[Ip-health] Ranbaxy gets USFDA approval for generic Lipitor - death of a cash cow...

Riaz K Tayob riaz.tayob at gmail.com
Thu Dec 1 01:47:15 PST 2011

New Delhi, December 1, 2011

  Ranbaxy gets USFDA approval for generic Lipitor

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AP Atorvastain calcium tablets, commonly known as Lipitor tablets is the 
most sold cholestrol-lowering medicine.

The United States health regulator on Wednesday 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," U.S. Food and Drug Administration (USFDA) said in a 

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 

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 U.S. 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 It was later withdrawn in the same year.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 U.S.

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 U.S. patents expired on Tuesday.

U.S.-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.

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