NDAORALFOR SOLUTION
Approved
Dec 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
2
Data completeness
4/8 — Partial
MONUROL (fosfomycin tromethamine) by Zambon is clinical pharmacology absorption: fosfomycin tromethamine is rapidly absorbed following oral administration and converted to the free acid, fosfomycin. First approved in 1996.
Drug data last refreshed 16h ago · AI intelligence enriched 19h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MONUROL (fosfomycin tromethamine) is an oral antibiotic that inhibits bacterial cell wall synthesis through a unique mechanism of action. It is indicated for uncomplicated urinary tract infections (UTIs), particularly acute cystitis in women. Fosfomycin concentrates in the urinary tract and bladder tissue, achieving high local concentrations that exceed typical serum levels.
$0.079MPart D
LOE ApproachingDeclining
LOE-stage product with minimal claims volume indicates small, defensive commercial team focused on maintaining existing patient base rather than growth.
Mechanism of Action
CLINICAL PHARMACOLOGY Absorption: Fosfomycin tromethamine is rapidly absorbed following oral administration and converted to the free acid, fosfomycin. Absolute oral bioavailability under fasting conditions is 37%. After a single 3 gram dose of fosfomycin tromethamine granules for oral solution,…
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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.