DUBLIN--(BUSINESS WIRE)-- Research and Markets (http://www.researchandmarkets.com/research/5bdfbb/emerging_opportuni) has announced the addition of the "Emerging Opportunities in Inhalation & Nasal Spray Generic Drugs 2010" report to their offering.
With high-profile inhalable drugs coming off patent, the prospects for the generic sector should be good - but only if companies can overcome production, regulatory and litigation hurdles.
The inhalation and intranasal drugs discussed in detail in this report had combined sales exceeding US$20 billion in 2009. These drugs are used in the treatment of asthma, COPD, allergic rhinitis, influenza, migraine and osteoporosis. In the longer term, novel inhalation and intranasal drug candidates which are being developed now could greatly expand the therapeutic coverage of these drug delivery technologies and potentially provide a lucrative future for the generic industry.
Asthma/COPD: A valuable sector... The biggest selling inhalable drugs for the treatment of asthma and/or COPD by value, are GlaxoSmithKline's Seretide/Advair (fluticasone+salmeterol) with sales of 4,977 million (US$7,794 million) in 2009, Boehringer Ingelheim's Spiriva (tiotropium) with sales of EUR 2,070 million (US$3,046 million) in 2008, and AstraZeneca's Symbicort (budesonide+formoterol) with sales of US$2,294 million in 2009.
...facing patent expiry GSKs combination patent on Seretide/Advair will expire in the US in September 2010 and in most European markets in 2013; the UK patent was revoked. Combination patents covering Symbicort have been revoked in Europe, and AstraZenecas data exclusivity will end in August 2010. The US patents for Symbicort begin to expire in 2011. The US patents for Spiriva begin to expire from December 2012, although there are patents running right up to 2023. From emerging specialist manufacturers to established companies seeking new opportunities, new products in niche markets are increasingly being seen as a route to a competitive edge.
During the next ten years, at least 12 significant drugs in this sector will lose patent protection in key markets - and this number could increase depending on the outcome of patent challenges. The inhalation and intranasal drugs discussed in detail in this report had combined sales exceeding US$22 billion in 2007. These drugs are used in the treatment of asthma, COPD, allergic rhinitis, influenza, migraine and osteoporosis, and in general anaesthesia. Successful IP challenges and regulatory approval will be critical With major blockbusters in the Asthma/COPD sector, the generic industry is keen to secure a slice of the action. However, they must overcome well defended IP claims. The biggest prize is GSKs US$7 billion product Seretide/Advair. The patents on the specific combination of fluticasone propionate and salmeterol xinafoate are due to expire in 2010 in the US and in 2013 in Europe, including Supplementary Protection Certificate extensions, after which generic companies are expected to be able to enter the market. Patent expiry in the US is not necessarily a gateway to generic competition, however, due to the historic difficulty in gaining approval for inhalable generics from the FDA. Flixotide/Flovent has been off patent for some time and, while generic versions are available in Europe, generics have yet to be approved in the US and the product remains a top seller for GSK. As the generic industry matures companies are increasingly looking for higher profit margins. From emerging specialist manufacturers to established companies seeking new opportunities, new products plus novel drug delivery are increasingly being seen as a route to a competitive edge in the generics industry.
That is why this report focuses on the opportunities for inhalation and nasal spray generic drugs.
- Amphastar Pharmaceuticals
- Barr Pharmaceuticals
- Baxter Healthcare
- Beximco Pharmaceuticals
- Hi-Tech Pharmacal
- Hovione FarmaCiencia
- Nephron Pharmaceuticals
- Ranbaxy Laboratories
- Roxane Laboratories
- Teva Pharmaceutical Industries
- Watson Pharmaceuticals
For more information visit http://www.researchandmarkets.com/research/5bdfbb/emerging_opportuni
Source: Espicom Business Intelligence Ltd
Research and Markets
Laura Wood, Senior Manager
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
INDUSTRY KEYWORDS: Health Pharmaceutical