NDAINTRAVENOUSSOLUTIONPriority Review
Approved
Jun 2009
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
CALDOLOR (ibuprofen) by Cumberland Pharmaceuticals is cyclooxygenase inhibitors [moa]. First approved in 2009.
Drug data last refreshed 13h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CALDOLOR is an intravenous formulation of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) that works by inhibiting cyclooxygenase enzymes to reduce inflammation and pain. Approved in 2009, it is indicated for fever reduction and pain management in hospitalized patients who cannot take oral medication. The IV route enables rapid onset and reliable dosing in acute care settings.
Peak5.4 years to LOE
The product is in peak lifecycle with minimal competitive pressure, indicating stable team size and market position, though ASP at $3.18 suggests a niche acute-care market.
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)
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
Ibuprofen Plus Acetaminophen for Enhanced Pain Reduction
Started Mar 2021
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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.