NDAORALTABLET
Approved
Jul 1961
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
COLBENEMID (colchicine; probenecid) by Merck & Co. is elucidated; however, evidence suggests that colchicine may interfere with the intracellular assembly of the inflammasome complex present in neutrophils and monocytes that mediates activation of interleukin-1β. Approved for gout flares, acute gout flares, children four years and 1 more indications. First approved in 1961.
Drug data last refreshed 12h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
COLBENEMID is a fixed-dose combination of colchicine and probenecid for oral treatment of acute gout flares and familial Mediterranean fever (FMF) in patients aged 4 years and older. Colchicine works by inhibiting inflammasome assembly in immune cells and disrupting microtubule formation to reduce neutrophil activation and migration. Probenecid acts as a uricosuric agent to lower serum uric acid levels.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100); brand team likely focused on retention strategies and lifecycle management rather than growth initiatives.
Mechanism of Action
elucidated; however, evidence suggests that colchicine may interfere with the intracellular assembly of the inflammasome complex present in neutrophils and monocytes that mediates activation of interleukin-1β. Additionally, colchicine disrupts cytoskeletal functions through inhibition of β-tubulin…
Indications (4)
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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.