Shire Files Lawsuits Against Sandoz and Amneal for Infringement of VYVANSE Patents

Shire plc SHPGY announces that it has filed lawsuits in the U.S. District Court for the District of New Jersey against each of Amneal Pharmaceuticals, LLC and Sandoz, Inc. for infringement of certain of Shire's VYVANSE patents. The lawsuits were initiated in response to Abbreviated New Drug Applications filed by Amneal and Sandoz seeking FDA approval to market and sell generic versions of all currently approved doses of VYVANSE. Under the Hatch-Waxman Act, the FDA must refrain from approving the Sandoz and Amneal ANDAs for 30 months (expiring August 23, 2014), or until a district court decision finding that the patents are invalid or not infringed, whichever occurs earlier.