Generics triumph in anti-inflammatory patent battle

Pfizer has settled a long-running patent dispute with generics heavyweights Teva and Actavis, which will allow them to produce generic versions of Pfizer’s non-steroidal anti-inflammatory drug Celebrex (celecoxib) in the US.

The deals allow Teva and Actavis to launch their generic versions of the selective COX-2 inhibitor in December 2014, or potentially earlier under certain circumstances. Both companies have filed for approval with the US Food and Drug Administration, and will jostle for ‘first to file’ priority, which under US law will grant 180 days’ exclusivity for generic versions from the successful company.

The settlement follows a prolonged back-and-forth skirmish, with a US court invalidating one of Pfizer’s patents, only for it to be reinstated on appeal. But a successful challenge from Actavis knocked it back down again. By settling the dispute, Pfizer has bought itself seven months extra exclusivity, while allowing the generics companies to enter the market 11 months earlier than they would have done had the patent stood.