醫院用注射劑:學名藥及生技仿製藥的未來的預測

學名藥的注射劑市場規模已超過112億美金，許多高價注射劑產品在今後十年的主要市場中專利將會到期。Teva、Sandos、Mylan、Hospira、Hikma等等企業在這二、三年內，透過收購以保住自己在注射劑部門的地位。今後不但學名藥製造商，就連Pfizer等製藥公司，也開始相當關注注射劑市場。

本報告提供全球注射劑市場相關調查分析，第1卷為市場概要及各疾病的趨勢，第2卷則彙整加入此市場的主要企業簡介等資料，為您概述為以下內容。

第1卷:學名藥及生技仿製藥的機會

序文

摘要整理

概要

• 注射劑市場
  • 歐洲
  • 美國
• 主要的競爭企業

癌症

• 荷爾蒙療法
• 化療
• 單株抗體
• 支持性治療

血液

• 紅血球生成素
• 血栓塞

免疫疾病

• 多發性硬化症
• 類風濕關節炎

感染

圖表

第2卷:企業簡介

企業簡介

• ACTAVIS
• AKORN
• AMERICAN REGENT
• AMPHASTAR PHARMACEUTICALS
• APOTEX
• AUROBINDO PHARMA
• BEDFORD LABORATORIES
• CLARIS LIFESCIENCES
• FRESENIUS KABI
• HIKMA PHARMACEUTICALS
• HOSPIRA
• MYLAN
• PADDOCK LABORATORIES
• SAGENT PHARMACEUTICALS
• SANDOS
• STRIDES ARCOLAB
• SUN PHARMA
• TEVA PHARMACEUTICAL INDUSTRIES
• WOCKHARDT

附錄1:FDA ANDA同意

附錄2:英國的非專利藥品注射劑的同意

情報來源

圖表

Abstract

As biosimilars become the focus of attention, generics companies must overcome some significant challenges - who will win and what are the products to watch?

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.

Table of Contents

Volume I: Generic & Biosimilar Opportunities

• FOREWORD
• EXECUTIVE SUMMARY
• OVERVIEW

• INJECTABLE DRUGS MARKET
  • European Markets
    • Biosimilars Approved in the EU
    • Austria
    • Belgium
    • Denmark
    • France
    • Germany
    • Italy
    • Netherlands
    • Spain
    • Sweden
    • Switzerland
    • United Kingdom
  • US Market
• MAJOR COMPETITORS

• CANCER

• HORMONAL THERAPIES
  • Faslodex (fulvestrant)
    • Mode of Action
    • Approvals
    • Lifecycle Development
    • Competition within the Marketplace
    • Patents
    • Generic Company Activity
    • Market Outlook
  • Zoladex (goserelin)
  • Mode of Action
  • Approvals
  • Competition within the Marketplace
    • Breast Cancer
    • Prostate Cancer
  • Patents
  • Generic Company Activity
    • Europe
    • North America
  • Market Outlook

• CHEMOTHERAPY
  • Eloxatin (oxaliplatin)
    • Mode of Action
    • Approvals
    • Competition within the Marketplace
    • Patents
    • Generic Company Activity
      • The ‘874 Patent Litigation: At Risk Launches and Subsequent Withdrawals’
      • Europe
    • Market Outlook
  • Taxotere (docetaxel)
    • Mode of Action
    • Approvals
    • Competition within the Marketplace
    • Patents
    • Generic Company Activity
      • Europe
      • US
    • Market Outlook
  • Abraxane (paclitaxel protein-bound particles for injectable suspension; albumin-bound)
    • Mode of Action
    • Approvals
    • Lifecycle Development
    • Competition within the Marketplace
    • Patents
    • Market Outlook
  • Alimta (pemetrexed)
    • Mode of Action
    • Approvals
    • Lifecycle Development
    • Competition within the Marketplace
    • Patents
    • Generic Company Activity
    • Market Outlook
  • Velcade (bortezomib)
    • Mode of Action
    • Approvals
    • Lifecycle Development
  • Competition within the Marketplace
  • Patents
  • Generic Company Activity
  • Market Outlook

