Intellectual Thoughts by Sanjay Panda: August 2011

Ranbaxy may sale Generic rights of Lipitor if the approval gets delayed

Ranbaxy may sell rights to make a generic version of Pfizer’s Lipitor, the world’s best-selling medicine, should it fail to win timely U.S. approval for the cholesterol pill, said Credit Suisse. 

A legal settlement with Pfizer gave Ranbaxy six months’ exclusivity to market generic Lipitor in the U.S.    Delays in USFDA  approval may prevent Ranbaxy from selling its copies as planned from Nov. 2011.   Lipitor is the highest-selling drug of all time, generating $10.7 billion last year. The most likely outcome will involve Ranbaxy paying a hefty fine to the FDA, which would subsequently clear the path for Lipitor approval.The company and most industry experts remain confident a resolution will be reached in time for Ranbaxy to launch on Nov. 30. 
If the Nov. 30 deadline isn’t met, Ranbaxy may postpone the release of its copycat Lipitor, said  the Credit Suisse report .  This would also delay the timeline for other generic manufacturers wanting to sell their own copies, as Ranbaxy’s 180-day exclusivity period does not start until it begins commercial marketing.   This  delay may  benefit Watson Pharmaceuticals which negotiated with Pfizer to begin selling a so-called authorized generic by Nov. 30. Alternatively, Ranbaxy may waive exclusivity in exchange for payment from a rival generic-drug maker, Credit Suisse said.