Fresenius, Medicines Co., Teva cardiovascular news
The Medicines Co. filed three separate lawsuits in the U.S. District Court for the District of Delaware alleging that ANDAs filed by Fresenius' APP Pharmaceuticals Inc. subsidiary, Teva and Teva's Pliva Hrvatska d.d. subsidiary for generic versions of the biotech's Angiomax bivalirudin, infringe U.S. Patent No. 7,582,727. The ANDAs contain a paragraph IV certification against the '727 patent, which expires on July 27, 2028 and covers formulation and manufacture of Angiomax. The Medicines Co. is seeking to prevent the marketing of generic versions of Angiomax. The small molecule direct thrombin inhibitor is approved as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI) and in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA). At June 30, the biotech recorded six-month sales of $194.3 million in U.S. for Angiomax. ...