FDA sued over generic celecoxib approval

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FDA sued over generic celecoxib approval

Generics/News | Posted 09/05/2014 0 Post your comment

Generics makers Actavis and Mylan Pharmaceuticals (Mylan) have sued the US Food and Drug Administration (FDA) over the agency’s decision to award exclusive rights to Teva Pharmaceutical Industries (Teva) to sell a generic version of Pfizer’s blockbuster anti-inflammatory painkiller Celebrex (celecoxib).

Actavis filed a lawsuit against FDA on 28 April 2014 in the US District Court for the District of Columbia, claiming that the FDA’s decision to award Teva sole exclusivity on generic celecoxib was ‘improper’. The US-based generics maker claims that the decision goes against an earlier ruling from the US Court of Appeals for the Federal Circuit that resulted in the triggering and subsequent expiration of Teva’s sole exclusivity on the product. Actavis says that it should have shared 180-day marketing exclusivity for its generic version of celecoxib.

Mylan, in its lawsuit of 25 April 2014, states that the FDA ‘has seriously erred in its decision in this case’. The India-based generics maker maintains that it is in a position to receive final approval on 30 May 2014, upon expiration of Celebrex’s remaining patents. Other companies, including Actavis and Teva, have settled for a December 2014 launch date and will be unable to launch on 30 May 2014.

The basic patent for celecoxib was due to expire on 30 May 2014 (including six months of paediatric exclusivity). Pfizer was granted a reissue patent, covering methods of treating osteoarthritis and other approved conditions with celecoxib, extending patent protection on Celebrex until 2 December 2015 [1]. However, on 12 March 2014, the District Court for East Virginia invalidated this reissue patent, opening up the door to generics from 30 May 2014 [2].

In light of this decision, Mylan is seeking an order compelling FDA to grant final approval of its abbreviated new drug application (ANDA) on 30 May 2014.

Celebrex, which 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, earned Pfizer US$2.2 billion worldwide during 2013, according to IMS Health data.

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 May 9]. Available from: http://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 May 9]. Available from: www.gabionline.net/Generics/News/Celecoxib-generics-could-come-sooner-than-expected

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Source: Actavis, Mylan