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Celecoxib generics could come sooner than expected

Generics/News | Posted 28/03/2014 0 Post your comment

Pharma giant Pfizer confirmed on 12 March 2014 that the United States District Court for East Virginia had invalidated its reissue patent covering methods of treating osteoarthritis and other approved conditions with celecoxib, the active ingredient in its blockbuster anti-inflammatory painkiller Celebrex.

Celecoxib is a sulfonamide non-steroidal anti-inflammatory drug (NSAID) and selective COX-2 inhibitor. It is indicated for the treatment of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, acute pain, painful menstruation and menstrual symptoms.

The reissue patent, which was granted by the US Patent Office on 5 March 2013 and included six months of paediatric exclusivity, was due to expire on 2 December 2015. The basic patent for celecoxib will expire on 30 May 2014 (including six months of paediatric exclusivity) [1], opening up the door to generic competition sooner than expected.

Pfizer was expecting an extra 18 months of protection for the drug, which earned the company US$2.2 billion in the US alone during 2013. The company had also been suing generics companies Apotex, Lupin Pharmaceuticals USA, Mylan Pharmaceuticals (Mylan), Teva Pharmaceuticals USA and Watson Laboratories (now Actavis) for infringement of the reissue patent.

Pfizer has announced that it will appeal the decision, but the news has already prompted generics companies Actavis and Mylan to announce that they will launch their celecoxib generics in May 2014, following expiration of the basic patent on celecoxib. Both have already filed Abbreviated New Drug Applications (ANDAs) with the US Food and Drug Administration (FDA). Actavis also announced that it believes that it may be the ‘first-to-file’, giving it 180-day of market exclusivity for its generic version.

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Reference

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 Mar 28]. Available from: www.gabionline.net/Generics/News/Pfizer-delays-generic-celecoxib-entry-in-US

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