NDAINTRAMUSCULAR, SUBCUTANEOUSSOLUTION
Approved
Oct 2021
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
5/8 — 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. Approved for opioid overdose, fentanyl overdose. First approved in 2021.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZIMHI is a naloxone hydrochloride solution administered via intramuscular or subcutaneous injection for rapid reversal of opioid overdose, including fentanyl-related emergencies. It works as a pure opioid antagonist by competing for µ, κ, and σ receptor sites in the central nervous system, with highest affinity for the µ receptor. Onset of action occurs within 2 minutes IV, with slightly slower onset via IM/SC routes.
$0.011MPart D
Peak15.1 years to LOEZIMHI is in peak commercial phase with minimal Part D penetration; team growth likely limited to maintenance and defensive positioning against stronger competitors.
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.