Wednesday, July 8, 2026

Drug profile · INN

ibuprofen

ibuprofen (APO-IBUPROFEN 400) is a cyclooxygenase inhibitor. Associated with Lacuna Pharma Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved Cardiovascular system (C01) C01EB16
US status approved
Patents linked 15
Pipeline programs 31
News articles 0
Drug details — ibuprofen
US status
approved
Class
Cardiovascular system (C01)
Route
ORAL
Patents
15
Programs
31
Data quality
0.89

Quick answer

ibuprofen (APO-IBUPROFEN 400) is a cyclooxygenase inhibitor. Associated with Lacuna Pharma Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN ibuprofen
Brand APO-IBUPROFEN 400
Mechanism Cyclooxygenase inhibitor
Target Cyclooxygenase
Therapeutic class Cardiovascular system (C01)
Route ORAL
Formulation CAPSULE
ATC code C01EB16

Mechanism of action

Cyclooxygenase inhibitor

Primary target: Cyclooxygenase

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved

Pipeline programs

  1. 600 mg Ibuprofen Phase 3 · United Therapeutics Europe · Tibial Fractures
  2. CT-P13 3.11 Phase 3 · Celltrion Healthcare Australia · Rheumatoid arthritis
  3. Caldolor Phase 3 · Cumberland Pharmaceuticals · Fever
  4. Caldolor Phase 3 · Cumberland Pharmaceuticals · Pain
  5. Caldolor Phase 3 · Cumberland Pharmaceuticals · Burns
  6. Ibuprofen Phase 3 · Cumberland Pharmaceuticals · Fever
  7. Intravenous Ibuprofen Phase 3 · Cumberland Pharmaceuticals · Postoperative Pain
  8. Intravenous ibuprofen Phase 3 · Cumberland Pharmaceuticals · Tonsillectomy

Related & competitor drugs

  1. alirocumab Cardiovascular system (C10)
  2. aliskiren Cardiovascular system (C09)
  3. aspirin Cyclooxygenase inhibitor
  4. azilsartan medoxomil Cardiovascular system (C09)
  5. bempedoic acid Cardiovascular system (C10)
  6. bosentan Cardiovascular system (C02)
  1. US 11806400

    Injectable ibuprofen formulation

    Expires Mon Nov 02 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 9931311

    Treating critically ill patients with intravenous ibuprofen

    Expires Mon Mar 29 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 9649284

    Treating critically ill patients with intravenous ibuprofen

    Expires Mon May 11 2037 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 9295639

    Treating critically ill patients with intravenous ibuprofen

    Expires Mon Mar 24 2036 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 9138404

    Treating critically ill patients with intravenous ibuprofen

    Expires Mon Sep 17 2035 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  6. US 9114068

    Treating patients with intravenous ibuprofen

    Expires Mon Aug 20 2035 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  7. US 9072661

    Injectable ibuprofen formulation

    Expires Mon Jul 02 2035 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  8. US 9072710

    Injectable ibuprofen formulation

    Expires Mon Jul 02 2035 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  9. US 9012508

    Administration of intravenous ibuprofen

    Expires Mon Apr 16 2035 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  10. US 8871810

    Treating critically ill patients with intravenous ibuprofen

    Expires Mon Oct 23 2034 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  11. US 8790641

    Production of high mannose proteins in plant culture and therapeutic uses thereof

    Expires Mon Jul 24 2034 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  12. US 8742079

    Saccharide-containing protein conjugates and uses thereof

    Expires Mon May 29 2034 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  13. US 8735452

    Treating patients with intravenous ibuprofen

    Expires Mon May 22 2034 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  14. US 7655781

    Variants of human glycoprotein hormone alpha chain: compositions and uses thereof

    Expires Mon Jan 28 2030 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  15. US 6066332

    Immediate-effect ibuprofen-containing medicament and its use

    Expires Mon May 18 2020 00:00:00 GMT+0000 (Coordinated Universal Time)

    expired

Frequently asked questions

What is ibuprofen?

ibuprofen (APO-IBUPROFEN 400) is a cyclooxygenase inhibitor. Associated with Lacuna Pharma Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for ibuprofen?

APO-IBUPROFEN 400 is a marketed brand name for ibuprofen. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of ibuprofen?

ibuprofen has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.