Apixaban

Lowers the risk of stroke and systemic embolism. Sold as Eliquis, Eliquis Sprinkle, Apixaban, Abanta. Every FDA application for this active ingredient: 4 branded and 23 generic.

As of Nov 14, 2026, FDA lists 27 applications for Apixaban (sold as Eliquis, Eliquis Sprinkle, Apixaban and others), first approved Dec 28, 2012, with 4 new uses approved and 0 published complete response letters.

First approved: Dec 28, 2012
Applications: 27
New uses approved: 4
Complete response letters: 0
Medicare spending, 2025: $24.0B
First approved in the EU: May 18, 2011
First approved in Japan: Dec 25, 2012

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Eliquis	Part D	$24.0B	+16%	4,806,752

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

ELIQUIS 2.5 MG TABLET: $5.51 per unitBrand · -43% in a year
ELIQUIS 5 MG TABLET: $5.52 per unitBrand · -43% in a year

Approvals in the EU (EMA)

First approved in the EU 19 months before the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Apixaban Accord, genericAccord Healthcare S.L.U. · Jul 23, 2020
Eliquis, new substanceBristol-Myers Squibb / Pfizer EEIG · May 18, 2011

Approvals in Japan (PMDA)

First approved in Japan the same month as the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

EliquisDrugs with a new additional indication and a new dosage for the treatment and prevention of the recurrence of venous thromboembolism (deep vein thrombosis… · Bristol-Myers K.K. · Dec 21, 2015
Eliquis, new ingredientDrugs with a new active ingredient indicated for prevention of ischemic stroke and systemic embolism in patients with nonvalvular atrial fibrillation. · Bristol-Myers K.K. · Dec 25, 2012 · Review report

Clinical Trials

114 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Vortosiran in Atrial FibrillationNon-valvular Atrial Fibrillation (AF) · Ribocure Pharmaceuticals AB	Phase 2	Not yet recruiting	Oct 13, 2026
Comparison of DOACs and LMWH for Thromboprophylaxis After Total Knee ArthroplastyTotal Knee Arthroplasty, Venous Thromboembolism · Military Hospital of Tunis	Not applicable	Recruiting	Oct 9, 2026
Effect of Two Weeks of Low-Dose Apixaban on Platelet Reactivity in Patients With Stable Coronary Artery Disease on Dual Antiplatelet Therapy (Aspirin and Clopidogrel)Coronary Artery Disease, High On-treatment Platelet Reactivity (HTPR) · The University of The West Indies	Phase 4	Active, not recruiting	Oct 2, 2026
Edoxaban Versus Apixaban in Cancer-Associated Venous ThromboembolismVenous Thromboembolism, Active Cancer · Samsung Medical Center	Phase 4	Not yet recruiting	Oct 1, 2026
Optimal Anti-Thrombotic Management Following Percutaneous Left Atrial Appendage OcclusionAtrial Fibrillation (AF) · Texas Cardiac Arrhythmia Research Foundation	Phase 3	Recruiting	Sep 25, 2026
Strategies for the Management of Atrial Fibrillation in patiEnts Receiving Dialysis 2 (SAFE-D2)Atrial Fibrillation, Atrial Flutter · Unity Health Toronto	Phase 3	Not yet recruiting	Aug 21, 2026
Net Clinical Benefit of Edoxaban Versus Apixaban in Patients With Atrial Fibrillation and Coronary Artery DiseaseAtrial Fibrillation (AF), Coronary Arterial Disease (CAD) · Samsung Medical Center	Phase 4	Recruiting	Aug 7, 2026
Population Pharmacokinetics of Apixaban in Asian Patients With Atrial FibrillationNon Valvular Atrial Fibrillation (nv AF) · Chulalongkorn University	—	Not yet recruiting	Aug 5, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Dec 28, 2012	EliquisNDA 202155 · New molecular entity	Bristol Myers Squibb	24	Marketed
Dec 23, 2019	ApixabanANDA 210013	Micro Labs	2	Discontinued
Dec 23, 2019	ApixabanANDA 210128	Mylan	2	Discontinued
Apr 8, 2020	ApixabanANDA 210152	Bionpharma	2	Discontinued
Jul 28, 2020	ApixabanANDA 210180	Accord Hlthcare	1	Marketed
Sep 11, 2020	ApixabanANDA 209898	Regcon Holdings	2	Marketed
Jul 26, 2021	ApixabanANDA 209845	Breckenridge	0	Discontinued
Feb 27, 2023	ApixabanANDA 210185	Zydus Pharms	0	Discontinued
May 26, 2023	ApixabanANDA 210026	Aurobindo Pharma Ltd	0	Discontinued
Nov 21, 2023	ApixabanANDA 210066	Hetero Labs Ltd V	0	Discontinued
Feb 16, 2024	ApixabanANDA 210091	Apotex	0	Discontinued
Dec 17, 2024	ApixabanANDA 210156	Torrent	0	Discontinued
Feb 14, 2025	ApixabanANDA 209810	Impax	0	Discontinued
Feb 27, 2025	ApixabanANDA 210067	Macleods Pharms	0	Discontinued
Apr 17, 2025	Eliquis Sprinkle, EliquisNDA 220073 · New dosage form	Bristol	1	Marketed
—	ApixabanANDA 209944	Sunshine Lake	0	Discontinued
—	ApixabanANDA 210053	Sigmapharm Labs LLC	0	Discontinued
—	ApixabanANDA 210082	Dr Reddys Labs Inc	0	Discontinued
—	ApixabanANDA 210108	Unichem Labs Ltd	0	Discontinued
—	ApixabanANDA 210133	Prinston Pharma Inc	0	Discontinued
—	ApixabanANDA 210142	Teva Pharms USA Inc	0	Discontinued
—	ApixabanANDA 210171	Sun Pharm Industries	0	Marketed
—	ApixabanANDA 213903	Zhejiang Yongning Pharmaceutical Co Ltd	0	Discontinued
—	ApixabanANDA 218119	Sciegen Pharmaceuticals Inc	0	Discontinued
—	ApixabanANDA 218519	Fosun Wanbang (Jiangsu) Pharmaceutical Group Co.,	0	Discontinued
—	ApixabanNDA 220446	Lupin	0	Marketed
—	AbantaNDA 221024	Azurity	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA