NDAINTRAMUSCULAR, SUBCUTANEOUSSOLUTIONPriority Review
Approved
Feb 2022
Lifecycle
Peak
Competitive Pressure
8/100
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 4h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Naloxone HCl autoinjector is a rapid-acting opioid antagonist administered via intramuscular or subcutaneous injection to reverse opioid overdose and toxicity. It works by competitively binding to opioid receptors, reversing respiratory depression, sedation, hypotension, and dysphoric effects of opioid agonists and agonist-antagonists. This product addresses the critical public health emergency of opioid overdose mortality.
Peak4.7 years to LOE
Product is in peak revenue phase with high competitive pressure (score: 8/10), indicating significant ongoing commercial activity and cross-functional team engagement.
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.