NDAINJECTIONINJECTABLE
Approved
Jun 2000
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
2
Data completeness
3/8 — Basic
ARGATROBAN (argatroban) by Novartis is site. First approved in 2000.
Drug data last refreshed Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Argatroban is a small-molecule direct thrombin inhibitor administered by injection for treatment of heparin-induced thrombocytopenia (HIT) and associated thrombosis. It works by directly inhibiting both free and clot-bound thrombin without requiring antithrombin III as a cofactor, blocking fibrin formation and platelet aggregation.
LOE Approaching
As LOE approaches, brand positions are consolidating with multiple generic manufacturers at peak lifecycle; expect staffing rationalization and shift toward efficiency and compliance roles.
Mechanism of Action
site. Argatroban does not require the co-factor antithrombin III for antithrombotic activity. Argatroban exerts its anticoagulant effects by inhibiting thrombin-catalyzed or -induced reactions, including fibrin formation; activation of coagulation factors V, VIII, and XIII; activation of protein C;…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (2)
Significance of Antibodies to Heparin/Platelet Factor 4 Complex in Vein Graft Patency and Potential Role of Argatroban for Prevention of Vein Graft Occlusion
Started Nov 2010
9 enrolled
Coronary Artery Bypass Graft SurgeryPresence of Heparin/Platelet Factor 4 Antibody
Evaluation of Argatroban Injection in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin
Started Sep 2003
24 enrolled
ThrombocytopeniaThrombosis
Worked on ARGATROBAN 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.