Ranbaxy wins FDA approval to sell generic version of cholesterol-lowering drug
Pfizer looks set to take a hit on its sales of Lipitor (atorvastatin) as the US FDA approved the first generic version of the cholesterol-lowering drug yesterday (30 November).
The patent expiration opens the door to cheaper generic versions of the drug, yet analysts have suggested that Pfizer could retain as much as 40% of its Lipitor sales in the coming months.
Ranbaxy Laboratories of India has received approval to manufacture and distribute generic atorvastatin calcium tablets in 10mg, 20mg, 40mg, and 80mg strengths. The FDA said Ohm Laboratories of New Brunswick, NJ, US would manufacture the drug.
According to an agreement between Ranbaxy and Teva Pharmaceuticals USA, a portion of the profits from sales of atorvastatin during Ranbaxy’s 180-day first-to-file exclusivity period will be paid to Teva.
Pfizer said it would sell Lipitor ‘at or below the cost of a generic’ during Ranbaxy’s 180-day exclusivity period.
Ranbaxy originally submitted a request for approval from the FDA in 2002. In 2008, the firm reached agreement with Pfizer allowing for sales to start on 30 November.
Watson Pharmaceuticals of New Jersey has launched an ‘authorised generic version’ of Lipitor, as part of an exclusive five-year deal with Pfizer.
Under the terms of the agreement, Pfizer will manufacture and supply Watson with all dosage strengths of the product. Watson will handle marketing and distribution in the US. Pfizer will receive a share of the net sales from Watson.
For the 12 months ending 30 September, Lipitor had sales of approximately US$7.8bn, according to IMS Health data.
‘This medication is widely used by people who must manage their high cholesterol over time, so it is important to have affordable treatment options,’ said Janet Woodcock, director of the FDA’s Centre for Drug Evaluation and Research.
‘We are working very hard to get generic drugs to people as soon as the law will allow.’