Watson and Ranbaxy kick off genericization of Lipitor, launching their approved copies in USA

1 December 2011

US generic drug major Watson Pharmaceuticals (NYSE: WPI) was the first to confirm yesterday that it has launched an authorized generic version of pharma behemoth Pfizer’s (NYSE: PFE) all-time blockbuster cholesterol lowerer Lipitor (atorvastatin) as part of an exclusive agreement with Pfizer, saying that it will be the largest generic product launch in US history. However, investors failed to be impressed, as Watson’s shares fell 4% to $64.62 in a sharply higher overall market (the Nasdaq rose 4.2%).

Late in the day this was followed by India’s largest drugmaker Ranbaxy Laboratories (RANB: BO), which is 64% owned by Japan’s Daiichi Sankyo, revealing that it has received final approval from the US Food and Drug Administration to manufacture and market atorvastatin and has also launched the product in the US market.

Ranbaxy, which is also an authorized supplier of generic Lipitor and, like Watson, has 180 days of exclusivity from other generic competitors for the drug, has for the past three years been prevented from launching several of its products in the USA due to quality control problems identified at two of its Indian manufacturing facilities by the US FDA. Thus the news, “in the nick of time,” was a welcome outcome for the Indian firm.

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