US generic drugs major Mylan (Nasdaq: MYL) and certain of its subsidiaries have entered into a settlement and license agreement with US pharma giant Pfizer (NYSE: PFE) to settle patent litigation relating to Mylan's Abbreviated New Drug Application filed with the US Food and Drug Administration for sildenafil citrate tablets, a generic version of the blockbuster erectile dysfunction drug Viagra.
Under the terms of the accord, otherwise known as a pay-for-delay deal, Mylan will be able to launch its ANDA products under 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 December 31, 2014, Viagra had US sales of around $1.3 billion, according to IMS Health data quoted by Mylan.
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