Atorvastatin is a cholesterol-reducing medicine, the generic equivalent of the brand Lipitor, which generated total annual sales of USD 7.89 billion in the US through September 2011.
Arun Sawhney, CEO & MD, Ranbaxy, said, "Atorvastatin helps millions of Americans manage healthy cholesterol levels, and we are pleased to have received U.S. FDA 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, prescribers and the U.S. healthcare system."
"Ranbaxy Laboratories Ltd has gained approval to make generic atorvastatin calcium tablets in 10 milligram, 20 mg, 40 mg, and 80 mg strengths. The drug will be manufactured by Ohm Laboratories in New Brunswick, NJ," US Food and Drug Administration (USFDA) said in a statement.
The approval has bought huge relief for the company as Ranbaxy has spent millions of dollars in product development and legal costs and failure to launch the generic version of Lipitor could adversely affect the company.
However, it has not been clear as to whether the USFDA had resolved pending issue of manufacturing norm violation by two plants of company in india, in Dewas & Paonta Sahib. In 2008, the USFDA had banned 30 generic drugs produced by Ranbaxy in those plants.
Ranbaxy, is one of two companies entitled to sell generic Lipitor for six months after its US patents expired yesterday. US-based Watson Pharmaceuticals Inc, which has been authorised by Pfizer to sell generic version of Lipitor, doesn't need regulatory approval and has started selling the drug from November 30.
Experts opined that success of Ranbaxy would highly ride on the approval from FDA for generic version of Lipitor, as it can add Rs 30-40 in EPS of company in next few years.
Also, Ranbaxy Laboratories posted net loss after tax of Rs 439.19 crore for quarter ended September 2011 as compared to net profit of Rs 221.76 crore in the same period a year ago.