|
Published by: Espicom Healthcare Intelligence
Published: Dec. 16, 2009 - 318 Pages
Table of Contents
- Foreword
- Executive Summary
- Overview
- Leading Generic Markets
- Injectables
- Biosimilars
- Monoclonal Antibodies
- Major Therapeutic Areas
- Leading Companies and Competition
- Cancer Injectables
- Breast Cancer
- Colorectal Cancer
- Lung Cancer
- Prostate Cancer
- FDA Approved Generics
- Hormonal Therapies
- Faslodex (fulvestrant)
- Patents
- Market Outlook
- Zoladex (goserelin)
- Patents
- Generic Company Activity
- Market Outlook
- Lupron Depot (leuprorelin)
- Patents
- Generic Company Activity
- Market Outlook
- Eligard (leuprolide)
- Patents
- Chemotherapy
- Taxotere (docetaxel)
- NICE Guidance
- Patents
- Generic Company Activity
- Formulation
- API
- Compulsory Licensing
- Market Outlook
- Abraxane (paclitaxel protein-bound particles for injectable suspension; albumin-bound)
- Patents
- Litigation
- Generic Company Activity
- Market Outlook
- Camptosar (irinotecan)
- NICE Guidance
- Patents
- Generic Company Activity
- Market Outlook
- Eloxatin (oxaliplatin)
- NICE Guidance
- Patents
- Generic Company Activity
- Teva
- Hospira
- Sun Pharma
- Fresenius Kabi Oncology
- Ebewe (Sandoz)
- Pliva
- Market Outlook
- Gemzar (gemcitabine)
- Patents
- Generic Company Activity
- Market Outlook
- Alimta (pemetrexed)
- NICE Guidance
- Patents
- Generic Company Activity
- Market Outlook
- Velcade (bortezomib)
- Patents
- Generic Company Activity
- Market Outlook
- Somatostatin Analogue
- Sandostatin (octreotide acetate)
- Patents
- Generic Company Activity
- Market Outlook
- Supportive Therapies
- Zometa/Aclasta/Reclast (zoledronic acid)
- FDA Alert on Bisphosphonates
- Patents
- Generic Company Activity
- Market Outlook
- Kytril (granisetron)
- Patents
- Generic Company Activity
- Market Outlook
- G-CSF
- Biosimilar Activity
- Teva, ratiopharm and CT Arzneimittel receive EU approval
- Teva submits BLA for XM02 for CT-induced neutropenia
- Sandoz gains EC filgrastim approval
- Hospira acquires rights to biosimilar filgrastim
- Cangene signs deal for Maxygen’s MAXY-G34 in ARS
- Merck acquires follow-on biologics platform from Insmed
- Apotex
- Abraxis/Biocon
- EMEA Guidelines for Recombinant Granulocyte-Colony Stimulating Factor
- Neupogen (filgrastim)
- Patents
- Market Outlook
- Neulasta (pegfilgrastim)
- Market Outlook
- Neutrogin/Granocyte (lenograstim)
- Market Outlook
- Leukine (sargramostim)
- Patents
- Erythropoietin
- Biosimilar Activity
- Positive opinions from the EMEA for two more biosimilars
- First biosimilar approvals for EPO in the EU
- EMEA recommendation of new warning for EPO in cancer patients
- Epogen/Eprex (epoetin alpha)
- Patents
- Market Outlook
- Aranesp (darbepoetin alpha)
- Patents
- Biosimilar Activity
- Market Outlook
- NeoRecormon/Epogin (epoetin beta)
- Market Outlook
- Monoclonal Antibodies
- Rituxan/Mab Thera (rituximab)
- Rituximab potential in Type I diabetes
- Biosimilar Activity
- Market Outlook
- Injectable Anti-infectives
- FDA Approved Generics
- Merrem (meropenem)
- Patents
- Generic Company Activity
- Market Outlook
- Zosyn (piperacillin+tazobactam)
- Patents
- Generic Company Activity
- Market Outlook
- Primaxin (imipenem+cilastatin sodium)
- Patents
