1. Pink Sheet

FDA Wins Abilify Exclusivity Battle; Court Rejects Otsuka's 'Legal Equivalence'

 
• By Brenda Sandburg

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.

court house

The US FDA once again prevailed in its interpretation of the scope of three-year market exclusivity as an appeals court rejected Otsuka Pharmaceutical Co. Ltd.'s claim that its atypical antipsychotic Abilify Maintena (long-acting injectable aripiprazole) is "legally equivalent" to Alkermes PLC's Aristada (aripiprazole lauroxil).

In an Aug. 29

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