Ranbaxy Wins Approval to Sell Generic of Pfizer’s Lipitor

01 Dec 2011 Evaluate

Ranbaxy Laboratories Ltd. (RBXY)’s generic version of PfizerInc. (PFE)’s $10.7 billion Lipitor cholesterol pill was approved for U.S. saleby the Food and Drug Administration. Ranbaxy’s copy of the world’s top-sellingdrug, known chemically as atorvastatin, will be manufactured by the company’sOhm Laboratories unit in New Brunswick, New Jersey. Ranbaxy, based nearNew Delhi, had sought to persuade the FDA that its copy is equivalent to theoriginal and that approval shouldn’t be thwarted by violations cited in 2009 ata plant identified in the company’s drug application. As the first generic tochallenge Pfizer’s patent, Ranbaxy is allowed six months before other genericversions can come on the market under a 1984 law. 

Watson Pharmaceuticals Inc. has also began selling a copy ofLipitor in the U.S. under an agreement with New York-based Pfizer. Watson’sversion didn’t require FDA clearance because Pfizer is providing the drug tosell without the brand label in return for a share of the revenue.

Mylan Inc. of Canonsburg, Pennsylvania; Teva PharmaceuticalIndustries Ltd. of Petach Tikvah, Israel and Dr. Reddy’s Laboratories Ltd. ofHyderabad, India, are among generic-drug makers seeking FDA approval to sellLipitor copies after Ranbaxy’s six-month exclusivity expires, according to U.S.court filings.

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Company Name CMP
Sun Pharma Inds. 1804.95
Dr. Reddys Lab 1275.05
Cipla 1520.55
Zydus Lifesciences 931.45
Lupin 2097.65
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