PharmaRadar360

PharmaRadar360

CardiovascularDrug intelligence

Eliquis

Apixaban

Factor Xa inhibitor. Developed by Bristol Myers Squibb. Clinical, regulatory, and source evidence are connected below.

Company
Bristol Myers Squibb
Target / MOA
Factor Xa · F10
Aliases
Eliquis
Signals
20
Clinical trials
19
Approvals
0
Evidence sources
20

Latest signals

What changed

The three most recent source-backed changes linked to this drug.

clinical trialClinicalTrials.gov

BEACON-AA: Apixaban With or Without Clopidogrel in Stroke Patients With Atrial Fibrillation and Cerebral Atherosclerosis

Phase 4 · RECRUITING · Yonsei University

clinical trialClinicalTrials.gov

Pharmacokinetics of Apixaban in Patients With Short Bowel Syndrome Requiring Long Term Parenteral Nutrition

Phase 4 · COMPLETED · Universitaire Ziekenhuizen KU Leuven

clinical trialClinicalTrials.gov

Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation

Phase 2 · RECRUITING · Regeneron Pharmaceuticals

Approved uses

What regulators have approved

The indications section of each current US label, word for word, and the EU summary of each authorised product. Official sources as of Oct 18, 2026.

United States (FDA label)

Eliquis · NDA202155 · label version 30, effective Apr 17, 2025 · DailyMed

Label section 1

1 INDICATIONS AND USAGE 1.1 Reduction of Risk of Stroke and Systemic Embolism in Nonvalvular Atrial Fibrillation ELIQUIS is indicated to reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation. 1.2 Prophylaxis of Deep Vein Thrombosis Following Hip or Knee Replacement Surgery ELIQUIS is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in adult patients who have undergone hip or knee replacement surgery. 1.3 Treatment of Deep Vein Thrombosis ELIQUIS is indicated for the treatment of adults with deep vein thrombosis (DVT). 1.4 Treatment of Pulmonary Embolism ELIQUIS is indicated for the treatment of adults with pulmonary embolism (PE). 1.5 Reduction in the Risk of Recurrence of Deep Vein Thrombosis and Pulmonary Embolism ELIQUIS is indicated to reduce the risk of recurrent deep vein thrombosis (DVT) and pulmonary embolism (PE) in adult patients following initial therapy. 1.6 Treatment of Venous Thromboembolism and Reduction in the Risk of Recurrent Venous Thromboembolism in Pediatric Patients ELIQUIS is indicated for the treatment of venous thromboembolism (VTE) and reduction in the risk of recurrent VTE in pediatric patients from birth and older after at least 5 days of initial anticoagulant treatment.

European Union (EMA)

Eliquis · EMEA/H/C/002148 · Authorised, authorised May 18, 2011 (Commission decision C(2011) 3595) · EPAR

Treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric patients from 28 days to less than 18 years of age. AdultsPrevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery. Prevention of stroke and systemic embolism in adult patients with non valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age ≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients).Paediatric population Treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric patients from 28 days to less than 18 years of age. AdultsPrevention of stroke and systemic embolism in adult patients with non valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients).Paediatric populationTreatment of venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric patients from 28 days to less than 18 years of age.

EMA's summary; the full indication is in the product information on the EPAR page.

Regulatory history

Approvals over time

US original approvals and efficacy supplements (new indications, populations or dosing) from Drugs@FDA; EU authorisations and CHMP opinions on extensions. Official sources as of Oct 18, 2026.

United States

NDA202155 · BRISTOL MYERS SQUIBB · first approved Dec 28, 2012

4 efficacy supplements approved

European Union

  • Eliquis: Authorised since May 18, 2011

Patents and exclusivity

What FDA lists (US)

Patents and exclusivity as FDA lists them in the Orange Book (drugs) and the Purple Book (biologics), with approved generics and biosimilars. Expired listings are not shown. Official sources as of Oct 18, 2026.

NDA202155 (Orange Book)

4 listed patents, latest expiry Aug 24, 2031
  • US 6967208 · expires Nov 21, 2026 · drug substance, drug product, U-1501, U-1200, U-1302, U-1729, U-1301, U-1730, U-1167, U-1323, U-4178, U-4179, U-1502
  • US 6967208*PED · expires May 21, 2027 · no claim type flagged
  • US 9326945 · expires Feb 24, 2031 · drug product
  • US 9326945*PED · expires Aug 24, 2031 · no claim type flagged

Exclusivity: NPP until Apr 17, 2028 (some products only: ELIQUIS 2.5MG, ELIQUIS 5MG); NS until Apr 17, 2028 (some products only: ELIQUIS 0.5MG); PED until Oct 17, 2028 · Orange Book entry

