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Hospital Injectable Drugs: Future Prospects for Generics & BiosimilarsThe generic injectables sector exceeds US$11.2 billi...
Table Of ContentsFOREWORD . 1EXECUTIVE SUMMARY 3OVERVIEW . 4INJECTABLE DRUGS MARKET. 4European Markets 6Biosimilars Approv...
Mode of Action . 37Approvals 37Competition within the Marketplace . 37Patents . 38Generic Company Activity 38The ‘874 Pate...
Market Outlook . 61Herceptin (trastuzumab) . 63Mode of Action 63Approvals 63Lifecycle Development 64Competition within the...
HAEMATOLOGY 82ERYTHROPOIETIN . 82Epogen/Eprex (epoetin alfa) . 83Mode of Action . 83Approvals 83Competition within the Mar...
Sandoz and Momenta 101Mylan and Natco Pharma 102Market Outlook 102Avonex (interferon beta-1a) 104Mode of Action . 104Appro...
Market Outlook . 124Remicade (infliximab) 125Mode of Action . 125Approvals 125Competition within the Marketplace . 126Pate...
PegIntron (peginterferon alfa-2b) 149Mode of Action . 149Approvals 149Competition within the Marketplace . 149Patents . 15...
Manufacturing . 12Products . 12APOTEX 14Company Overview 14Manufacturing . 14Major Developments . 15Agreements 15Cangene a...
Strategic partnership with Hubei Haosun 34Baxter Healthcare’s Injectables Business 34Strategic partnership with Unimark Re...
Major Developments . 52Acquisitions 52Ebewe Pharma injectables business . 52Litigation . 53Generic Copaxone litigation 53M...
WOCKHARDT . 73Company Overview 73Manufacturing . 73Major Developments . 74Divestitures . 74Wockhardt sells its German busi...
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ReportsnReports – Hospital Injectable Drugs: Future Prospects for Generics & Biosimilars

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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.

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ReportsnReports – Hospital Injectable Drugs: Future Prospects for Generics & Biosimilars

  1. 1. Hospital Injectable Drugs: Future Prospects for Generics & BiosimilarsThe generic injectables sector exceeds US$11.2 billion and numerous high-value injectableproducts will face patent expiry in major markets over the next decade. This critical newreport evaluates the markets, players and products in detail.Buy Now: Hospital Injectable Drugs MarketBrowse All: Latest Market Research ReportsAs 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 injectablessector through acquisitions in the last couple of years. And interest has not been limited toestablished generic companies, as pharmaceutical majors like Pfizer have also becomeattracted to the generic injectables market.High risks, high rewardThis 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 genericinjectables sector already exceeds US$11.2 billion and numerous high-value injectableproducts will face patent expiry in major markets over the next decade. But, many of thebig sellers are biological products and biosimilar approvals will only be possible for a fewcompanies. Gaining regulatory approval in developed markets is more complex forbiosimilars. For companies who are able to navigate the approval process, the sector forbiosimilars is inherently different to the traditional generics market. Market acceptanceremains 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 asgood as the originator products, they will also have to compete with the originatorcompanies who are unlikely to exit the market as they may previously have done whenfaced 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 adiminishing number of non-biological products. Progress to developing a biosimilar marketto date has been patchy and slow, and few competitive therapies are beyond early-stageresearch. 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 evaluationsAbout the author: The report has been researched and written by Espicom’s SeniorPharmaceuticals Analyst, Karen Holmes. Karen has over 15 years pharmaceutical andhealthcare market analysis experience. Her recent studies include Injectable Generic Drugs:Prospects and Opportunities, Emerging Opportunities in Inhalation and Nasal Spray GenericDrugs, and Ophthalmology Drug Futures.
