Injectable Generic Drugs: Prospects & Opportunities to 2013

Date: December 22, 2009
Pages: 318
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Publisher: Espicom Business Intelligence
Report type: Strategic Report
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Injectable Generic Drugs: Prospects & Opportunities to 2013
For more than half of the injectable generics approved in recent years, just one or two manufacturers have received ANDA approvals and 86% of molecules have fewer than five generic competitors

The generic industry is known for producing ‘affordable medicines’. Cost has been an important factor in their development, particularly for oral drugs that are relatively cheap to produce and can be introduced to the market at a fraction of the price of the original drugs. As the generic industry matures however, companies are increasingly looking towards alternative drug delivery technologies as a route to a competitive edge in a crowded market.

A changing corporate landscape

The continuing importance of the injectable generic sector is evidenced by the ongoing developments in the corporate landscape. Pfizer’s agreements with Aurobindo and Claris Lifesciences have been strengthened and Novartis’ acquisition of Ebewe has improved Sandoz’s access to injectable products. Akorn Strides and Fresenius Kabi are new names to the top flight, with the latters acquisition of Dabur and APP putting it in a strong position in the US.

A biosimilar future

Generic manufacturers are beginning to look towards a biosimilar market for future growth. While several biosimilars have now been approved in the EU, a viable regulatory process has yet to be approved in the US. A biosimilar regulation is now more or less agreed as part of President Obama’s general health reform bill, but it remains to be seen whether or not this will be passed. Despite the hurdles, for those companies with the capability to produce biologicals, and the money to invest in their development, there is enormous potential in this high-value market.

Some of the most promising generic drug opportunities due to come off patent in the next few years are injectable

Cancer

Cancer is a leading cause of morbidity and mortality in the developed world and is increasing in the developing world. In 2008, more than US$30 billion was spent on injectables used in the treatment of cancer.

According to the latest WHO estimates, deaths due to cancer will increase from around eight million globally in 2008 to 12 million by 2030. In 2008, 13.8% of deaths from all causes were attributable to cancer. Cancer is responsible for around 21% of all reported deaths in the Western Pacific region and 20% in Europe and the Americas.

Espicom estimates that 1.5 million people will be diagnosed with cancer in the US in 2010 and 580,000 people will die from the disease. Lung, breast, prostate and colorectal cancers will account for more than half of new cases and deaths, with new cases of breast and prostate cancers exceeding the number of new lung cancer cases.

In the last five years, a number of high value cancer therapies have lost market exclusivity in the US, opening the market to generic competition. Recently these have included include Roche’s Kytril and Pfizer’s Camptosar.

Camptosar: A case in point

The launch of generics in the US market had an immediate effect on Pfizer’s sales of Camptosar, which were down by 36% in the first quarter of 2008 compared to the same period in 2007. A small increase in international sales reduced the global decline to 16%. The company has inevitably continued to lose revenue from Camptosar as generic competition has intensified. While the patents for use in combination with 5-FU and LV for metastatic CRC do not expire until 2020, generics will be used off-label. By 2014, Espicom expects sales of Camptosar to be down to around US$187 million.

Questions, Questions

Which generics company has the most comprehensive portfolio of FDA approved anti-cancer injectables?

Which company filed an NDA with the US FDA in July 2009 for sanofi-aventis’ Taxotere and who are the other generic companies pursuing legal challenges?

Sales of Abraxis’ Abraxane are expected to continue growing despite many generic versions of paclitaxel – why?

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List of Tables

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)
5-year sales forecasts
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 (US$ Million)

