METRONIDAZOLE
LOE ApproachingNDAORALTABLET
Approved
Oct 1982
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
METRONIDAZOLE by Fosun Pharma is clinical pharmacology absorption disposition of metronidazole in the body is similar for both oral and intravenous dosage forms. Approved for the treatment of asymptomatic t, the treatment of acute intestinal amebiasis (amebic dysentery), amebic liver abscess and 1 more indications. First approved in 1982.
Drug data last refreshed 21h ago · AI intelligence enriched Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Metronidazole is a nitroimidazole small-molecule antibiotic effective against anaerobic bacteria and protozoan parasites. It is indicated for treatment of asymptomatic trichomoniasis, acute intestinal amebiasis, amebic liver abscess, and serious infections caused by susceptible anaerobic bacteria. The drug works through reduction of its nitro group in anaerobic organisms, disrupting DNA and inhibiting nucleic acid synthesis.
LOE Approaching
As loss of exclusivity approaches, brand teams face significant generic erosion; focus shifts to cost management and niche indications rather than market expansion.
Mechanism of Action
CLINICAL PHARMACOLOGY Absorption Disposition of metronidazole in the body is similar for both oral and intravenous dosage forms. Following oral administration, metronidazole is well absorbed, with peak plasma concentrations occurring between one and two hours after administration. Plasma…
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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.