"Shared Exclusivity" Ruling Could Impact Eight First-Time Generics Over Two Years, FDA Says
This article was originally published in The Pink Sheet Daily
Executive Summary
The agency seeks a stay of a court ruling invalidating its "shared exclusivity" policy on paroxetine (Paxil) generics and outlines a number of "new policy determinations" it would have to make if it adopts a "one first applicant" approach instead.
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Generic Exclusivity For Omeprazole 40 Mg Challenged By Apotex
A federal appeals court should rule on the validity of FDA’s patent-based approach to awarding exclusivity for Paxil generics because “it is an absolute certainty” that Apotex will litigate the same issue for Prilosec 40 mg, company attorney Rakoczy tells the appellate judges.
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