- Generic Company Activity
- Market Outlook
- Levaquin (levofloxacin)
- Patents
- Generic Company Activity
- Market Outlook
- Cancidas (caspofungin acetate)
- Patents
- Generic Company Activity
- Market Outlook
- Vfend (voriconazole)
- Patents
- Generic Company Activity
- Market Outlook
- Tygacil (tygacycline)
- Patents
- Generic Company Activity
- Market Outlook
- Cubicin (daptomycin)
- Patents
- Generic Company Activity
- Interferon alpha
- Biosimilar Activity
- EMEA issues draft guidelines for biosimilar interferon alpha
- Intron A (interferon alpha-2b)
- Market Outlook
- PegIntron (peginterferon alpha-2b)
- Market Outlook
- Pegasys (pegylated-40K interferon alpha-2a)
- Market Outlook
- CNS Injectables
- FDA Approved Generics
- Multiple Sclerosis
- Copaxone (glatiramer)
- Patents
- Generic Company Activity
- Sandoz and Momenta
- Mylan and Natco Pharma
- Market Outlook
- Interferon beta
- Biopartners withdraws interferon beta application
- Avonex (interferon beta-1a)
- Patents
- Market Outlook
- Rebif (interferon beta-1a)
- Market Outlook
- Betaferon/Betsaseron (interferon beta-1b)
- Patents
- Market Outlook
- Schizophrenia
- Abilify (aripiprazole)
- Patents
- Generic Company Activity
- Market Outlook
- Risperdal Consta (risperidone)
- Patents
- Generic Company Activity
- Market Outlook
- Zyprexa (olanzapine)
- Patents
- Generic Company Activity
- Market Outlook
- Other
- Precedex (dexmedetomidine)
- Patents
- Generic Company Activity
- Cardiovascular Injectables
- EMEA Guideline on Non-Clinical and Clinical Development of Similar Biological Medicinal Products
- Containing Low-Molecular-Weight-Heparins
- FDA Approved Generics
- Lovenox (enoxaparin)
- Patents
- Generic Company Activity
- Market Outlook
- Arixtra (fondaparinux)
- Patents & Exclusivity
- Generic Company Activity
- Market Outlook
- Integrilin (eptifibatide)
- Patents
- Generic Company Activity
- Market Outlook
- Angiomax (bivalrudin)
- Patents
- Generic Company Activity
- Market Outlook
- Cardene IV (nicardipine)
- Patents
- Generic Company Activity
- Endocrine Disorders
- Recombinant Insulin & Insulin Analogues
- Biosimilar Activity
- Biocon
- Bioton
- EMEA Guidelines for Recombinant Human Insulin
- Humulin (insulin human [rDNA origin])
- Market Outlook
- Humalog (insulin lispro)
- Patents
- Market Outlook
- Lantus (insulin glargine)
- Safety Issues
- Patents
- Market Outlook
- Levemir (insulin detemir)
- Patents
- Market Outlook
- NovoRapid/NovoLog (insulin aspart)
- Patents
- Market Outlook
- NovoMix/NovoLog Mix
- Patents
- Market Outlook
- Recombinant Human Growth Hormone
- Biosimilar Activity
- Sandoz
- BioPartners
- Cangene
- Teva
- EMEA Guidelines for Somatropin
- Genotropin
- Patents
- Market Outlook
- Humatrope
- Market Outlook
- Norditropin
- Patents
- Market Outlook
- Nutropin
- Patents
- Market Outlook
- Saizen/Serostim
- Market Outlook
- Inflammatory Conditions
- Enbrel (etanercept)
- Patents
- Biosimilar Activity
- Market Outlook
- Remicade (infliximab)
- Market Outlook
- Company Profiles
- Akorn
- Products
- Financials
- Agreements
- Akorn enters agreement for injectable products with Bioniche
- Akorn signs premix product supply agreement with Fresenius
- Akorn enters ANDA development and supply agreement with Hyaluron
