BIVALIRUDIN

Post-LOE

bivalirudin

Accord Biopharma

ANDAINTRAVENOUSINJECTABLE

Approved

Nov 2017

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

4/8 — Partial

BIVALIRUDIN (bivalirudin) by Accord Biopharma is thrombin inhibitors [moa]. Approved for anti-coagulant [epc]. First approved in 2017.

Drug data last refreshed 18h ago

Mechanism of Action

Thrombin Inhibitors

Pharmacologic Class:

Anti-coagulant

Indications

Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.

Clinical Trials (4)

NCT02052635Phase 4Terminated

Ticagrelor vs Clopidogrel in Non-ST Elevation Acute Coronary Syndrome Patients Undergoing PCI With Bivalirudin.

Started Sep 2014

34 enrolled

Non-ST Elevation Acute Coronary Syndrome

NCT01848106Phase 3Terminated

A Study To Determine the Efficacy and Safety of REG1 Compared to Bivalirudin in Patients Undergoing PCI

Started Sep 2013

3,232 enrolled

Coronary Artery Disease

NCT00812370Phase 1Completed

The UNBLOCK Study: Utilization of Bivalirudin On Clots in Kids

Started Sep 2008

18 enrolled

Deep Venous Thrombosis

NCT00464087Phase 3Completed

Switching From Fondaparinux to Bivalirudin or Unfractionated Heparin in ACS Patients Undergoing PCI

Started Jun 2007

100 enrolled

Acute Coronary Syndromes

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Data Sources

Drug label: DailyMed / FDA
Clinical trials: ClinicalTrials.gov
Patent data: FDA Orange Book
Spending data: CMS Medicare

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.