Pharma

N.C. pharma Pozen files court challenge to block generic competitor

Looming patent expiration on the migraine drug Treximet has led pharmaceutical company Pozen to take […]

Looming patent expiration on the migraine drug Treximet has led pharmaceutical company Pozen to take further legal action to fend off generic competition.

Chapel Hill, North Carolina-based Pozen (NASDAQ:POZN) said Tuesday it has filed a preliminary injunction to prevent Par Pharmaceuticals from launching a Treximet generic. Pozen made the filing in the U.S. District Court for the Eastern District of Texas, where Pozen’s ongoing patent litigation against Par and several other generic companies is pending. The company holds three patents on the drug; two that expire in 2017 and one that expires in 2025. Treximet’s regulatory exclusivity on Treximet expires much sooner — April 15. In the absence of a court decision stating otherwise, Par would be able to market its generic Treximet after that date.

The U.S. Food and Drug Administration approved Treximet in 2008 for the treatment of migraines. Treximet generated $15.4 million in 2010 royalty revenue for Pozen. The drug was developed and marketed in partnership with British pharmaceutical company GlaxoSmithKline (NYSE:GSK), which has its U.S. headquarters in Research Triangle Park, North Carolina.

Pozen has tried to get the FDA to extend the regulatory exclusivity of Treximet. But the company last month disclosed that the FDA did not accept clinical study data regarding pediatric use of Treximet. The company was seeking an additional six months of pediatric exclusivity.

Including Par, four generics makers have filed applications with the FDA seeking approval to market generic versions of Treximet. A settlement with Teva Pharmaceuticals was reached last year. Litigation with Par, Alphapharm and Dr. Reddy’s Laboratories has been consolidated into one suit, which is still pending.

Treximet is not the only Pozen product facing a generic challenge. The company disclosed in a regulatory filing earlier this month that Dr. Reddy’s, a generics company based in India, sent a letter notifying the company it had filed an application with the FDA seeking approval to market a generic version of Vimovo. Vimovo is an osteoarthritis drug co-developed and co-marketed with partner AstraZeneca (NYSE:AZN).

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