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 3h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Fentanyl Citrate is a potent synthetic opioid injectable used for pain management and anesthesia support in clinical settings. It is a mu-opioid receptor agonist that provides rapid analgesia and sedation. The drug is administered via injection for acute and perioperative pain control.
$0.063BPart D
LOE ApproachingLate-stage product with minimal Part D penetration and high competitive pressure (30% intensity) signals defensive commercial strategy and potential team restructuring ahead.
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 the Management of Breakthrough Pain
Started Sep 2005
120 enrolled
Chronic Neuropathic Pain
Study to Evaluate the Efficacy and Safety of ORAVESCENT Fentanyl Citrate for Management of Breakthrough Pain
Started Sep 2005
Chronic Low Back Pain
Career Relevance
Working on Fentanyl Citrate offers limited career growth due to its mature, commoditized status and approaching LOE phase. Roles focus on operational excellence, compliance, and cost management rather than innovation or expansion.
Worked on FENTANYL CITRATE at Hikma? 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.