- Amphastar Pharmaceuticals
- Injectable Products
- Proposed generic enoxaparin
- Apotex
- Injectable Products
- Financials
- Agreements
- Apotex to develop biosimilar G-CSF with IBP
- Orchid Chemicals & Pharmaceuticals
- BioGeneriX
- Litigation
- Sanofi-aventis sues Apotex over docetaxel
- Baxter
- Generic Injectable Products
- Financials
- Bedford Laboratories
- Products
- Financials
- Agreements
- Novo Nordisk
- Claris Lifesciences
- Products
- Marketing agreement with Pfizer
- Fresenius Kabi
- Products
- Financials
- Acquisitions
- APP Acquisition
- Dabur acquisition
- GeneraMedix
- Products
- Agreements
- Watson and GeneraMedix reach sodium ferric gluconate licence agreement
- GeneraMedix to sell improved epoprostenol formulation to Actelion
- HollisterStier enters agreement with GeneraMedix
- Akorn signs commercial manufacturing supply agreement with GeneraMedix
- Hikma Pharmaceuticals
- Injectable Products
- Financials
- Acquisitions & Agreements
- Acquisition of Egypt’s Alkan Pharma
- Acquisition of Thymoorgan
- Acquisition of Ribosepharm
- Hikma and Hospira enter European marketing agreements
- Hospira
- Products
- Financials
- Acquisitions & Agreements
- Hospira and Celltrion enter biosimilars agreement
- Hospira gains filgrastim rights and manufacturing facility from Pliva
- Mayne Pharma acquisition
- Hikma Pharmaceuticals agreement
- Orchid Chemicals & Pharmaceuticals
- Products
- Financials
- Agreements, Acquisitions & Joint Ventures
- Strategic alliance with Ranbaxy
- Actavis agreement
- Apotex agreement
- Bexel Pharmaceuticals Inc.
- Biotechnological Chemical Development Ltd.
- Mano Pharmaceuticals & Sali Healthcare
- NCPC Orchid Pharmaceuticals Ltd.
- Paddock Laboratories
- Products
- PharmaForce
- Products
- Sagent Pharmaceuticals
- Products
- Agreements
- Agreement with Astral
- Agreement with Strides Arcolab
- Co-promotion agreement with Anesiva
- Sandoz
- Products
- Biosimilars
- Financials
- Major Developments
- Teva files amended complaint against Momenta/Sandoz
- Sandoz completes acquisition of Ebewe Pharma injectables business
- Sandoz receives regulatory guidance on enoxaparin ANDA
- Collaboration with Momenta Pharmaceuticals
- Strides Arcolab
- Products
- Financials
- Sun Pharma
- Products
- Financials
- Acquisitions
- Able Laboratories acquisition
- Caraco equity stake
- Teva Pharmaceutical Industries
- Products
- Antares/Teva file sNDA for needlefree injector for HGH product
- Financials
- Major Developments
- Teva files amended complaint against Momenta/Sandoz
- CHMP adopts positive opinion on Taxotere and Temodal generics
- FDA accepts Mylan ANDA for glatiramer
- Sicor acquisition
- Wockhardt
- Injectable Products
- Financials
- Acquisitions
- Morton Grove acquisition
- Wockhardt acquires France’s Negma Laboratories
- Appendix I: FDA ANDA Approvals
- Appendix II: UK Injectable Generic Approvals
- SOURCES
- Espicom Sources
- Others
- List of Tables
- US Patent Expiry for Major Injectable Drugs
- Biosimilars Approved in the EU
- Leading Monoclonal Antibodies
- Injectables with Eight or More Generic Competitors in the US Market
- Cancer in the US, 2010 Estimates
- FDA Approved Generic Cancer Injectables, 2004-2009
- Faslodex Sales 2004-2008 (US$ Million)
