The companies have filed a patent infringement lawsuit in U.S. District Court for the District of New Jersey against India-based generics company Dr. Reddy’s Laboratories (NYSE:RDY). Dr. Reddy’s notified both companies in March that it had submitted notice to the U.S. Food and Drug Administration that it was seeking approval to market a generic version of Vimovo prior to the expiration of a patent relating to delayed, time-release Vimovo tablets. The patent in question expires in 2023.
Chapel Hill, North Carolina-based Pozen developed Vimovo with AstraZeneca. The drug combines a delayed release form of pain reliever naproxen with AstraZeneca’s stomach acid-reducing drug Nexium. Together, the drugs offer a product that delivers pain relief in a form that’s easier on the stomach. Pozen and AstraZeneca are targeting the market for oral anti-arthritis non-steroidal anti-inflammatory drugs, or NSAIDS. Prescription sales of such drugs for arthritis were $2.7 billion in 2010. The companies are still building sales of Vimovo. In 2010, Pozen received just $15,000 in Vimovo royalty revenue, according to the company’s annual report.
Under the terms of Pozen’s agreement with AstraZeneca, AstraZeneca will take the lead role in prosecuting the suit against Dr. Reddy’s. The filing of the suit within 45 days of receipt of Dr. Reddy’s notice letter will result in the FDA automatically instituting a stay of final approval of Dr. Reddy’s 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. Vimovo currently has regulatory exclusivity through April 30, 2013.
Pozen is also fighting a patent infringement claim for its migraine drug Treximet. A Texas judge earlier this month granted a preliminary injunction ordering Par Pharmaceutical not to make or sell a generic version of the drug.