NEW YORK — Generic drug maker Mylan is suing the Food and Drug Administration in an effort to prevent Gurgaon, India-based competitor Ranbaxy Labs from launching its generic version of Pfizer’s cholesterol medication Lipitor, according to published reports.
Bloomberg reported that Mylan said in a complaint filed in federal court in Washington that because of past manufacturing violations at two of Ranbaxy’s factories in India, other companies should be able to launch versions of Lipitor (atorvastatin) once Pfizer’s patent expires in June. The FDA restricted certain imports from Ranbaxy’s plants in India in 2008 and 2009 after an inspection of plants in Dewas and Paonta Sahib turned up current good manufacturing practice violations there. The FDA also had found cGMP violations at the Paonta Sahib plant in 2006.
Ranbaxy, mostly owned by Japanese drug maker Daiichi Sankyo, has been slated to launch a generic version of Lipitor this year since 2008, under an agreement with Pfizer. Under FDA regulations, Ranbaxy would be entitled to six months in which to compete directly with Pfizer, after which the atorvastatin molecule would become fair game for any generic manufacturer. But Mylan is hoping to use Ranbaxy’s past cGMP violations to expedite the process.
A victory for Mylan would be a major loss for Ranbaxy given Lipitor’s status as the world’s top-selling drug, with annual sales of more than $7 billion in the United States alone, according to IMS Health.
In other news, Bloomberg reported that the Supreme Court rejected Mylan’s challenge to Daiichi Sankyo’s patent on the hypertension drugs Benicar (olmesartan) and Azor (olmesartan and amlodipine).