................... 54
Mode of Action .............. 54
Approvals ......................... 54
Lifecycle Development 55
Competition within the Marketplace .............. 55
Patents .............................. 55
Generic Company Activity .................... 56
Market Outlook .............. 56
MONOCLONAL ANTIBODIES .........58
Rituxan/MabThera (rituximab) ............. 58
Mode of Action ............... 58
Approvals ......................... 59
Lifecycle Development 60
Competition within the Marketplace ....................... 60
Patents .............................. 61
Biosimilar Activity .......... 61
Market Outlook.............. 61
Herceptin (trastuzumab) ...... 63
Mode of Action ............... 63
Approvals ......................... 63
Lifecycle Development 64
Competition within the Marketplace .............. 64
Breast Cancer ......64
Gastric Cancer .....65
Patents .............................. 65
Biosimilar Activity .......... 65
Market Outlook .............. 65
Avastin (bevacizumab) ............................................... 67
Mode of Action ............... 67
Approvals ......................... 67
Lifecycle Development 68
Competition within the Marketplace .............................. 69
Patents .............................. 69
Biosimilar Potential ....... 69
Market Outlook .............. 69
Erbitux (cetuximab) ..................... 71
Mode of Action ............... 71
Approvals ......................... 71
Lifecycle Development 71
Competition within the Marketplace ..................................... 72
Patents .............................. 72
Biosimilar Activity .......... 72
Market Outlook .............. 72
SUPPORTIVE THERAPIES.............................. 74
G-CSF ............ 74
Neupogen (filgrastim) ................ 74
Mode of Action .............. 74
Approvals ......................... 75
Competition within the Marketplace ............ 75
Patents .............................. 76
Biosimilar Activity ......... 76
EU .......................... 76
US .......................... 77
Market Outlook .............. 78
Neulasta (pegfilgrastim) ........................ 79
Mode of Action .............. 79
Approvals ......................... 79
Competition within the Marketplace .............. 80
Patents .............................. 80
Biosimilar Activity ......... 80
Market Outlook .............. 80
HAEMATOLOGY ........................ 82
ERYTHROPOIETIN 82
Epogen/Eprex (epoetin alfa) .... 83
Mode of Action .............. 83
Approvals ......................... 83
Competition within the Marketplace .......... 83
Patents .............................. 84
Biosimilar Epoetin ......... 84
EU .......................... 84
US .......................... 85
Market Outlook .............. 86
Aranesp (darbepoetin alfa) ................ 87
Mode of Action .............. 87
Approvals ......................... 87
Lifecycle Development 87
Competition within the Marketplace .......... 88
Patents .............................. 88
Biosimilar Development 88
Market Outlook .............. 89
NeoRecormon (epoetin beta) ...... 90
Mode of Action .............. 90
Approvals ......................... 90
Competition within the Marketplace ........................ 91
Market Outlook .............. 91
Mircera (methoxy polyethylene glycol-epoetin beta) ............................. 92
Mode of Action ............... 92
Approvals Competition within the Marketplace .......................... 92
Market Outlook .............. 92
THROMBOSIS .... 94
Lovenox/Clexane (enoxaparin) ......... 94
Mode of Action ......................... 94
Approvals ...................................... 94
Competition within the Marketplace ........... 95
Patents .............................. 95
Generic Company Activity ................. 95
Momenta & Sandoz file enoxaparin suit against Teva .....96
Market Outlook .............. 96
IMMUNOLOGY .......................... 98
MULTIPLE SCLEROSIS ............. 98
Copaxone (glatiramer acetate) .......................................... 100
Mode of Action ............ 100
Approvals ...................... 100
Lifecycle Development 100
Competition within the Marketplace............................. 101
Patents ........................... 101
Generic Company Activity .......... 101
Sandoz and Momenta ............. 101
Mylan and Natco Pharma ....... 102
Market Outlook ........... 102
Avonex (interferon beta-1a) ............... 104
Mode of Action ............ 104
