Actually, It's Not About The Patient – At Least When It Comes To Product Exclusivity
Otsuka sues FDA for allowing Alkermes' ‘chemical trick’ to skirt Abilify Maintena's exclusivity, but agency says active moieties of the two drugs are not the same, regardless how they behave in patients.
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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)
Pink Sheet reporter and editors examine the struggle over the FDA’s reputation, whether a coronavirus vaccine could be made available without sponsor cooperation, and the late Supreme Court Justice Ruth Bader Ginsburg’s legacy for pharma.