Data updated: Jun 28, 2026
FENTORA (fentanyl citrate) · CEPHALON
Pain
Approved 2006-09-25
FENTORA is FDA-approved to treat 4 conditions (same as FENTANYL CITRATE PRESERVATIVE FREE).
2
Indications
--
Phase 3 Trials
19
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2006-09-25
- Patent Cliff
- 2028
- Routes
- BUCCAL, SUBLINGUAL
- Dosage Forms
- TABLET
FENTORA Approval History
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
174 FDA actions from 2006 to 2025 · 1 indication expansions
Jan 2017 SUPPL
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May 2016 SUPPL
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Aug 2014 SUPPL
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What FENTORA Treats
4 indicationsFENTORA is approved for 4 conditions since its original approval in 2006. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pain during anesthesia induction and maintenance
- Postoperative pain in the recovery room
- Supplement to general or regional anesthesia
- Anesthesia for high-risk surgeries (such as open heart, neurological, or orthopedic procedures)
Same approved indications as FENTANYL CITRATE PRESERVATIVE FREE (same active ingredient).
Source: FDA Label
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Clinical Trial Registry
14 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05437575 PAIN | STUDY22010164 HT9425-25-F-0041 | Ph 3 | recruiting | Prehospital Analgesia INtervention Trial (PAIN) |
| NCT06051227 FORE-PAIN | FP-2023 2022-500176-63-00, U1111-1287-7486 | Ph 3 | recruiting | Fentanyl or Esketamine for Traumatic PAIN (FORE-PAIN) Trial |
| NCT04645823 | Versio4_22112020 2020-005506-26 | Ph 4 | completed | Spinal Fentanyl or Epidural Analgesia in the Early First Phase of Induced Labor |
| NCT03018756 | DMED-1921-16 | Ph 3 | completed | Nebulized Fentanyl in Patients With Mild to Moderate Interstitial Lung Disease and Chronic Dyspnea |
| NCT03405090 | DMED-1926-16 | Ph 4 | completed | Differential Mechanisms of Dyspnea Relief in Advanced COPD: Opiates vs. Bronchodilators |
| NCT06017141 | STUDY00149314 NCI-2023-05587, IIT-2022-VIVA | Ph 2 | recruiting | Inhalational or Intravenous Anesthesia During Surgery for Patients With Colon Cancer, VIVA Study |
| NCT03809455 FARADI | UC-0106/1607 SdS 02 FARADI | Ph 2 | withdrawn | Effectiveness and Tolerance of Fentanyl Citrate in Painful Pain Induced During Diagnostic or Therapeutic Examinations in Cancer Patients |
| NCT01516684 results posted | IRB00017079 NCI-2012-00019, CCCWFU 01211 | Ph 2 | completed | Local Anesthetic Cream in Younger Patients Undergoing Lumbar Punctures |
| NCT03682211 | SCC01 2011-005161-20, ISRCTN67469672 | Ph 4 | completed | Intranasal Fentanyl Versus Intravenous Morphine in the Treatment of Severe Painful Sickle Cell Crises in Children |
| NCT01482091 results posted | 11-09-343 | Ph 4 | completed | Intranasal Fentanyl for Initial Treatment of a Vaso-occlusive Crisis |
| NCT02576353 | INS002-15-049 | Ph 1 | completed | Fentanyl Sublingual Spray and Fentanyl Citrate Intravenous (IV) in Opioid Naive Subjects |
| NCT01308320 | 4-2009-0111 | Ph 4 | completed | Dose-dependent Effect of Fentanyl on Cough Attenuation During Emergence From General Anaesthesia |
| NCT00795314 PABADUC | NMU-2008-FY10MZ31 NJFY0811-MZ02 | Ph 4 | completed | Propofol-butorphanol Anesthesia During Uterine Curettage |
| NCT00738192 CARAN | NMU-FY2008-311 NJFY0807311M | Ph 4 | completed | Comparison of Analgesic Efficacy of Fentanyl, Sufentanil and Butorphanol After Remifentanil Anesthesia |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
FENTORA FDA Label Details
Indications & Usage
FDA Label (PDF)FENTORA is FDA-approved to treat 4 conditions — same approved indications as FENTANYL CITRATE PRESERVATIVE FREE.
View full patent landscape →
2 OB patents · 2 families ·
71 international docs across 25 countries
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Deep insights for FENTORA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2028
- • 60 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.