• MONOCLONAL ANTIBODIES
  • Rituxan/MabThera (rituximab)
    • Mode of Action
    • Approvals
    • Lifecycle Development
    • Competition within the Marketplace
    • Patents
    • Biosimilar Activity
    • Market Outlook
  • Herceptin (trastuzumab)
    • Mode of Action
    • Approvals
    • Lifecycle Development
    • Competition within the Marketplace
      • Breast Cancer
      • Gastric Cancer
    • Patents
    • Biosimilar Activity
    • Market Outlook
  • Avastin (bevacizumab)
    • Mode of Action
    • Approvals
    • Lifecycle Development
    • Competition within the Marketplace
    • Patents
    • Biosimilar Potential
    • Market Outlook
  • Erbitux (cetuximab)
    • Mode of Action
    • Approvals
    • Lifecycle Development
    • Competition within the Marketplace
    • Patents
    • Biosimilar Activity
    • Market Outlook

• SUPPORTIVE THERAPIES
  • G-CSF
  • Neupogen (filgrastim)
    • Mode of Action
    • Approvals
    • Competition within the Marketplace
    • Patents
    • Biosimilar Activity
      • EU
      • US
    • Market Outlook
  • Neulasta (pegfilgrastim)
    • Mode of Action
    • Approvals
    • Competition within the Marketplace
    • Patents
    • Biosimilar Activity
    • Market Outlook

• HAEMATOLOGY

• ERYTHROPOIETIN
  • Epogen/Eprex (epoetin alfa)
    • Mode of Action
    • Approvals
    • Competition within the Marketplace
    • Patents
    • Biosimilar Epoetin
      • EU
      • US
    • Market Outlook
  • Aranesp (darbepoetin alfa)
    • Mode of Action
    • Approvals
    • Lifecycle Development
    • Competition within the Marketplace
    • Patents
    • Biosimilar Development
    • Market Outlook
  • NeoRecormon (epoetin beta)
    • Mode of Action
    • Approvals
    • Competition within the Marketplace
    • Market Outlook
  • Mircera (methoxy polyethylene glycol-epoetin beta)
    • Mode of Action
    • Approvals
    • Competition within the Marketplace
    • Market Outlook

• THROMBOSIS
  • Lovenox/Clexane (enoxaparin)
    • Mode of Action
    • Approvals
    • Competition within the Marketplace
    • Patents
    • Generic Company Activity
      • Momenta & Sandoz file enoxaparin suit against Teva
    • Market Outlook

• IMMUNOLOGY

• MULTIPLE SCLEROSIS
  • Copaxone (glatiramer acetate)
    • Mode of Action
    • Approvals
    • Lifecycle Development
    • Competition within the Marketplace
    • Patents
    • Generic Company Activity
      • Sandoz and Momenta
      • Mylan and Natco Pharma
    • Market Outlook
  • Avonex (interferon beta-1a)
    • Mode of Action
    • Approvals
    • Lifecycle Development
    • Competition within the Marketplace
    • Patents
    • Market Outlook
  • Rebif (interferon beta-1a)
    • Mode of Action
    • Approvals
    • Lifecycle Development
    • Competition within the Marketplace
    • Market Outlook
  • Betaferon/Betaseron & Extavia (interferon beta-1b)
    • Mode of Action
    • Approvals
    • Lifecycle Development
    • Competition within the Marketplace
    • Patents
    • Market Outlook
  • Tysabri (natalizumab)
    • Mode of Action
    • Approvals
    • Lifecycle Development
    • Competition within the Marketplace
    • Patents
    • Market Outlook

• RHEUMATOID ARTHRITIS
  • Enbrel (etanercept)
    • Mode of Action
    • Approvals
    • Competition within the Marketplace
    • Patents
    • Biosimilar Activity
      • Merck & Co.
      • Avesthagen
      • Protalix BioTherapeutics
      • Simcere
    • Market Outlook
  • Humira (adalimumab)
    • Mode of Action
    • Approvals
    • Competition within the Marketplace
    • Patents
    • Biosimilar Activity
    • Market Outlook
  • Remicade (infliximab)
    • Mode of Action
    • Approvals
    • Competition within the Marketplace
    • Patents
    • Biosimilar Activity
    • Market Outlook

