Dr. Reddy’s Laboratories (NYSE: RDY) announced today that it has launched over-the-counter (OTC) Lansoprazole delayed-release capsules in the U.S. market on May 18, 2012, following Dr. Reddy’s ANDA approval by the United States Food & Drug Administration (USFDA).
Dr. Reddy’s will market the product under store brand labels in the U.S. market. The product is the bioequivalent version of Novartis Consumer Health’s Prevacid®24 HR capsule which received Rx-to-OTC switch approval with 3 year exclusivity from the FDA on March 18, 2009. The Prevacid®24 HR capsule market had brand sales of approximately $115 million for the twelve months ending March 2012 according to SymphonyIRI InfoScan Reviews™.
Dr. Reddy’s Lansoprazole Capsule in 15 mg strength is available in 14, 28 and 42 count pack size.
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
– 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:
Prevacid®24 HR is a registered trademark of Takeda Pharmaceuticals North America, Inc.
SymphonyIRI InfoScan Reviews™; FDMx 52 weeks ending March 2012.