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news.Shire, a global specialty biopharmaceutical company, has said that the US District Court for the District of Columbia has backed up the decision of US FDA to award 5-year New Chemical Entity (NCE) exclusivity to lisdexamfetamine dimesylate, currently marketed by Shire US, for the treatment of attention-deficit hyperactivity disorder, under the name Vyvanse.
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FDA determined that Vyvanse qualified as an NCE within the meaning of the governing statutes and regulations. As an NCE, Vyvanse is entidtled to 5-year market exclusivity. The agency therefore aptly refused to file the abbreviated new drug application (ANDA) submitted by Actavis Elizabeth for generic lisdexamfetamine dimesylate.
Actavis sued the FDA in the District Court of the District of Columbia, on February 24, 2009, challenging the NCE decision. On April 13, 2009, the agency opened a public docket to consider Actavis’s challenge to its regulations governing NCE exclusivity and the corresponding award of exclusivity to Vyvanse.
The agency affirmed on October 23, 2009, after a thorough administrative review, that lisdexamfetamine, the active ingredient in Vyvanse, is a new active moiety and its prior designation of Vyvanse as an NCE was just.
The five-year exclusivity period for Vyvanse expires on February 23, 2012, and precludes generic manufacturers from submitting an ANDA to FDA until that time, or until February 23, 2011 in case a generic applicant challenges the US patents covering Vyvanse, which remain in effect until June 29, 2023.