The United States District Court for the District of Columbia has upheld a decision by the US Food and Drug Administration (FDA) to grant five-year New Chemical Entity (NCE) exclusivity to Shire for its attention-deficit hyperactivity disorder (ADHD) drug Vyvanse.
The FDA previously refused to file an Abbreviated New Drug Application (ANDA) submitted by Actavis Elizabeth for the generic version of lisdexamfetamine dimesylate.
On 24 February 2009, Actavis sued the FDA in the District Court of the District of Columbia challenging the NCE decision. In October the agency affirmed that lisdexamfetamine, the active ingredient in Vyvanse, is a new active moiety and that prior designation as an NCE was correct.
After reviewing the requisite clinical studies submitted on behalf of Vyvanse, the FDA determined that the drug qualified as an NCE within the meaning of the governing statutes and regulations.
As an NCE Vyvanse (lisdexamfetamine dimesylate) will now be entitled to five-year market exclusivity precluding generic manufacturers from submitting their own version up to February 2012.