NDAORALSUSPENSIONPriority Review
Approved
Mar 1987
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
Priority Review
NAPROSYN (naproxen) by Hamilton medical is cyclooxygenase inhibitors [moa]. First approved in 1987.
Drug data last refreshed 14h ago · AI intelligence enriched 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NAPROSYN (naproxen) is an oral nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase enzymes to reduce pain, inflammation, and fever. It is available as a suspension formulation and is indicated for various inflammatory and pain conditions. The drug has been on the market since 1987 and remains a widely used over-the-counter and prescription NSAID.
LOE Approaching
As a mature NSAID facing loss of exclusivity, the product likely operates with a stable but lean team focused on cost management and generic transition strategies rather than growth initiatives.
Mechanism of Action
Cyclooxygenase Inhibitors
Pharmacologic Class:
Nonsteroidal Anti-inflammatory Drug
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
PK,PD and DDI of Epaminurad and Naproxen in Healthy Volunteers
Started Jun 2024
57 enrolled
Healthy
A Multiple-Dose Safety Study of Fixed Combination of Acetaminophen/Naproxen Sodium in Adolescents With Orthodontic Pain
Started Jan 2024
0Orthodontic Pain
A Study of Acetaminophen/Naproxen Sodium Fixed Combination Tablets in Adolescents 12 to <17 Years of Age With Pain
Started Sep 2023
24 enrolled
Orthodontic Pain
A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy
Started Sep 2023
143 enrolled
Pain
A Study of an Acetaminophen/Naproxen Sodium Fixed Combination, Acetaminophen and Naproxen Sodium in Postoperative Dental Pain
Started May 2023
447 enrolled
Pain
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.