  2. 2. Table Of ContentsFOREWORD . 1EXECUTIVE SUMMARY 3OVERVIEW . 4INJECTABLE DRUGS MARKET. 4European Markets 6Biosimilars Approved in the EU . 7Austria 8Belgium 8Denmark 9France . 11Germany 11Italy 12Netherlands 14Spain . 15Sweden 16Switzerland . 17United Kingdom . 17US Market . 21MAJOR COMPETITORS 23CANCER . 27HORMONAL THERAPIES . 27Faslodex (fulvestrant). 27Mode of Action 27Approvals 27Lifecycle Development 28Competition within the Marketplace 28Patents . 29Generic Company Activity 29Market Outlook . 29Zoladex (goserelin) . 31Mode of Action 31Approvals 31Competition within the Marketplace 32Breast Cancer .32Prostate Cancer .33Patents . 33Generic Company Activity 33Europe . 33North America . 34Market Outlook . 34CHEMOTHERAPY 36Eloxatin (oxaliplatin). 37
  3. 3. Mode of Action . 37Approvals 37Competition within the Marketplace . 37Patents . 38Generic Company Activity 38The ‘874 Patent Litigation: At Risk Launches and Subsequent Withdrawals . 38Europe . 40Market Outlook . 41Taxotere (docetaxel) 42Mode of Action . 42Approvals 42Competition within the Marketplace . 43Patents . 43Generic Company Activity 44Europe . 44US . 46Market Outlook . 46Abraxane (paclitaxel protein-bound particles for injectable suspension; albumin-bound) 48Mode of Action . 48Approvals 48Lifecycle Development 48Competition within the Marketplace . 49Patents . 49Market Outlook . 50Alimta (pemetrexed) 51Mode of Action . 51Approvals 51Lifecycle Development 52Competition within the Marketplace . 52Patents . 52Generic Company Activity 52Market Outlook . 53Velcade (bortezomib) 54Mode of Action . 54Approvals 54Lifecycle Development 55Competition within the Marketplace 55Patents . 55Generic Company Activity 56Market Outlook . 56MONOCLONAL ANTIBODIES 58Rituxan/MabThera (rituximab) . 58Mode of Action 58Approvals 59Lifecycle Development 60Competition within the Marketplace 60Patents . 61Biosimilar Activity . 61
  4. 4. Market Outlook . 61Herceptin (trastuzumab) . 63Mode of Action 63Approvals 63Lifecycle Development 64Competition within the Marketplace 64Breast Cancer .64Gastric Cancer 65Patents . 65Biosimilar Activity . 65Market Outlook . 65Avastin (bevacizumab) 67Mode of Action 67Approvals 67Lifecycle Development 68Competition within the Marketplace 69Patents . 69Biosimilar Potential 69Market Outlook . 69Erbitux (cetuximab) 71Mode of Action 71Approvals 71Lifecycle Development 71Competition within the Marketplace 72Patents . 72Biosimilar Activity . 72Market Outlook . 72SUPPORTIVE THERAPIES 74G-CSF . 74Neupogen (filgrastim) . 74Mode of Action . 74Approvals 75Competition within the Marketplace . 75Patents . 76Biosimilar Activity 76EU . 76US . 77Market Outlook . 78Neulasta (pegfilgrastim) . 79Mode of Action . 79Approvals 79Competition within the Marketplace . 80Patents . 80Biosimilar Activity 80Market Outlook . 80
  5. 5. HAEMATOLOGY 82ERYTHROPOIETIN . 82Epogen/Eprex (epoetin alfa) . 83Mode of Action . 83Approvals 83Competition within the Marketplace . 83Patents . 84Biosimilar Epoetin 84EU . 84US . 85Market Outlook . 86Aranesp (darbepoetin alfa) 87Mode of Action . 87Approvals 87Lifecycle Development 87Competition within the Marketplace . 88Patents . 88Biosimilar Development 88Market Outlook . 89NeoRecormon (epoetin beta) . 90Mode of Action . 90Approvals 90Competition within the Marketplace . 91Market Outlook . 91Mircera (methoxy polyethylene glycol-epoetin beta) . 92Mode of Action 92Approvals 92Competition within the Marketplace 92Market Outlook . 92THROMBOSIS . 94Lovenox/Clexane (enoxaparin) . 94Mode of Action 94Approvals 94Competition within the Marketplace 95Patents . 95Generic Company Activity 95Momenta & Sandoz file enoxaparin suit against Teva 96Market Outlook . 96IMMUNOLOGY 98MULTIPLE SCLEROSIS 98Copaxone (glatiramer acetate) 100Mode of Action . 100Approvals . 100Lifecycle Development . 100Competition within the Marketplace . 101Patents 101Generic Company Activity . 101
