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 15h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Metronidazole is a small-molecule nitroimidazole antibiotic with bactericidal and trichomonacidal activity used to treat serious infections caused by susceptible anaerobic bacteria, amebiasis, and trichomoniasis. The drug works by penetrating bacterial and protozoal cells, where it is reduced to reactive metabolites that damage DNA and inhibit nucleic acid synthesis. It is available as oral tablets and capsules with rapid absorption and broad tissue distribution, including penetration into cerebrospinal fluid and hepatic abscess sites.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30%), indicating potential for team restructuring and shift toward generic life-cycle management.
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.