Generic Drugs
Injectable Generic Drugs
Prospects & Opportunities to 2013
| Publication Date | July 2008 |
| Publisher | Espicom |
| Product Type | Report |
| Pages | 264 |
| ISBN Number | not applicable |
| Product Code | ESP00733 |
Price
£1,295.00
approximately: $1,961 | €1,445
approximately: $1,961 | €1,445
Order above formats by FAX
Summary
This report provides
- Individual analysis of 48 leading therapies
- Product forecasts by value 2008/2013
- Comprehensive patent information by product and patent expiry opportunities to 2015
- The market context for injectable drugs
- Evaluation of companies competing in the sector
- Analysis of significant litigation
Key therapy sectors covered
- Cancer
- CNS
- Cardiovascular
- Anti-Infectives
- Diabetes
- Growth Disorders
Some of the most promising generic drug opportunities due to come off patent in the USA and Europe over the next few years are injectable
This new report focuses on the market potential for sterile drugs delivered by injection or infusion. These drugs are used to treat major illnesses, such as cancer, central nervous system (CNS) disorders, acute cardiovascular conditions and severe infections. More than one third of the injectable generics approved in the US during the last five years are used in cancer therapy.
A further 23% are anti-infectives, 16% are used in the CNS setting and 9% are used for cardiovascular therapy.
A relatively small number of injectable drugs have received significant attention from generic companies, resulting in the approval of numerous versions following patent expiry. Some of these are high profile cancer drugs. For example, when Bristol-Myers Squibb's Paraplatin (carboplatin) became generically available 11 companies received FDA approval for generic versions.
Significant opportunities still exist
Obviously where intense competition exists, the potential for significant market share is reduced. The vast majority of injectable generics are, however, less hotly contested. For more than half of the injectable generics approved since 2003, just one or two manufacturers have received ANDA approvals and over 85% of molecules have less than five generic competitors. While the potential market may not be as valuable for these products, with less competition for price reductions, higher profit margins than have traditionally been available for oral generics are possible. Companies are, therefore, able to capitalise on opportunities for specialty injectable generics in niche areas.
Contents
- Executive Summary
- Overview
- Leading Generic Markets
- Injectables
- 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 (leuprolide)
- Patents
- Generic Company Activity
- Market Outlook
- Eligard (leuprolide)
- Patents
- Chemotherapy
- Taxotere (docetaxel)
- NICE Guidance
- Patents
- Generic Company Activity
- 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
- Market Outlook
- Gemzar (gemcitabine)
- Patents
- Generic Company Activity
- Market Outlook
- Alimta (pemetrexed)
- NICE Guidance
- Patents
- Generic Company Activity
- Market Outlook
- Somatostatin Analogue
- Sandostatin (octreotide acetate)
- Patents
- Generic Company Activity
- Market Outlook
- Targeted Therapy
- Rituxan/MabThera (rituximab)
- Biosimilar Activity
- Market Outlook
- Supportive Therapies
- Zometa/Aclasta/Reclast (zoledronic acid)
- FDA Alert on Bisphosphonates
- Patents
- Market Outlook
- Kytril (granisetron)
- Patents
- Generic Company Activity
- Market Outlook
- G-CSF
- Biosimilar Activity
- CHMP issues positive opinion for biosimilar filgrastim
- Apotex
- Insmed
- 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
- EMEA recommendation of new warning for EPO in cancer patients
- Epogen/Eprex (epoetin alpha)
- Patents
- Market Outlook
- Aranesp (darbepoetin alpha)
- Patents
- Market Outlook
- NeoRecormon/Epogin (epoetin beta)
- 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
- Market Outlook
- 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
- Tentative approval for sumatriptan
- Multiple Sclerosis
- Copaxone (glatiramer)
- Patents
- Generic Company Activity
- Market Outlook
- Interferon beta
- Biosimilar Activity
- Avonex (interferon beta-1a)
- Market Outlook
- Rebif (interferon beta-1a)
- Market Outlook
- Betaferon/Betsaseron (interferon beta-1b)
- Market Outlook
- Schizophrenia
- Abilify (aripiprazole)
- Patents
- Generic Company Activity
- Market Outlook
