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Generics competition for Pfizer’s sildenafil Posted 23/11/2012

Apotex Corporation, Dr Reddy’s Laboratories, Mylan, Torrent Pharmaceuticals and Watson Laboratories have all received FDA approval for bioequivalent generic versions of Pfizer’s Revatio (sildenafil citrate – Viagra in Europe) in the US market following the approval by FDA of the generics companies abbreviated new drug applications (ANDAs) for sildenafil tablets.

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

Pfizer had tried to stop generic versions hitting the market in the US by filing a patent-infringement lawsuit against generics companies Actavis, Amneal Pharmaceuticals, Apotex and Mylan, all of whom had submitted ANDAs for sildenafil citrate to FDA. Pfizer had thought that its 2012 patent would protect the blockbuster until it expired in October 2019, however, it seems the pharma giant has lost its fight.

Viagra is the world leader in erectile dysfunction, and Pfizer has much to lose. Worldwide sales in 2009 of US$1.89 billion made up approximately 3.8% of Pfizer’s total revenue.

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Source: Dr Reddy’s, FDA, Watson

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