NDAINTRAVENOUSPOWDER
Approved
Jul 2023
Lifecycle
Growth
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
MEROPENEM (meropenem) by R-Pharm US is [ see microbiology () ]. First approved in 2023.
Drug data last refreshed 12h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Meropenem is a broad-spectrum beta-lactam antibiotic administered intravenously as a powder formulation. It is indicated for serious bacterial infections caused by susceptible organisms. The drug works by inhibiting bacterial cell wall synthesis through beta-lactamase-resistant mechanisms.
$0.003BPart D
GrowthRecent NDA approval in 2023 positions meropenem in early growth phase with moderate market penetration; commercial teams will focus on market expansion and provider education.
Mechanism of Action
[ see Microbiology () ].
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study to Evaluate the Efficacy and Safety of Meropenem and Pralurbactam in HABP/VABP
Started Jan 2026
420 enrolled
Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia
Assess the Plasma, Epithelial Lining, and Alveolar Macrophage Concentrations of Intravenous Meropenem-Pralubactam (Meropenem/FL058) in China Healthy Adult Participants
Started Sep 2025
16 enrolled
Infections
Cefepime-taniborbactam vs Meropenem in Adults With VABP or Ventilated HABP
Started Jun 2025
0Ventilator-associated PneumoniaHospital-acquired Pneumonia
Evaluation of the Concentration of ANT3310 and Meropenem in the Lung in Healthy Adult Participants
Started Apr 2025
26 enrolled
Pharmacokinetics Study on Healthy Volunteers Adults
Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in Carbapenem-Resistant Enterobacteriaceae Infections
Started Apr 2025
80 enrolled
Hospital-acquired Bacterial Pneumonia (HABP)Ventilator-associated Bacterial Pneumonia (VABP)Complicated Intra-abdominal Infection (cIAI)+2 more
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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.