Shire files lawsuit against Watson over generic Vyvanse

Jul 8 2011

Watson Pharmaceuticals, Inc. (NYSE: WPI) today confirmed that its subsidiary, Watson Laboratories, Inc., filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market lisdexamfetamine dimesylate capsules.  Watson's lisdexamfetamine dimesylate capsules are a generic version of Shire LLC's Vyvanse®. Vyvanse® is a prescription medicine for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children ages 6 to 17 and adults.

Shire filed suit against Watson on July 7, 2011 in the United States District Court for the Central District of California seeking to prevent Watson from commercializing its product prior to the expiration of certain U.S. Patents. Shire's lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson's ANDA until August 23, 2014 or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.  

For the twelve months ending April 30, 2011, Vyvanse® capsules had total U.S. sales of approximately $1.1 billion according to IMS Health data.