New Delhi: The US health regulator today granted approval to Ranbaxy Laboratories to produce generic version of cholesterol lowering drug Lipitor, a move that will help the India-based firm to launch the drug in the American market.
"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.
It was, however, not clear whether the USFDA had resolved pending issue of manufacturing norm violation by some of the company`s plants in India. When contacted, Ranbaxy officials declined to comment on the development.
Settling the issue with the USFDA was of immense importance to Ranbaxy as the Gurgaon-based firm has exclusive rights to the off-patent version of Lipitor, Pfizer`s blockbuster cholesterol lowering drug which had sales of over USD 10 billion for the year ended September, 2010.
In 2008, the USFDA had banned 30 generic drugs produced by Ranbaxy at its Dewas (Madhya Pradesh) and Paonta Sahib and Batamandi unit in Himachal Pradesh, citing gross violation of approved manufacturing norms.
In the same year, the US Department of Justice had also moved a motion against the company in a local court alleging forging of documents and fraudulent practice. It was later withdrawn in the same year.
Despite having six months exclusivity, 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 US.
The USFDA grants FTF (First-to-file) status to a company for a product if it is the first to successfully apply and get approval to launch a generic copy of a patented drug.
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.
Ranbaxy and Pfizer had settled all of their litigations worldwide over the Lipitor patent in 2008.
Japanese drug maker Daiichi Sankyo had acquired majority stake in Ranbaxy in 2008 for a total outgo of around Rs 22,000 crore.
The company also expects to launch an anti malaria drug in India towards the end of 2011 or early 2012.