Sandoz to market authorised generic Angiomax in USA for PCI- The Medicines Company
The Medicines Company announced an agreement with Sandoz Inc. for the distribution of an authorized generic of Angiomax (bivalirudin) for injection in the United States.
Angiomax is indicated in patients undergoing percutaneous coronary intervention (PCI) with provisional use of GPI and in patients with, or at risk of, heparin-induced thrombocytopenia and thrombosis syndrome (HIT/HITTS) undergoing PCI. In addition, Angiomax is also indicated for use as an anticoagulant in patients with Unstable Angina undergoing percutaneous transluminal coronary angioplasty (PTCA). Angiomax is intended for use with aspirin. Angiomax is not approved for use in patients with acute coronary syndromes (ACS) not undergoing PCI or PTCA.
Comment: The US Court of Appeals for the Federal Circuit ruled recently that two patents on Angiomax were invalid in a case brought by Hospira, which is now free to market generic versions of the drug in the US.
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