Dr. Reddy’s Laboratories has announced that the U.S. District Court (Southern District, New York) has granted a summary judgment that the Omeprazole Mg OTC ANDA filed by Dr. Reddy’s does not infringe the patents in suit related to Astra Zeneca’s Prilosec OTC®. Commenting on the judgment, Amit Patel, Head – North America Generics, Dr. Reddy’s, said, “We are very pleased with the favorable summary judgment ruling in the Omeprazole Mg OTC litigation. This is a key event supporting our strategy to deliver one upside opportunity every year. We have submitted our ANDA filing and are awaiting FDA response. At this point in time, we will continue to work through the regulatory approval process while simultaneously progressing manufacturing and commercialization preparation.” Omeprazole Mg is indicated for the treatment of heartburn and the Dr. Reddy’s formulation contains 20.6mg Omeprazole Mg (Salt). The Prilosec OTC® brand product has annual sales of approximately $362 million in the United States, based on IRI sales data as of July 13, 2008.
