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 6h ago · AI intelligence enriched 4d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MONUROL (fosfomycin tromethamine) is an oral antibiotic that inhibits bacterial cell wall synthesis via a unique mechanism distinct from beta-lactams and other common UTI agents. It is indicated for uncomplicated urinary tract infections and is administered as a single 3-gram dose. The drug achieves high urinary concentrations (706 mcg/mL peak) within 2–4 hours, making it effective for acute cystitis in women.
$0.079BPart D
LOE ApproachingProduct is in late lifecycle (LOE approaching) with modest Part D spending; teams are typically smaller and focused on lifecycle management and generic transition planning.
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.