PITTSBURGH, April 11, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today confirmed that a federal district court has granted its request to enforce a settlement agreement between Endo Pharmaceuticals and Mylan settling patent litigation in connection with Mylan's filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Frovatriptan Succinate Tablets, 2.5 mg. This product is the generic version of FROVA®, which is used to treat acute migraine headaches in adults.
As a result of the decision, the Court has vacated its January 28, 2014, decision in favor of Endo regarding the parties' patent litigation over this product, which could have prevented Mylan from launching its generic version of FROVA until after the expiration of U.S. Patent 5,464,864 patent on November 7, 2015. By enforcing the settlement, Mylan can launch its product pursuant to the terms of the settlement, contingent upon final FDA approval.
For the 12 months ending Dec. 31, 2013, Frovatriptan had U.S. sales of approximately $66.41 million, according to IMS Health.
Currently, Mylan has 187 ANDAs pending FDA approval representing $94.9 billion in annual brand sales, according to IMS Health. Forty-two of these pending ANDAs are potential first-to-file opportunities, representing $25.4 billion in annual brand sales, for the 12 months ending Dec. 31, 2013, according to IMS Health.
This press release includes statements that constitute "forward-looking statements," including with regard to the settlement of litigation 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; 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 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 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 more than 1,300 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 approximately 140 countries and territories. Our workforce of more than 20,000 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.