Shire Pharmaceuticals Group plc announced that its subsidiary Shire Laboratories Inc. has served Nostrum Pharmaceuticals, Inc. with a complaint for patent infringement of Shire Laboratories' US Patent Nos. 5,912,013 ('013 Patent) and 5,326,570 ('570 Patent). The complaint was filed in the US District Court for the District of New Jersey.
The lawsuit results from an ANDA (Abbreviated New Drug Application) filed by Nostrum for a generic version of the 300 mg dosage strength of Carbatrol, pursuant to which Nostrum provided notice that it would seek to market its generic product before the expiration of the '013 and '570 Patents.
Carbatrol is Shire's leading extended-release medication for the treatment of epilepsy.