NDABUCCAL, SUBLINGUALTABLET
Approved
Sep 2006
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
4
Data completeness
6/8 — Strong
FENTORA (fentanyl citrate) by Teva is analgesia. Approved for breakthrough pain. First approved in 2006.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FENTORA is a buccal/sublingual fentanyl citrate tablet approved in 2006 for breakthrough pain management across multiple chronic pain conditions including neuropathic pain, low back pain, traumatic injury, severe burns, and sickle cell anemia. It works through opioid receptor agonism to provide rapid analgesia via transmucosal absorption. The product targets opioid-tolerant patients requiring fast-acting pain relief outside scheduled dosing.
$0.001BPart D
LOE Approaching2.1 years to LOEWith only $1M in Part D spending and 46 claims in 2023, FENTORA operates in a niche market facing imminent generic competition; commercial teams should prioritize retention strategies and cost-containment support programs.
Mechanism of Action
analgesia.
Indications (1)
Clinical Trials (4)
Effentora® in Clinical Practice - a Non-interventional Study to Evaluate Satisfaction and Tolerability
Started Jul 2011
600 enrolled
CancerPain
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
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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.