NDAINTRAVENOUSSOLUTION
Approved
Dec 2017
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
4
Data completeness
3/8 — Basic
BIVALIRUDIN IN 0.9% SODIUM CHLORIDE (bivalirudin) by Baxter International is anion-binding exosite of circulating and clot-bound thrombin. First approved in 2017.
Drug data last refreshed 14h ago · AI intelligence enriched 4d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Bivalirudin is a reversible direct thrombin inhibitor administered intravenously as a 0.9% sodium chloride solution. It binds to both circulating and clot-bound thrombin, preventing fibrin formation and thrombin-mediated platelet activation. The drug is used in anticoagulation therapy, particularly in percutaneous coronary intervention and acute coronary syndromes.
Peak
Product is at peak commercial maturity with established market presence; commercial teams are focused on defending market position against competitive and generic threats.
Mechanism of Action
anion-binding exosite of circulating and clot-bound thrombin. Thrombin is a serine proteinase that plays a central role in the thrombotic process, acting to cleave fibrinogen into fibrin monomers and to activate Factor XIII to Factor XIIIa, allowing fibrin to develop a covalently cross-linked…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (4)
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
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
The UNBLOCK Study: Utilization of Bivalirudin On Clots in Kids
Started Sep 2008
18 enrolled
Deep Venous Thrombosis
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.