The first generic version of the blockbuster cholesterol-lowering drug Lipitor was approved by the Food and Drug Administration Nov. 30.
Ranbaxy Laboratories has gained approval to make generic atorvastatin in 10-mg, 20-mg, 40-mg, and 80-mg doses. The drug will be manufactured by Ohm Laboratories in New Brunswick, N.J., the FDA said.
"This medication is widely used by people who must manage their high cholesterol over time, so it is important to have affordable treatment options," Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.
An agreement between Ranbaxy and Teva Pharmaceuticals USA directs a portion of the profits from sales of atorvastatin during Ranbaxy’s 180-day first-to-file exclusivity period to Teva, according to a statement on the Ranbaxy website.
Lipitor was the best-selling prescription medication in the United States in 2010, with sales of $7.2 billion, and has been the U.S. sales leader since at least 2004, according to data from health care analytics firm IMS Health.
Notes: Based on sales data from IMS Health. Availability dates for first-time generics are subject to significant change.
Source: Medco