- Faslodex US Patent
- Zoladex Sales, 2004-2008 (US$ Million)
- Zoladex US Patents
- Lupron Depot/Leuplin Sales, 2004-2008 (US$ Million)
- Lupron Depot US Patents
- FDA ANDA Approvals for Leuprolide
- Eligard US Patents
- Taxotere Sales, 2004-2008 (EUR & US$ Million)
- Taxotere US Patents
- Abraxane Sales, 2005-2008 (US$ Million)
- Abraxane US Patents
- FDA ANDA Approvals for Paclitaxel
- Camptosar Sales, 2004-2008 (US$ Million)
- Camptosar US Patents
- FDA ANDA Approvals for Irinotecan
- Eloxatin Sales, 2004-2008 (EUR & US$ Million)
- Eloxatin US Patents
- Gemzar Sales, 2004-2008 (US$ Million)
- Gemzar US Patents
- FDA ANDA Approval for Gemcitabine
- Tentative ANDA Approvals for Gemcitabine
- Alimta Sales, 2004-2008 (US$ Million)
- Alimta US Patents
- Velcade Sales, 2007-2008 (US$ Million)
- Velcade US Patents
- Sandostatin Sales, 2004-2008 (US$ Million)
- Sandostatin US Patents
- FDA ANDA Approvals for Octreotide Acetate
- Sandostatin Sales, 2004A-2014E (US$ Million)
- Zometa Sales, 2004-2008 (US$ Million)
- Zometa US Patents
- Kytril Sales, 2003-2007 (SFr & US$ Million)
- Kytril US Patents
- FDA ANDA Approvals for Granisetron Injection
- Neupogen Sales, 2004-2008 (US$ Million
- Neulasta Sales, 2004-2008 (US$ Million)
- Neutrogin/Granocyte Sales, 2004-2008 (¥ Billion & US$ Million)
- Epogen/Eprex Sales, 2004-2008 (US$ Million)
- Amgen’s Erythropoietin US Patents
- Aranesp Sales, 2004-2008 (US$ Million)
- NeoRecormon/Epogin Sales, 2004-2008 (CHF & US$ Million)
- FDA Approved Generic Anti-infective Injectables, 2004-2009
- Merrem Sales, 2004-2008 (US$ Million)
- Meropen Sales, 2004-2008 (¥ Billion & US$ Million)
- Merrem US Patent
- Zosyn Sales, 2004-2008 (US$ Million)
- Primaxin Sales, 2004-2008 (US$ Million)
- Levaquin/Floxin Sales, 2004-2008 US$ Million)
- Cravit Sales, 2004-2008 (¥ Million & US$ Million)
- Levaquin US Patent
- Tentative ANDA Approvals for Levofloxacin Injection
- Cancidas Sales, 2004-2008 (US$ Million)
- Cancidas US Patents
- Vfend Sales, 2004-2008 (US$ Million)
- Vfend US Patents
- Tygacil Sales 2005-2008 (US$ Million)
- Tygacil US Patents
- Cubicin Sales 2004-2008 (US$ Million)
- Cubicin US Patents
- Intron A Sales, 2004-2008 (US$ Million)
- PegIntron Sales, 2004-2008 (US$ Million)
- Pegasys Sales, 2003-2008 (SFr & US$ Million)
- FDA Approved Generic CNS Injectables, 2004-2009
- FDA ANDA Approvals for Mitoxantrone
- Copaxone Sales, 2004-2008 (EUR & US$ Million)
- Copaxone US Patents
- Avonex Sales, 2004-2008 (US$ Million)
- Rebif Sales, 2004-2008 (EUR & US$ Million)
- Betaferon/Betaseron Sales, 2004-2008 (EUR & US$ Million)
- Abilify Sales, 2004-2008 (US$ Million)
- Abilify Injection US Patents
- Risperdal Consta Sales, 2006-2008 (US$ Million)
- Risperdal Consta US Patents
- Zyprexa Sales, 2004-2008 (US$ Million)
- Zyprexa Injection US Patent
- Precedex US Patents
- FDA Approved Generic Cardiovascular Injectables, 2004-2009
- Lovenox/Clexane Sales, 2004-2008 (EUR & US$ Million)
- Lovenox US Patents
- Arixtra Sales, 2004-2008 (£ & US$ Million)
- Integrilin Sales, 2004-2008 (US$ Million)
- Integrilin US Patents
- Angiomax Sales, 2004-2008 (US$ Million)
- Angiomax US Patents
- Cardene IV US Patent
- Humulin Sales, 2004-2008 (US$ Million)
- Humalog Sales, 2004-2008 (US$ Million)