• INFECTION
  • Merrem/Meropen (meropenem)
    • Mode of Action
    • Approvals
    • Competition within the Marketplace
    • Generic Approvals
    • Market Outlook
  • Zosyn/Tazocin (piperacillin+tazobactam)
    • Mode of Action
    • Approvals
    • Competition within the Marketplace
    • Patents
    • Generic Approvals
    • Market Outlook
  • Primaxin (imipenem+cilastatin sodium)
    • Mode of Action
    • Approvals
    • Competition within the Marketplace
    • Generic Approvals
    • Market Outlook
  • Cubicin (daptomycin)
    • Mode of Action
    • Approvals
    • Competition within the Marketplace
    • Patents
    • Generic Company Activity
    • Market Outlook
  • Tygacil (tygecycline)
    • Mode of Action
    • Approvals
    • Competition within the Marketplace
    • Patents
    • Generic Company Activity
    • Market Outlook
  • Synagis (palivizumab)
    • Mode of Action
    • Approvals
    • Competition within the Marketplace
    • Patents
    • Market Outlook
  • PegIntron (peginterferon alfa-2b)
    • Mode of Action
    • Approvals
    • Competition within the Marketplace
    • Patents
    • Biosimilar Activity
    • Market Outlook
  • Pegasys (pegylated-40K interferon alfa-2a)
    • Mode of Action
    • Approvals
    • Competition within the Marketplace
    • Patents
    • Biosimilar Activity
    • Market Outlook

List of Tables

• Global Sales of Injectable Pharmaceuticals, 2009-2010 (US$ Million)
• European Hospital Markets, 2009 (US$ millions)
• Sales of Injectable Pharmaceuticals in Western Europe, 2010
• Biosimilars Approved in the EU
• Austria: Pharmaceuticals at Wholesale Prices, 2005-2009 (EUR Million)
• Belgium: Pharmaceutical Market, 2000-2010 (EUR Million)
• Denmark: Pharmaceutical Sales at Retail Prices, 2004-2008 (DKK Million)
• Denmark: Hospital Pharmaceutical Sales, 2006-2008 (DKK Million)
• Leading Injectable Drugs by Sales in Denmark, 2005-2008 (DKK Million)
• Pharmaceutical Sales in France, 2005-2009 (EUR Million)
• Sales of Hospital-only Drugs in Germany, 2004-2008 (EUR Million)
• Top 10 GKV Injectables, 2009
• Pharmaceutical Expenditure in Italy by Drug Class, 2006-2009 (EUR Million)
• Hospital Sales by Therapeutic Area, 2006 -2009 (EUR Million)
• Leading Injectable Drugs in the Italian Hospital Sector, 2009
• Pharmaceutical Revenue in the Netherlands, 2003-2008 (EUR Million)
• Market Value by Sector and Product Type, 2008
• Pharmaceutical Market by Sector, 2005-2009
• Pharmaceutical Sales in Sweden by Type, 2004-2008 (SEK Million)
• Inpatient Hospital Sales by Therapeutic Group, 2007-2008 (SEK Million)
• Leading Injectables in Sweden, 2007-2008 (SEK & US$ Million)
• Pharmaceutical Market by Sales Channel, 2005-2009 (CHF Million)
• Estimated Cost of Medicines in England, 2009 (£ Million)
• Estimated Cost of Injectables Approved by NICE, 2009 (£000s)
• Top Ten NICE Approved Hospital Injectables, 2009 (£000s)
• US Sales of Injectables, 2010 (US$ Million)
• US Patent Expiry for Injectable Drugs
• Faslodex US Patents
• Faslodex Sales, 2009-2016 (US$ Million)
• Zoladex US Patents
• Zoladex Sales, 2009-2016 (US$ Million)
• Eloxatin US Patents
• FDA Approvals for Generic Oxaliplatin
• UK MHRA Marketing Authorisations for Generic Oxaliplatin
• Eloxatin Sales, 2009-2016 (EUR & US$ Million)
• Taxotere US Patents
• EU Marketing Authorisations for Generic Docetaxel
• UK MHRA Marketing Authorisations for Generic Docetaxel
• Taxotere Sales, 2009-2016 (EUR & US$ Million)
• Abraxane US Patents
• Abraxane Sales, 2009-2016 (US$ Million)
• Alimta US Patents
• Tentative ANDA Approval for Pemetrexed
• Alimta Sales 2009-2016 (US$ Million)
• Velcade US Patents
• Velcade Sales by Company, 2009-2016 (US$ Million)
• Rituxan/MabThera Sales, 2009-2016 (CHF & US$ Million)
• Herceptin US Patents
• Herceptin Sales, 2009-2016 (CHF & US$ Million)
• Avastin Sales, 2009-2016 (CHF & US$ Million)
• Erbitux Sales by Company, 2009-2016 (EUR & US$ Million)
• Filgrastim US Patents
• EU Marketing Authorisations for Biosimilar Filgrastim
• Neupogen Sales, 2009-2016 (US$ Million)
• Pegfilgrastim Patents
• Neulasta Sales, 2009-2016 (US$ Million)
• Epogen US Patents
• EU Marketing Authorisations for Biosimilar Eprex
• Epogen/Eprex Sales, 2009-2016 (US$ Million)
• Aranesp US & EU Patents
• Aranesp Sales, 2009-2016 (US$ Million)
• NeoRecormon/Epogin Sales, 2009-2016 (EUR & US$ Million)
• Mircera Sales, 2009-2016 (CHF & US$ Million)
• Lovenox US Patents
• Lovenox/Clexane Sales, 2009-2016 (EUR & US$ Million)
• FDA ANDA Approvals for Mitoxantrone
• Copaxone US Patents
• Copaxone Sales by Company, 2009-2016 (US$ Million)
• Avonex US Patents
• Avonex Sales 2009-2016 (US$ Million)
• Rebif Sales, 2009-2016 (US$ Million)
• Betaferon/Betaseron & Extavia Sales, 2009-2016 (US$ Million)
• Tysabri Sales by Company, 2009-2016 (US$ Million)
• Enbrel US Patents
• Enbrel Sales by Company, 2009-2016 (US$ Million)
• Humira US Patents
• Humira Sales by Company, 2009-2016 (US$ Million)
• Remicade US Patents
• Remicade Sales by Company, 2009-2016 (US$ Million)
• FDA ANDA Approvals for Meropenem
• UK MHRA Marketing Authorisations for Generic Meropenem
• Merrem/Meropen Sales by Company, 2009-2016 (US$ Million)
• Zosyn US Patents
• FDA ANDA Approvals for Piperacillin+tazobactam
• UK MHRA Marketing Authorisations for Generic Piperacillin+tazobactam
• Zosyn/Tazocin Sales, 2009-2016 (US$ Million)
• UK MHRA Marketing Authorisations for Generic Imipenem+Cilastatin
• Primaxin Sales, 2009-2016 (US$ Million)
• Cubicin US Patents
• Cubicin Sales, 2009-2016 (US$ Million)
• Tygacil US Patents
• Tygacil Sales, 2009-2016 (US$ Million)
• Synagis US Patents
• Synagis Sales (US$ Million)
• PegIntron US Patents
• PegIntron Sales, 2009-2016 (US$ Million)
• Pegasys US Patent
• Pegasys Sales, 2009-2016 (CHF & US$ Million)

