Mylan Settles Patent Litigation Over Pfizer’s Viagra

Mylan has settled patent litigation related to Pfizer’s Viagra, paving the way for generic copies of the erectile dysfunction blockbuster in the U.S. in 19 months.

Under the terms of the settlement and a licensing agreement, Mylan can launch generic Viagra (sildenafil citrate) on or after Dec. 11, 2017, subject to any exclusive arrangement that may be granted to third parties, Pfizer spokeswoman Neha Wadhwa said.

Pfizer v Mylan — filed in October 2010 in the U.S. District Court for the Southern District of New York — accused the generics maker of infringing on Viagra’s patent when it submitted an ANDA to the FDA for sildenafil citrate tablets, 25 mg, 50 mg and 100 mg. The patent is set to expire in 2020.

In 2014, Viagra had U.S. sales of roughly $1.3 billion, according to IMS Health. Global sales of Viagra dropped 24 percent last year, compared with the 2013, due mainly to loss of exclusivity in Europe, according to Prizer’s 2014 annual report.

The agreement is subject to review by the Department of Justice and Federal Trade Commission. — Jonathon Shacat