- Humalog US Patents
- Lantus Sales, 2004-2008 (EUR & US$ Million)
- Lantus US Patents
- Levemir Sales, 2005-2008 (DKr & US$ million)
- Levemir US Patents
- NovoRapid/NovoLog Sales, 2005-2008 (DKr & US$ million)
- NovoLog US Patents
- NovoLog Mix US Patents
- Genotropin Sales, 2004-2008 (US$ Million)
- Genotropin US Patents
- Humatrope Sales, 2003-2007 (US$ Million)
- Novo Nordisk Growth Hormone Therapy Sales, 2004-2008 (DKr & US$ Million)
- Norditropin US Patents
- Nutropin/Protropin Sales, 2004-2008 (SFr & US$ Million)
- Nutropin US Patent
- Saizen & Serostim Sales, 2004-2008 (EUR & US$ Million)
- Enbrel Sales, 2004-2008 (US$ Million)
- Enbrel US Patents
- Remicade Sales, 2004-2008 (US$ Million)
- Akorn ANDA Approvals for Injectables, 2008-2009
- Akorn-Strides ANDA Approvals, 2007-2009
- Akorn Financial Results, 2004-2008 (US$ Million)
- Amphastar ANDA Approval
- International Medication Systems ANDA Approvals, 2002-2005
- Apotex ANDA Approvals for Injectables, 2002-2009
- Cangene Financial Results, 2004-2008 (C$ Million)
- Baxter ANDA Approvals for Injectables, 2002-2008
- Baxter Financial Results, 2004-2008 (US$ Million)
- Bedford Laboratories ANDA Approvals, 2002-2009
- Bedford Laboratories Sales, 2005-2007 (EUR & US$ Million)
- Claris Lifesciences ANDA Approvals
- APP ANDA Approvals, 2002-2009
- Fresenius Kabi Oncology ANDA Approvals, 2006-2009
- Fresenius Kabi Financial Results, 2005-2008 (US$ Million)
- APP Financial Results, 2004-2007 (US$ Million)
- GeneraMedix ANDA Approvals, 2007-2009
- Hikma ANDA Approvals for Injectables, 2002-2009
- Hikma Financial Results, 2004-2008 (US$ Million)
- Hospira ANDA Approvals, 2004-2009
- Abbott ANDA Approvals for Injectables, 2002-2004
- Hospira Tentative ANDA Approval
- Hospira Financial Results by Region, 2006-2008 (US$ Million)
- Orchid Healthcare ANDA Approvals for Injectables, 2005-2009
- Orchid Financial Results, 2005-2009
- Paddock Laboratories ANDA Approvals for Injectables, 2003-2009
- PharmaForce ANDA Approvals for Injectables, 2002-2009
- Sagent Strides ANDA Approval
- Approved ANDAs Acquired From Spectrum Pharmaceuticals
- Sandoz ANDA Approvals for Injectables, 2005-2009
- Ebewe Pharma ANDA Approvals for Injectables, 2007-2009
- Sabex ANDA Approvals, 2003-2005
- Eon Labs ANDA Approval for Injectable, 2005
- Biochemie ANDA Approval for Injectable, 2002
- Sandoz financial results, 2004-2008 (US$ Million)
- Akorn-Strides ANDA Approvals
- Sagent-Strides ANDA Approvals
- Strides Financial Results, 2005-2008
- Sun Pharma ANDA Approvals for Injectables
- Sun Pharma Tentative ANDA Approval for Injectable
- Sun Pharma: Financial Results, 2005-2009
- 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, 2004-2007
- Teva Financial Results, 2004-2008 (US$ millions)
- Wockhardt ANDA Approvals for Injectables
- Wockhardt Financial Results, 2004-2008
- FDA ANDA Approvals for Injectable Drugs, 2007-2009
- UK MHRA Injectable Generic Approvals, 2007-2009
- List of Figures
- Generic Pharmaceutical Expenditure, 2009 (US$ Billions)
- Generic Pharmaceutical Expenditure per capita, 2009 (US$)
- Generic Pharmaceutical Expenditure as % of Total, 2009
- FDA ANDA Approvals by Therapeutic Area, 2004-2009
- FDA ANDA Approvals by Therapeutic Area, 2004-2009 (%)
