Plenty of attention for attention deficit medicine
Impax Laboratories has filed a declaratory judgment complaint against Shire Laboratories, a subsidiary of Shire Pharmaceuticals, over an ANDA (Abbreviated New Drug Application) it filed in order to gain FDA approval to market and sell generic versions of various doses of Shire's Adderall XR products, a medicine for attention deficit hyperactivity disorder.
Impax Laboratories has filed a declaratory judgment complaint against Shire Laboratories, a subsidiary of Shire Pharmaceuticals, over an ANDA (Abbreviated New Drug Application) it filed in order to gain FDA approval to market and sell generic versions of various doses of Shire's Adderall XR products, a medicine for attention deficit hyperactivity disorder.
The company is alleging that Shire's US Patent No. 6,913,768 ('the '768 patent'), issued on 5th July 2005, is invalid and that it is consequently not infringing upon it, although Shire has already filed a lawsuit in the US District Court for the Southern District of New York, on 20th October 2005, against Barr Laboratories and Impax for infringement of the same patent. Shire also has separate pending patent litigations against Barr and Impax regarding US Patent Nos. 6,322,819 and 6,605,300, in New York and Delaware, respectively.