The Medicines Company (MDCO) has settled lawsuits in the U.S. District Court for the District of Delaware relating to the abbreviated new drug applications (ANDAs) filed by Teva Parenteral Medicines, and its affiliate, Pliva Hrvatska, for generic versions of bivalirudin (Angiomax).
The settlement included a license by MDCO to Teva Pharmaceuticals USA and its affiliates under which the Petah Tikva, Israel-based Teva may launch a generic bivalirudin product under one of its ANDAs in the U.S. on June 30, 2019. In certain limited circumstances, MDCO said its license to Teva would become effective prior to June 30, 2019.
As part of the agreement, Teva admitted that the two patents asserted in the lawsuits are valid and enforceable against, and would be infringed by, Teva's proposed generic bivalirudin products, MDCO said.The patents at issue in the litigation are listed in the Orange Book and expire on July 27, 2028.
MDCO also entered into an agreement with Teva under which Teva will supply bivalirudin active pharmaceutical ingredient to MDCO. This provides an additional source of API to support planned growth of product use.
"We are delighted to partner with Teva, who will provide us needed additional manufacturing capacity and a second source of high quality Angiomax active ingredient which we can finish, fill and supply to our hospital customers," said Clive Meanwell, MD, PhD, chairman and CEO of MDCO.
As required by law, MDCO and Teva will submit the agreements to the U.S. Federal Trade Commission and the U.S. Department of Justice.
On Sept. 4, 2009, MDCO announced that it had received a paragraph IV certification notice letter from Teva notifying MDCO that Teva had submitted ANDAs to the FDA for approval to market generic versions of Angiomax. On Oct. 8, 2009, and Dec. 28, 2009, MDCO filed patent infringement lawsuits against the Teva defendants. The complaints, which were filed in the U.S. District Court for the District of Delaware, alleged infringement of U.S. Patent Nos. 7,582,727 and 7,598,343, which expire on July 27, 2028.
MDCO remains in infringement litigations involving U.S. Patent Nos. 7,582,727 and 7,598,343 with APP Pharmaceuticals, Hospira, Mylan Pharmaceuticals and Dr. Reddy's Laboratories.