Drug intelligence / Profile preview

EP-6101

Development stage
Discontinued
Lead developer
Eagle Pharmaceuticals
Modality
Peptides
Administration
Intravenous
01

Overview

EP-6101 is a novel, ready-to-use (RTU) liquid formulation of **bivalirudin**, a synthetic 20-amino acid peptide and direct thrombin inhibitor. Developed by **Eagle Pharmaceuticals** in partnership with **SciDose** and **TherDose Pharma**, EP-6101 was designed as a 505(b)(2) regulatory candidate to provide a more convenient alternative to the standard lyophilized bivalirudin (Angiomax), which requires manual reconstitution before administration. Bivalirudin acts as a specific and reversible anticoagulant by binding to both the catalytic site and the anion-binding exosite of thrombin. In December 2017, Eagle Pharmaceuticals and its partners settled a long-standing legal dispute with **The Medicines Company** (MDCO) regarding a terminated 2008 development agreement. As part of the settlement, the defendants paid $1.7 million and assigned all intellectual property rights for EP-6101 to The Medicines Company, effectively ending Eagle's involvement in the product's development.

Other names
bivalirudin ready-to-use injectionready-to-use bivalirudinRTU bivalirudin
02

Targets

F2 (Thrombin)

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