NDASUBCUTANEOUSSOLUTIONPriority Review
Approved
Dec 2001
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
ARIXTRA (fondaparinux sodium) by Viatris (2) is (atiii)-mediated selective inhibition of factor xa. First approved in 2001.
Drug data last refreshed 4h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ARIXTRA (fondaparinux sodium) is a synthetic pentasaccharide anticoagulant that selectively inhibits Factor Xa through antithrombin III (ATIII) potentiation, preventing thrombin formation and thrombus development. Administered subcutaneously, it is indicated for thromboprophylaxis in patients undergoing hip fracture surgery, knee replacement surgery, abdominal surgery, or those with acute coronary syndromes. The drug does not inactivate thrombin directly and has no effect on platelet function or fibrinolytic activity at therapeutic doses.
$0.219MPart D
LOE ApproachingDeclining
As LOE approaches, the brand team is likely consolidating and shifting focus toward retention and lifecycle extension strategies rather than growth initiatives.
Mechanism of Action
(ATIII)-mediated selective inhibition of Factor Xa. By selectively binding to ATIII, fondaparinux sodium potentiates (about 300 times) the innate neutralization of Factor Xa by ATIII. Neutralization of Factor Xa interrupts the blood coagulation cascade and thus inhibits thrombin formation and…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
ARIXTRA® Adherence in SVT Patients.
Started Oct 2012
1 enrolled
Thrombosis, Venous
Special Drug Use Investigation (Retrospective) for Arixtra® (Fondaparinux) Venous Thromboembolism Treatment (Over 100kg)
Started Mar 2012
5 enrolled
Ataxia
Special Drug Use Investigation for Arixtra® (Fondaparinux) Venous Thromboembolism Treatment
Started Jan 2012
200 enrolled
Ataxia
Hemorrhage Risk Prescribed Arixtra
Started Jan 2010
13,442 enrolled
Thrombosis, Venous
Special Drug Use Investigation for ARIXTRA (Fondaparinux) Abdominal General Surgery
Started Sep 2009
329 enrolled
Cardiovascular Disease
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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.