HYDERABAD, India--(BUSINESS WIRE)--Dr. Reddy’s Laboratories (NYSE: RDY) announced today that it has launched CLOPIDOGREL TABLETS, USP 75 mg & 300 mg, a bioequivalent generic version of PLAVIX®, in the U.S. market on May 18, 2012. The ANDAs for Clopidogrel Tablets USP, 75 mg & 300 mg are approved by the United States Food & Drug Administration (USFDA). Dr. Reddy’s Laboratories was among the first applicants to submit a substantially complete ANDA for Clopidogrel Tablets USP, 300 mg with a Paragraph IV certification, and was awarded 180 days of marketing exclusivity for this strength.
The PLAVIX® brand had U.S. sales of approximately $6.740 billion for the most recent twelve months ending March 2012 according to IMS Health.
Dr. Reddy’s Clopidogrel Tablets USP, 75 mg are available in bottle count sizes of 30, 90 and 500, and Clopidogrel Tablets USP, 300 mg are available in blister packs of 30's count.
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.
About Dr. Reddy’s
Dr. Reddy’s Laboratories Ltd. (NYSE: RDY) is an integrated global pharmaceutical company committed to providing affordable and innovative medicines for healthier lives. Through its three businesses - Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars, differentiated formulations and NCEs. Therapeutic focus is on gastro-intestinal, cardiovascular, diabetology, oncology, pain management, anti-infective and pediatrics. Major markets include India, USA, Russia and CIS, Germany, UK, Venezuela, S. Africa, Romania, and New Zealand. For more information, log on to: www.drreddys.com
Plavix® is a registered trademark of Sanofi-Aventis.
IMS National Sales Perspectives: Retail and Non-Retail MAT March 2012