METRONIDAZOLE
LOE ApproachingNDAORALTABLET
Approved
Mar 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 4h ago · AI intelligence enriched 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Metronidazole is a small-molecule nitroimidazole antibiotic and antiprotozoal agent used to treat serious infections caused by susceptible anaerobic bacteria, as well as parasitic infections including amebiasis and amebic liver abscess. It works by disrupting bacterial and protozoal DNA, exhibiting bactericidal activity. The drug is well-absorbed orally with peak plasma concentrations occurring 1-2 hours post-administration and is eliminated primarily via renal excretion.
LOE Approaching
Product approaching loss of exclusivity with multiple generic competitors already in market; brand team focus likely transitioning to cost containment and legacy indication management.
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.