Pediatric Exclusivity: Court Backs US On When Studies 'Fairly Respond' To Requests
However, FDA must explain why denial of Sensipar's pediatric exclusivity was consistent with exclusivity award for J&J's Ortho Tri-Cyclen, US judge says. In swipe at plaintiff Amgen, court says pediatric study reports themselves guide exclusivity determinations, not the amount of effort a sponsor puts into those studies.
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In the course of a week, Teva received final ANDA approval for cinacalcet, launched its generic and reached a deal with Amgen to come off the market until mid-2021. The fast but short launch allowed Teva to take some sales away from Amgen without triggering entry of other ANDA sponsors who previously settled, Bernstein Senior Analyst Ronny Gal says.
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.