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Dr. Reddy’s Announces Settlement of Exelon® ANDA Litigation With Novartis
Monday, January 21, 2008
Hyderabad, India -- Dr. Reddy’s Laboratories (NYSE: RDY) today announced that it has entered into a settlement agreement with Novartis Pharma AG which involves a stipulation of dismissal of the lawsuits in the United States relating to the Abbreviated New Drug Applications filed by Dr. Reddy’s for a generic version of rivastigmine tartrate capsules sold under the trade-name Exelon.
Under the terms of the agreement, Dr. Reddy’s will not launch its generic Rivastigmine Tartrate capsules until sometime before the expiry of the Orange Book patents claiming Rivastigmine. The exact date of launch and other terms of this agreement are confidential. In October 2007, the Company received the final approval from U.S. FDA on its ANDA for Rivastigmine capsules.
Rivastigmine tartrate capsules is the generic version of the Novartis product Exelon indicated for the treatment of mild-to-moderate Alzheimer’s disease dementia. As per the IMS June 2007 Moving Annual Total, the annual sales of this product in the US were $199 million.
About Dr. Reddy’s
Dr. Reddy’s Laboratories was established in 1984 in Hyderabad, India, and is a global pharmaceutical company with proven research capabilities. Dr. Reddy’s conducts research in the areas of diabetes, cardiovascular, anti-infectives, inflammation and cancer. The Indian based company produces finished dosage forms, active pharmaceutical ingredients and biotechnology products which are marketed globally, with focus on India, US, Europe and Russia.
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.
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