Shire plc has filed lawsuits in the U.S. District Court for
the District of New Jersey against Roxane Laboratories, Inc., and in the U.S.
District Court for the Central District of California against Watson
Laboratories, Inc., respectively, for infringement of certain of Shire’s VYVANSE
The lawsuits were initiated in response to Abbreviated New
Drug Applications (“ANDAs”) filed by each of Roxane and Watson
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 Roxane and Watson ANDAs before August 23, 2014, or until a
district court decision finding that the patents are invalid or not infringed, whichever