First generic celecoxib approved by FDA

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First generic celecoxib approved by FDA

Generics/News | Posted 13/06/2014 0

The US Food and Drug Administration (FDA) announced on 30 May 2014 that it had approved the first generic versions of celecoxib capsules.

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.

FDA granted approval to market generic celecoxib in 50, 100, 200 and 400 mg dosages to Teva Pharmaceutical Industries (Teva), giving Teva 180-days of marketing exclusivity in the US.

The product is a generic of Pharma giant Pfizer’s blockbuster anti-inflammatory painkiller Celebrex (celecoxib). Pfizer had been trying to delay the entry of generics in the US, and had been granted a reissue patent covering methods of treating osteoarthritis and other approved conditions with celecoxib, the active ingredient in Celebrex [1].

The reissue patent would have extended the patent protection on Celebrex to 2 December 2015 and Pfizer had sued several generics companies including Actavis, Mylan Pharmaceuticals (Mylan) and Teva for infringement of the reissue patent. 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].

FDA’s decision to grant Teva exclusive rights to market generic celecoxib as the ‘first to file’ an abbreviated new drug application (ANDA) was challenged by Actavis and Mylan. The generics makers sued FDA, claiming that FDA’s decision to award Teva sole exclusivity on generic celecoxib was ‘improper’ and that they should share the rights to exclusivity [3]. However, Teva announced on 30 May 2014 that the US District Court for West Virginia had denied the motion and upheld FDA’s decision to grant Teva marketing exclusivity.

In April 2014, Teva entered into a settlement agreement with Pfizer related to generic celecoxib. The agreement allows Teva to launch its generic in December 2014, or earlier under certain circumstances. Therefore whether generic celecoxib will hit the market soon or whether the agreement will delay generics until December 2014 waits to be seen.

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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 Jun 13]. 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 Jun 13]. 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 Jun 13]. Available from: www.gabionline.net/Generics/News/FDA-sued-over-generic-celecoxib-approval

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Source: FDA, Teva