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

India green lights production of patented cancer drug

20 March 2012 News and Analysis

news image

For the first time India has invoked a 'compulsory licence' clause to cut the cost of a patented anti-cancer drug

Most Read

Higher levels of some metals in e-cigarette smoke

8 September 2014 Research

news image

Scientists call for regulators to help clear smoke and mirrors surrounding vaping safety

Isotope effect produces new type of chemical bond

22 October 2014 Research

news image

Evidence emerges for vibrational bond first proposed 30 years ago

Most Commented

Indian U-turn on diabetes drug ban

16 August 2013 News and Analysis

news image

Suspension of cheap and popular medicine reversed but will now come with new safety warnings

DNA waves don't wash

10 July 2013 The Crucible

news image

Philip Ball asks why a spectacular claim seems to have been overlooked. Sometimes science doesn’t work the way it’s suppo...