NDAINTRAMUSCULAR, SUBCUTANEOUSSOLUTIONPriority Review
Approved
Feb 2022
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
3/8 — Basic
Priority Review
NALOXONE HYDROCHLORIDE (AUTOINJECTOR) (naloxone hydrochloride) by R-Pharm US is sites. First approved in 2022.
Drug data last refreshed 12h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Naloxone HCl autoinjector is a rapid-acting opioid antagonist administered intramuscularly or subcutaneously to reverse opioid overdose and its life-threatening effects including respiratory depression, sedation, and hypotension. It also reverses dysphoric effects of agonist-antagonist opioids such as pentazocine. This is a critical emergency medicine product targeting the opioid crisis.
Peak4.9 years to LOE
Product is in peak commercial phase with no direct patent LOE pressure until 2031, suggesting stable team infrastructure and sustained investment in market penetration.
Mechanism of Action
sites. Naloxone HCl reverses the effects of opioids, including respiratory depression, sedation, and hypotension. Also, it can reverse the psychotomimetic and dysphoric effects of agonist-antagonists such as pentazocine.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Why This Matters for Your Career
LOE in ~5 years — strategic planning for patent cliff underway
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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.