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Report reveals record patent expiries

A report from EvaluatePharma shows that 13 US blockbuster drugs will lose patent exclusivity in the next two years

A report from EvaluatePharma shows that 13 US blockbuster drugs, including Pfizer's Viagra (sildenafil citrate) and Lipitor (atorvastatin calcium); AstraZeneca's Seroquel (quetiapine) and Bristol-Myers Squibb's Plavix (clopidogrel bisulfate), will lose patent exclusivity in the next two years.

It has been known for some time that several patent expiries were due to occur during 2011 and 2012, but it is the analysis of data that highlights the financial impact most clearly.

Data from EvaluatePharma shows that patent expiries in 2011 will result in a loss of £15.8bn. However, in 2012, losses due to generic competition will be more than double at $33.2bn. 

The top five products to go off patent in 2011: Pfizer's Lipitor, Eli Lilly's Zyprexa (olanzapine), Johnson&Johnson's Levaquin (levofloxacin) and Concerta (methylphenidate) and Pfizer's Protonix (pantoprazole sodium), had combined sales in 2010 of $10,756m. This figure is expected to fall by 25 per cent in 2011 and by more than 86 per cent in 2012, with annual US sales of only $1,464m.

Of all the top pharmaceutical companies, Pfizer will be hit the hardest with 68 per cent of its portfolio at risk of patent expiry over the next three years. Lipitor, the company's cholesterol drug, made sales of $11bn in 2010. Its patent expires in November 2011, when Ranbaxy Laboratories' 180 day exclusivity period for its generic version of the drug will commence. Watson Pharmaceuticals will also be introducing a generic version of the drug.

The US Food and Drug Administration (FDA) has just awarded a six-month paediatric extension to patent protection to Bristol Myers-Squibb and sanofi-aventis for Plavix, meaning the blood thinner is protected from generic competition until May 2012. 

Several patent litigation cases have meant that diabetes therapy, Actos (pioglitazone HCl) from Japanese company Takeda, will only start facing competition in 2012, 19 months later than initially expected. 

AstraZeneca has managed to maintain sales of Seroquel due to its franchise extension with Seroquel XR, which became a multi-billion dollar product in its own right in 2010, and has patent exclusivity until 2017.

According to the report, the rate of decline of branded pharmaceutical products is set to remain relatively high until 2015.

3rd February 2011

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