Dr Reddy's Laboratories has received clearance from a US court that its over-the-counter drug `Omeprazole Mg' does not infringe the patents in suit related to Astra Zeneca's `Prilosec OTC'.
In a summary judgment, the district court of the southern district of New York has granted that the ANDA filed by Dr Reddy's does not infringe the trademark of patented Astra Zeneca drug `Prilosec OTC'.
''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,'' Amit Patel, head of North America Generics, Dr Reddy's, said.
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 13 July 2008, the company said in its release.
Dr Reddy's said the statements were based on its current expectations and projections about future events and that they may involve known and unknown risks, uncertainties and other factors that may cause actual results to differ materially.
Dr Reddy's Laboratories is a vertically integrated pharmaceutical company with a presence across the pharmaceutical value chain through its core businesses of generics, pharmaceutical services and active ingredients, and proprietary products, which includes new chemical entities, biosimilars, Specialty and differentiated formulations. The company's products are marketed globally, with a focus on India, the US, Europe and Russia.