Two Firms Fight FDA Exclusivity Battles In US
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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Alvogen and Dr Reddy’s have launched generic versions of Indivior’s Suboxone in the US, after the Supreme Court denied the originator’s attempt to further frustrate generic launches. But these two versions will compete with an authorized generic launched by Indivior through Sandoz.
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)