NDAORALTROCHE/LOZENGEPriority Review
Approved
Oct 1993
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
Priority Review
FENTANYL (fentanyl citrate) by Teva is analgesia. First approved in 1993.
Drug data last refreshed 20m ago · AI intelligence enriched 20m ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Fentanyl citrate is a potent synthetic opioid agonist approved in oral transmucosal (troche/lozenge) form for analgesia. It works by binding to mu-opioid receptors in the central nervous system to produce rapid pain relief. This formulation is typically reserved for opioid-tolerant patients requiring breakthrough pain management.
LOE Approaching
Product is in LOE-approaching phase with moderate competitive pressure (30%), signaling a contracting team and shift toward lifecycle management rather than growth initiatives.
Mechanism of Action
analgesia.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Phase 2 Safety, Tolerability, PK, and Efficacy Study of CS-1103 Following Fentanyl Challenge With Naloxone Blockade
Started May 2026
16 enrolled
Fentanyl OverdoseFentanyl Poisoning
A Study of Inhaled Fentanyl Aerosol in Chinese Patients With Malignant Tumors
Started Sep 2025
100 enrolled
Cancer
A Comparative Study on Three Different Doses of Intrathecal Hyperbaric Prilocaine With Fentanyl for Optimal Dose to be Used in Elderly Patients Undergoing Day Case Lower Abdominal and Urologic Surgeries.
Started Nov 2022
45 enrolled
Three Different Doses of Intrathecal Hyperbaric Prilocaine With Fentanyl
Effectiveness and Tolerance of Inhaled Fentanyl Aerosol (25µg/Dose) in Chinese Patients With BTcP
Started Oct 2021
60 enrolled
Breakthrough Cancer Pain
Effectiveness and Tolerance of Inhaled Fentanyl Aerosol (25µg/Dose) in Chinese Patients With Breakthrough Cancer Pain
Started Mar 2021
96 enrolled
Breakthrough Cancer Pain
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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.