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.
Additional Information
This report will provide industry planners, commercial developers and the investment community with a thorough review of the operating landscape for generic injectables. The report is packed with primary source information and market forecasts, and takes a balanced view of the players and products that will shape this high value market sector.
Cancer
Cancer is a leading cause of morbidity and mortality in the developed world and is increasing in the developing world. In 2007, more than US$14 billion was spent on injectables used in the treatment of cancer.
It is estimated that deaths due to cancer will increase from 7.4 million globally in 2004 to 11.8 million by 2030. In Western Europe, 25.4% of all deaths are attributed to cancer. In Italy, cancer accounted for 31.6% of deaths in 2003. In the UK and France, 27% of reported deaths were attributed to malignant neoplasms in 2005. In Germany, in the same year the proportion was 26.1%. In the Americas, around 18.4% of registered deaths are due to cancer; in the USA the proportion is 22.8% (2005). The American Cancer Society estimates that in 2008, 1.4 million people in the USA will be diagnosed with cancer and around 565,650 will die from the disease.
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. Most recently these have included Roche's Kytril and Pfizer’s Camptosar.
Questions, Questions
Which generics company has the most comprehensive portfolio of FDA approved anti-cancer injectables?
How will generic competition to sanofi-aventis' Taxotere in 2010 affect its total sales potential?
Sales of Abraxis’ Abraxane are expected to continue growing despite many generic versions of paclitaxel - why?
How was Mayne Pharma (Hospira) able to introduce oxaliplatin in Europe before the product's patent expiry?
Camptosar: A case in point
In February 2008, Pfizer’s topoisomerase inhibitor, Camptosar (irinotecan hydrochloride) lost marketing exclusivity in the US. Following the 20th February 2008 expiry of paediatric exclusivity on Pfizer’s US patent, the FDA approved several generic versions of Camptosar. Watson Laboratories was the first company to gain FDA ANDA approval for generic irinotecan injection, on the day of patent expiry. Seven days later, a further six companies received ANDA approval from the FDA for their versions of the product.
Anti-Infectives
While the anti-infectives market is dominated by oral medicines, there is a sizeable market for injectable anti-infectives. In 2007, the combined sales of the injectable anti-infectives featured in this chapter amounted to US$6.4 billion. These products are:
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; and
Merck & Co’s antifungal agent, Cancidas (caspofungin acetate); and
Interferon alpha brands, Intron A and PegIntron from Schering-Plough, and Roche’s Pegasys. 9
Questions, Questions
What regulatory boost in June 2008 did Roche receive for Pegasys?
What regulatory approach have Orchid and Sandoz taken in pursuit of generic versions of Wyeth’s Zosyn?
What is hampering the development of biosimilar interferon in the EU?
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).
The highest profile anti-infective to reach the generic market recently was ceftriaxone sodium, following the expiry of the US patent on Roche’s leading injectable antibiotic, Rocephin, in 2005.
In the first 6 months of 2008, there have been 17 ANDA’s issued in this sector, mainly for ciprofloxacin.
CNS
Multiple Sclerosis and Schizophrenia
In the last five years, the number of injectable CNS therapies to lose protection in the US has been significant. The largest market sector for CNS injectables is multiple sclerosis; global sales of injectables used in the treatment of multiple sclerosis were over US$8.5 billion in 2007. In the schizophrenia sector, injectable formulations have been introduced as part of the life-cycle management of leading anti-psychotics.
A number of companies have received FDA approval for generic versions of Pfizer’s Cerebyx (fosphenytoin sodium). Following expiry of the US patent, eight companies received approval for fosphenytoin sodium, 50mg/mL injectables in August 2007: Apotex, APP Pharmaceuticals, Baxter Healthcare, Bedford Laboratories, Hospira, IV Therapeuticals, Teva Parenteral and Wockhardt. In March 2008, Akorn Strides and Sun Pharma received approval for their ANDAs for generic fosphenytoin sodium. The product is used for short-term parenteral administration when other means of phenytoin administration are unavailable or unusable.
Questions, Questions
Despite patent protection to 2014, there is already generic interest in Teva’s proprietary blockbuster Copaxone. Who from and where?
How critical to Janssen's sales will be the successful defence of injectable Risperdal?
Focus on Multiple Sclerosis
The three interferon products, along with Teva’s Copaxone and Merck Serono’s Tysabri, are immunomodulators. Novantrone, which is used to treat more severe cases and SPMS, is an immunosuppressant with dose limiting toxicities.
Avonex, Rebif, Betaferon and Tysabri are all biological products. At present, the interferon beta products are the most likely to face biosimilar competition, the most advanced of which is Biopartners’ (Bioton) Biferonex, which was filed with the EMEA in 2007.
Copaxone will become susceptible to generic competition following patent expiry; the US patents expire in 2014. An ANDA with Paragraph IV certification challenging Teva’s patent has recently been filed with the FDA for this drug, however, prompting patent litigation. Novantrone has lost patent protection and is available generically. Merck Serono reported sales of Novantrone at US$70 million in 2005, falling to US$27.1 million in 2006 as the product began to face generic competition.
Four companies received FDA ANDA approval for generic mitoxantrone on 11th April 2006: Bedford Laboratories (Boehringer Ingelheim), Mayne Pharma (Hospira), Sicor (now Teva Parenteral) and APP. In May 2008, Dabur Oncology gained FDA approval for its ANDA for mitoxantrone hydrochloride injection.
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. In 2005, an estimated 1.1 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 3.8 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;
Novo Nordisk’s Levemir and NovoRapid/NovoLog range.
These products accounted for global sales of US$7.8 billion in 2007.
Questions, Questions
What moves have been made by Bioton and Biocon to develop generic recombinant human insulin and what is the current status of their efforts?
Despite a fall in demand how did Lilly’s Humulin post a 17% increase in sales in the first quarter of 2008?
What is the potential of Roche’s growth hormone Nutropin which loses patent protection in 2009?
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$2.6 billion in 2007.
In 2006, Sandoz’ HGH, Omnitrope, became the first biosimilar to be approved in the EU. It has also been approved in the US via the 505(b)(2) route. Also in 2006, BioPartners (Bioton) announced EU marketing authorisation for its rHGH product, Valtropin, which is biosimilar to Eli Lilly’s Humatrope. In January 2008, Cangene received FDA approval for its somatropin product, Accretropin, also filed via the 505(b)(2) route.
Cardiovascular Injectables
Injectable generics approved include treatments for acute hypertension, hypotension, rhythm disorders of the heart and drugs to treat oedema associated with congestive heart failure.
In April 2008, the FDA approved Teva’s ANDA for epoprostenol, the first generic version of GlaxoSmithKline’s Flolan for injection. On 28th June 2008, GeneraMedix received marketing authorisation from the FDA for epoprostenol injection. The company received approval as a new manufacturer via an NDA rather than an ANDA.
While not one of the more vibrant opportunity areas in the generic sector, opportunities exist. For example, little work is being undertaken to gain share in GSK’s Arixta market, which could achieve sales of US$769 by 2013.
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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.
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