NDAORALSUSPENSION/DROPS
Approved
Jan 1998
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
INFANT'S ADVIL (ibuprofen) by GSK is cyclooxygenase inhibitors [moa]. First approved in 1998.
Drug data last refreshed Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Infant's Advil is an oral ibuprofen suspension formulated for pediatric use, indicated for pain and fever management in infants and young children. It works as a cyclooxygenase inhibitor, reducing prostaglandin synthesis to provide anti-inflammatory, analgesic, and antipyretic effects. The product addresses a critical gap in pediatric pain management where dosing precision and taste palatability are essential.
LOE Approaching
Product approaching loss of exclusivity after 26+ years on market; expect declining brand team headcount and shift toward cost-containment and generic-to-brand competitive strategies.
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)
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.