Pfizer delays generic celecoxib entry in US

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Pfizer delays generic celecoxib entry in US

Generics/News | Posted 08/03/2013 0 Post your comment

Pharma giant Pfizer announced on 5 March 2013 that the US Patent Office had given the company an extra 18 months of exclusivity for its blockbuster anti-inflammatory painkiller Celebrex (celecoxib).

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

The US Patent Office has granted Pfizer a reissue patent covering methods of treating osteoarthritis and other approved conditions with celecoxib, the active ingredient in Celebrex.

The basic patent for celecoxib was due to expire on 30 May 2014 (including six months of paediatric exclusivity). The reissue patent will expire on 2 December 2015, which also includes six months of paediatric exclusivity.

Pfizer also announced that it had filed law suits against Apotex, Lupin Pharmaceuticals USA, Mylan Pharmaceuticals, Teva Pharmaceuticals USA and Watson Laboratories in the US District Court for the Eastern District of Virginia for infringement of the reissue patent. The generics companies have filed abbreviated new drug applications with FDA seeking approval to market generics of celecoxib in the US beginning in May 2014, prior to the 2 December 2015 expiration of the reissue patent.

Celebrex earned Pfizer US$2.7 billion worldwide during 2012, with US$1.7 billion coming from the US, making it one of the company’s bestsellers now that Lipitor (atorvastatin) is off patent. The extra 18 months delay before generics can enter the US market could mean an extra couple of billion in sales, with each day that Pfizer can delay generics competition estimated to bring in about US$5 million in revenue for the company.

Pfizer is not one to give up easily when it comes to competition from generics. The company notoriously pulled out all the stops to delay generic erosion of its market share in the case of its blockbuster cholesterol-reducing drug Lipitor (atorvastatin), even after its patent protection expired [1, 2].

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Reference

1. GaBI Online - Generics and Biosimilars Initiative. Pfizer continues to fight for Lipitor [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Mar 8]. Available from: www.gabionline.net/Generics/News/Pfizer-continues-to-fight-for-Lipitor

2. GaBI Online - Generics and Biosimilars Initiative. Can generic competition succeed at reducing cost of atorvastatin? [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Mar 8]. Available from: www.gabionline.net/Generics/Research/Can-generic-competition-succeed-at-reducing-cost-of-atorvastatin

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Source: Bloomberg, Pfizer, Reuters