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Generic bivalirudin approved in US Posted 07/08/2015

US-based injectables and biosimilars specialist Hospira announced on 16 July 2015 the approval of its abbreviated new drug application (ANDA) for generic bivalirudin for injection by the US Food and Drug Administration (FDA).

The drug is a generic version of The Medicines Company’s Angiomax (bivalirudin), which is a direct thrombin inhibitor indicated for use in combination with aspirin as an anticoagulant in patients: 

  • with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA)
  • undergoing percutaneous coronary intervention (PCI) with provisional use of glycoprotein IIb/IIIa inhibitor (GPI) as in the REPLACE-2 study
  • with, or at risk of, heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia and thrombosis syndrome (HITTS), undergoing PCI.

Hospira’s generic bivalirudin is available in a single-dose flip-top vial, which is the same format as the brand-name drug. However, in a good example of generics innovation, Hospira also plans to launch a differentiated presentation of the 250 mg generic bivalirudin in the company’s unique ADD-Vantage vial. The ADD-Vantage system, which is a standardized, ready-to-mix drug delivery system, allows for easier medication mixing.

The approval of Hospira’s ANDA is not good news for The Medicines Company, which only received approval for Angiomax in 2000 and who had expected its two patents (‘343 and ‘727) on the drug to protect it until January 2029 (including paediatric exclusivity).

Sales of Angiomax in 2014 in the US were approximately US$500 million.

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Source: Hospira

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