POTTERS BAR, England, April 13, 2015 /PRNewswire/ -- Mylan N.V. (NASDAQ: MYL) today announced that its subsidiaries Mylan Inc. and Mylan Pharmaceuticals Inc. (“Mylan”) 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 U.S. Food and Drug Administration (“FDA”) 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.
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 U.S. Department of Justice and the Federal Trade Commission.
For the 12 months ending Dec. 31, 2014, Viagra had U.S. sales of approximately $1.3 billion, according to IMS Health.
This press release includes statements that constitute “forward-looking statements,” including with regard to the settlement of litigation, product approvals, and sales of products. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: any legal or regulatory challenges to the settlement; strategies by competitors or other third parties to delay or prevent product introductions; risks inherent in legal and regulatory processes; uncertainties and matters beyond the control of management, and the other risks detailed in the company’s filings with the Securities and Exchange Commission. The company undertakes no obligation to update these statements for revisions or changes after the date of this release.
Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what’s right, not what’s easy; and impact the future through passionate global leadership. We offer a growing portfolio of around 1,400 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which approximately 40% of HIV/AIDS patients in developing countries depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in about 145 countries and territories. Our workforce of approximately 30,000 people is dedicated to creating better health for a better world, one person at a time. Learn more at mylan.com
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SOURCE Mylan N.V.
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