NDAORALTABLET
Approved
Mar 2023
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
5/8 — Partial
COMBOGESIC (acetaminophen and ibuprofen) by Aurobindo Pharma is cyclooxygenase inhibitors [moa]. Approved for minor aches, pains due to: headache toothache backache menstrual cramps muscular aches minor pain of arthritis. First approved in 2023.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
COMBOGESIC is an oral tablet combining acetaminophen and ibuprofen, two cyclooxygenase inhibitors approved in March 2023 by the FDA. It is indicated for minor aches and pains including headache, toothache, backache, menstrual cramps, muscular aches, and minor arthritis pain. The combination mechanism leverages dual inhibition of prostaglandin synthesis for enhanced analgesic and anti-inflammatory effect.
Peak12.8 years to LOE
Product is in peak commercial phase with strong patent protection through 2039; brand teams will focus on market expansion and maintaining competitive differentiation in a crowded OTC segment.
Mechanism of Action
Cyclooxygenase Inhibitors
Pharmacologic Class:
Nonsteroidal Anti-inflammatory Drug
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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.