Authorized Generic Angiomax Launched by Sandoz

Sandoz has launched a generic version of the injectable anticoagulant, bivalirudin (Angiomax), following a completed supply and distribution deal with The Medicines Company.

Bivalirudin is a direct thrombin inhibitor indicated for use with aspirin in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA), those undergoing percutaneous coronary intervention (PCI), and patients with or at risk of heparin-induced thrombocytopenia or heparin-induced thrombocytopenia and thrombosis syndrome undergoing PCI.

“This agreement with The Medicines Company for an authorized generic bivalirudin reflects our commitment to making high-quality generic injectables available to patients and health care professionals,” stated Sandoz president Peter Goldschmidt in a press release.

The company will market the generic drug in a 250-mL, 10-pack lyophilized vial injection.

Bivalirudin is contraindicated in patients with active major bleeding and hypersensitivity to Angiomax or its components. The drug’s safety and effectiveness have not been studied in patients with acute coronary syndromes who are not undergoing PTCA or PCI.

In addition to bleeding episodes, Angiomax has commonly reported adverse reactions of hypotension, hypertension, pelvic pain, and fever, among others. The drug is also associated with an increased risk of thrombus formation, which can be fatal.

Total US sales for brand-name Angiomax were approximately $485 million for 1 year ending in April 2015, according to IMS Health data.