TheraRadar
Data updated: May 26, 2026

NAPROXEN SODIUM

Pain Approved 1993-08-31

NAPROXEN SODIUM is indicated for the treatment of Arthritis; Back Pain; Menstrual Cramps; Headache; Toothache; Common Cold; Fever.

Source: FDA Label • Dr. Reddy's
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
33
Indications
--
Phase 3 Trials
32
Years on Market

Details

Status
Prescription
First Approved
1993-08-31
Patent Cliff
2026

Pro Metrics

Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
TABLET, CAPSULE, TABLET, EXTENDED RELEASE

Companies

Dr. Reddy's CATALENT Teva ABLE AMNEAL PHARMS NY MARKSANS PHARMA ONESOURCE SPECIALTY PERRIGO LNK INTL INC BIONPHARMA PHARMOBEDIENT Sun Pharma NOVELGENIX THERAPS PUREPAC PHARM WATSON LABS CONTRACT PHARMACAL Aurobindo Pharma YICHANG HUMANWELL IVAX SUB TEVA PHARMS ROXANE Novartis GRANULES INDIA HETERO LABS LTD V GLENMARK PHARMS LTD SCIEGEN PHARMS PATHEON SOFTGELS HAMILTON PHARMS PLIVA PURACAP PHARM LLC Hikma PLD ACQUISITIONS LLC
Active Ingredient: NAPROXEN SODIUM

NAPROXEN SODIUM Approval History

1994
1995
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2003
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2007
2008
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2010
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2012
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2015
2016
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2019
2020
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2026
Original
New Indication
New Form
Label Update
442 FDA actions from 1993 to 2026
Jan 2026 SUPPL
Label · Labeling
Jan 2026 SUPPL
Label · Labeling
FDA Letter Label
Sep 2025 SUPPL
Label · Labeling

What NAPROXEN SODIUM Treats

7 indications

NAPROXEN SODIUM is approved for 7 conditions since its original approval in 1993. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Arthritis
  • Back Pain
  • Menstrual Cramps
  • Headache
  • Toothache
  • Common Cold
  • Fever
Source: FDA Label

NAPROXEN SODIUM 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?

PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
Dr. Reddy's
2025 8 indic.
BIMZELX
UCB INC
2023 5 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 NAPROXEN SODIUM

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

ANAPROX DS
NAPROXEN SODIUM
7 shared
ATNAHS PHARMA US
Shared indications:
ArthritisBack PainMenstrual Cramps +4 more
ALLZITAL
ACETAMINOPHEN
5 shared
PHARMOBEDIENT
Shared indications:
HeadacheArthritisToothache +2 more
ANEXSIA 5/325
ACETAMINOPHEN
5 shared
SPECGX LLC
Shared indications:
HeadacheArthritisToothache +2 more
View all 20 similar drugs Pro
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Clinical Trial Registry

9 trials
Trial Sponsor ID Phase Status Title
NCT04145518 MCUP EH19-040 R01HD098193-01A1 Ph 4 completed Mechanistic Characterization of Uterine Pain
NCT04015596 results posted 2019P000623 Ph 4 terminated Trial of Naproxen Sodium for the Treatment of OCD in Children With PANDAS
NCT05761574 CCSPAA005199 CCSPAA005199 Ph 3 completed A Study of an Acetaminophen/Naproxen Sodium Fixed Combination, Acetaminophen and Naproxen Sodium in Postoperative Dental Pain
NCT05982392 2889 Ph 2, Ph 3 completed Effect of Preoperative Tramadol and Naproxen Sodium on Post Operative Pain
NCT01107236 ICP-109-201 Ph 2 completed Study to Evaluate Efficacy and Safety of IW-6118 in Patients Undergoing Third Molar Extraction
NCT03291418 ATB-346-P2GIS Ph 1, Ph 2 completed To Compare the Gastrointestinal Safety of a 14-Day Oral Dosing Regimen of ATB-346 to Sodium Naproxen in Healthy Subjects
NCT01090050 results posted 112839 Ph 4 completed Treximet in the Treatment of Chronic Migraine
NCT01300546 results posted 114933 Ph 4 completed Treximet Trademark (TM) in the Prevention and Modification of Disease Progression in Migraine
NCT00692016 Keifer 13080 Ph 1 completed Fast & Fed Pharmacokinetic (PK) Study
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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.

NAPROXEN SODIUM FDA Label Details

Indications & Usage

FDA Label (PDF)

NAPROXEN SODIUM is indicated for the treatment of Arthritis; Back Pain; Menstrual Cramps; Headache; Toothache; Common Cold; Fever.

View full patent landscape →
5 OB patents · 1 families · 37 international docs across 14 countries

NAPROXEN SODIUM Patents & Exclusivity

Latest Patent: Mar 2026

Patents (5 active)

US10028925 Expires Mar 3, 2026
US10022344 Expires Mar 3, 2026
US11090280 Expires Mar 3, 2026
US9693979 Expires Mar 3, 2026
US9693978 Expires Mar 3, 2026
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for NAPROXEN SODIUM

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2026
  • • 8 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • 20 similar drugs
  • • Same target/indication analysis
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Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: ANDA078486 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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