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Pfizer sues as Celebrex patent is reissued in US

Court extends exclusivity of osteoarthritis treatment by 18 months

Pfizer has filed lawsuits against several generic drugmakers in the US after a key patent for its anti-inflammatory drug Celebrex was reinstated, extending its exclusivity for the drug by around 18 months.

Celebrex (celecoxib) remains a major product for Pfizer, with global sales growing 9 per cent to $2.7bn last year, mainly as a treatment for osteoarthritis. However, the drug was due to lose US patent protection on May 30, 2014, placing almost $1.7bn in US sales at risk of competition.

Generic pharmaceutical companies including Actavis, Apotex, Lupin Pharmaceuticals, Mylan and Teva have already filed for approval to market generics after that date, but a reissued US patent has extended Pfizer's exclusivity for Celebrex in the US to December 2, 2015.

The patent (No. RE44048) covers methods of treating osteoarthritis and other approved conditions with celecoxib, said Pfizer in a statement.  A US appeals court had invalidated the patent following to a challenge by Teva, but this decision has now been overturned.

"Continued development of new medicines that enhance patient lives is supported by protecting intellectual property and innovation," said Amy Schulman, executive vice president and general counsel for Pfizer.

"We are pleased with the reissuance of this patent protecting the invention of using celecoxib to treat osteoarthritis and other approved conditions."

Given that blockbuster products can lose upwards of 80 per cent of sales in the first year after patent expiry, the extension amounts to a sizeable windfall for Pfizer as it copes with generic competition to other major brands, notably cholesterol drug Lipitor (atorvastatin).

The company is trying to recoup lost sales with a crop of new products, such as Xeljanz (tofacitinib) for the treatment of moderate-to-severe rheumatoid arthritis and new anticoagulant Eliquis (apixaban) which are both being rolled out in international markets.

6th March 2013

From: Sales

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