NDAORALFOR SOLUTION
Approved
Dec 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
2
Data completeness
5/8 — 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. Approved for urinary tract infection. First approved in 1996.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MONUROL (fosfomycin tromethamine) is an oral antibiotic indicated for uncomplicated urinary tract infections and Pseudomonas infections. It works by inhibiting bacterial cell wall synthesis through a unique mechanism of action distinct from beta-lactams and fluoroquinolones. The drug is rapidly absorbed orally with peak serum concentrations achieved within 2-4 hours and achieves high urinary concentrations suitable for UTI treatment.
$0.079MPart D
LOE ApproachingDeclining
Product is in late-stage lifecycle with minimal market claims, indicating reduced team size and commercial investment focused on managed care maintenance rather than growth initiatives.
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.