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

2008-12-23 15:29:02 -

Dr. Reddy's Laboratories today announced that it 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.
About Dr. Reddy's
Established in 1984, Dr. Reddy's Laboratories (NYSE:RDY) is an emerging global pharmaceutical company with proven research capabilities. The Company is vertically integrated with a presence across the pharmaceutical value chain. It produces finished dosage forms, active pharmaceutical ingredients and biotechnology products and markets them globally, with focus on India, US, Europe and Russia. The Company conducts research in the areas of cancer, diabetes, cardiovascular, inflammation and bacterial infection. For further information please see: www.drreddys.com
Disclaimer
This press release includes forward-looking statements, as defined in the U.S. Private Securities Litigation Reform Act of 1995. We have based these forward-looking statements on our current expectations and projections about future events. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results to differ materially. Such factors include, but are not limited to, changes in local and global economic conditions, our ability to successfully implement our strategy, the market acceptance of and demand for our products, our growth and expansion, technological change and our exposure to market risks. By their nature, these expectations and projections are only estimates and could be materially different from actual results in the future.

for Dr. Reddy's Laboratories

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