NDAINTRAMUSCULAR, SUBCUTANEOUSSOLUTION
Approved
Oct 2021
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
4/8 — Partial
ZIMHI (naloxone hydrochloride) by R-Pharm US is clinical pharmacology complete or partial reversal of opioid depression naloxone hydrochloride prevents or reverses the effects of opioids including respiratory depression, sedation, and hypotension. First approved in 2021.
Drug data last refreshed 4h ago · AI intelligence enriched 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZIMHI is a naloxone hydrochloride solution administered via intramuscular or subcutaneous injection designed for rapid reversal of opioid overdose and depression. It works as a pure opioid antagonist by competitively blocking µ, κ, and σ opioid receptors in the central nervous system, with greatest affinity for the µ receptor. The drug restores respiratory function, consciousness, and hemodynamic stability within minutes of administration.
$0.011BPart D
Peak14.7 years to LOEProduct is at peak lifecycle stage with modest Part D utilization, indicating stable but limited commercial scale relative to broader naloxone market.
Mechanism of Action
CLINICAL PHARMACOLOGY Complete or Partial Reversal of Opioid Depression Naloxone hydrochloride prevents or reverses the effects of opioids including respiratory depression, sedation, and hypotension. Also, naloxone hydrochloride can reverse the psychotomimetic and dysphoric effects 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.