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 5h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
COLBENEMID is a fixed-dose oral combination of colchicine and probenecid indicated for acute gout flares and familial Mediterranean fever (FMF) in children age 4 and older. The colchicine component disrupts inflammasome assembly and microtubule polymerization to suppress neutrophil activation and interleukin-1β release, while probenecid enhances uric acid excretion. This dual mechanism addresses both acute inflammation and underlying uric acid burden.
LOE Approaching
As a decades-old fixed-dose product approaching loss of exclusivity with moderate competitive pressure (30%), this brand faces team consolidation and requires defensive positioning rather than growth investment.
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)
Worked on COLBENEMID at Merck & Co.? Share your interview experience or compensation data (+7 days Pro)
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.