CHAPEL HILL, N.C. — A generic drug maker is being sued for patent infringement for its version of a fixed-dose combination drug co-created by Pozen and AstraZeneca.
Pozen and AstraZeneca on Monday said that they have filed the suit in the U.S. District Court for the District of New Jersey against Dr. Reddy's. The drug makers said Dr. Reddy's is seeking approval from the Food and Drug Administration for its generic version of Vimovo (naproxen/esomeprazole magnesium) delayed-release tablets prior to the patent's expiration date. Vimovo currently has regulatory exclusivity through April 30, 2013, Pozen and AstraZeneca said.
The filing of this patent infringement lawsuit by AstraZeneca and Pozen within 45 days of receipt of Dr. Reddy’s notice letter will result in the FDA automatically instituting a stay or bar of final approval of Dr. Reddy’s abbreviated new drug application for up to 30 months, or until a final court decision is entered in the infringement suit in favor of Dr. Reddy’s, whichever occurs first.