Approvals ...................... 104
Lifecycle Development 104
Competition within the Marketplace .......................... 104
Patents ........................... 105
Market Outlook ........... 105
Rebif (interferon beta-1a) ............ 107
Mode of Action.............. 107
Approvals...................... 107
Lifecycle Development ....... 107
Competition within the Marketplace ........................... 108
Market Outlook ................ 108
Betaferon/Betaseron & Extavia (interferon beta-1b) ........... 110
Mode of Action ..................... 110
Approvals ................................................ 110
Lifecycle Development . 111
Competition within the Marketplace ................ 111
Patents ............................ 111
Market Outlook ............ 111
Tysabri (natalizumab) ............... 113
Mode of Action ............ 113
Approvals ....................... 113
Lifecycle Development ........... 114
Competition within the Marketplace ................. 114
Patents ............................ 114
Market Outlook ............ 114
RHEUMATOID ARTHRITIS............................ 116
Enbrel (etanercept) ...................... 117
Mode of Action ............ 117
Approvals ....................... 118
Competition within the Marketplace ............. 119
Patents Biosimilar Activity ....... 119
Merck & Co ......... 119
Avesthagen ....... 120
Protalix BioTherapeutics .............. 120
Simcere............... 120
Market Outlook............ 120
Humira (adalimumab) ................ 122
Mode of Action............ 122
Approvals....................... 122
Competition within the Marketplace .................. 123
Patents............................ 123
Biosimilar Activity....... 123
Market Outlook............ 124
Remicade (infliximab) .................... 125
Mode of Action............ 125
Approvals....................... 125
Competition within the Marketplace .................... 126
Patents............................ 126
Biosimilar Activity....... 127
Market Outlook ............... 127
INFECTION .................................... 129
Merrem/Meropen (meropenem) .................... 129
Mode of Action............ 129
Approvals...................... 129
Competition within the Marketplace .................... 130
Generic Approvals...... 130
Market Outlook........... 131
Zosyn/Tazocin (piperacillin+tazobactam) ................. 133
Mode of Action............ 133
Approvals...................... 133
Competition within the Marketplace ................ 133
Patents........................... 134
Generic Approvals...... 134
Market Outlook........... 137
Primaxin (imipenem+cilastatin sodium) ................. 138
Mode of Action............ 138
Approvals...................... 138
Competition within the Marketplace 38
Generic Approvals...... 138
Market Outlook........... 139
Cubicin (daptomycin) ..................... 141
Mode of Action............ 141
Approvals...................... 141
Competition within the Marketplace ................... 142
Patents........................... 142
Generic Company Activity ....................................... 142
Market Outlook........... 143
Tygacil (tygecycline) ....................................................... 144
Mode of Action............ 144
Approvals...................... 144
Competition within the Marketplace ........................... 144
Patents........................... 144
Generic Company Activity ........................... 145
Market Outlook........... 145
Synagis (palivizumab) ................................. 147
Mode of Action............ 147
Approvals...................... 147
Competition within the Marketplace ................................................... 147
Patents........................... 147
Market Outlook........... 148
PegIntron (peginterferon alfa-2b) ......................... 149
Mode of Action............ 149
Approvals....................... 149
Competition within the Marketplace ................................................... 149
Patents............................ 150
Biosimilar Activity....... 150
Market Outlook............ 150
Pegasys (pegylated-40K interferon alfa-2a) .............................. 152
Mode of Action............ 152
Approvals....................... 152
Competition within the Marketplace ....................... 153
Patents ........................................................ 153
Biosimilar Activity ...................................... 153
Market Outlook............ 154

