India-based pharmaceutical company Dr. Reddy's Laboratories has said that the U.S. District Court for the Southern District of New York has ruled 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.
Amit Patel, Head - North America Generics at 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.”