Dr Reddy's gets favorable Prilosec ruling

Indian-owned pharmaceutical firm Dr Reddy's Laboratories says that the US District Court (Southern District, New York) has granted a summary  judgment that its omeprazole over-the-counter Abbreviated New Drug  Application does not infringe the patents in suit related to Astra  Zeneca's Prilosec (omeprazole) OTC. The Anglo-Swedish drug major had  sued Dr Reddy's to prevent it selling a version of the drug.

Commenting on the judgment, Amit Patel, head - North America generics -  at Dr Reddy's, said: "we are very pleased with the favorable summary  judgment ruling in the omeprazole 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 Food and Drug  Administration response. At this point in time, we will continue to work  through the regulatory approval process while simultaneously progressing  manufacturing and commercialization preparation."

Omeprazole 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 around $362.0 million in the USA,  based on IRI sales data as of July 13, 2008.