List of Tables

Global Sales of Injectable Pharmaceuticals, 2009-2010 (US$ Million) ................................. 4
European Hospital Markets, 2009 (US$ millions) .................... 6
Sales of Injectable Pharmaceuticals in Western Europe, 2010 ................... 7
Biosimilars Approved in the EU .................. 8
Austria: Pharmaceuticals at Wholesale Prices, 2005-2009 (EUR Million) ........ 8
Belgium: Pharmaceutical Market, 2000-2010 (EUR Million) ... 9
Denmark: Pharmaceutical Sales at Retail Prices, 2004-2008 (DKK Million) ... 9
Denmark: Hospital Pharmaceutical Sales, 2006-2008 (DKK Million) 10
Leading Injectable Drugs by Sales in Denmark, 2005-2008 (DKK Million) ............ 10
Pharmaceutical Sales in France, 2005-2009 (EUR Million) ..... 11
Sales of Hospital-only Drugs in Germany, 2004-2008 (EUR Million) ....... 11
Top 10 GKV Injectables, 2009 ........... 12
Pharmaceutical Expenditure in Italy by Drug Class, 2006-2009 (EUR Million) ........ 13
Hospital Sales by Therapeutic Area, 2006 -2009 (EUR Million) ........... 13
Leading Injectable Drugs in the Italian Hospital Sector, 2009 ........ 14
Pharmaceutical Revenue in the Netherlands, 2003-2008 (EUR Million) ........ 15
Market Value by Sector and Product Type, 2008 ............... 15
Pharmaceutical Market by Sector, 2005-2009 ........... 15
Pharmaceutical Sales in Sweden by Type, 2004-2008 (SEK Million) ........... 16
Inpatient Hospital Sales by Therapeutic Group, 2007-2008 (SEK Million) .............. 16
Leading Injectables in Sweden, 2007-2008 (SEK & US$ Million) ......... 17
Pharmaceutical Market by Sales Channel, 2005-2009 (CHF Million) ........ 17
Estimated Cost of Medicines in England, 2009 (£ Million) ................... 18
Estimated Cost of Injectables Approved by NICE, 2009 (£000s) .............. 19
Top Ten NICE Approved Hospital Injectables, 2009 (£000s) .............. 20
US Sales of Injectables, 2010 (US$ Million) ........ 21
US Patent Expiry for Injectable Drugs ............ 22
Faslodex US Patents ................................ 29
Faslodex Sales, 2009-2016 (US$ Million) ..................... 29
Zoladex US Patents ............ 33
Zoladex Sales, 2009-2016 (US$ Million) .............. 34
Eloxatin US Patents .................................. 38
FDA Approvals for Generic Oxaliplatin .............. 39
UK MHRA Marketing Authorisations for Generic Oxaliplatin .................. 40
Eloxatin Sales, 2009-2016 (EUR & US$ Million) Taxotere US Patents ............................ 44
EU Marketing Authorisations for Generic Docetaxel ........... 44
UK MHRA Marketing Authorisations for Generic Docetaxel ............................. 45
Taxotere Sales, 2009-2016 (EUR & US$ Million) ................................. 46
Abraxane US Patents ............................... 49
Abraxane Sales, 2009-2016 (US$ Million) .................... 50
Alimta US Patents ............................. 52
Tentative ANDA Approval for Pemetrexed ........................ 53
Alimta Sales 2009-2016 (US$ Million) ........... 53
Velcade US Patents ................................................. 56
Velcade Sales by Company, 2009-2016 (US$ Million) ....................... 57
