Mylan, Pfizer Settle Viagra Litigation

Mylan N.V. and its subsidiaries, Mylan Inc. and Mylan Pharmaceuticals Inc., have entered into a settlement and license agreement with Pfizer Inc., Pfizer Limited and Pfizer Ireland Pharmaceuticals to settle patent litigation relating to Mylan’s abbreviated new drug application ANDA) filed with the US Food and Drug Administration (FDA) for sildenafil citrate tablets 25 mg, 50 mg, and 100 mg. This product is the generic version of Pfizer’s Viagra, which is indicated to treat erectile dysfunction.

Under the terms of the agreement, Mylan will be able to launch its ANDA products pursuant to a royalty-bearing license as early as December 11, 2017, or sooner under certain conditions, subject to FDA approval. All other terms and conditions of the settlement and license agreement are confidential, and the agreement itself is subject to review by the US Department of Justice and the Federal Trade Commission.

For the 12 months ending Dec. 31, 2014, Viagra had US sales of approximately $1.3 billion, according to IMS Health, and as reported by Mylan.

Source: Mylan

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