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Data updated: May 26, 2026

XARACOLL (bupivacaine hydrochloride)

Other Approved 2020-08-28
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
5
Years on Market

Details

Status
Discontinued
First Approved
2020-08-28
Patent Cliff
2033

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Routes
IMPLANTATION
Dosage Forms
IMPLANT

Companies

INNOCOLL PHARMS
Active Ingredient: BUPIVACAINE HYDROCHLORIDE

XARACOLL Approval History

2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2020 to 2020
Aug 2020 ORIGINAL
Update · Type 3 - New Dosage Form and Type 4 - New Combination
FDA Letter Label

What XARACOLL Treats

1 FDA approvals

Originally approved for its first indication in 2020 .

  • Other (1)
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Clinical Trial Registry

56 trials
Trial Sponsor ID Phase Status Title
NCT07512635 Ming-Yi-Yuan-Ethics-2024-54/02 Ph 4 not yet recruiting Effect of Intercostal Nerve Block With Liposomal Bupivacaine on Quality of Recovery in VATS Partial Pneumonectomy
NCT03854344 results posted 143321 Ph 4 completed Liposomal Bupivacaine Versus Lidocaine for Skin Graft Donor Site Pain
NCT06077422 Pro2022001580 Ph 2, Ph 3 enrolling by invitation Exparel vs. Marcaine ESP Block for Post-cardiac Surgical Pain
NCT06575699 Pro00115981 Ph 4 completed Rectus Sheath Block for Analgesia After Gynecological Laparotomy
NCT04928352 17300615 Ph 3 recruiting Nebulized Bupivacaine Analgesia for Cleft Palate Repair
NCT05891613 21-007358 Ph 4 completed A Study of Liposomal Bupivacaine Versus 0.25% Bupivacaine Hydrochloride Post Breast Reduction
NCT06799845 SPARK 2 ATX-101-TKA-004 Ph 2 completed Study Assessing Pain Relief After Replacement of the Knee
NCT06179004 Vs 23-1116 Ph 3 recruiting Supraclavicular Bupivacaine Vs. Supraclavicular Liposomal Bupivacaine for Orthopedic Wrist Surgery
NCT04897841 OBLiBupi results posted UPH-Meriter IRB 2021-005 A532860, SMPH/OBSTET & GYNECOL Ph 4 completed Obstetric Liposomal Bupivacaine Via Surgical Transversus Abdominis Plane Block for Post Cesarean Pain Control
NCT06577233 H-55139 Ph 4 recruiting Superior Hypogastric Nerve Plexus Block With Bupivacaine After Robotic Resection of Endometriosis
NCT06569953 LBPB Ph 4 recruiting Efficacy and Safety of Liposomal Bupivacaine Injection for Paravertebral Nerve Block in the Treatment of Acute and Chronic Pain After Thoracoscopic Pneumonectomy: A Multicenter, Randomized, Double-blind, Controlled Clinical Trial
NCT03360214 results posted AAAQ4708 Ph 4 completed PEMF and PEC Blocks in Mastectomy Reconstruction Patients
NCT06386770 Asw.U./742 /2/23 Ph 3 recruiting Systemic Versus Local Dexmedetomidine as An Adjuvant to Bupivacaine in Ultrasound Guided Erector Spinae Block
NCT06502262 MS 571/2023 Ph 1 completed A Comparative Study of Intrathecal Dexmedetomidine and Fentanyl As Additives to Bupivacaine in Pott's Fracture
NCT06146842 2023p003001 Ph 4 recruiting ED90 of Bupivacaine After Lidocaine Test Dose with DPE and EPL
NCT04260854 STU00211424 Ph 1 enrolling by invitation Bupivacaine Hydrochloride for Pain Control in Cutaneous Surgery
NCT05139030 results posted 402-C-335 Ph 3 completed Phase 3 Adductor Canal Block With EXPAREL in Subjects Undergoing Primary Unilateral Total Knee Arthroplasty
NCT05303311 8035-7-11-2021 Ph 4 completed Intrathecal Pethidine Plus Dexamethasone for Distal Lower Orthopedic Surgeries
NCT05133687 MS-445-2021 Ph 3 completed The Hemodynamic Effects of Different Volumes of Bupivacaine 0.25% Caudal Blocks in Pediatrics Undergoing Lower Abdominal Surgeries as Measured by Electrical Cardiometry
NCT03638960 APP-18-01917 Ph 4 completed Interscalene Single Shot With Plain Bupivacaine Versus Liposomal Bupivacaine for Arthroscopic Shoulder Surgery
NCT03789318 results posted CA-PS-204 Ph 2 completed Study in Subjects Undergoing Complete Abdominoplasty
NCT02892500 results posted SanfordHealth Ph 2 terminated Investigation of Corticosteroid Versus Placebo Injection in Patients With Syndesmotic Ligament Injury or High Ankle Sprain
