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. First approved in 2025.
Drug data last refreshed 2h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ELIQUIS SPRINKLE is an oral suspension formulation of apixaban, a Factor Xa inhibitor indicated for thromboembolic prevention. It works by selectively inhibiting free and clot-bound Factor Xa, thereby decreasing thrombin generation and thrombus development without requiring antithrombin III. This sprinkle formulation enables dosing flexibility for patients who cannot swallow tablets.
Growth14.7 years to LOE
Early-stage commercial launch with significant pricing pressure from IRA negotiation signals need for strong brand and market access expertise.
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
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
to Evaluate the Safety and the Pharmacokinetic and Pharmacodynamic Interactions Between JP-1366 and Clopidogrel, Aspirin, Atorvastatin and Apixaban
Started Nov 2025
96 enrolled
Drug Drug Interaction (DDI)
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Started Jun 2025
2,000 enrolled
Venous Thromboembolism (VTE)
Treatment With Apixaban Versus Warfarin in Patients With Left Ventricular Thrombus After Acute Myocardial Infarction
Started Apr 2025
212 enrolled
Left Ventricular ThrombusAcute Myocardial Infarction
Bioequivalence Study of Apixaban 5 mg Film-coated Tablets in Healthy Thai Volunteers
Started Aug 2024
28 enrolled
Healthy Volunteer
Treatment of Post-Punch Biopsy Bleeding in Apixaban-Treated Patients Using Self-Administered BXP154B
Started Jan 2024
24 enrolled
Wound Bleeding
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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.