Pfizer Settlement With Ranbaxy Delays Generic Lipitor Entry
Pfizer expects to hold off generic competition for Lipitor (atorvastatin) in the United States until November 2011 under a settlement agreement with Ranbaxy
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Ranbaxy launches generic atorvastatin despite not having reached a final settlement with FDA on GMP violations and data integrity issues. Teva’s role in Ranbaxy’s approval and launch is unclear, although the company will get a cut of the first-filer’s profits during the 180-day exclusivity period.
MUMBAI - Shares of Ranbaxy Laboratories Ltd., listed on the Indian stock exchanges, plunged 6% May 5 to 426 Indian Rupees ($9.48) per share, reacting sharply to a Fortune magazine report that claimed the company may be fined over $1 billion as part of a protracted negotiation and settlement process with U.S. FDA
Call it the Duragesic-ization or the Prevacid-ization, but not the Zocor-ization, of Lipitor.