Shire, the global specialty biopharmaceutical company, announces that the US Court of Appeals for the District of Columbia Circuit has affirmed the ruling of the US District Court for the District of Columbia and the US Food and Drug Administration to grant five-year New Chemical Entity exclusivity to lisdexamfetamine dimesylate, currently marketed by Shire US Inc. under the name Vyvanse.
The five-year exclusivity period for Vyvanse expires on February 23, 2012. Vyvanse is further protected by US patents, the first of which expires on June 29, 2023. As a result of this confirmation of Vyvanse's NCE status, generic manufacturers cannot submit an ANDA to FDA until February 23, 2011 at the earliest.
Shire’s strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Company focuses its business on Attention Deficit Hyperactivity Disorder (ADHD), Human Genetic Therapies (HGT) and GastroIntestinal (GI) diseases as well as opportunities in other therapeutic areas to the extent they arise through acquisitions.
Shire’s in-licensing, merger and acquisition efforts are focused on products in specialist markets with strong intellectual property protection and global rights. They believe that a carefully selected and balanced portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.