Teva Wins FDA Approval for First Viagra Generic, Will Not Launch Until 2017

Teva Pharmaceuticals will take a bite out of Pfizer’s blockbuster Viagra (sildenafil citrate) sales as the US Food and Drug Administration approved a generic version of the erectile dysfunction drug on Wednesday.

But the generic savings will not come until December 2017. Teva spokeswoman Denise Bradley told Focus that because of a 2013 pay-for-delay settlement with Pfizer, Teva has agreed to not launch the generic until December 2017.

Generic giant Mylan also agreed with Pfizer not to launch its generic version of Viagra until 2017.

Israel-based Teva won FDA approval for three different strengths of the drug: 25 mg, 50 mg and 100 mg and has been selling its generic version in the EU since 2013.Teva will pay royalties through the expiration of the Viagra patent in the US in April 2020.

At least nine other generic manufacturers have filed abbreviated new drug applications with FDA seeking approval for their versions of generic Viagra. 

FDA Approval of Generic Viagra