- Risperdal (risperidone)
- Patents
- Generic Company Activity
- Market Outlook
- Zyprexa (olanzapine)
- Patents
- Generic Company Activity
- Market Outlook
- Cardiovascular Injectables
- FDA Approved Generics
- Lovenox (enoxaparin)
- Patents
- Generic Company Activity
- Market Outlook
- Arixtra (fondaparinux)
- Patents & Exclusivity
- Generic Company Activity
- Market Outlook
- Integrilin (eptifibatide)
- Patents
- Market Outlook
- Angiomax (bivalrudin)
- Patents
- Market Outlook
- 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)
- Patents
- Market Outlook
- Novo Nordisk's insulin analogues
- Levemir (insulin detemir)
- Patents
- NovoRapid/NovoLog (insulin aspart [rDNA origin])
- Patents
- 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
- Company Profiles
- Amphastar Pharmaceuticals
- Injectable Products
- Proposed generic enoxaparin
- Apotex
- Injectable Products
- Financials
- Relevant Agreements
- Apotex to develop biosimilar G-CSF with IBP
- Orchid Chemicals & Pharmaceuticals
- BioGeneriX
- APP Pharmaceuticals
- Products
- Financials
- Major Developments
- Abraxis Bioscience Demerger
- Abraxis acquisition of AstraZeneca's US anaesthetic and analgesic injectable products
- Baxter
- Generic Injectable Products
- Voluntary heparin recall
- Financials
- Major Developments
- Acquisition of ESI Lederle
- Bedford Laboratories
- Products
- Sales
- Agreements
- Novo Nordisk
- Hikma Pharmaceuticals
- Injectable Products
- Financials
- Major Developments
- Acquisition of Egypt's Alkan Pharma
- Acquisition of Thymoorgan
- Acquisition of Ribosepharm
- Hospira
- Products
- Financials
- Hikma Pharmaceuticals agreement
- Orchid Chemicals & Pharmaceuticals
- Products
- Financials
- Major Developments
- Orchid forms Japanese subsidiary
- Relevant Agreements
- Strategic alliance with Ranbaxy
- Actavis agreement
- Apotex agreement
- Acquisitions & Joint Ventures
- Bexel Pharmaceuticals Inc
- Biotechnological Chemical Development Ltd
- Mano Pharmaceuticals & Sali Healthcare
- NCPC Orchid Pharmaceuticals Ltd
- Paddock Laboratories
- Products
- PharmaForce
- Products
- Sagent Pharmaceuticals
- Products
- Major Developments
- Agreement with Astral
- Agreement with Strides Arcolab
- Co-promotion agreement with Anesiva
- Sandoz
- Products
- Financials
- Major Developments
- Sandoz receives regulatory guidance on enoxaparin ANDA
- Collaboration with Momenta Pharmaceuticals
- Sun Pharma
- Products
- Financials
- Major Developments
- Able Laboratories acquisition
- Caraco equity stake
- Teva Pharmaceutical Industries
- Products
- Financials
- Major Developments
- Relevant Patent Litigation
- Adenoscan
- Gemzar
- Lovenox
- IVAX acquisition
- Sicor acquisition
- Wockhardt
- Injectable Products
- Financials
- Major Developments
- Morton Grove acquisition
- Wockhardt acquires France's Negma Laboratories
- Appendix I: FDA ANDA Approvals
- Appendix II: UK Injectable Generic Approvals
- SOURCES
- Espicom Sources
- Others
- INJECTABLE GENERIC DRUGS
- List of Tables
- US Patent Expiry for Major Injectable Drugs
- Injectables with Eight or More Generic Competitors in the US Market
- FDA Approved Generic Cancer Injectables, 2003-2008
- Faslodex Sales 2003-2007 (US$ Million)
- Faslodex US Patents
- Zoladex Sales, 2003-2007 (US$ Million)
- Zoladex US Patents
- Lupron Depot/Leuplin Sales, 2003-2007E (US$ Million)
- Lupron Depot US Patents
- FDA ANDA Approvals for Leuprolide
- Eligard US Patents
- Taxotere Sales, 2003-2007 (EUR & US$ Million)
- Taxotere US Patents
- Abraxane Sales, 2005-2007 (US$ Million)
- Abraxane US Patents
- FDA ANDA Approvals for Paclitaxel, 2002-2008
- Camptosar Sales, 2003-2007 (US$ Million)
- Camptosar US Patents
- FDA ANDA Approvals for Irinotecan
- Eloxatin Sales, 2003-2007 (EUR & US$ Million)
- Eloxatin US Patents
- Gemzar Sales, 2003-2007 (US$ Million)
- Gemzar US Patents
- Tentative ANDA Approvals for Gemcitabine
- Alimta Sales, 2004A-2013E (US$ Million)
- Alimta US Patents
- Sandostatin Sales, 2003-2007 (US$ Million)
- Sandostatin US Patents
- FDA ANDA Approvals for Octreotide Acetate
- Sandostatin Sales, 2003A-2013E (US$ Million)
- Rituxan/MabThera Sales, 2003-2007 (US$ Million)
- Zometa Sales, 2003-2007 (US$ Million)
- Zometa US Patents
- Kytril Sales, 2003-2007 (SFr & US$ Million)
- Kytril US Patents
- FDA ANDA Approvals for Granisetron Injection
- Neupogen Sales, 2003-2007 (US$ Million
- Neulasta Sales, 2003-2007 (US$ Million)
