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14 Apr 2015

Mylan settles Viagra patent litigation with Pfizer

Mylan N.V. announced that its subsidiaries Mylan Inc. and Mylan Pharmaceuticals Inc. reached 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 or “ANDA” filed with the U.S. Food and Drug Administration for Sildenafil Citrate Tablets 25 mg, 50 mg, and 100 mg. This product is the generic version of Viagra, which is indicated to treat erectile dysfunction.

As per 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 U.S. Department of Justice and the Federal Trade Commission.

For the 12 months ending December 31, 2014, Viagra had U.S. sales of about $1.3 billion, according to IMS Health.

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