NDAINJECTIONINJECTABLE
Approved
Jul 1984
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
4/8 — Partial
Drug Shortage Active
FENTANYL CITRATE is currently in shortage. Reason: Available. This may impact manufacturing, supply chain, and quality hiring at the manufacturer.
Drug data last refreshed 16h ago · AI intelligence enriched 19h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Fentanyl Citrate is a potent synthetic opioid analgesic administered via injection for acute and chronic pain management, particularly in perioperative and palliative care settings. It works by binding to mu-opioid receptors in the central nervous system to produce analgesia and sedation. The injectable formulation allows rapid onset and precise dose titration for inpatient and procedural use.
$0.063BPart D
LOE ApproachingDeclining
Approaching loss of exclusivity with modest Part D utilization signals a mature, commoditized product with limited commercial growth and likely rightsizing of brand teams.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (3)
Study to Evaluate the Efficacy and Safety of OraVescent Fentanyl Citrate Treatment for the Management of Breakthrough Pain in Opioid-Tolerant Patients With Noncancer-Related Chronic Pain
Started Aug 2006
120 enrolled
Pain
Study to Evaluate the Efficacy and Safety of ORAVESCENT Fentanyl Citrate for Management of Breakthrough Pain
Started Sep 2005
Chronic Low Back Pain
Study to Evaluate the Efficacy and Safety of ORAVESCENT Fentanyl Citrate for the Management of Breakthrough Pain
Started Sep 2005
120 enrolled
Chronic Neuropathic Pain
Career Relevance
Working on Fentanyl Citrate offers limited career growth due to its mature, generic-dominated market position and approaching LOE. Roles available are primarily operational or compliance-focused rather than commercial or innovative, making this product less attractive for career advancement in brand management or clinical development.
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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.