Ranbaxy to get USFDA nod for Lipitor generic

2 December 2011:  Ranbaxy Laboratories, one of India's largest generic drug manufacturers, is on a way to receive an approval from US drug regulator United States Food and Drugs Administration (USFDA) to launch a copycat version of Pfizer's block-buster drug Lipitor shortly.

Ranbaxy has a first-to-file (FTF) opportunity to launch the generic version of Lipitor in the US market today, after Pfizer's patent on the drug expires. The FTF gives Ranbaxy the right to market the drug exclusively in the US for a period of six months. Lipitor is a cholesterol-lowering drug which accounts for more than $12 billion (approx Rs. 61,644 crore) in annual sales for Pfizer. Pfizer has an agreement with Watson Pharmaceuticals to market an authorized generic version of Lipitor as part of an agreement between the two companies.

Source: Economic Times