TheraRadar
Data updated: May 26, 2026

ACUVAIL (ketorolac tromethamine)

Pain Approved 2009-07-22

ACUVAIL is indicated for the treatment of Pain; Inflammation.

Source: FDA Label • AbbVie
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How ACUVAIL Works

Ketorolac tromethamine acts by inhibiting the enzyme cyclooxygenase, thereby blocking the biosynthesis of prostaglandins. By reducing the concentration of these inflammatory mediators, the drug exerts potent local analgesic and anti-inflammatory effects.

Source: FDA Label
1
Indication
--
Phase 3 Trials
16
Years on Market

Details

Status
Prescription
First Approved
2009-07-22
Patent Cliff
2029

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Routes
OPHTHALMIC
Dosage Forms
SOLUTION/DROPS

Companies

AbbVie
Active Ingredient: KETOROLAC TROMETHAMINE

ACUVAIL Approval History

2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
6 FDA actions from 2009 to 2024
May 2024 SUPPL
Label · Labeling
FDA Letter Label
Dec 2014 SUPPL
Label · Labeling
FDA Letter Label
Nov 2012 SUPPL
Mfg · Manufacturing (CMC)
FDA Letter Label

What ACUVAIL Treats

2 indications

ACUVAIL is approved for 2 conditions since its original approval in 2009. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Pain
  • Inflammation
Source: FDA Label

ACUVAIL Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

BYQLOVI
HARROW EYE
2024 2 indic.
FLUOROMETHOLONE
DIFGEN PHARMS
2024 2 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to ACUVAIL

3 of 20

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HARROW EYE
Shared indications:
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Shared indications:
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Clinical Trial Registry

