Wednesday, July 8, 2026

Drug profile · INN

naproxen

naproxen (ANAPROX 550) is a cyclooxygenase inhibitor. Associated with Amneal Pharma Europe Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved TGA: approved
US status approved
Patents linked 3
Pipeline programs 9
News articles 0
Drug details — naproxen
US status
approved
Class
Route
ORAL
Patents
3
Programs
9
Data quality
0.89

Quick answer

naproxen (ANAPROX 550) is a cyclooxygenase inhibitor. Associated with Amneal Pharma Europe Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN naproxen
Brand ANAPROX 550
Mechanism Cyclooxygenase inhibitor
Target Cyclooxygenase
Route ORAL
Formulation TABLET, DELAYED RELEASE

Mechanism of action

Cyclooxygenase inhibitor

Primary target: Cyclooxygenase

Approval history

Authority Status Date
FDA approved
TGA approved

Pipeline programs

  1. Lansoprazole and naproxen and aspirin Phase 3 · Takeda · Osteoarthritis
  2. MyelomaXIV Phase 3 · Takeda · Multiple Myeloma
  3. AMY106EU Phase 2 · Anaxis Pharma · Endometriosis
  4. Naproxen Phase 2 · Protalix Biotherapeutics · Healthy Volunteers
  5. 1062/25 Phase 1 · Tillomed Laboratories · Bioavailability study in healthy volunteers under fasting co
  6. CFA-1042-1-24 Phase 1 · Tillomed Laboratories · No medical condition
  7. CFA-1042-3-26 Phase 1 · Tillomed Laboratories · No medical condition
  8. Naproxen Approved · Teva Pharma · Menorrhagia

Related & competitor drugs

  1. aspirin Cyclooxygenase inhibitor
  2. bromfenac sodium Cyclooxygenase inhibitor
  3. diclofenac potassium Cyclooxygenase inhibitor
  4. diclofenac sodium Cyclooxygenase inhibitor
  5. diflunisal Nervous system (N02)
  6. fenoprofen calcium Cyclooxygenase inhibitor
  1. 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
  2. US 8742079

    Saccharide-containing protein conjugates and uses thereof

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

    granted
  3. 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

Frequently asked questions

What is naproxen?

naproxen (ANAPROX 550) is a cyclooxygenase inhibitor. Associated with Amneal Pharma Europe Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for naproxen?

ANAPROX 550 is a marketed brand name for naproxen. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of naproxen?

naproxen 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.