  6. 6. Sandoz and Momenta 101Mylan and Natco Pharma 102Market Outlook 102Avonex (interferon beta-1a) 104Mode of Action . 104Approvals . 104Lifecycle Development . 104Competition within the Marketplace . 104Patents 105Market Outlook 105Rebif (interferon beta-1a) . 107Mode of Action . 107Approvals . 107Lifecycle Development . 107Competition within the Marketplace . 108Market Outlook 108Betaferon/Betaseron & Extavia (interferon beta-1b) 110Mode of Action . 110Approvals 110Lifecycle Development 111Competition within the Marketplace . 111Patents . 111Market Outlook . 111Tysabri (natalizumab) 113Mode of Action . 113Approvals 113Lifecycle Development 114Competition within the Marketplace . 114Patents . 114Market Outlook . 114RHEUMATOID ARTHRITIS. 116Enbrel (etanercept) . 117Mode of Action . 117Approvals 118Competition within the Marketplace . 119Patents . 119Biosimilar Activity 119Merck & Co 119Avesthagen 120Protalix BioTherapeutics . 120Simcere 120Market Outlook . 120Humira (adalimumab) . 122Mode of Action . 122Approvals 122Competition within the Marketplace . 123Patents . 123Biosimilar Activity 123
  7. 7. Market Outlook . 124Remicade (infliximab) 125Mode of Action . 125Approvals 125Competition within the Marketplace . 126Patents . 126Biosimilar Activity 127Market Outlook . 127INFECTION 129Merrem/Meropen (meropenem) 129Mode of Action . 129Approvals . 129Competition within the Marketplace . 130Generic Approvals . 130Market Outlook 131Zosyn/Tazocin (piperacillin+tazobactam) . 133Mode of Action . 133Approvals . 133Competition within the Marketplace . 133Patents 134Generic Approvals . 134Market Outlook 137Primaxin (imipenem+cilastatin sodium) 138Mode of Action . 138Approvals . 138Competition within the Marketplace . 138Generic Approvals . 138Market Outlook 139Cubicin (daptomycin) 141Mode of Action . 141Approvals . 141Competition within the Marketplace . 142Patents 142Generic Company Activity . 142Market Outlook 143Tygacil (tygecycline) . 144Mode of Action . 144Approvals . 144Competition within the Marketplace . 144Patents 144Generic Company Activity . 145Market Outlook 145Synagis (palivizumab) 147Mode of Action . 147Approvals . 147Competition within the Marketplace . 147Patents 147Market Outlook 148
  8. 8. PegIntron (peginterferon alfa-2b) 149Mode of Action . 149Approvals 149Competition within the Marketplace . 149Patents . 150Biosimilar Activity 150Market Outlook . 150Pegasys (pegylated-40K interferon alfa-2a) 152Mode of Action . 152Approvals 152Competition within the Marketplace . 153Patents . 153Biosimilar Activity 153Market Outlook . 154COMPANY PROFILES . 1ACTAVIS 1Company Overview . 1Manufacturing . 1Major Developments 2EC clears acquisition of control of Actavis by Deutsche Bank 2Acquisitions & Agreements 2Actavis plans biosimilars entry with help from Biopartners acquisition . 2US development, supply and marketing agreement with Sagent 3Co-development relationship with Bioluz 3Litigation . 3Oxaliplatin patent settlement 3Products 3AKORN 5Company Overview . 5Major Developments 5Agreements 5Injectable products agreement with Bioniche . 5Premix product supply agreement with Fresenius . 5Divestitures . 6Akorn-Strides product portfolio sold to Pfizer 6Products 6Financials. 6AMERICAN REGENT. 8Company Overview . 8Major Developments 8Acquisitions 8PharmaForce 8Temporary suspension of manufacturing and distribution . 8Products 9AMPHASTAR PHARMACEUTICALS 12Company Overview 12
  9. 9. Manufacturing . 12Products . 12APOTEX 14Company Overview 14Manufacturing . 14Major Developments . 15Agreements 15Cangene acquires US commercialisation rights for HepaGam B . 15Products . 15Financials . 16AUROBINDO PHARMA 18Company Overview 18Manufacturing 18Major Developments . 18Trident Life Sciences acquisition 18Products . 19Financials . 20BEDFORD LABORATORIES . 21Company Overview 21Products . 21CLARIS LIFESCIENCES 24Company Overview 24Manufacturing 24Major Developments . 24Marketing agreement with Pfizer . 24Product withdrawals and FDA warning letter 24Products . 25Financials . 26FRESENIUS KABI 27Company Overview 27Major Developments . 27Acquisitions 27APP . 27Dabur . 28Agreements 28APP and Teva enter gemcitabine agreement 28Products . 28Financials . 31HIKMA PHARMACEUTICALS . 33Company Overview 33Manufacturing 33Major Developments . 34Acquisitions & Agreements 34