Rituxan/MabThera Sales, 2009-2016 (CHF & US$ Million)
Herceptin US Patents Herceptin Sales, 2009-2016 (CHF & US$ Million) ......................................... 66
Avastin Sales, 2009-2016 (CHF & US$ Million) ...................................................... 70
Erbitux Sales by Company, 2009-2016 (EUR & US$ Million) .............................. 73
Filgrastim US Patents ................................................. 76
EU Marketing Authorisations for Biosimilar Filgrastim ............... 77
Neupogen Sales, 2009-2016 (US$ Million) ........... 78
Pegfilgrastim Patents ............ 80
Neulasta Sales, 2009-2016 (US$ Million) ................... 80
Epogen US Patents ............... 84
EU Marketing Authorisations for Biosimilar Eprex ..... 85
Epogen/Eprex Sales, 2009-2016 (US$ Million) .................................................. 86
Aranesp US & EU Patents ............... 88
Aranesp Sales, 2009-2016 (US$ Million) ........... 89
NeoRecormon/Epogin Sales, 2009-2016 (EUR & US$ Million) ........... 91
Mircera Sales, 2009-2016 (CHF & US$ Million) .................. 93
Lovenox US Patents ........... 95
Lovenox/Clexane Sales, 2009-2016 (EUR & US$ Million) ....... 96
FDA ANDA Approvals for Mitoxantrone............. 99
Copaxone US Patents ............ 101
Copaxone Sales by Company, 2009-2016 (US$ Million) ........ 103
Avonex US Patents ............. 105
Avonex Sales 2009-2016 (US$ Million)... 105
Rebif Sales, 2009-2016 (US$ Million) ...... 108
Betaferon/Betaseron & Extavia Sales, 2009-2016 (US$ Million) ....... 111
Tysabri Sales by Company, 2009-2016 (US$ Million) .. 114
Enbrel US Patents ....119
Enbrel Sales by Company, 2009-2016 (US$ Million) 21
Humira US Patents ............. 123
Humira Sales by Company, 2009-2016 (US$ Million) .......................... 124
Remicade US Patents ......... 126
Remicade Sales by Company, 2009-2016 (US$ Million) ..................... 127
FDA ANDA Approvals for Meropenem
UK MHRA Marketing Authorisations for Generic Meropenem Merrem/Meropen
Sales by Company, 2009-2016 (US$ Million) Zosyn US Patents 134
FDA ANDA Approvals for Piperacillin+tazobactam UK MHRA Marketing
Authorisations for Generic Piperacillin+tazobactam .................................................. 136
Zosyn/Tazocin Sales, 2009-2016 (US$ Million) ...................................... 137
UK MHRA Marketing Authorisations for Generic Imipenem+Cilastatin ............... 139
Primaxin Sales, 2009-2016 (US$ Million) ............................. 139
Cubicin US Patents.......................................... 142
Cubicin Sales, 2009-2016 (US$ Million) ............. 143
Tygacil US Patents ..................................... 145
Tygacil Sales, 2009-2016 (US$ Million) .................... 145
Synagis US Patents ..................... 147
Synagis Sales (US$ Million) ........................... 148
PegIntron US Patents ................................... 150
PegIntron Sales, 2009-2016 (US$ Million) ............... 150
Pegasys US Patent ............................. 153
Pegasys Sales, 2009-2016 (CHF & US$ Million) .................... 154