List of Figures

• Dispensing of NICE Approved Injectables, 2009 (%)
• FDA ANDA Approvals by Company, January 2006-May 2011
• FDA ANDA Approvals by Company, January 2009-May 2011
• Faslodex Sales, 2007-2016
• Zoladex Sales, 2007-2016
• Eloxatin Sales, 2007-2016
• Taxotere Sales, 2007-2016
• Abraxane Sales, 2007-2016
• Alimta Sales 2007-2016
• Velcade Sales, 2007-2016
• Rituxan/MabThera Sales, 2007-2016
• Herceptin Sales, 2007-2016
• Avastin Sales, 2007-2016
• Erbitux Sales, 2007-2016
• Neupogen Sales, 2007-2016
• Neulasta Sales, 2007-2016
• Epogen/Eprex Sales, 2007-2016
• Aranesp Sales, 2007-2016
• NeoRecormon/Epogin Sales, 2007-2016
• Mircera Sales, 2008-2016
• Lovenox/Clexane Sales, 2007-2016
• Copaxone Sales, 2007-2016
• Avonex Sales, 2007-2016
• Rebif Sales, 2007-2016
• Betaferon/Betaseron & Extavia Sales, 2007-2016
• Tysabri Sales, 2007-2016
• Enbrel Sales, 2007-2016
• Humira Sales, 2007-2016
• Remicade Sales, 2007-2016
• Merrem/Meropen Sales, 2007-2016
• Zosyn/Tazocin Sales, 2007-2016
• Primaxin Sales, 2007-2016
• Cubicin Sales, 2007-2016
• Tygacil Sales, 2007-2016
• Synagis Sales, 2007-2016
• PegIntron Sales, 2007-2016
• Pegasys Sales, 2007-2016

