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Data updated: May 26, 2026

SUBSYS (fentanyl)

Pain Approved 2012-01-04
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
14
Years on Market

Details

Status
Discontinued
First Approved
2012-01-04
Patent Cliff
2030

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Routes
SUBLINGUAL
Dosage Forms
SPRAY

Companies

BTCP PHARMA
Active Ingredient: FENTANYL

SUBSYS Approval History

2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
147 FDA actions from 2012 to 2022
Dec 2022 SUPPL
Update · REMS
FDA Letter
Aug 2022 SUPPL
Update · REMS
FDA Letter
Dec 2021 SUPPL
Update · REMS
FDA Letter

What SUBSYS Treats

1 FDA approvals

Originally approved for its first indication in 2012 .

  • Other (1)
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Clinical Trial Registry

204 trials
Trial Sponsor ID Phase Status Title
NCT07556523 IRB2025-0154 Ph 4 recruiting Patient Quality of Recovery After TAVR With Different Sedation Regimens
NCT07224620 FenHydro 2025P000456 Ph 2 recruiting Fentanyl Versus Hydromorphone in Patients on Mechanical Ventilation
NCT06868589 RELIEF-LT 20243140 Ph 4 active not recruiting Reducing Pain With Methadone and Ketamine in Liver Transplant
NCT07459166 CS-1103-03 5UG3DA059286 Ph 2 not yet recruiting A Phase 2 Safety, Tolerability, PK, and Efficacy Study of CS-1103 Following Fentanyl Challenge With Naloxone Blockade
NCT06867068 2014-3556 Ph 1 completed Comparison of Two Intravenous Drug Combinations for Ambulatory Oral & Maxillofacial Surgery
NCT05905367 SIFI H23-00111 Ph 4 completed Symptom-inhibited Fentanyl Induction
NCT06784180 23-3302 Ph 4 withdrawn Intrathecal Hydromorphone vs Intrathecal Morphine to Treat Post Cesarean Pain in Patients With Opioid Use Disorder Taking Buprenorphine
NCT06772727 MD-265-2024 Ph 4 completed Lidocaine-based Versus Opioid-based Induction of Anesthesia in Emergency Laparotomy
NCT03214510 2016-1111 NCI-2018-01124, 2016-1111 Ph 3 active not recruiting Thoracic Epidural Analgesia or Four-Quadrant Transversus Abdominus Plane Block in Reducing Pain in Patients Undergoing Liver Surgery
NCT07443085 RC24/2/2026 Ph 2 recruiting Effect of Dexmedetomidine Dosage on Postoperative Delirium in Geriatric Orthopedic Surgery
NCT07435337 RIC/RERC/29/26 Ph 4 recruiting Effect of Nalbuphine Versus Fentanyl on Hemdoynamic Effects of Laryngoscopy
NCT03476369 FACTPCI results posted 1801-05 Ph 4 terminated Fentanyl and Crushed Ticagrelor in Percutaneous Coronary Intervention
NCT07078201 IRB00012098- Serial0307331 Ph 4 recruiting Comparative Analysis of Intraoperative Effect Dexmedetomidine and Fentanyl as an Adjuvant to Heavy Bupivacaine in Spinal Anaesthesia in Lower Limb Orthopedic Surgeries to Evaluate the Hemodynamic Stability and Onset and Duration of Motor Block of Using Intrathecal Dexmedetomidine and Fentanyl
NCT07276906 NOA 2387143-1 Ph 4 not yet recruiting Comparing Intramuscular Fentanyl and Ketorolac With Nerve of Arnold (NOA) Block for Bilateral Myringotomy
NCT07238101 216 /KEPK/USU/2024 Ph 4 completed Hemodynamic Effects of Fentanyl Vs Dexmedetomidine in Spine Surgery
NCT03726268 OSPREy results posted Pro00089977 1R01DA042985-01 Ph 4 completed Optimizing Outpatient Anesthesia (OSPREy-Outpatient Surgery Pain Relief Enhancement)
NCT05980546 2023-0063 Ph 4 completed Genicular and Anterior Femoral Cutaneous Nerve Blocks for Total Knee Arthroplasty
NCT06479655 USM/JEPeM/KK/24010062 Ph 4 recruiting Compare the Efficacy and Outcome Between Fentanyl and Morphine as Analgo-sedation in Mechanically Ventilated Patients
NCT06395727 hemodynamics FMASU R57/2024 Ph 4 completed Effect of Topical Airway Block on Hemodynamic Stability Post Induction of Anaesthesia in Cardiac Surgeries
NCT07148882 MS683/2023 Ph 2, Ph 3 completed Pain Managment in Preterm Neonates
NCT06823349 SSSA Asw.Uni. / 926 / 5 / 24 Ph 4 recruiting Comparative Analysis of Analgesic Efficacy: by Single Shot Intrathecal Analgesia (SSSA) in Normal Labor
NCT06763705 607/45/15284 Ph 4 recruiting Comparison of Safety and Efficacy for Different Sedation Regimens During Colonoscopy
NCT07035223 KFSIRB200-594 Ph 4 completed Clinical Comparative Study Aiming to Evaluate Postoperative Effect of Using Intrathecal Dexmedetomidine and Fentanyl as an Adjuvant to Heavy Bupivacaine in Lower Limb Vascular Surgeries on Pain Intensity, Analgesic Requirement and Shivering. Patients and Methods After Approval of Medical Institution
NCT06364540 KETAFEN 2023-08-14 Ph 4 recruiting Nebulized Ketamine to Nebulized Fentanyl for Treating Acute Painful Conditions in the ED
NCT03834363 MoreFoRCOPD MoreFoRCOPD Ph 4 completed Morphine or Fentanyl for Refractory Dyspnea in COPD
