Mylan Inc. Announces Settlement Agreement in Litigation Relating to its Generic Xopenex®
PITTSBURGH, May 29, 2012 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that Mylan Specialty L.P., f/k/a Dey Pharma, L.P., has entered into a settlement agreement with Sunovion Pharmaceuticals Inc., f/k/a Sepracor Inc., that will resolve the parties' patent litigation in connection with Mylan Specialty's Abbreviated New Drug Application (ANDA) for Levalbuterol Hydrochloride (HCl) Inhalation Solution, 0.31 mg/3 mL, 0.63 mg/3 mL, 1.25 mg/3 mL and 1.25 mg/0.5mL. Levalbuterol HCl is the generic version of Sunovion's Xopenex® product.
According to the terms of the settlement, Mylan Specialty is licensed to continue sales of its concentrate product (Levalbuterol HCl 1.25 mg/0.5mL) and will have a royalty-bearing license to sell its non-concentrate product (Levalbuterol HCl 0.31mg/3mL, 0.63mg/3mL, and 1.25mg/3mL) upon receiving final approval from the U.S. Food and Drug Administration. The settlement also releases Mylan from payment of the $18 million jury damage award to Sunovion.
Pursuant to the agreement, pending litigation will be dismissed. Other details of the settlement are confidential, and the agreement itself is subject to review by the U.S. Department of Justice and the Federal Trade Commission.
This press release includes statements that constitute "forward-looking statements," including with regard to the settlement of the litigation and sales of the product. 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.