NDAORALSUSPENSION
Approved
Sep 2023
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
4/8 — Partial
LIKMEZ (metronidazole oral) by Saptalis Pharms is 12. First approved in 2023.
Drug data last refreshed 2h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LIKMEZ is an oral suspension formulation of metronidazole, a nitroimidazole antimicrobial agent that works through a bactericidal mechanism targeting anaerobic organisms and protozoa. The drug is well-absorbed orally with peak plasma concentrations occurring 0.25–6 hours post-administration and demonstrates similar systemic exposure whether taken with or without food. Metronidazole appears in cerebrospinal fluid, saliva, and breast milk at concentrations similar to plasma, enabling broad tissue penetration.
Peak12.9 years to LOE
Product is in peak commercial lifecycle phase with 13 years of patent protection remaining; teams are likely focused on market penetration and indication expansion rather than launch activities.
Mechanism of Action
12.1 Mechanism of Action Metronidazole is a nitroimidazole antimicrobial drug [ see ] . 12.3 Pharmacokinetics Metronidazole pharmacokinetics are similar for both oral and intravenous dosage forms. The C max is dose proportional between 250 mg, 500 mg, and 2,000 mg for metronidazole oral tablets,…
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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.