Shire plc’s subsidiary Shire LLC has filed a lawsuit in the U.S. District Court for the Southern District of New York against Watson Pharmaceuticals, Inc. and its subsidiaries Watson Laboratories, Inc.-Florida, Watson Pharma, Inc., Andrx Corporation, and Andrx Pharmaceuticals, L.L.C. for infringement of Shire's U.S. Reissue Patent No. RE 41,148, U.S. Reissue Patent No. RE 42,096 and U.S. Patent No. 6,913,768 and also for breach of contract.
The lawsuit results from an Abbreviated New Drug Application (ANDA) recently filed by Watson for generic versions of 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg ADDERALL XR, pursuant to which Watson provided notice that it would seek to market its generic products before the expiration of Shire's patents. The lawsuit alleges that all of Watson's generic strengths infringe the patents-in-suit. Pursuant to Hatch-Waxman legislation, there will be up to a 30-month stay with respect to Watson's proposed generic products. The lawsuit also alleges that Watson has violated existing settlement and license agreements between Shire and Watson, signed in November 2007, arising from an ANDA that Watson filed in 2006, which also sought approval to market generic versions of ADDERALL XR.
Shire submitted a Citizen Petition (CP) to the FDA in October 2005 requesting that the FDA impose stricter bioequivalence standards before approving any ANDA for ADDERALL XR. The FDA responded that the CP raised "complex issues" and has not resolved the matter. The FDA has not approved any ANDA for ADDERALL XR.