Pfizer Inc.'s Generic Lipitor May be Delayed by Ranbaxy Laboratories Problems
Published: Sep 01, 2011
Pfizer Inc. (PFE) may get a reprieve from generic competition to its $11 billion Lipitor cholesterol pill as Ranbaxy Laboratories Ltd. (RBXY) fights regulatory breaches that threaten to derail its push to produce the first U.S. copies. Ranbaxy, India’s third-largest drugmaker by revenue, plans to introduce its copy of Lipitor, the world’s best-selling medicine, on Nov. 30. It must first persuade the Food and Drug Administration that its copy is equivalent to the original and that approval shouldn’t be thwarted by violations cited in 2009 at a plant identified in Ranbaxy’s drug application.