May 18 2006
Shire plc has announced that its subsidiary Shire Laboratories has filed a lawsuit in the U.S. District Court for the District of New Jersey against Corepharma LLC for infringement of some of Shire Laboratories' U.S. Patents.
The lawsuit results from an Abbreviated New Drug Application ("ANDA") filed by Corepharma for generic versions of Shire's 100 mg, 200 mg, and 300 mg CARBATROL products, as to which Corepharma provided notice to Shire that it is seeking FDA approval to market its generic products prior to the expiration of the ‘570 and ‘013 Patents. Pursuant to Hatch-Waxman legislation, the lawsuit triggers a stay of FDA approval of up to 30 months from Corepharma's notice to allow the court to resolve the suit.