NDAINTRAVENOUSSOLUTIONPriority Review
Approved
Jun 2009
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
Priority Review
CALDOLOR (ibuprofen) by Cumberland Pharmaceuticals is cyclooxygenase inhibitors [moa]. Approved for pain, postoperative pain, dental pain and 4 more indications. First approved in 2009.
Drug data last refreshed 19h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CALDOLOR is an intravenous nonsteroidal anti-inflammatory drug (NSAID) containing ibuprofen, approved in 2009 for acute pain management including postoperative, dental, and musculoskeletal pain. It works by inhibiting cyclooxygenase enzymes to reduce inflammation and pain. This is a unique IV formulation of a well-known oral NSAID, enabling use in hospitalized and perioperative patients.
Peak5.9 years to LOE
Product is in peak lifecycle with stable but limited pricing pressure, suggesting a mature specialty IV formulation team focused on hospital channel penetration and surgical pain management protocols.
Mechanism of Action
Cyclooxygenase Inhibitors
Pharmacologic Class:
Nonsteroidal Anti-inflammatory Drug
Indications (7)
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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.