Medicines Co., Mylan cardiovascular news

The U.S. District Court for the Northern District of Illinois ruled that Mylan's ANDA submission to FDA for a generic version of anticoagulant Angiomax bivalirudin infringes The Medicines Co.'s U.S. Patent No. 7,582,727. Specifically, the court ruled that the ANDA infringes certain '727 claims specifying limitations on the allowable levels of the impurity Asp9 in batches of bivalirudin. Mylan's ANDA is seeking approval of generic bivalirudin with Asp9 impurity levels of 0-2%, a range that includes the '727 patent's claimed range of 0-0.6%. The ruling prevents FDA approval and launch of Mylan's generic in the U.S. until the '727 patent expires in 2028. Mylan submitted an appeal. ...