Volume II: Company Profiles

• COMPANY PROFILES

• ACTAVIS
  • Company Overview
    • Manufacturing
  • Major Developments
    • EC clears acquisition of control of Actavis by Deutsche Bank
  • Acquisitions & Agreements
    • Actavis plans biosimilars entry with help from Biopartners acquisition
    • US development, supply and marketing agreement with Sagent
    • Co-development relationship with Bioluz
  • Litigation
    • Oxaliplatin patent settlement
  • Products

• AKORN
  • Company Overview
  • Major Developments
    • Agreements
      • Injectable products agreement with Bioniche
      • Premix product supply agreement with Fresenius
    • Divestitures
      • Akorn-Strides product portfolio sold to Pfizer
    • Products
    • Financials

• AMERICAN REGENT
  • Company Overview
  • Major Developments
  • Acquisitions
    • PharmaForce
    • Temporary suspension of manufacturing and distribution
  • Products

• AMPHASTAR PHARMACEUTICALS
  • Company Overview
    • Manufacturing
  • Products

• APOTEX
  • Company Overview
    • Manufacturing
  • Major Developments
    • Agreements
      • Cangene acquires US commercialisation rights for HepaGam B
  • Products
  • Financials

• AUROBINDO PHARMA
  • Company Overview
    • Manufacturing
  • Major Developments
    • Trident Life Sciences acquisition
  • Products
  • Financials

• BEDFORD LABORATORIES
  • Company Overview
  • Products

• CLARIS LIFESCIENCES
  • Company Overview
    • Manufacturing
  • Major Developments
    • Marketing agreement with Pfizer
    • Product withdrawals and FDA warning letter
  • Products
  • Financials

• FRESENIUS KABI
  • Company Overview
  • Major Developments
    • Acquisitions
      • APP
      • Dabur
    • Agreements
      • APP and Teva enter gemcitabine agreement
    • Products
    • Financials

• HIKMA PHARMACEUTICALS
  • Company Overview
    • Manufacturing
  • Major Developments
    • Acquisitions & Agreements
      • Strategic partnership with Hubei Haosun
      • Baxter Healthcare' s Injectables Business
      • Strategic partnership with Unimark Remedies
      • Biosimilars agreement with Celltrion for MENA
    • Products
    • Financials

• HOSPIRA
  • Company Overview
    • Manufacturing
  • Major Developments
    • Acquisitions & Agreements
      • Javelin Pharma
      • Orchid Pharma
      • Biosimilars Agreement with Celltrion
    • Litigation
      • Oxaliplatin patent settlement
      • Precedex (dexmedetomidine) lawsuits
    • FDA Warning Letter
  • Products
    • Biosimilars
  • Financials

• MYLAN
  • Company Overview
    • Manufacturing
  • Major Developments
    • Bioniche Injectable Business Acquisition
    • Mylan Withdraws Marketing Application for Docetaxel
  • Products
  • Financials

• PADDOCK LABORATORIES
  • Company Overview
  • Products

• SAGENT PHARMACEUTICALS
  • Company Overview
  • Major Developments
    • Sagent Pharmaceuticals announces initial public offering
    • Claris Lifesciences' products withdrawn
  • Agreements
    • Exclusive collaboration with Actavis
  • Products
  • Financials

• SANDOZ
  • Company Overview
    • Manufacturing
  • Major Developments
    • Acquisitions
      • Ebewe Pharma injectables business
    • Litigation
      • Generic Copaxone litigation
      • Momenta & Sandoz file enoxaparin suit against Teva
  • Products
    • Biosimilars
      • Rituximab Phase II trial
      • Marketed biosimilar products
    • Financials

• STRIDES ARCOLAB
  • Company Overview
    • Manufacturing
  • Major Developments
    • Acquisitions & Agreements
      • Strides gains controlling stake in Inbiopro
      • Strides acquires injectable facility in Brazil from Aspen
      • Strides & Aspen restructure oncology partnership
      • Pfizer and Strides collaborate on generics
    • Products
    • Financials

