Published on April 9, 2009 at 1:40 PM
Mylan Inc. has announced the settlement of all patent litigation relating to Desloratadine Tablets, 5 mg, the generic version of Schering- Plough's Clarinex allergy medication.
This litigation has been pending in the U.S. District Court of New Jersey since September 2006.
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.
http://www.mylan.com/