  10. 10. Strategic partnership with Hubei Haosun 34Baxter Healthcare’s Injectables Business 34Strategic partnership with Unimark Remedies 34Biosimilars agreement with Celltrion for MENA 34Products . 35Financials 36HOSPIRA 37Company Overview 37Manufacturing . 37Major Developments . 38Acquisitions & Agreements 38Javelin Pharma 38Orchid Pharma 38Biosimilars Agreement with Celltrion .39Litigation . 39Oxaliplatin patent settlement 39Precedex (dexmedetomidine) lawsuits .39FDA Warning Letter . 39Products . 40Biosimilars . 43Financials 43MYLAN . 44Company Overview 44Manufacturing . 44Major Developments . 45Bioniche Injectable Business Acquisition 45Mylan Withdraws Marketing Application for Docetaxel . 46Products . 46Financials 47PADDOCK LABORATORIES 48Company Overview 48Products . 48SAGENT PHARMACEUTICALS . 49Company Overview 49Major Developments . 49Sagent Pharmaceuticals announces initial public offering .49Claris Lifesciences’ products withdrawn .50Agreements 50Exclusive collaboration with Actavis 50Products . 50Financials 51SANDOZ 52Company Overview 52Manufacturing 52
  11. 11. Major Developments . 52Acquisitions 52Ebewe Pharma injectables business . 52Litigation . 53Generic Copaxone litigation 53Momenta & Sandoz file enoxaparin suit against Teva . 53Products . 53Biosimilars . 55Rituximab Phase II trial 55Marketed biosimilar products 56Financials . 56STRIDES ARCOLAB . 57Company Overview 57Manufacturing 57Major Developments . 58Acquisitions & Agreements 58Strides gains controlling stake in Inbiopro. 58Strides acquires injectable facility in Brazil from Aspen 58Strides & Aspen restructure oncology partnership . 58Pfizer and Strides collaborate on generics . 58Products . 59Financials . 59SUN PHARMA 61Company Overview 61Manufacturing 61Major Developments . 62Acquisitions & Agreements 62Merck & Co and Sun form emerging markets joint venture . 62Caraco Laboratories . 62Litigation . 62Court ruling stops Sun Pharma’s oxaliplatin sales . 62Products . 63Financials . 64TEVA PHARMACEUTICAL INDUSTRIES . 66Company Overview 66Strategic Review . 66Manufacturing 67Major Developments . 68Acquisitions 68ratiopharm .68Litigation . 68Eli Lilly gains pemetrexed patent victory 68Oxaliplatin patent settlement 68Products . 68Biopharmaceuticals and Biosimilars 71Financials 72
  12. 12. WOCKHARDT . 73Company Overview 73Manufacturing . 73Major Developments . 74Divestitures . 74Wockhardt sells its German business 74Products . 74Financials 75Appendix I: FDA ANDA Approvals . 77Appendix II: UK Injectable Generic Approvals . 84SOURCES . 98Espicom Sources . 98Others . 98Latest Market Research Reports:Power Monthly Deal Analysis – M&A and Investment Trends, July 2011Oil and Gas Monthly Deals Analysis – M&A and Investment Trends, July 2011Saudi Arabia Oil Markets, 2011The United Kingdom Oil Markets, 2011Planned LNG Terminals Market – Global Analysis, Competitive Landscape and CapacityForecasts to 2016Planned Oil and Gas Pipelines – Global Market Analysis, Competitive Landscape and MajorProjects to 2015About Us:ReportsnReports is an online library of over 75,000 market research reports and in-depthmarket research studies & analysis of over 5000 micro markets. We provide 24/7 online andoffline support to our customers. Get in touch with us for your needs of market researchreports.Follow us on Twitter: http://twitter.com/marketsreportsOur Facebook Page: http://www.facebook.com/pages/ReportsnReports/191441427571689Contact:Mr. Priyank7557 Rambler road,Suite 727, Dallas, TX 75231Tel: +1-888-989-8004 EXT 106E-mail: sales@reportsandreports.comhttp://www.reportsnreports.comBlog: http://www.reportsnreportsblog.com

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