List of Figures

Dispensing of NICE Approved Injectables, 2009 (%) ................................... 18
FDA ANDA Approvals by Company, January 2006-May 2011 ................... 25
FDA ANDA Approvals by Company, January 2009-May 2011 ....................... 26
Faslodex Sales, 2007-2016 .............. 30
Zoladex Sales, 2007-2016 ....................... 35
Eloxatin Sales, 2007-2016 .......................... 41
Taxotere Sales, 2007-2016................................ 47
Abraxane Sales, 2007-2016 ............................................................. 50
Alimta Sales 2007-2016 .................................... 53
Velcade Sales, 2007-2016 ......................................... 57
Rituxan/MabThera Sales, 2007-2016 ................. 62
Herceptin Sales, 2007-2016 ..................... 66
Avastin Sales, 2007-2016 .................................. 70
Erbitux Sales, 2007-2016 ................ 73
Neupogen Sales, 2007-2016 ................... 78
Neulasta Sales, 2007-2016 ...................... 81
Epogen/Eprex Sales, 2007-2016 ...................... 86
Aranesp Sales, 2007-2016 .............. 89
NeoRecormon/Epogin Sales, 2007-2016 ........................................ 91
Mircera Sales, 2008-2016 ........................ 93
Lovenox/Clexane Sales, 2007-2016 ............... 97
Copaxone Sales, 2007-2016 ............................ 103
Avonex Sales, 2007-2016 ................... 106
Rebif Sales, 2007-2016 ........................... 109
Betaferon/Betaseron & Extavia Sales, 2007-2016 .................. 112
Tysabri Sales, 2007-2016 ................... 115
Enbrel Sales, 2007-2016 .................. 121
Humira Sales, 2007-2016 ....................... 124
Remicade Sales, 2007-2016 ........... 128
Merrem/Meropen Sales, 2007-2016 ................................ 132
Zosyn/Tazocin Sales, 2007-2016 ............ 137
Primaxin Sales, 2007-2016 ................... 140
Cubicin Sales, 2007-2016 ........................ 143
Tygacil Sales, 2007-2016 46
Synagis Sales, 2007-2016 ............ 148
PegIntron Sales, 2007-2016 .................... 151
Pegasys Sales, 2007-2016 ............................................. 154

