NDAORALCAPSULE
Approved
May 1995
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
FLAGYL (metronidazole) by Pfizer is clinical pharmacology absorption disposition of metronidazole in the body is similar for both oral and intravenous dosage forms. First approved in 1995.
Drug data last refreshed 26m ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FLAGYL (metronidazole) is a nitroimidazole antimicrobial small molecule used to treat anaerobic bacterial and parasitic infections, including trichomoniasis and bacterial vaginosis. It works by disrupting the DNA of anaerobic organisms, making it bactericidal at therapeutic concentrations. The drug is available as an oral capsule formulation with rapid absorption and broad tissue distribution.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30%); expect defensive positioning and team consolidation over next 2-3 years.
Mechanism of Action
CLINICAL PHARMACOLOGY Absorption Disposition of metronidazole in the body is similar for both oral and intravenous dosage forms. FLAGYL 375 capsules have been shown to have a rate and extent of absorption similar to metronidazole tablets (FLAGYL) and were bioequivalent at an equal single dose of…
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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.