All three companies have launched generic celecoxib in dosages of 50, 100, 200 and 400 mg, as part of a settlement agreement with Pfizer.

Pharma giant Pfizer’s originator product, Celebrex (celecoxib) is indicated for the relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis, and for the management of acute pain in adults. The blockbuster anti-inflammatory painkiller had annual US sales of approximately US$2.6 billion, according to IMS Health data as of October 2014.

Pfizer had hoped to keep generics competition at bay until December 2015, after the company received a reissue patent covering methods of treating osteoarthritis and other approved conditions with celecoxib, the active ingredient in Celebrex [1]. However, in March 2014 the United States District Court for East Virginia invalidated the reissue patent – opening the door to generics from 30 May 2014, when the basic patent on Celebrex expired [2].

That was not the end of the controversy surrounding Celebrex. Actavis and Mylan sued FDA after the agency granted Teva exclusive rights to market generic celecoxib as the ‘first to file’ an abbreviated new drug application (ANDA). The generics makers claimed that the FDA’s decision to award Teva sole exclusivity on generic celecoxib was ‘improper’ and that they should share the rights to exclusivity [3].

This joint launch of generic celecoxib by all three generics makers concerned appears to have vindicated this point of view.

Related article
First generic celecoxib approved by FDA

References
1.   GaBI Online - Generics and Biosimilars Initiative. Pfizer delays generic celecoxib entry in US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Dec 12]. Available from: www.gabionline.net/Generics/News/Pfizer-delays-generic-celecoxib-entry-in-US 
2.   GaBI Online - Generics and Biosimilars Initiative. Celecoxib generics could come sooner than expected [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Dec 12]. Available from: www.gabionline.net/Generics/News/Celecoxib-generics-could-come-sooner-than-expected 
3.   GaBI Online - Generics and Biosimilars Initiative. FDA sued over generic celecoxib approval [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Dec 12]. Available from: www.gabionline.net/Generics/News/FDA-sued-over-generic-celecoxib-approval 

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