- FDA ANDA Approvals by Company 2004-2009
- FDA ANDA Approvals by Company 2008-2009
- Competition for Generic Injectables
- Regional Cancer Deaths as % of Total Deaths, 2008
- Global Cancer Deaths by Region (%)
- Faslodex Sales, 2004A-2014E (US$ Million
- Zoladex Sales, 2004A-2014E (US$ Million)
- Lupron Sales, 2004A-2014E (US$ Million)
- Taxotere Sales, 2004A-2014E (US$ Million)
- Abraxane Sales, 2005A-2014E (US$ Million)
- Camptosar Sales, 2004A-2014E (US$ Million)
- Eloxatin Sales, 2004A-2014E (US$ Million)
- Gemzar Sales, 2004A-2014E (US$ Million)
- Alimta Sales, 2004A-2014E (US$ Million)
- J&J’s Sales of Velcade, 2007A-2014E (US$ Million)
- Zometa/Aclasta/Reclast Sales, 2004A-2014E (US$ Million)
- Kytril Sales, 2004A-2014E (US$ Million)
- Neupogen Sales, 2004A-2014E (US$ Million)
- Neulasta Sales, 2004A-2014E (US$ Million)
- Neutrogin/Granocyte Sales, 2004A-2014E (US$ Million)
- Epogen/Eprex Sales, 2004A-2014E (US$ Million)
- Aranesp Sales, 2004A-2014E (US$ Million)
- NeoRecormon/Epogin Sales, 2004A-2014E (US$ Million)
- Rituxan/Mab Thera Sales, 2004A-2014E
- Merrem/Meropen Sales, 2004A-2014E (US$ Million)
- Zosyn/Tazocin Sales, 2004A-2014E (US$ Million)
- Primaxin Sales, 2004A-2014E (US$ Million)
- Levaquin/Cravit Sales, 2004A-2014E (US$ Million)
- Cancidas Sales, 2004A-2014E (US$ Million)
- Vfend Sales, 2004A-2014E (US$ Million)
- Tygacil Sales, 2005A-2014E (US$ Million)
- Intron-A Sales, 2004A-2014E (US$ Million)
- PegIntron Sales, 2004A-2014E (US$ Million)
- Pegasys Sales, 2004A-2014E (US$ Million)
- Copaxone Sales, 2004A-2014E (US$ Million)
- Avonex Sales, 2004A-2014E (US$ Million)
- Rebif Sales, 2004A-2014E (US$ Million)
- Betaferon/Betaseron Sales, 2004A-2014E (US$ Million)
- Abilify Sales (all formulations), 2004A-2014E (US$ Million)
- Risperdal Consta Sales, 2006A-2014E (US$ Million)
- Zyprexa Sales (all formulations), 2004A-2014E (US$ Million)
- Lovenox Sales, 2004A-2014E (US$ Million)
- Arixtra Sales, 2004A-2014E (US$ Million)
- Integrilin Sales, 2004A-2014E (US$ Million)
- Angiomax Sales, 2004A-2014E (US$ Million)
- Humulin Sales, 2004A-2014E (US$ Million)
- Humalog Sales, 2004A-2014E (US$ Million)
- Lantus Sales, 2004A-2014E (US$ Million)
- Levemir Sales, 2005-2014E (US$ Million)
- NovoRapid/NovoLog Sales, 2005-2014E (US$ Million)
- NovoMix/NovoLog Sales 2005-2014E (US$ Million)
- Genotropin Sales, 2004A-2014E (US$ Million)
- Humatrope Sales, 2004A-2014E (US$ Million)
- Novo Nordisk Growth Hormone Therapy Sales, 2004A-2014E (US$ Million)
- Nutropin/Protropin Sales, 2004A-2014E (US$ Million)
- Saizen/Serostim Sales, 2004A-2014E (US$ Million)
- Amgen Enbrel Sales, 2004A-2014E (US$ Million)
- Wyeth Enbrel Sales, 2004A-2014E (US$ Million)
- J&J Remicade Sales, 2004A-2014E (US$ Million)
- Schering-Plough Remicade Sales, 2004A-2014E (US$ Million)
AbstractThis market leading strategic analysis from Espicom provides the market context for injectable generic drugs, individual analysis of 55 leading therapies and evaluation of 19 companies active in the sector. Key therapy sectors include cancer, CNS, cardiovascular, anti-infectives, diabetes, growth disorders and inflammatory conditions.
Get Full Details About This Report >>
|
|
US: 800.298.5699
Int'l: +1.240.747.3093
|
|
|