COMPANY PROFILES . 1
ACTAVIS 1
Company Overview . 1
Manufacturing . 1
Major Developments .... 2
EC clears acquisition of control of Actavis by Deutsche Bank .... 2
Acquisitions & Agreements 2
Actavis plans biosimilars entry with help from Biopartners acquisition ... 2
US development, supply and marketing agreement with Sagent .. 3
Co-development relationship with Bioluz .. 3
Litigation ..... 3
Oxaliplatin patent settlement .... 3
Products .... 3
AKORN .. 5
Company Overview . 5
Major Developments .... 5
Agreements 5
Injectable products agreement with Bioniche . 5
Premix product supply agreement with Fresenius ..... 5
Divestitures . 6
Akorn-Strides product portfolio sold to Pfizer .. 6
Products .... 6
Financials... 6
AMERICAN REGENT... 8
Company Overview . 8
Major Developments .... 8
Acquisitions 8
PharmaForce .... 8
Temporary suspension of manufacturing and distribution . 8
Products .... 9
AMPHASTAR PHARMACEUTICALS .. 12
Company Overview .... 12
Manufacturing ..... 12
Products . 12
APOTEX .... 14
Company Overview .... 14
Manufacturing ..... 14
Major Developments . 15
Agreements .... 15
Cangene acquires US commercialisation rights for HepaGam B . 15
Products . 15
Financials ..... 16
AUROBINDO PHARMA 18
Company Overview .... 18
Manufacturing .... 18
Major Developments . 18
Trident Life Sciences acquisition 18
Products . 19
Financials ..... 20
BEDFORD LABORATORIES ..... 21
Company Overview .... 21
Products . 21
CLARIS LIFESCIENCES .. 24
Company Overview .... 24
Manufacturing .... 24
Major Developments . 24
Marketing agreement with Pfizer . 24
Product withdrawals and FDA warning letter .... 24
Products . 25
Financials ..... 26
FRESENIUS KABI 27
Company Overview .... 27
Major Developments . 27
Acquisitions .... 27
APP . 27
Dabur ... 28
Agreements .... 28
APP and Teva enter gemcitabine agreement 28
Products . 28
Financials ..... 31
HIKMA PHARMACEUTICALS . 33
Company Overview .... 33
Manufacturing .... 33
Major Developments . 34
Acquisitions & Agreements .... 34
Strategic partnership with Hubei Haosun 34
Baxter Healthcare’s Injectables Business ..34
Strategic partnership with Unimark Remedies ....34
Biosimilars agreement with Celltrion for MENA ..34
Products . 35
Financials 36
HOSPIRA .. 37
Company Overview .... 37
Manufacturing ..... 37
Major Developments . 38
Acquisitions & Agreements .... 38
Javelin Pharma ....38
Orchid Pharma ....38
Biosimilars Agreement with Celltrion .39
Litigation ... 39
Oxaliplatin patent settlement ..39
Precedex (dexmedetomidine) lawsuits .....39
FDA Warning Letter . 39
Products . 40
Biosimilars . 43
Financials 43
MYLAN ..... 44
Company Overview .... 44
Manufacturing ..... 44
Major Developments . 45
Bioniche Injectable Business Acquisition .. 45
Mylan Withdraws Marketing Application for Docetaxel ..... 46
Products . 46
Financials 47
PADDOCK LABORATORIES .... 48
Company Overview .... 48
Products . 48
SAGENT PHARMACEUTICALS ..... 49
Company Overview .... 49
Major Developments . 49
Sagent Pharmaceuticals announces initial public offering .....49
Claris Lifesciences’ products withdrawn ...50
Agreements .... 50
Exclusive collaboration with Actavis ..50
Products . 50
Financials 51
SANDOZ .. 52
Company Overview .... 52
Manufacturing .... 52
Major Developments . 52
Acquisitions .... 52
Ebewe Pharma injectables business ... 52
Litigation ... 53
Generic Copaxone litigation .... 53
Momenta & Sandoz file enoxaparin suit against Teva . 53
Products . 53
Biosimilars . 55
Rituximab Phase II trial .. 55
Marketed biosimilar products .. 56
Financials ..... 56
STRIDES ARCOLAB . 57
Company Overview .... 57
Manufacturing .... 57
Major Developments . 58
Acquisitions & Agreements .... 58
Strides gains controlling stake in Inbiopro..... 58
Strides acquires injectable facility in Brazil from Aspen 58
Strides & Aspen restructure oncology partnership ... 58
Pfizer and Strides collaborate on generics ..... 58
Products . 59
Financials ..... 59
SUN PHARMA .... 61
Company Overview .... 61
Manufacturing .... 61
Major Developments . 62
Acquisitions & Agreements .... 62
Merck & Co and Sun form emerging markets joint venture ..... 62
Caraco Laboratories . 62
Litigation ... 62
Court ruling stops Sun Pharma’s oxaliplatin sales ... 62
Products . 63
Financials ..... 64
TEVA PHARMACEUTICAL INDUSTRIES . 66
Company Overview .... 66
Strategic Review . 66
Manufacturing .... 67
HOSPITAL INJECTABLE DRUGS
© espicom BUSINESS INTELLIGENCE
July 2011 v
Major Developments . 68
Acquisitions .... 68
ratiopharm .....68
Litigation ... 68
Eli Lilly gains pemetrexed patent victory ..68
Oxaliplatin patent settlement ..68
Products . 68
Biopharmaceuticals and Biosimilars ..71
Financials 72
WOCKHARDT ..... 73
Company Overview .... 73
Manufacturing ..... 73
Major Developments . 74
Divestitures ..... 74
Wockhardt sells its German business ..74
Products . 74
Financials 75
Appendix I: FDA ANDA Approvals ..... 77
Appendix II: UK Injectable Generic Approvals ... 84
SOURCES ... 98
Espicom Sources ..... 98
Others . 98


