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FDA approves Teva’s Viagra generic Posted 25/03/2016

Israeli generics giant Teva Pharmaceuticals (Teva) has received US Food and Drug Administration (FDA) approval for its generic version of Pfizer’s blockbuster erectile dysfunction drug Viagra (sildenafil), which is also called Revatio in the US.

Teva received approval for 25, 50 and 100 mg tablets of sildenafil from FDA on 9 March 2016. However, due to a 2013 pay-for-delay settlement with Pfizer, Teva would not be able to launch the drug until December 2017 at the earliest. Pfizer has also made a similar agreement with Mylan to delay its generic version until 2017.

Teva already launched a generic version of Viagra in Europe back in June 2013 [1].

The erectile-dysfunction drug has been a big earner for Pfizer. The Revatio brand had US sales of approximately US$339 million for the 12 months ending September 2012 according to IMS Health.

Pfizer had thought that its 012 patent would protect the blockbuster until it expired in October 2019 and has tried to protect its drug with patent litigation. However, as well as Teva, Apotex Corporation, Dr. Reddy’s Laboratories, Mylan, Torrent Pharmaceuticals and Watson Laboratories have all received FDA approval for bioequivalent generic versions of Pfizer’s Viagra [2].

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Source: US FDA

References
1. GaBI Online - Generics and Biosimilars Initiative. Viagra generics hit the market in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Mar 10]. Available from: www.gabionline.net/Pharma-News/Viagra-generics-hit-the-market-in-Europe

2. GaBI Online - Generics and Biosimilars Initiative. Generic competition for Pfizer’s sildenafil [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Mar 10]. Available from: www.gabionline.net/Generics/News/Generics-competition-for-Pfizer-s-sildenafil

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