Data updated: May 26, 2026
ADVIL DUAL ACTION WITH ACETAMINOPHEN (acetaminophen)
Pain
Approved 2020-02-28
1
Indication
--
Phase 3 Trials
6
Years on Market
Details
- Status
- Over-the-counter
- First Approved
- 2020-02-28
- Patent Cliff
- 2041
- Routes
- ORAL
- Dosage Forms
- TABLET
ADVIL DUAL ACTION WITH ACETAMINOPHEN Approval History
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
4 FDA actions from 2020 to 2025
What ADVIL DUAL ACTION WITH ACETAMINOPHEN Treats
1 FDA approvalsOriginally approved for its first indication in 2020 .
- Other (1)
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Clinical Trial Registry
251 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04165096 results posted | 3475-01C MK-3475-01C, KEYMAKER-U01C | Ph 2 | completed | KEYMAKER-U01 Substudy 3: Efficacy and Safety Study of Pembrolizumab (MK-3475) When Used With Investigational Agents in Participants With Advanced Non-small Cell Lung Cancer (NSCLC), Previously Treated With Anti-programmed Cell Death Receptor Ligand 1 (PD-L1) Therapy (MK-3475-01C/KEYMAKER-U01C) |
| NCT06009926 | NCI-2023-06404 NCI-2023-06404, STUDY00003544 | Ph 2 | active not recruiting | Evaluation of Broccoli Seed and Sprout Extract for Detoxification of Carcinogens in Firefighters |
| NCT07570173 | 1045-005 MK-1045-005, 2025-522267-15-00 | Ph 2, Ph 3 | recruiting | A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005) |
| NCT05878015 | 23-000547 | Ph 4 | enrolling by invitation | A Study of Intravenous Acetaminophen for Small Bowel Obstruction |
| NCT07567924 | SIUT-ERC-2024/A-475 | Ph 4 | active not recruiting | Comparison Between Pregabalin and Acetaminophen for the Treatment of Post-Mastectomy Pain Syndrome |
| NCT04221477 REGENCY results posted | CA41705 2019-004034-42, 2023-503628-22-00 | Ph 3 | active not recruiting | A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis |
| NCT06043323 | 2023-0087 NCI-2023-07173 | Ph 2 | recruiting | A Phase II Study of Axicabtagene Ciloleucel, an Anti-CD19 Chimeric Antigen Receptor (CAR) Tcell Therapy, in Combination With Radiotherapy (RT) in Relapsed/Refractory Follicular Lymphoma |
| NCT07571252 | 2603555595 | Ph 4 | not yet recruiting | Impact of Preemptive Analgesia on Postoperative Pain in Orthognathic Surgery |
| NCT06762600 | HRS-4729-101 | Ph 1 | completed | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-4729 Injection in Healthy Subjects |
| NCT07525791 | NN9662-8158 U1111-1328-3457 | Ph 1 | recruiting | A Research Study Looking Into How NNC0662-0419 Works With Birth Control Pills and Emptying of the Stomach in Women Not Able to Become Pregnant With Excess Body Weight |
| NCT07508241 | C6491010 MET097-25-106 | Ph 1 | recruiting | A Study to Learn About the Effect of Study Medicine Called PF-08653944 on How Quickly the Stomach Empties Its Content in Healthy Adults With Overweight or Obesity |
| NCT07525219 | IRB00146434 | Ph 3 | not yet recruiting | Suzetrigine Frame Trial Comparing Suzetrigine and Acetaminophen |
| NCT03823534 | 28927 | Ph 3 | recruiting | Post-Op Pain Control for Prophylactic Intramedullary Nailing. |
| NCT05722002 CARES | HUM00215416 CER-2021C1-22398 | Ph 4 | recruiting | Comparing Analgesic Regimen Effectiveness and Safety for Surgery (CARES) Trial |
| NCT05285813 | 2021-1124 NCI-2022-02215 | Ph 2 | active not recruiting | A Phase II Study of Vibecotamab (XmAb14045) for MRD- Positive AML and MDS After Hypomethylating Agent Failure |
| NCT03759028 | IRB# 18-001158 | Ph 4 | recruiting | Supracondylar Post-Operative Pain Study |
| NCT04629248 MAJESTY | WA41937 2020-003233-38, 2023-506525-11-00 | Ph 3 | active not recruiting | A Study Evaluating the Efficacy and Safety of Obinutuzumab in Participants With Primary Membranous Nephropathy |
| NCT06214468 | 23-067/2026659-2 | Ph 1 | completed | Protective Effect of Nicotinamide Riboside Against Acetaminophen Toxicity |
| NCT06187584 results posted | STUDY00000286 | Ph 4 | completed | Supracondylar Humerus Fracture (SCHF) Post-Op Study Between Opioid and Non-Opioid Pain Management |
| NCT07502001 | HDM1005-104 | Ph 1 | not yet recruiting | Influence of HDM1005 on Gastric Emptying and Pharmacokinetics of Metformin, Atorvastatin, Warfarin, and Digoxin |
| NCT04268498 ADVANCE | 20201316 2019-001645-41, 19-339 | Ph 2 | active not recruiting | A Study of Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone in Patients With Newly-Diagnosed Multiple Myeloma |
| NCT03818932 results posted | 123192 | Ph 2, Ph 3 | completed | Nonopioid Analgesia After Anterior Cruciate Ligament Reconstruction |
| NCT03258593 results posted | 170157 17-C-0157 | Ph 1 | completed | Durvalumab and Vicineum in Subjects With High-Grade Non-Muscle-Invasive Bladder Cancer Previously Treated With Bacillus Calmette-Guerin (BCG) |