Generics and biosimilars

13 approved generics (ANDA)
  • MICRO LABS LTD · ANDA210013 · approved Dec 23, 2019
  • MYLAN PHARMACEUTICALS INC · ANDA210128 · approved Dec 23, 2019
  • BIONPHARMA INC · ANDA210152 · approved Apr 8, 2020
  • ACCORD HEALTHCARE INC · ANDA210180 · approved Jul 28, 2020
  • REGCON HOLDINGS LLC · ANDA209898 · approved Sep 11, 2020
  • BRECKENRIDGE PHARMACEUTICAL INC · ANDA209845 · approved Jul 26, 2021
  • ZYDUS PHARMACEUTICALS USA INC · ANDA210185 · approved Feb 27, 2023
  • AUROBINDO PHARMA LTD · ANDA210026 · approved May 26, 2023
  • HETERO LABS LTD UNIT V · ANDA210066 · approved Nov 21, 2023
  • APOTEX INC · ANDA210091 · approved Feb 16, 2024
  • TORRENT PHARMACEUTICALS LTD · ANDA210156 · approved Dec 17, 2024
  • IMPAX LABORATORIES LLC · ANDA209810 · approved Feb 14, 2025
  • MACLEODS PHARMACEUTICALS LTD · ANDA210067 · approved Feb 27, 2025

*PED is FDA's mark for a patent's period extended by six months of pediatric exclusivity.

FDA's listings only: an approved generic or licensed biosimilar may not be on the market yet. Not a forecast of when they may launch, and not legal advice.

Safety

Boxed warnings and FDA safety communications

The boxed warning on each current US label, and FDA Drug Safety Communications that name the drug (FDA's list from January 2020). Official sources as of Oct 18, 2026.

Boxed warning

Eliquis label

WARNING: (A) PREMATURE DISCONTINUATION OF ELIQUIS INCREASES THE RISK OF THROMBOTIC EVENTS (B) SPINAL/EPIDURAL HEMATOMA (A) PREMATURE DISCONTINUATION OF ELIQUIS INCREASES THE RISK OF THROMBOTIC EVENTS Premature discontinuation of any oral anticoagulant, including ELIQUIS, increases the risk of thrombotic events. If anticoagulation with ELIQUIS is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant [see Dosage and Administration (2.5) , Warnings and Precautions (5.1) , and Clinical Studies (14.1) ] . (B) SPINAL/EPIDURAL HEMATOMA Epidural or spinal hematomas may occur in patients treated with ELIQUIS who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include: • use of indwelling epidural catheters • concomitant use of other drugs that affect hemostasis, such as nonsteroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants • a history of traumatic or repeated epidural or spinal punctures • a history of spinal deformity or spinal surgery • optimal timing between the administration of ELIQUIS and neuraxial procedures is not known [see Warnings and Precautions (5.3) ] Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary [see Warnings and Precautions (5.3) ] . Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated [see Warnings and Precautions (5.3) ] .

FDA Drug Safety Communications

None on FDA's list names this drug.

Clinical trials

Key active studies

A focused view of recently updated studies · 19 linked records.

Phase 4RECRUITINGNCT07237308

BEACON-AA: Apixaban With or Without Clopidogrel in Stroke Patients With Atrial Fibrillation and Cerebral Atherosclerosis

Yonsei University · Updated Oct 16, 2026

Phase 4COMPLETEDNCT04344717

Pharmacokinetics of Apixaban in Patients With Short Bowel Syndrome Requiring Long Term Parenteral Nutrition

Universitaire Ziekenhuizen KU Leuven · Updated Oct 15, 2026

Phase 2RECRUITINGNCT07175428

Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation

Regeneron Pharmaceuticals · Updated Oct 9, 2026

Phase 4ACTIVE NOT RECRUITINGNCT07853612

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)

The University of The West Indies · Updated Oct 2, 2026

Phase 4RECRUITINGNCT04642430

COmparison of Bleeding Risk Between Rivaroxaban and Apixaban in Patients With Atrial Fibrillation

Ottawa Hospital Research Institute · Updated Oct 1, 2026

Phase 3RECRUITINGNCT07160686

Apixaban to Prevent Venous Thromboembolism in Ambulatory Lung Cancer Patients Undergoing Systemic Anticancer Treatment

University of Birmingham · Updated Sep 28, 2026

Regulatory timeline

Approvals and agency activity

Verified regulatory records in reverse chronological order.

No regulatory event is available in this snapshot.

Source evidence

Where this profile comes from

Facts link back to original registries, regulators, labels, and publishers. Counts change as source records update.

ClinicalTrials.govofficial · Latest Oct 16, 202620
Professional referenceThis profile summarizes linked public evidence. It is not medical, legal, regulatory, or investment advice. Verify decisions against original sources.