A U.S. district court judge in D.C. has upheld an FDA decision to grant five years of market exclusivity to Shire's ADHD drug Vyvanse (lisdexamfetamine), spoiling Actavis' plans to sell a generic copy of the drug--which had sales of roughly $505 million last year--before 2012.
The FDA approved Vyvanse in February 2007, awarding it new chemical entity (NCE) status, which prohibited potential generic rivals from submitting their ANDAs from the drug until February 2012. But Actavis objected to the agency's actions and submitted an application in January 2009, maintaining that the drug's active ingredient, lisdexamfetamine, is ineligible for NCE exclusivity. The company based its arguments on the idea that the molecule that actually provided the therapeutic effect at the site of drug action (the active moiety) is dextroamphetamine, which was approved by the FDA more than two decades ago. But the FDA disagreed and rejected Actavis' arguments and its app.
Undeterred, Actavis sued the FDA in the District Court of the District of Columbia, challenging the NCE decision. The agency agreed to open a public docket to consider Actavis's challenge to the regulations governing NCE exclusivity. After weighing the comments to the docket, the agency affirmed giving NCE exclusivity to Vyvanse was proper, leading Actavis to renew its challenge.
U.S. District Judge Rosemary Collyer was unmoved by Actavis, saying the company had based part of its arguments on "an outdated draft of an internal [FDA] document not having the force of law and superseded by formal regulation." She also found the agency had acted reasonably in determining that lisdexamfetamine was the active moeity.
- see Shire's release
- read Collyer's decision