| NCT04459117 TREOCAPA | C19-29 2019-004297-26 | Ph 2, Ph 3 | completed | Prophylactic Treatment of the Ductus Arteriosus in Preterm Infants by Acetaminophen |
| NCT05896228 Iber-KDd | 20230227 | Ph 2 | recruiting | Iberdomide, Daratumumab, Carfilzomib, and Dexamethasone (Iber-KDd) in Patients With Relapsed/Refractory Multiple Myeloma |
| NCT02858310 results posted | 160154 16-C-0154 | Ph 1, Ph 2 | completed | E7 TCR T Cells for Human Papillomavirus-Associated Cancers |
| NCT05597878 | IRB00091354 WFBCCC 01122 | Ph 2, Ph 3 | suspended | Opioid-Free Pain Control Regimen Following Robotic Radical Prostatectomy |
| NCT06671002 CARES for Kids | HUM00252793 BPS-2023C1-32147 | Ph 4 | recruiting | Comparing Analgesic Regimen Effectiveness and Safety for Surgery for Kids Trial |
| NCT03974932 results posted | HTX-011-306 | Ph 3 | completed | Total Knee Arthroplasty (TKA) Study of HTX-011 in an Multimodal Analgesic Regimen (MMA) Regimen |
| NCT03695367 results posted | HTX-011-215 | Ph 2 | completed | Phase 2 Herniorrhaphy Study for Opioid Elimination |
| NCT07429032 | 20230012 | Ph 1 | completed | The Effect of AMG 133 on Gastric Emptying |
| NCT06356571 SubQSA | LPS18183 U1111-1298-7348 | Ph 2 | recruiting | A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma |
| NCT04224558 | Pro00051458 | Ph 1, Ph 2 | recruiting | Stem Cell Transplantation in Crohn's Disease |
| NCT06994442 OPTICOM | 24-12028276 U01HD116260 | Ph 3 | recruiting | Optimizing Pain Treatment in Children On Mechanical Ventilation |
| NCT03913559 | INOMRD NCI-2019-01062 | Ph 2 | terminated | Inotuzumab Ozogamicin for Children With MRD Positive CD22+ Lymphoblastic Leukemia |
| NCT05488847 results posted | 15592 | Ph 4 | active not recruiting | Opioid-Free Pain Protocol After Shoulder Arthroplasty |
| NCT07101445 | STUDY00008909 NCI-2025-03018, STUDY00008909 | Ph 4 | recruiting | Evaluating Premedication Regimens (Methylprednisolone vs Dexamethasone-based) for the Prevention of Systemic and Injection Site Reactions to Motixafortide in Patients With Multiple Myeloma Undergoing Stem Cell Mobilization, PARADE Trial |
| NCT05640674 results posted | 52475 | Ph 4 | terminated | Post-operative Pain Management in Children With Supracondylar Humerus Fractures |
| NCT04918147 results posted | DAIT AIG01 UM1AI144298, NIAID CRMS ID#: 38708 | Ph 2 | terminated | Elotuzumab in Immunoglobulin G4-Related Disease (IgG4-RD) |
| NCT01391962 results posted | 110200 11-C-0200 | Ph 2 | completed | Sunitinib or Cediranib for Alveolar Soft Part Sarcoma |
| NCT04681105 | 20472 NCI-2020-08118, 20472 | Ph 1 | completed | Flotetuzumab for the Treatment of Relapsed or Refractory Advanced CD123-Positive Hematological Malignancies |
| NCT06997016 | Baylor IRB #025-220 | Ph 4 | enrolling by invitation | Enhanced Recovery After Surgery (ERAS) in Live Donor Kidney Transplant Recipients |
| NCT02797522 results posted | ARC5211001 | Ph 1 | terminated | A Study of ARC-521 Injection in Normal Adult Volunteers and Patients With Chronic Hepatitis B (CHB) |
| NCT05211336 results posted | 10000516 000516-C | Ph 1 | active not recruiting | Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (VIPOR) for Diffuse Large B-cell Lymphoma Involving the Central Nervous System |
| NCT03978767 PANDA | 201901202 | Ph 2 | completed | Preeclampsia And Nonsteroidal Drugs for Analgesia: a Randomized Non Inferiority Trial |
| NCT05704049 IZALCO | ACT17453 U1111-1280-5090, 2023-508870-27 | Ph 2 | active not recruiting | A Study to Investigate Subcutaneous Isatuximab in Combination With Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma |
| NCT05603832 | 100-CIP02-P | Ph 3 | completed | A Phase 3 Study of F14 for Management of Pain Following Total Knee Replacement |
| NCT04270409 | EFC15992 U1111-1222-7068, 2023-507419-37 | Ph 3 | active not recruiting | Isatuximab in Combination With Lenalidomide and Dexamethasone in High-risk Smoldering Multiple Myeloma |
| NCT03997851 results posted | 20190133 | Ph 1, Ph 2 | completed | Topical Acetaminophen for Itch Relief: a Proof of Concept Study in Healthy Subjects |
| NCT05035407 results posted | 10000045 000045-C | Ph 1 | terminated | T Cell Receptor Gene Therapy Targeting KK-LC-1 for Gastric, Breast, Cervical, Lung and Other KK-LC-1 Positive Epithelial Cancers |
Showing 50 of 251 trials
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ADVIL DUAL ACTION WITH ACETAMINOPHEN FDA Label Details
View full patent landscape →
1 OB patents · 1 families ·
21 international docs across 13 countries
ADVIL DUAL ACTION WITH ACETAMINOPHEN Patents & Exclusivity
Latest Patent: Jul 2041
Patents (1 active)
US11918693
Expires Jul 9, 2041
Source: FDA Orange Book
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Data Sources
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