NDAINTRAVENOUSINJECTABLE
Approved
Dec 2000
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
4
Data completeness
6/8 — Strong
ANGIOMAX (bivalirudin) by Novartis is thrombin inhibitors [moa]. Approved for anti-coagulant [epc]. First approved in 2000.
Drug data last refreshed 24m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ANGIOMAX (bivalirudin) is an intravenous direct thrombin inhibitor approved in 2000 for anticoagulation in patients undergoing percutaneous coronary intervention. It works by reversibly binding to thrombin, preventing clot formation in acute coronary syndromes. The drug is indicated as an anticoagulant for patients at risk of thrombotic complications during interventional cardiology procedures.
LOE Approaching2.6 years to LOE
Product approaching loss of exclusivity with moderate competitive pressure; commercial teams are likely focusing on managed care defense and niche positioning rather than growth expansion.
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)
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
Worked on ANGIOMAX at Novartis? Share your interview experience or compensation data (+7 days Pro)
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.