US Court upholds FDA's grant of five-year market exclusivity for Shire's ADHD drug Vyvanse

The US District Court for the District of Columbia has upheld the Food and Drug Administration's decision reaffirming that UK drugmaker Shire's Vyvanse (lisdexamfetamine) is entitled to 5-year market exclusivity for the treatment of attention-deficit hyperactivity disorder (ADHA).

Accordingly, the five-year exclusivity period for Vyvanse - which generates annual sales of around $505 million - expires on February 23, 2012, and thus precludes generic manufacturers from submitting an Abbreviated New Drug Application to the FDA until that time.

Previously, after determining Vyvanse as a New Chemical Entity, the FDA refused to file Icelandic generics group Actavis' ANDA for generic lisdexamfetamine dimesylate. Following this action Actavis challenged the FDA's NCE decision in February 2009. After a thorough administrative review, the agency affirmed that lisdexamfetamine is a new active moiety and that its prior designation of Vyvanse as an NCE was proper.