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announced today that it has launched Bivalirudin for Injection, 250 mg/vial, a therapeutic equivalent generic version of Angiomax (Bivalirudin) for Injection, approved by the U.
7,598,343 (the '727 and '343 patent, respectively), both of which cover the injectable anticoagulant drug Angiomax (bivalirudin) and are set to expire on July 27, 2028.
The company said that bivalirudin for injection is the generic version of The Medicines Company's Angiomax.
A long-standing ordeal over the patent on a blood thinner marketed by The Medicines Company (TMC) has apparently ended, enabling the pharmaceutical manufacturer to continue selling the anticlotting drug Angiomax.
The FDA didn't clear the use of Angiomax in hospital emergency rooms for acute coronary syndrome, a range of disorders including chest pain that can signal reduced blood flow to the heart.
The data were collected in the Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE)-2 trial, which compared two different anticoagulant regimens in 6,010 patients undergoing PCI.
Professor Harvey White, principal investigator in the trial, reported to the European Society of Cardiology meeting in Stockholm, that in the trial ANGIOMAX reduced the combined incidence of death or investigator-reported second myocardial infarction compared to heparin at 30 days by 1.
In the United States, Angiomax with provisional use of glycoprotein IIb/IIIa inhibitor (GPI) is indicated for use in patients undergoing angioplasty, also called percutaneous coronary intervention (PCI), and in patients with, or at risk of, heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia and thrombosis syndrome (HIT/HITTS) undergoing PCI.
M2 EQUITYBITES-July 10, 2015-The Medicines Company to market generic ANGIOMAX for percutaneous coronary intervention (PCI)
M2 PHARMA-July 10, 2015-The Medicines Company to market generic ANGIOMAX for percutaneous coronary intervention (PCI)
The Medicines Company (NASDAQ: MDCO) announced that a prospective analysis of the ACUITY (Acute Catheterization and Urgent Intervention Triage StrategY) trial showed that total hospital stay costs were lowest with Angiomax monotherapy (mean difference range: $184 to $1,081, p <0.
The company said RTU bivalirudin is a stable liquid intravenous formulation of bivalirudin, the same active ingredient as in The Medicine Company's Angiomax (bivalirudin).