Shire files suit against Amneal, Sandoz over generic Vyvanse
DUBLIN — Shire has filed patent infringement suits against two generic drug makers relating to its attention deficit hyperactivity disorder treatment.
Shire said it has filed lawsuits in the U.S. District Court for the District of New Jersey against Amneal Pharmaceuticals and Sandoz. Amneal and Sandoz recently filed abbreviated new drug applications with the Food and Drug Administration to market generic Vyvanse (lisdexamfetamine), an ADHD drug.
Citing the Hatch-Waxman Act, Shire said that the FDA mustn't approve the ANDAs for generic Vyvanse until the patents expire on Aug. 23, 2014, or until a district court decision finding that the patents are invalid or not infringed, whichever occurs earlier.