36 trials
Trial Sponsor ID Phase Status Title
NCT05324358 NTM-001-CT001 Ph 3 suspended Ketorolac Applied by Continuous IV Infusion for Treatment of Moderately Severe Postoperative Pain Following Bunionectomy
NCT06513208 HP-00109853 Ph 4 recruiting Ketorolac Effects on Post-operative Pain and Lumbar Fusion
NCT05641363 KETODOSE KETODOSE20221107 Ph 3 completed Comparison of Ketorolac at Three Doses in Children With Acute Pain
NCT03913702 results posted UTMB IRB #: 18-0156 Ph 2 terminated Subacromial Methylprednisolone Versus Ketorolac for Shoulder Impingement
NCT03453541 4923 Ph 4 terminated Ketorolac Use in Pediatric Patients Undergoing Tonsillectomy
NCT04733326 CairoU0 Ph 1 completed Evaluation of Post-operative Pain and Expression of IL-8 Using Ketolac or Cryoirrigation as a Final Flush in Single Visit Endodontic Treatment in Teeth With Symptomatic Irreversible Pulpitis and Apical Periodontitis.Randomized Clinical Trial.
NCT06395428 WMed-2024-1032 Ph 4 recruiting Haloperidol for Pain Control in Patients With Acute Musculoskeletal Back Pain in the Emergency Department
NCT06160778 KETOAPP 23-0952 Ph 3 recruiting Intravenous Ketorolac Vs. Morphine In Children With Acute Abdominal Pain
NCT04666701 EMS1319 - ESCÓCIA Ph 2 withdrawn Efficacy and Safety of Escócia Association in the Treatment of Acute Pain
NCT05382546 NTM-001-AHC001 Ph 1 completed A Pharmacokinetic Study of Intravenous NTM-001 in Healthy Chinese Subjects
NCT04439396 19-387 Ph 1 completed Toradol (Ketorolac) in Breast Surgery to Reduce Pain & Opioid Use
NCT04554862 M419 Ph 4 completed The Analgesic Efficacy of Magnesium and Ketorolac in Ultrasound Supraclavicular Block
NCT04939987 IRB00074034 Ph 2, Ph 3 withdrawn Opioid-Free Pain Control Regiment Following Robotic Radical Prostatectomy
NCT01471899 CTRGEMS0611 Ph 3 completed Comparison Of Ketorolac Tromethamine Oral Drops Versus Naproxen For Moderate to Severe Back Pain Treatment
NCT01471886 CTREMS0611 Ph 3 completed Comparison Of Ketorolac Tromethamine Versus Naproxen For Moderate to Severe Back Pain Treatment
NCT02902770 results posted 2016-03-09 Ph 4 completed Intravenous Lidocaine and Ketorolac for Pain Management
NCT02923687 AZadUMS-P/190/D Ph 2 completed Premedication Efficacy of Ketorolac Infiltration on Post Endodontic Pain
NCT03410212 IANB IR.IAU.DENTAL.REC.1396,31 Ph 2 completed Efficacy of Block Injection of an Anti Inflammatory Medicine in Patients With Mandibular Dental Pain
NCT02658149 results posted 2015-422 Ph 4 completed Psoas Compartment Block Versus Periarticular Local Anesthetic for Total Hip Arthroplasty
NCT02313675 results posted PRO14110464 Ph 4 completed Pain Outcomes of Intra-operative IV Tylenol and/or IV Toradol for Carpal Tunnel and Distal Radius Fracture Surgeries
NCT03007381 KANGAROO KANGAROO Ph 4 withdrawn Ketorolac for Analgesia followiNG Autologous Breast RecOnstructiOn
NCT02638831 DRL_RUS/PMS/2012/KETG Ph 4 completed Ketorol Gel in Gonarthrosis and Low Back Pain
NCT01609881 Prostaglandin 12022 Ph 1 withdrawn The Role of Prostaglandins in the Progression of Diabetic Retinopathy
NCT02729285 2014MEKY042 Ph 4 completed Preoperative Ketorolac for Pain Control in Scleral Buckle Surgery
NCT02601911 AzadUMS P/66/D Ph 2 completed Effect of Premedication on Success of Inferior Alveolar Nerve Block Injection
NCT02614118 AZadUMS-P/139/D Ph 2 completed Premedication Efficacy of Oral Ketorolac and Ketorolac/ Acetaminophen on Post Treatment Pain
NCT02536430 AZadUMS-P/212/D Ph 2 completed Efficacy of Ketorolac Buccal Infiltration on Success Rate of Inferior Alveolar Nerve Block
NCT00907114 HJM 1667/09.03.24 Ph 2 completed Topic Ketorolac Added to Panphotocoagulation in Proliferative Diabetic Retinopathy
NCT01596166 EDMigraine-4 EDMIGR-004-01 Ph 4 completed Intravenous Ketorolac and Metoclopramide for Pediatric Migraine in the Emergency Department
NCT01542190 0018014600011 Ph 4 completed Comparison of Topical Ketorolac 0,4% Versus Placebo in Cataract Surgery
NCT02000401 0703-2012-SPRIX Ph 4 completed Intranasal Ketorolac Tromethamine (Sprix) for Acute Pain of Interstitial Cystitis Flare of Pain
NCT01365624 results posted ROX 2007-02 Ph 1 completed Safety and Pharmacokinetics Study of Intranasal Ketorolac in Elderly and Nonelderly Adult Healthy Subjects
NCT01436032 N1539-05 Ph 3 terminated Efficacy, Safety and Tolerability Study of N1539 in Subjects After Abdominal Laparoscopic Surgery
NCT01291472 3214 2011-000367-27 Ph 4 completed Disposition of Intravenous Ketorolac
NCT01015235 KAI-1678-002 Ph 2 completed Safety and Efficacy Study of KAI-1678 to Treat Subjects With Postoperative Pain
NCT01021761 results posted 2009 0199 Ph 4 completed A Comparison of Prostaglandin E2 (PGE2) Inhibition of Acuvail(Ketorolac 0.45%), Xibrom (Bromfenac 0.09%)and Nevanac (Nepafenac)in Patients Undergoing Phacoemulsification
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

ACUVAIL FDA Label Details

Indications & Usage

FDA Label (PDF)

ACUVAIL is indicated for the treatment of Pain; Inflammation.

View full patent landscape →
3 OB patents · 3 families · 91 international docs across 22 countries

ACUVAIL Patents & Exclusivity

Latest Patent: Aug 2029

Patents (3 active)

US7842714 Expires Aug 15, 2029
US8512717 Expires Mar 7, 2028
US9192571 Expires Mar 7, 2028
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for ACUVAIL

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2029
  • • 3 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • 20 similar drugs
  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA022427 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.