Sensipar Generics: US Court Victory, FDA Approval Position Piramal For Launch
Just days after Piramal was one of three generic drug sponsors found not to have infringed a Sensipar formulation patent, FDA approved company’s ANDA, threatening Amgen’s de facto exclusivity on the blockbuster calcium-sensing receptor agonist.
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Amgen asserts FDA improperly tied pediatric exclusivity denial to lack of meaningful labeling resulting from the studies; justices question whether Amgen's data were adequate to support exclusivity but also agency's public silence on how it decides when a sponsor has 'fairly responded' to a written request.
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.
Of three accelerated approval drugs that have been ordered withdrawn to date, Pepaxto marks the shortest interval between the FDA drugs center's withdrawal proposal and the agency’s final order, suggesting that FDORA’s expedited withdrawal procedures helped move things along more quickly.