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 19h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
COLBENEMID is a fixed-dose combination of colchicine and probenecid approved in 1961 for the treatment of gout flares and acute gout attacks in children aged 4+ years and adults, as well as familial Mediterranean fever (FMF). Colchicine works by inhibiting inflammasome assembly in immune cells and disrupting microtubule formation, thereby reducing neutrophil activation and migration that drives gout symptoms. Probenecid acts as a uricosuric agent to lower uric acid levels.
LOE Approaching
This mature product faces moderate competitive pressure (30% rating) with LOE approaching, signaling a small, maintenance-focused brand team managing a legacy franchise.
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.