Sun Pharma: An update on generic Protonix® litigation

Mumbai, July 17, 2010: Sun Pharma announced that the U.S. District Court for the District of New Jersey denied its motion for judgment as a matter of law seeking to reverse the earlier jury verdict in the patent litigation over generic Protonix®.  The detailed opinion of the Court supporting this order has not yet been issued.  Sun Pharma continues to believe that the patent is invalid and unenforceable and will pursue all available legal remedies including appeals.

Other claims of Sun Pharma, including patent misuse and unclean hands, that also concern the validity and enforceability of the patents remain pending.  In view of this, the Court denied Wyeth and Nycomed’s motion seeking a court order to set the effective approval date for the ANDA to January 20, 2011, the first day after the end of pediatric exclusivity.  As a result, Sun Pharma is not prohibited from further selling the product prior to January 20, 2011.

Pantoprazole Sodium DR Tablets are the AB-rated generic equivalent of Wyeth's Protonix® DR Tablets.  Sun Pharma had announced a commercial launch of the product on January 30, 2008, after the December 22, 2007 commercial launch by Teva Pharmaceutical Industries Ltd. of generic Pantoprazole Sodium tablet products, and after the January 29, 2008 commercial launch by Wyeth of generic Pantoprazole Sodium tablets product through its designated distributor.

Protonix® is a registered trademark of Wyeth Pharmaceuticals, Inc.

About Sun Pharmaceutical Industries Ltd.

Established in 1983, listed since 1994 and headquartered in India, Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715) is an international, integrated, speciality pharmaceutical company.  It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India, US and several other markets across the world.  In India, the company is a leader in niche therapy areas of psychiatry, neurology, cardiology, diabetology, gastroenterology, and orthopedics.  The company has strong skills in product development, process chemistry, and manufacturing of complex API, as well as dosage forms. More information about the company can be found at www.sunpharma.com.