Anti-Infectives

While the anti-infectives market is dominated by oral medicines, there is a sizeable market for injectable anti-infectives. In 2008, the combined sales of the injectable anti-infectives featured in this chapter of the report amounted to around US$8 billion, including:
  • AstraZeneca/Dainippon Sumitomo’s carbapenem antibiotic, marketed as Merrem/Meropen (meropenem);
  • Wyeth’s Zosyn, a combination of piperacillin (semi-synthetic penicillin) and tazobactam, a beta lactamase inhibitor;
  • Merck & Co’s Primaxin, a combination of the broad-spectrum antibiotic imipenem and cilastatin sodium, an inhibitor of dehydropeptidase I;
  • Levaquin IV (levofloxacin), the S-isomer of the quinolone antibacterial, ofloxacin, which is marketed by Ortho-McNeil (J&J) in the US, by Daiichi Sankyo as Cravit, and by sanofi-aventis as Tavanic;
  • Merck & Co’s antifungal agent, Cancidas (caspofungin acetate);
  • Wyeth’s broad-spectrum antibiotic, Tygacil (tygacyline);
  • Cubist’s antibiotic, Cubicin (daptomycin);
  • Pfizer’s triazole antifungal agent, Vfend (voriconazole); and,
  • Interferon alpha brands, Intron A and PegIntron from Schering-Plough, and Roche’s Pegasys.
  • In recent years, a number of injectable anti-infectives have lost market exclusivity in the US, opening the market to generic competition. These include Bayer’s broad-spectrum fluoroquinolone antibiotic, Cipro IV (ciprofloxacin), Pfizer’s bis-triazole antifungal, Diflucan (fluconazole) and Bristol-Myers Squibb’s fourth-generation, broad-spectrum injectable cephalosporin, Maxipime (cefepime hydrochloride).
  • In the first 11 months of 2009, there were 14 ANDA's issued in this sector, including cefazolin, azithromycin and piperacillin+tazobactam, with Hospira, APP Pharmaceuticals, Cephazone Pharma and Orchid all being active in the sector.

List of Tables

FDA Approved Generic Anti-infective Injectables, 2004-2009
Merrem Sales, 2004-2008 (US$ Million)
Meropen Sales, 2004-2004 (¥ 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)

5-year sales forecasts
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)

Questions, Questions

Why is Cubist’s novel antibiotic Cubicin of interest to Teva?

Why might generic competition be slow to impact Wyeth’s (Pfizer) novel broad spectrum antibiotic Tygacil?

How might early generic approval of the injectable formulation of Schering-Plough’s anti-fungal Vfend affect sales?

CNS
Multiple Sclerosis and Schizophrenia


In the last five years, a number of injectable CNS therapies have lost market exclusivity in the US, opening the market to generic competition.

The largest market sector for CNS injectables is MS; global sales of injectables used in the treatment of MS were over US$9.6 billion in 2008. In the schizophrenia sector, injectable formulations have been introduced as part of the life-cycle management of leading anti-psychotics. In this sector, sales of Risperdal Consta, an intramuscular injectable sustained-release formulation of risperidone amounted to US$1.3 billion in 2008.

In February 2009, the first ANDAs for sumatriptan succinate injection were approved by the FDA. The products are the generic equivalent of GlaxoSmithKline’s Imitrex, which is used in the treatment of acute migraine attacks. In 2008, sales of this product were worth around US$1 billion.

Focus on Multiple Sclerosis

Avonex, Rebif, Betaferon and Tysabri are all biological products. At present, the interferon beta products are the most likely to face competition from similar products. However, this is not likely to be imminent. BioPartners (Bioton) had submitted an application with the EMEA for an innovative interferon beta-1a product, Biferonex. In February 2009, however, this was rejected by the EMEA as the CHMP considered the benefit not to be sufficiently established by the submitted data.

Copaxone will become susceptible to generic competition either following patent expiry, or as a result of patent infringement litigation going against Teva. The US patents expire in 2014. In the meantime, Sandoz, in collaboration with Momenta Pharmaceuticals, and Mylan have filed ANDAs with the FDA containing Paragraph IV certifications and litigation is ongoing.

Merck Serono reported sales of Novantrone at US$70 million in 2005. By 2008, sales of the branded products were down to around US$10 million.

Four companies received FDA ANDA approval for generic mitoxantrone in 2006: Bedford Laboratories (Boehringer Ingelheim), Mayne Pharma (Hospira), Sicor (now Teva Parenteral) and APP. In May 2008, Dabur Oncology (now Fresenius Kabi Oncology) gained FDA approval for its ANDA for mitoxantrone hydrochloride injection. In April 2009, GeneraMedix received FDA approval.

List of Tables

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
5-year sales forecasts
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)

Questions, Questions

On what basis is Teva defending Mylan’s ANDA for Copaxone?

How critical to Janssen’s (J&J) potential 2014 sales of US$1.5 billion will the successful defence of injectable Risperdal be?

What boost did Biogen Idec receive in September 2009 in respect to Avonex?

What is the potential for the injectable form of Lilly’s Zyprexa after 2011?

