India's Ranbaxy Laboratories' manufacturing problems have devastated its share of the U.S. generic Lipitor market. On top of that, an expanded lawsuit in New Jersey seeks to have the drugmaker recall all of the drug that it has in the U.S.
In November, the company voluntarily halted production of atorvastatin at a plant in India after it discovered that a piece of glass was missing from a shield on equipment. Ranbaxy said it was possible that glass had been ground into some of the product. The company and the FDA said the chance of any harm coming from it was small, but Ranbaxy voluntarily recalled 41 lots.
According to The Economic Times, since then Ranbaxy's market share for generic Lipitor has fallen to near nothing. Citing IMS Health stats, the publication says Ranbaxy's market share was 3% in January, after free-falling from 43% in early November before production was interrupted. Competitors Mylan ($MYL), Apotex and Dr. Reddy's have been picking up that business.
The Economic Times says plaintiffs claiming that they were harmed by the recalled product have asked a judge in federal court in New Jersey to force Ranbaxy to pull all of the generic Lipitor off the shelves in the U.S. Ranbaxy had no comment to the publication.
Ranbaxy's FDA approval to make generic Lipitor looked like it would herald the triumphant return to the U.S. market for what was supposed to be a reformed company, which is controlled by Japan's Daiichi Sankyo. The Indian generics maker was selling boatloads of atorvastatin from an Indian plant that is operating under super close scrutiny by outside consultants and the FDA as part of a 5-year consent decree. The company had been nailed for a plethora of manufacturing and reporting problems, but had undertaken strict compliance measures to get back in the game. The full impact of the problems will be discussed later this month when Ranbaxy reports earnings.
- read the Economics Times story