NCT05367336 results posted EGME#04-2021 Ph 2 terminated Platelet Reactivity With Fentanyl, Morphine, or no Narcotic
NCT05487196 results posted STUDY22030095 Ph 2 completed Effectiveness of Clonidine, Dexmedetomidine, and Fentanyl Adjuncts for Labor Epidural Analgesia
NCT04062123 MCA results posted STUDY19030183 R35GM146822 Ph 1 completed Memory & Conditioning Under Anesthesia
NCT03167905 CODEPAD 2017/2090 Ph 2, Ph 3 active not recruiting CODEPAD (Collaborative Outcomes of DEpression and Pain Associated With Delivery)
NCT06590870 INFENT PICC 24-0072-A 46585 Ph 3 completed Intranasal Fentanyl in Preterm Infants Undergoing Peripherally Inserted Central Catheter Placement
NCT06834854 FMASU MS149/2024 Ph 1 completed Opioid Free Anesthesia in Shoulder Arthroscope
NCT06502262 MS 571/2023 Ph 1 completed A Comparative Study of Intrathecal Dexmedetomidine and Fentanyl As Additives to Bupivacaine in Pott's Fracture
NCT02617758 CR108059 FENPAI1023 Ph 1 completed Bioequivalence Study of Fentanyl Transdermal System (JNJ-35685-AAA-G021) Compared With DURAGESIC Fentanyl Transdermal Patch in Healthy Participants
NCT06799442 DEX/Fentanyl DEX/Fentanyl ESPB Nephrectomy Ph 2, Ph 3 not yet recruiting Dexmedetomidine Versus Fentanyl as Adjuvants to Erector Spinae Plane Block for Postoperative Analgesia Following Simple Nephrectomy: A Randomized Clinical Trial
NCT03084536 results posted 201703053 Ph 2 completed PECS Block vs. Multimodal Analgesia for Prevention of Persistent Postoperative Pain in Breast Surgery
NCT04528173 results posted 19-016618 Ph 4 terminated Opioid-Free Anesthetic for Tonsillectomy
NCT06722963 fentanyl vs nalbuphine cholecy Ph 4 not yet recruiting Comparison of the Efficacy of Intraperitoneal Instillation of Fentanyl Versus Nalbuphine as Adjuvants to Bupivacaine for Postoperative Pain Relief in Patients Undergoing Laparoscopic Cholecystectomy
NCT06720506 fentanyl Vs nalbuphine LL surg Ph 4 not yet recruiting Comparsion Between Intrathecal Fentanyl and Intravenous Nalbuphine as a Postoperative Analgesia in Lower Limb Surgeries
NCT06318546 FMASU MS59/2024 Ph 1 completed Dexmedetomidine in Spinal Anesthesia Decreasing Post Spinal Shivering in Caesarean Section
NCT06630364 KVFPT E-10840098-772.02-4354Karar651 Istanbul Medipol University Ph 4 completed Comparing Ketamine and Fentanyl in Pediatric Tonsillectomy: Pain Control and Emergence Delirium Outcomes (KVFPT)
NCT06636578 R 611 Ph 4 recruiting Dexmedetomidine Ropivacaine Versus Plain Ropivacaine in Bilateral Pectoralis Nerve (PECS) Block
NCT02278601 COLEUS CTGL13feb013 Ph 3 active not recruiting Comparison of Regimens MPIB, CIPCEA, PCEA
NCT04011150 VVAMB AM/CT001/2018 Ph 3 recruiting Development of Variable Volume Automated Mandatory Boluses for Patient-controlled Epidural Analgesia During Labour
NCT06557473 PT (812) Ph 4 completed Lidocaine Versus Fentanyl for Hemodynamic Stability
NCT06558916 ErciyesUniversity-IT01 Ph 4 completed Comparison of the Analgesic Efficacy of Dexketoprofen Trometamol, Meperidine, and Paracetamol in Renal Colic
NCT06531759 Pain after nasal surgeries Ph 2 not yet recruiting Efficacy of Fentanyl Soaked Nasal Packs on Postoperative Pain in Nasal Surgeries.
NCT06498037 FERRARI 2023-507355-30 Ph 4 recruiting Optimizing Subcutaneous FEntanyl titRation: RApid Achievement of Adequate Exposure When Treating Cancer-Related paIn.
NCT03000413 MACANUDO 42324015.0.0000.5530 Ph 2, Ph 3 completed Ketamine Efficacy for Acute Severe Bronchospasm in ICU: MACANUDO Trial
NCT06417268 MD-16-2024 Ph 2 recruiting Combined Pericapsular Nerve Group Block and Lateral Femoral Cutaneous Nerve Block for Pediatric Hip Surgeries
NCT06394375 IndonesiaU23061029 Ph 2, Ph 3 completed Opioid Free Anesthesia in Abdominal Laparoscopic Surgery

Showing 50 of 204 trials

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Active Pipeline

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Key Completed Trials

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

SUBSYS FDA Label Details

View full patent landscape →
10 OB patents · 2 families · 67 international docs across 17 countries

SUBSYS Patents & Exclusivity

Latest Patent: Apr 2030

Patents (10 active)

US8486973 Expires Apr 27, 2030
US8486972 Expires Apr 27, 2030
US8835460 Expires Jan 25, 2027
US9642797 Expires Jan 25, 2027
US9289387 Expires Jan 25, 2027
US9241935 Expires Jan 25, 2027
US9642844 Expires Jan 25, 2027
US8835459 Expires Jan 25, 2027
US10610523 Expires Jan 25, 2027
US10016403 Expires Jan 25, 2027
Source: FDA Orange Book

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Patent Timeline

  • • Cliff: 2030
  • • 476 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA202788 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.