List of Tables

Actavis ANDA Approvals for Injectables, 2008-2010 . 4
Akorn ANDA Approvals for Injectables ... 6
Akorn Financial Results, 2006-2010 (US$ Million) . 7
PharmaForce ANDA Approvals for Injectables, 2002-2011 .... 10
Luitpold Pharmaceuticals ANDA Approvals for Injectables, 2002-2011 .... 11
Amphastar: Manufacturing Facilities... 12
Amphastar ANDA Approval .. 13
International Medication Systems ANDA Approvals .... 13
Apotex: Subsidiaries in Canada . 14
Apotex ANDA Approvals for Injectables, 2002-2011 .... 16
Cangene Financial Results, 2006-2010 (C$ Million & US$ Million) ... 17
Aurobindo ANDA Approvals for Injectables, 2008-2011 ... 19
Cephazone Pharma ANDA Approvals, 2007-2010 ... 19
Aurobindo Pharma: Financial Results, 2007-2011 ... 20
Bedford Laboratories ANDA Approvals, 2002-2011 22
Claris Lifesciences FDA ANDA Approvals .. 26
Claris Lifesciences Financial Results, 2009-2010 (Rs. Million & US$ Million) .... 26
APP ANDA Approvals, 2002-2011 ... 29
Fresenius Kabi Oncology ANDA Approvals, 2009-2011 ..... 31
Fresenius Kabi Financial Results, 2005-2010 (EUR Million & US$ Million) .. 31
APP Revenues, 2009-2010 (US$ Million) ... 32
Hikma Manufacturing Facilities . 33
Hikma ANDA Approvals for Injectables, 2002-2011 35
Hikma Financial Results, 2006-2010 (US$ Million) ... 36
Hospira: Principal Facilities ... 38
Hospira NDA Approvals, 2011 (Jan-Mar) ... 41
Hospira ANDA Approvals, 2004-2011 .. 42
Hospira Financial Results by Region, 2006-2010 (US$ Million) .... 43
Mylan: Principal Facilities 45
Bioniche Pharma ANDA Approvals, 2003-2011 .. 47
Mylan Financial Results, 2006-2010 (US$ Million) .... 47
Paddock Laboratories ANDA Approvals for Injectables .... 48
Approved ANDAs Acquired From Spectrum Pharmaceuticals ... 50
Sagent Strides ANDA Approvals, 2009-2011 . 51
Sagent ANDA Approvals, 2010-2011 .... 51
Sandoz ANDA Approvals for Injectables, 2005-2011 .... 54
Ebewe Pharma ANDA Approvals for Injectables, 2007-2009 . 55
Sandoz Financial Results, 2006-2010 (US$ Million) . 56
Sagent Strides ANDA Approvals, 2009-2011 . 59
Strides Arcolab Financial Results, 2006-2010 (Rs. Million & US$ Million) ... 60
Sun Pharma NDA Approval, 2011 ... 63
Sun Pharma ANDA Approvals for Injectables 64
Sun Pharma Financial Results, 2006-2010 (Rs. Million & US$ Million) ... 65
Teva: Principal Manufacturing Facilities .... 67
Teva Parenteral ANDA Approvals, 2002-2009 ..... 69
Teva Pharmaceuticals ANDA Approvals for Injectables, 2006 ..... 70
Pliva ANDA Approvals for Injectables, 2004-2008 ... 71
Pharmachemie ANDA Approvals for Injectables, 2004-2010 . 71
Teva Financial Results, 2006-2010 (US$ Million) . 72
Wockhardt ANDA Approvals for Injectables .. 75
Wockhardt Financial Results, 2006-2011 .. 76
FDA ANDA Approvals for Injectable Drugs, January 2009-May 2011 ... 77
UK MHRA Injectable Generic Approvals, January 2009-April 2011 .. 84

Generic Drug in United States

United States Generic Drug Sales, Us$bn, % Chg Y-o-y

• $ 250
• Industry data
• January 2013

Yearly, From 2009 To 2021
By Business Monitor International
Source: IMS Health, Pharmaceutical Research and Manufacturers of America (PhRMA), Food and Drug Administrati

• Industries : Generic Drug
• Countries : United States

United States Generic Drug Sales, Us$bn

• $ 250
• Industry data
• January 2013

Yearly, From 2008 To 2021
By Business Monitor International
Source: IMS Health, Pharmaceutical Research and Manufacturers of America (PhRMA), Food and Drug Administrati

• Industries : Generic Drug
• Countries : United States

United States Generic Drug Sales, Usdbn, % Chg Y-o-y

• $ 250
• Industry data
• January 2013

Yearly, From 2009 To 2021
By Business Monitor International
Source: IMS Health, Pharmaceutical Research and Manufacturers of America (PhRMA), Food and Drug Administrati

• Industries : Generic Drug
• Countries : United States

United States Generic Drug Sales, Usdbn

• $ 250
• Industry data
• January 2013

Yearly, From 2008 To 2021
By Business Monitor International
Source: IMS Health, Pharmaceutical Research and Manufacturers of America (PhRMA), Food and Drug Administrati

• Industries : Generic Drug
• Countries : United States

United States Generic Drug Sales, % Of Total Sales

• $ 250
• Industry data
• January 2013

Yearly, From 2008 To 2021
By Business Monitor International
Source: IMS Health, Pharmaceutical Research and Manufacturers of America (PhRMA), Food and Drug Administrati

• Industries : Generic Drug
• Countries : United States