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 6d ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Metronidazole is a small-molecule nitroimidazole antibiotic approved in 1982 used to treat bacterial vaginosis, intra-abdominal infections, C. difficile infection, and rosacea. It works by disrupting DNA synthesis in susceptible anaerobic bacteria and protozoa. The drug is available as an oral tablet with well-characterized pharmacokinetics and broad clinical utility across multiple therapeutic areas.
LOE Approaching
Product approaching loss of exclusivity with stable demand across multiple indications; expect transition from growth-focused commercial teams to lifecycle management and generic competition mitigation strategies.
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.