Global drug major Ranbaxy Laboratories on Thursday announced the launch of its generic version of its much sought after cholesterol-lowering drug Lipitor in the U.S. market.
The announcement of the launch came following the final approval from the U.S. health regulator to manufacture the generic version of Lipitor at the Ranbaxy's wholly owned Ohm Laboratories facility in New Brunswick, New Jersey, as well as market the product. “Ranbaxy Pharmaceuticals Inc, a wholly owned subsidiary of Ranbaxy Laboratories, has received final approval from the U.S. Food and Drug Administration to manufacture and market Atorvastatin and has launched the product in the U.S. market,'' the company said in a statement issued here.
Ranbaxy CEO and Managing Director Arun Sawhney, referring to the latest development, said: “Atorvastatin helps millions of Americans manage healthy cholesterol levels and we are pleased to have received USFDA approval to manufacture and market a safe, effective, affordable and accessible alternative to branded Lipitor. We are committed to continuing to expand our portfolio of products offered in the U.S. market for the benefit of patients, prescribes and the U.S. healthcare system.''
The statement said pursuant to an agreement between Ranbaxy and Teva Pharmaceuticals USA, Inc, a portion of the profits from sales of Atorvastatin during Ranbaxy's 180-day first-to-file exclusivity period will be paid to Teva.
The terms of the agreement will not be disclosed, it added.
Atorvastatin is a cholesterol-reducing medicine, the generic equivalent of Pfizer's Lipitor drug, which generated total annual sales of $7.6 billion in the U.S. through September, 2011, Ranbaxy said.
The Gurgaon-based firm has gained approval to make generic Atorvastatin calcium tablets in 10-mg, 20-mg, 40-mg and 80-mg strengths. FDA Centre for Drug Evaluation and Research Director Janet Woodcock said in a statement posted on the USFDA website that this medication is widely used by people who must manage their high cholesterol over time, so it is important to have affordable treatment options.
Despite having six months exclusivity to Lipitor, the company still needed final clearance from the FDA for its copy of the world's best-selling drug so that it could launch the generic version in the U.S.
Ranbaxy is one of two companies entitled to sell generic Lipitor for six months after the U.S. patents for the drug expired on Wednesday. U.S.-based Watson Pharmaceuticals Inc, which has been authorised by Pfizer to sell a generic version of Lipitor, does not need regulatory approval and has already started selling the drug from November 30.
Ranbaxy and Pfizer had settled all of their litigations worldwide over the Lipitor patent in 2008. Further in 2008, the USFDA had banned 30 generic drugs produced by Ranbaxy at its Dewas (Madhya Pradesh) and Paonta Sahib and Batamandi units in Himachal Pradesh, citing gross violation of approved manufacturing norms.
The company expects to launch an anti-malaria drug in India toward the end of 2011 or early 2012.