Endocrine Disorders
Focus on Diabetes and Growth Hormones

Diabetes

Diabetes has become a major cause of premature illness and death in most countries, mainly through the increased risk of cardiovascular disease. The International Diabetes Federation estimates that around 285 million people will be living with diabetes in 2010. In 2008, an estimated 1.3 million people around the world died directly from diabetes. The number of people whose death was recorded as heart disease or kidney failure where diabetes was a contributory factor is, however, considerably higher. Each year, diabetes related causes account for around four million deaths; equivalent to one death every ten seconds and claiming the lives of as many people as HIV/AIDS.

Injectable insulin forms a major component in the treatment of diabetes. Insulin was originally developed to treat Type I diabetes, in which it is a life-saving drug. It is also used to treat insulin resistant Type II diabetes. Recombinant insulin sales are dominated by three manufacturers: Eli Lilly, Novo Nordisk and sanofi-aventis. Leading brands include sanofi-aventis’ Lantus, Eli Lilly’s Humulin and Humalog and Novo Nordisk’s Levemir and NovoRapid/NovoLog range. These products accounted for global sales of US$9.8 billion in 2008.

Growth Hormones

Growth deficiency for a variety of reasons is commonly treated with somatropin, a form of the naturally occurring human growth hormone (HGH). Sales of the leading brands of HGH amounted to US$2.8 billion in 2008.

Sandoz' Omnitrope (somatropin) was the first biosimilar product to be approved in the EU in 2006. It was approved in the US in 2006 and, in 2009, Sandoz gained Japan's first ever marketing approval for a biosimilar, where the product will be marketed as Somatropin BS.

In January 2008, Cangene received FDA approval for its somatropin product, Accretropin, also filed via the 505(b)(2) route. Accretropin was developed under a research and development agreement with Apotex, Cangene's majority shareholder. While Apotex retains the marketing rights for the product, it is not yet marketed.

List of Tables

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, 2003-2007 (SFr & US$ Million)
Nutropin US Patent
Saizen & Serostim Sales, 2004-2008 (EUR & US$ Million)

5-year sales forecasts
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)

Questions, Questions
  • When is sanofi-aventis’ US$3 billion insulin glargine Lantus likely to come under generic pressure and how might that affect sales in 2014?
  • Why are sales of Merck Serono’s Serostim falling and Saizen rising?
  • What is the level of biosimilar activity in developing markets and who is involved?

Cardiovascular Injectables

During 2009, ANDAs have been approved for adenosine, metoprolol tartrate and chlorothiazide sodium injectables in the cardiovascular segment. Luitpold gained approvals for adenosine in April and metoprolol tartrate in September. Metoprolol tartrate is a beta blocker used in the treatment of various cardiovascular indications including hypertension, arrhythmia and myocardial infarction. Adenosine is an anti-arrhythmic drug used to treat paroxysmal supraventricular tachycardia.

In July 2009, Wockhardt gained approval for adenosine, increasing the number of companies competing for market share of this drug to five.

In October 2009, APP Pharmaceuticals received FDA approval for its chlorothiazide sodium for injection. The product is a generic version of Lundbeck Pharmaceuticals’ Diuril, which is a diuretic used to treat high blood pressure.

List of Tables

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

5-year sales forecasts
Lovenox Sales, 2004A-2014E (US$ Million)
Arixtra Sales, 2004A-2014E (US$ Million)
Integrilin Sales, 2004A-2014E (US$ Million)

Inflammatory Conditions

A number of inflammatory diseases, such as rheumatoid arthritis, are treated with biological drugs which are administered by injection. Among the currently approved treatments, Enbrel (etanercept), Rituxan/Mab Thera (rituximab) and Remicade (infliximab) have been on the market for more than a decade and will lose patent protection in the next few years. Assuming the regulatory and scientific hurdles can be overcome, the high revenue from these drugs is likely to make them attractive to companies developing biosimilars in the future.

List of Tables

Enbrel Sales, 2004-2008 (US$ Million)
Enbrel US Patents
Remicade Sales, 2004-2008 (US$ Million)

5-year sales forecasts
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)

Company Information

Generic substitution by health payers has continued apace and, allied with a generally low commercialisation of new drugs, this has spurred the generic market to double-digit growth.

However, much of that growth has been in mainstream drugs with tablet/capsule administration, and oversupply in some areas has led to low margins for generic companies.

The injectable generic business is bucking this trend. Relatively few companies produce injectables but a favourable cocktail of high prices, good yields and competitive pressure in the oral generic market is likely to make the sector more attractive to a wider range of companies.
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)
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