NDAINJECTIONINJECTABLE
Approved
Jul 1984
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
5/8 — Partial
Drug Shortage Active
FENTANYL CITRATE is currently in shortage. Reason: Available. This may impact manufacturing, supply chain, and quality hiring at the manufacturer.
FENTANYL CITRATE (fentanyl citrate) by Hikma is analgesia. First approved in 1984.
Drug data last refreshed 4h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Fentanyl citrate is a potent synthetic opioid agonist administered via injection for analgesia across acute and chronic pain conditions. It treats cancer pain, breakthrough pain, chronic neuropathic pain, traumatic injury, and severe burns through mu-opioid receptor activation. The drug works by binding opioid receptors in the central nervous system to produce rapid pain relief.
$0.063MPart D
LOE ApproachingAs LOE approaches on this 40-year-old product, brand teams face significant commercial headwinds and likely operate with lean staffing focused on margin protection rather than growth.
Mechanism of Action
analgesia.
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 growth trajectory but critical expertise in opioid compliance, risk management, and mature product stewardship. This role suits professionals seeking regulatory/compliance skill-building in a high-scrutiny therapeutic area rather than commercial advancement.
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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.