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.


Related Content

Generics giants jostle over pain drug

4 June 2014 Business

news image

Mylan and Actavis contest Teva’s generic celecoxib exclusivity

Teva fined $1.2bn in pay-for-delay case

1 June 2015 Business

news image

Company illegally blocked generic competition of sleep disorder drug, and settlement terms tighten up rules on anticompetitiv...

Most Commented

Rechargeable first for promising battery tech

6 May 2016 Research

news image

New cathode material makes for energetic, rechargeable sodium–carbon dioxide batteries that could power Mars vehicles

WHO clarifies glyphosate risks

23 May 2016 Business

news image

UN and WHO panel conclude the herbicide glyphosate is ‘unlikely’ to cause cancer at realistic exposure levels