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 9h ago · AI intelligence enriched 12h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MONUROL (fosfomycin tromethamine) is an oral antibiotic that inhibits bacterial cell wall synthesis, used to treat uncomplicated urinary tract infections (UTIs) in women. It is rapidly absorbed and achieves high concentrations in urine and bladder tissue, allowing single-dose therapy. Fosfomycin is excreted unchanged in urine and feces, with approximately 38% urinary recovery.
$0.079MPart D
LOE ApproachingLow Part D spending and claims volume indicate limited market penetration; LOE approaching suggests brand team focus will shift to market defense and lifecycle extension strategies.
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.