US FDA lifts curbs on Ranbaxy's generic Lipitor sales
01 Dec 2011
Ending uncertainity, the US Food and Drug Administration (FDA) yesterday lifted its curbs on Ranbaxy Laboratories' generic version of Pfizer's blockbuster cholesterol-lowering drug Lipitor for sales in the US.
Lipitor, the best-selling drug in history, which generated over $100-billion in sales for Pfizer since its introduction in 1997, lost its patent protection yesterday.
Without the US FDA approval, Ranbaxy's rights to 180 days of marketing exclusivity (for being tghe first to file a generic equivalent) would have been compromised. (See: No immediate gain for Ranbaxy despite Lipitor patent's expiry)
Ranbaxy will manufacture the generic version of the drug, chemically known as atorvastatin, in 10, 20, 40 and 80 milligram tablets at its Ohm Laboratories unit in New Brunswick, New Jersey.
Pfizer, the world's largest drugmaker, had launched Lipitor in the market in 1997 that generated total sales of around $100 billion, with annual sales touching $13 billion at its peak. The drug lowers bad LDL cholesterol and reduces the risk of heart attack and stroke.
The FDA had blocked New Delhi-based Ranbaxy from introducing the generic version of Lipitor into the US market and in 2008 blocked the company from importing about 30 different drugs into the US because of manufacturing defects at its manufacturing facilities in Madhya Pradesh and Himachal Pradesh, dating back to 2006.
