Hospira has obtained US Food and Drug Administration (FDA) approval for the launch of bivalirudin for injection, a generic version of The Medicines Company’s Angiomax. Branded sales of Angiomax in 2014 in the USA were approximately US$500m.
Hospira’s bivalirudin for injection is available in a single-dose flip-top vial, which matches the current branded offering available. In addition, the company plans to launch a differentiated presentation of the 250mg bivalirudin for injection in Hospira’s unique ADD-Vantage vial. Bivalirudin is intended for use with aspirin.
“Hospira is excited to launch the first generic of bivalirudin based on a successful challenge of the originator’s patents,” said Philippe Drouet, president, US Commercial, Hospira. “This approval further demonstrates our commitment to bringing safe, lower-cost generic versions of important medications to the market as soon as possible.”
Available in a lyophilised (powdered) format, Hospira’s bivalirudin for injection is a direct thrombin inhibitor indicated for use as an anticoagulant in patients:
- With unstable angina undergoing percutaneous transluminal coronary angioplasty;
- Undergoing percutaneous coronary intervention (PCI) with provisional use of glycoprotein IIb/IIIa inhibitor as in the REPLACE-2 study;
- With, or at risk of, heparin-induced thrombocytopenia or heparin-induced thrombocytopenia and thrombosis syndrome, undergoing PCI.