APP Pharmaceuticals Inc., a Fresenius Kabi Company, has settled its litigation with The Medicines Company relating to APP’s Abbreviated New Drug Application (ANDA) for a generic version of the anti-clotting drug Angiomax (bivalirudin for injection).

Under the settlement, The Medicines Company has licensed APP to begin selling APP’s generic version of Angiomax in the US on May 1, 2019.  Furthermore, in certain limited circumstances, The Medicines Company’s license to APP would become effective prior to May 1, 2019, and may include the right to market an authorized generic bivalirudin product supplied by The Medicines Company.

Additionally, APP entered into an agreement for the manufacture and supply of Angiomax finished product to The Medicines Company. The agreements are subject to review by the Federal Trade Commission and the US Department of Justice.

In 2007, APP filed an ANDA with the US Food and Drug Administration to manufacture and market a generic version of Angiomax. In 2009, APP amended that filing to include Paragraph IV certifications with respect to two Medicines Company patents that were filed in 2009 and issued in 2010 and are listed in the Orange Book in connection with Angiomax. In response to these filings, The Medicines Company filed lawsuits against APP alleging that the proposed product would infringe those patents, which expire July 27, 2028. As part of the settlement with The Medicines Company, APP admits that the two patents asserted in the lawsuits are valid and enforceable against, and would be infringed by, APP's proposed generic bivalirudin product. The settlement also includes APP’s agreement to dismiss its appeal of the August 2010 Federal District court decision holding that The Medicine Companies’ application for Hatch Waxman patent term extension of the Angiomax composition of matter patent was timely filed.

APP Pharmaceuticals, Inc. is a fully-integrated pharmaceutical company that develops, manufactures and markets injectable pharmaceutical products with a primary focus on the oncology, anti-infective, anaesthetic/analgesic and critical care markets.

Fresenius Kabi AG is the leader in infusion therapy and clinical nutrition in Europe and in its most important countries of Latin America and Asia Pacific. The company provides concepts for ambulatory health care and is focused on managing and providing home therapies.