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FDA Approves Generic Version of Viagra

03/10/2016

The FDA approved the first generic version of Viagra (sildenafil citrate, Teva Pharmaceutical Industries) for the treatment of erectile dysfunction. Generic sildenafil citrate tablets are approved at 25 mg, 50 mg, and 100 mg strengths.

Teva has 180-day exclusivity. In 2013, Teva and Pfizer, the original manufacturer of Viagra, reached a patent settlement that would allow the generic to enter the market on December 11, 2017—or earlier under certain circumstances—with patent royalties paid to Pfizer until April 2020, when the Viagra patent expired.

Generic ildenafil citrate has been sold in Europe since 2013.

 

Reference: US FDA grants final approval for generic Viagra. ThePharmaLetter. March 10, 2016. 

Pipeline Projections

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