NDAORALSUSPENSION/DROPS
Approved
May 1995
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
MOTRIN (ibuprofen) by Johnson & Johnson is cyclooxygenase inhibitors [moa]. First approved in 1995.
Drug data last refreshed 1h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MOTRIN is an oral ibuprofen suspension/drops approved in 1995 for pain, fever, and inflammatory conditions including arthritis and dysmenorrhea. It works by inhibiting cyclooxygenase enzymes to reduce prostaglandin production and inflammation. The product is a foundational over-the-counter and prescription analgesic/anti-inflammatory agent.
LOE Approaching
As a mature brand approaching loss of exclusivity with moderate competitive pressure, team size is likely stable to declining with focus on generic transition management and market defense.
Mechanism of Action
Cyclooxygenase Inhibitors
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Effect of Extracorporeal Radial Shock Wave Ibuprofen Phonophoresis on Subacromial Space in Patients With Impingement Syndrome.
Started Mar 2026
70 enrolled
RehabilitationShock WaveImpingement Syndrome
A Comparative Bioavailability Study of Reformulated Ibuprofen 2% and 4% Oral Suspensions (Berlin Chemie AG) and Versus Ibuprofen (Nurofen®) 200 mg/5 ml Oral Suspension
Started Nov 2023
74 enrolled
Healthy Male and Female Subjects
Efficacy and Safety of S (+) - Ibuprofen in Osteoarthritis Pain
Started Aug 2022
176 enrolled
Osteoarthritis
Efficacy and Safety of S (+) - Ibuprofen in the Treatment of Mechanical Low Back Pain
Started Jun 2022
177 enrolled
Low Back Pain, MechanicalLow Back PainAcute Low Back Pain
Postoperative Analgesic Effects of Ibuprofen Versus Ketorolac in Patients Undergoing in Orthopedic Surgery
Started Aug 2021
100 enrolled
Intravenous Drug UsageIbuprofenKetorolac+2 more
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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.