Mylan Inc. and Schering-Plough Corporation Settle Clarinex Patent Lawsuit
Pursuant to the settlement, Mylan will have the right to market Desloratadine Tablets, 5 mg, in the U.S. on July 1, 2012, or earlier in certain circumstances, provided that the U.S. Food and Drug Administration (FDA) approves Mylan's abbreviated new drug application (ANDA). Mylan's product may be the prescription form or an over-the-counter version, depending on the status of Clarinex at the time. Additional terms of the settlement are confidential, and the agreement is subject to review by the Department of Justice and the Federal Trade Commission.
Desloratadine Tablets, 5 mg, had U.S. sales of approximately $284 million for the 12 months ending Dec. 31, 2008, according to IMS Health.
This press release includes statements that constitute "forward-looking statements," including with regard to the settlement and marketing 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 Inc., which provides products to customers in more than 140 countries and territories, ranks among the leading diversified generics and specialty pharmaceutical companies in the world. The company maintains one of the industry's broadest - and highest quality - product portfolios, supported by a robust product pipeline; owns a controlling interest in the world's third largest active pharmaceutical ingredient manufacturer; and operates a specialty business focused on respiratory and allergy therapies. For more information, please visit www.mylan.com. Website: http://www.mylan.com/