• SUN PHARMA
  • Company Overview
    • Manufacturing
  • Major Developments
    • Acquisitions & Agreements
      • Merck & Co. and Sun form emerging markets joint venture
      • Caraco Laboratories
    • Litigation
      • Court ruling stops Sun Pharma' s oxaliplatin sales
    • Products
    • Financials

• TEVA PHARMACEUTICAL INDUSTRIES
  • Company Overview
    • Strategic Review
    • Manufacturing
  • Major Developments
    • Acquisitions
      • ratiopharm
    • Litigation
      • Eli Lilly gains pemetrexed patent victory
      • Oxaliplatin patent settlement
    • Products
      • Biopharmaceuticals and Biosimilars
    • Financials

• WOCKHARDT
  • Company Overview
    • Manufacturing
  • Major Developments
    • Divestitures
      • Wockhardt sells its German business
    • Products
    • Financials

• Appendix I: FDA ANDA Approvals

• Appendix II: UK Injectable Generic Approvals

• SOURCES

• Espicom Sources
• Others

List of Tables

• Actavis ANDA Approvals for Injectables, 2008-2010
• Akorn ANDA Approvals for Injectables
• Akorn Financial Results, 2006-2010 (US$ Million)
• PharmaForce ANDA Approvals for Injectables, 2002-2011
• Luitpold Pharmaceuticals ANDA Approvals for Injectables, 2002-2011
• Amphastar: Manufacturing Facilities
• Amphastar ANDA Approval
• International Medication Systems ANDA Approvals
• Apotex: Subsidiaries in Canada
• Apotex ANDA Approvals for Injectables, 2002-2011
• Cangene Financial Results, 2006-2010 (C$ Million & US$ Million)
• Aurobindo ANDA Approvals for Injectables, 2008-2011
• Cephazone Pharma ANDA Approvals, 2007-2010
• Aurobindo Pharma: Financial Results, 2007-2011
• Bedford Laboratories ANDA Approvals, 2002-2011
• Claris Lifesciences FDA ANDA Approvals
• Claris Lifesciences Financial Results, 2009-2010 (Rs. Million & US$ Million)
• APP ANDA Approvals, 2002-2011
• Fresenius Kabi Oncology ANDA Approvals, 2009-2011
• Fresenius Kabi Financial Results, 2005-2010 (EUR Million & US$ Million)
• APP Revenues, 2009-2010 (US$ Million)
• Hikma Manufacturing Facilities
• Hikma ANDA Approvals for Injectables, 2002-2011
• Hikma Financial Results, 2006-2010 (US$ Million)
• Hospira: Principal Facilities
• Hospira NDA Approvals, 2011 (Jan-Mar)
• Hospira ANDA Approvals, 2004-2011
• Hospira Financial Results by Region, 2006-2010 (US$ Million)
• Mylan: Principal Facilities
• Bioniche Pharma ANDA Approvals, 2003-2011
• Mylan Financial Results, 2006-2010 (US$ Million)
• Paddock Laboratories ANDA Approvals for Injectables
• Approved ANDAs Acquired From Spectrum Pharmaceuticals
• Sagent Strides ANDA Approvals, 2009-2011
• Sagent ANDA Approvals, 2010-2011
• Sandoz ANDA Approvals for Injectables, 2005-2011
• Ebewe Pharma ANDA Approvals for Injectables, 2007-2009
• Sandoz Financial Results, 2006-2010 (US$ Million)
• Sagent Strides ANDA Approvals, 2009-2011
• Strides Arcolab Financial Results, 2006-2010 (Rs. Million & US$ Million)
• Sun Pharma NDA Approval, 2011
• Sun Pharma ANDA Approvals for Injectables
• Sun Pharma Financial Results, 2006-2010 (Rs. Million & US$ Million)
• Teva: Principal Manufacturing Facilities
• Teva Parenteral ANDA Approvals, 2002-2009
• Teva Pharmaceuticals ANDA Approvals for Injectables, 2006
• Pliva ANDA Approvals for Injectables, 2004-2008
• Pharmachemie ANDA Approvals for Injectables, 2004-2010
• Teva Financial Results, 2006-2010 (US$ Million)
• Wockhardt ANDA Approvals for Injectables
• Wockhardt Financial Results, 2006-2011
• FDA ANDA Approvals for Injectable Drugs, January 2009-May 2011
• UK MHRA Injectable Generic Approvals, January 2009-April 2011