NEW YORK — A generic version of the world’s top-selling cholesterol treatment is expected to hit the market this year, but the branded version’s manufacturer is trying to put the brakes on the launch, according to media reports.
Gurgaon, India-based Ranbaxy Labs plans to launch its version of Pfizer’s cholesterol-lowering drug Lipitor (atorvastatin) in the United States in November and will receive six months’ market exclusivity in which to compete directly against Pfizer’s version, under the terms of the Hatch-Waxman Act of 1984.
Dr. Reddy’s Labs, based in Hyderabad, India, had planned to launch its own version in May 2012, but Pfizer has filed a lawsuit against the company to delay the launch, alleging that the launch would infringe its patents.
The last of the patents protecting Lipitor’s use in adults is set to expire in July 2016, according to the Food and Drug Administration. The drug had U.S. sales of $7.5 billion in 2009, according to IMS Health.