Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that it has settled all pending litigation with Sandoz, Inc. ("Sandoz") in connection with Sandoz's Abbreviated New Drug Application ("ANDA") and its attempt to market generic versions of Shire's ADDERALL XR(R) (mixed amphetamine salts) for the treatment of Attention Deficit Hyperactivity Disorder.
The settlement also provides Sandoz with a license to market it own generic versions of ADDERALL XR(R) in the United States beginning upon approval of its own generic products by the FDA, and Sandoz will pay Shire a royalty from those sales. To date, the US Food and Drug Administration has not approved any generic version of ADDERALL XR(R). No payments to Sandoz are involved in the settlement agreement. Impax Pharmaceuticals Inc. and Barr Laboratories Inc. remain the only authorized generic supplier of ADDERALL XR.
The litigation involves a patent infringement lawsuit covering Shire's U.S. patents Nos. 6,322,819 ("the '819 Patent"), and 6,605,300 ("the '300 Patent"). As part of the settlement, Sandoz has agreed to a consent judgment confirming that its proposed generic products infringe Shire's '819 and '300 Patents and that the two patents are valid and enforceable.
Resolution of the case against Sandoz ends all litigation against generic ANDA applicants over ADDERALL XR(R).
The agreements, which are effective immediately, have been submitted to the US Federal Trade Commission for its review as required by law.