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 8h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Fentanyl citrate is a potent synthetic opioid agonist approved as an oral troche/lozenge formulation for analgesia. It works by binding to opioid receptors in the central nervous system to provide rapid pain relief. This formulation enables quick-onset pain control suitable for breakthrough pain management.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30%); commercial teams should expect portfolio transition planning and defensive strategies.
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
Worked on FENTANYL at Teva? Share your interview experience or compensation data (+7 days Pro)
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.