PITTSBURGH, June 8, 2012 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has resolved all disputes with Teva Pharmaceuticals USA, Inc. stemming from litigation brought by Mylan in federal court in the District of Columbia against the U.S. Food and Drug Administration (FDA) concerning Mylan’s abbreviated new drug application (ANDA) for Modafinil Tablets, 100 mg and 200 mg. Modafinil Tablets are the generic version of Cephalon’s Provigil®, indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea and shift work disorder.
Pursuant to the terms of the agreement with Teva, Mylan is permitted to launch its Modafinil Tablets, 100 mg and 200 mg, on August 10, 2012, which is prior to the expiration of the 180-day marketing exclusivity period granted to Teva. Other details of the settlement are confidential, and the agreement is subject to review by the U.S. Department of Justice and the Federal Trade Commission.
Modafinil Tablets, 100 mg and 200 mg, had U.S. sales of $1.2 billion for the 12 months ending March 31, 2012, according to IMS Health.
This press release includes statements that constitute “forward-looking statements,” including with regard to the settlement of the litigation. 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; and the other risks detailed in the company’s periodic 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 health care. 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 a habit, do what’s right, not what’s easy and impact the future through passionate global leadership. We offer a growing portfolio of more than 1,100 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which approximately one-third of HIV/AIDS patients in developing countries depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in approximately 150 countries and territories. Our workforce of more than 18,000 people is dedicated to improving the customer experience and increasing pharmaceutical access to consumers around the world. But don’t take our word for it. See for yourself. See inside. mylan.com
SOURCE Mylan Inc.
