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Dr. Reddy’s Announces Settlement of Clarinex® (Desloratadine) ANDA Patent litigation With Schering Corporation and Sepracor Inc.

By Pharmaceutical Processing | December 23, 2008

Dr. Reddy’s Laboratories has entered into agreements with Schering and Sepracor which will allow Dr. Reddy’s to manufacture and market generic versions of the CLARINEX-D®-12 Hour and CLARINEX-D® -24 Hour products, with six months marketing exclusivity, and the CLARINEX® REDITABS® product, with six months marketing co-exclusivity, starting in 2012. Dr. Reddy’s will also market a generic version of the CLARINEX® 5 milligram tablet six months after the launch of the first generic version of that product. The agreements resolve all pending patent infringement actions filed by Schering and Sepracor against Dr. Reddy’s in the U.S. District Court for the District of New Jersey. The agreements provide for potential modification of select terms based on certain events and developments. The specific financial terms and conditions of the agreements have not been disclosed. The agreements are subject to review by the United States Federal Trade Commission and Department of Justice. CLARINEX®, a nonsedating antihistamine, offers relief from seasonal allergic rhinitis and perennial allergic rhinitis, as well as chronic idiopathic urticaria, or hives of unknown cause. CLARINEX-D® 24 Hour Extended Release Tablets is the only once-daily prescription antihistamine and decongestant combination treatment on the market to provide 24-hour relief of nasal and non-nasal allergy symptoms. Total U.S. sales for all formulations of CLARINEX® products were $362 million in 2007.

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