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SILVER SPRING, Md. — Ranbaxy Labs got the green light from the Food and Drug Administration Wednesday night to launch its generic version of Pfizer's cholesterol-lowering drug Lipitor.
The FDA announced the approval of Ranbaxy's atorvastatin calcium tablets in the 10-mg, 20-mg, 40-mg and 80-mg strengths. New Brunswick, N.J.-based Ohm Labs will manufacture the drug.
"Atorvastatin helps millions of Americans manage healthy cholesterol levels, and we are pleased to have received FDA approval to manufacture and market a safe, effective, affordable and accessible alternative to branded Lipitor," Ranbaxy CEO and managing director Arun Sawhney said.
Ranbaxy had been scheduled to launch earlier Wednesday to coincide with the expiration of Pfizer's patent on Lipitor, but the FDA held off approval until the resolution of quality-control issues related to two of its manufacturing plants in India. Watson Pharmaceuticals announced the launch of its authorized generic version Wednesday morning.
Under federal law, Ranbaxy is entitled to 180 days of market exclusivity in which to compete directly with Pfizer. While the FDA is not allowed to give final approval to any other generic version of the drug until that exclusivity period is over, Watson still can market its authorized generic because it is the branded version of the drug marketed under its generic name and is thus not subject to regulatory approval.
Ranbaxy said that due to an agreement between it and Teva Pharmaceuticals USA, a portion of the profits from sales of the drug during the exclusivity period, though terms of the agreement were not disclosed.
Lipitor had sales of $7.8 billion during the 12-month period ended in September, according to IMS Health.