US FDA Exclusivity Battles Continue: Alvogen and Sandoz Challenge Buprenorphine, Aubagio Awards
Alvogen contends Teva forfeited 180-day exclusivity with its settlement, while Sandoz claims Sanofi’s MS drug Aubagio isn’t an NCE because it is an active metabolite.
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Otsuka claimed Alkermes' Aristada is 'legally equivalent' to Abilify but DC Circuit deferred to FDA's finding that the two have different active moieties and thus Abilify's three-year exclusivity does not apply to Aristada.
FDA scored a victory when a district court ruled that it was correct in awarding five years of market exclusivity to Shire's attention-deficit hyperactivity disorder drug Vyvanse (lisdexamfetamine)