NDAINJECTIONINJECTABLE
Approved
Jan 1985
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
4/8 — Partial
FENTANYL CITRATE (fentanyl citrate) by Pfizer is 12. First approved in 1985.
Drug data last refreshed 14h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Fentanyl Citrate is a potent synthetic opioid agonist administered by injection for acute pain management, cancer pain, and breakthrough pain in opioid-tolerant patients. It works by binding to opioid receptors in the central nervous system to produce analgesia and sedation, with analgesic potency approximately 100 times that of morphine. The drug produces respiratory depression, miosis, gastrointestinal effects, and cardiovascular changes through its CNS and peripheral actions.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30), indicating a transition phase requiring defensive strategies and potential portfolio rebalancing.
Mechanism of Action
12.1 Mechanism of Action Fentanyl is an opioid agonist whose principal actions of therapeutic value are analgesic and sedation. 12.2 Pharmacodynamics Effects on the Central Nervous System Fentanyl produces respiratory depression by direct action on brain stem respiratory centers. The respiratory…
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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.