<em>Lipitor</em> Goes Generic, But First-Filer Ranbaxy’s Approval Leaves Plenty Of Questions In Its Wake

Lipitor Goes Generic, But First-Filer Ranbaxy’s Approval Leaves Plenty Of Questions In Its Wake

05 Dec 2011

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.

The Nov. 30 approval and launch of Ranbaxy Laboratories Ltd.’s atorvastatin provided clarity on who would be selling the initial generic versions of Pfizer Inc.’s Lipitor, but the approval may have raised as many questions as it answered.

Given that the all-important atorvastatin approval is now behind it, one key question surrounding Ranbaxy is when the company will reach a formal settlement agreement with FDA and the Justice Department over a longstanding investigation into

Lipitor Goes Generic, But First-Filer Ranbaxy’s Approval Leaves Plenty Of Questions In Its Wake

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