1. Pink Sheet

US Launch Of Sensipar Generics May Await Patent Case Even After FDA Approval

 
• By Sue Sutter

Aurobindo remains embroiled in litigation with Amgen on a Sensipar formulation patent, while Cipla settled ahead of  bench trial. Generic firms won approval of cinacalcet generics after two federal courts denied Amgen's emergency request for an injunction in dispute with FDA over pediatric exclusivity.

Gavel

Despite the US FDA's approval of two generic versions of Amgen Inc.'s Sensipar (cinacalcet), competition to the branded calcium-sensing receptor agonist may await the outcome of patent litigation in a Delaware federal court.

FDA approved cinacalcet abbreviated new drug applications (ANDAs) from Aurobindo Pharma Ltd. and Cipla Ltd. on March 8. This was the same day Amgen's drug substance patent (No

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