The Last Days Of Lipitor: Morass Of Regulatory, Legal Issues Could Mean Few Early Generics
Call it the Duragesic-ization or the Prevacid-ization, but not the Zocor-ization, of Lipitor.
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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.
Teva will share in Ranbaxy’s profits during its exclusivity period, as FDA announces approval of Ranbaxy’s first-filed ANDA more than 14 hours after Watson discloses that it began shipping its atorvastatin “authorized generic”.
Momenta Pharmaceuticals and Sandoz have enjoyed approximately 14 months of de facto generic exclusivity on Sanofi’s anticoagulant Lovenox (enoxaparin), but faced with the imminent threat of competition they are trying to maintain their hold on the market through patent litigation.