NDAORALFOR SUSPENSIONPriority Review
Approved
Apr 2025
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority ReviewIRA Negotiated
ELIQUIS SPRINKLE (apixaban) by Bristol Myers Squibb is fxa. Approved for atrial fibrillation, venous thromboembolism, stroke. First approved in 2025.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ELIQUIS SPRINKLE is an oral suspension formulation of apixaban, a Factor Xa inhibitor anticoagulant approved in April 2025. It treats deep vein thrombosis (DVT), pulmonary embolism (PE), venous thromboembolism (VTE), atrial fibrillation, and reduces recurrent VTE risk in pediatric patients. Apixaban inhibits free and clot-bound Factor Xa to decrease thrombin generation and prevent blood clot formation.
Growth15.0 years to LOE
New launch with significant pricing pressure from IRA negotiations; brand team will focus on pediatric uptake and formulation differentiation against tablet ELIQUIS.
Mechanism of Action
FXa. It does not require antithrombin III for antithrombotic activity. Apixaban inhibits free and clot-bound FXa, and prothrombinase activity. Apixaban has no direct effect on platelet aggregation, but indirectly inhibits platelet aggregation induced by thrombin. By inhibiting FXa, apixaban…
Indications (3)
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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.