APP Pharmaceuticals, The Medicines Co. settle Angiomax patent litigation

Fresenius Kabi AG’s APP Pharmaceuticals Inc. has settled patent litigation with The Medicines Co. pertaining to APP’s ANDA for a generic form of TMC’s Angiomax (bivalirudin injection) to prevent blood clots. TMC has granted APP a license to begin marketing an Angiomax generic in the US on May 1, 2019--or sooner under certain circumstances--and the agreement may include the right to sell an authorized bivalirudin generic supplied by TMC. (The TMC patents that were in question are set to expire at the end of July 2028.) APP also agreed to manufacture and supply TMC with a finished Angiomax product. APP will license and supply TMC with a portfolio of ten generics for acute cardiovascular, neurological, and infectious diseases in the hospital setting; for this license TMC will pay $30mm up front.