Dr Reddy's gets favorable ruling on Omeprazole Mg OTC

Dr. Reddy's Laboratories announced that the U S District (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 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 we 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 20.6 mg Omeprazole Mg (Salt). The Prilose OTC brand product has annual sales of about US$362mn in the United States, based on IRI sales data as of July 13, 2008.