NCT04727229 20-301 Ph 4 completed Stellate Ganglion Block for Major Depressive Disorder.
NCT04293809 402-C-123 Ph 1 completed Study to Evaluate the Pharmacokinetics and Safety of EXPAREL Administered as a Pectoral Plane Block in Women Undergoing Breast Augmentation
NCT04826484 Baby ORIOLES results posted IRB00284462 Ph 3 terminated Opioid Reduction Initiative During Outpatient Pediatric Urologic Procedures Using Exparel
NCT06109415 HTX-011-401 (Cohort 1) Ph 4 completed A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE.
NCT06109428 HTX-011-401 (Cohort 2) Ph 4 completed A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE
NCT05359731 OAIC 1249/22 Ph 4 completed Pharmacokinetic Analysis of Bupivacaine in the Presence and Absence of Perineural Dexamethasone in Axillary Blockade
NCT04766996 results posted STUDY00002021 Ph 4 terminated PROUD Study - Preventing Opioid Use Disorders
NCT05727098 Erector block after mastectomy Ph 2, Ph 3 completed Dexmedetomedine and Ketamine in Erector Spinae Block for Postoperative Analgesia Following Mastectomy.
NCT03702621 results posted 1806187876 Ph 3 completed Comparing Liposomal Bupivacaine Versus Standard Bupivacaine in Colorectal Surgery
NCT04778267 MD-342-2020 Ph 4 completed Effectiveness of Combined Erector Spinae and Pecto-intercostal Fascial Plane Blocks Versus Thoracic Paravertebral Block in Perioperative Pain in Modified Radical Mastectomy
NCT04613830 515 Ph 3 completed Continuous Erector Spinae Block for Post Analgesia in Pediatric Patients
NCT05502146 2022/05 Ph 4 completed Comparison of Two Different Norepinephrine Bolus Doses for Management of Spinal Anesthesia-Induced Maternal Hypotension
NCT03326180 SPAARK OR16/88494 2016-003154-32, 197936 Ph 3 completed Study of Peri-Articular Anaesthetic for Replacement of the Knee
NCT04814537 2020P003241 Ph 4 completed Optimal Bupivacaine Dose for Initiation of Labor Epidural Techniques
NCT04518462 STRIDE results posted 402-C-333 Ph 3 completed Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL, EXPAREL Admixed With Bupivacaine HCl vs. Bupivacaine HCl Administered as Combined Sciatic and Saphenous Nerve Blocks for Postsurgical Analgesia in Subjects Undergoing Lower Extremity Surgeries
NCT04368364 results posted HSC-MS-20-0143 Ph 4 terminated A Randomized Control Trial Comparing Analgesic Benefits of Ultrasound-guided Single vs Continuous Quadratus Lumborum Blocks (QLB)vs Intrathecal Morphine(ITM) for Post Cesarean Section Pain
NCT04353414 20-00058 Ph 4 completed Transmuscular Quadratus Lumborum Block Plus Pericapsular Injection vs Pericapsular Injection
NCT03885596 results posted CA-PS-205 Ph 2 completed Open-Label CA-008 (Vocacapsaicin) in Bunionectomy
NCT03907033 results posted 15-008413 Ph 4 terminated Liposomal Bupivacaine in Vaginal Hysterectomy
NCT03792906 N71-2018 Ph 4 completed Comparison of Two Norepinephrine Bolus Doses for Management of Post-spinal Hypotension During Cesarean Delivery
NCT03270514 results posted PRO17060305 Ph 3 completed Comparison of Sternal Wound Infiltration With Liposomal Bupivacaine v. Bupivacaine Hydrochloride
NCT03599089 results posted CA-PS-201 Ph 2 completed Study of CA-008 (Vocacapsaicin) in Bunionectomy Patients
NCT03098420 results posted F160421006 Ph 2, Ph 3 terminated Dose Escalation of Dexamethasone to Increase Duration of Transversus Abdominal Plane Block Following Cesarean Section
NCT03592537 Fentanyl versus midazolam Ph 2, Ph 3 completed Fentanyl Versus Midazolam as an Adjunct to Intrathecal Bupivacaine In Children
NCT04173611 402-C-121 Ph 1 terminated Evaluation of Safety, Pharmacokinetics and Pharmacodynamics of EXPAREL® Administered Via a Single Intrathecal Injection to Healthy Volunteers
NCT03663283 results posted 18-005366 Ph 4 completed Liposomal Bupivacaine Interscalene Nerve Block in Shoulder Arthroplasty
NCT02523599 MATRIX-1 results posted INN-CB-014 Ph 3 completed Phase 3 Study of Efficacy and Safety of the XaraColl® Bupivacaine Implant After Hernioplasty
NCT02525133 MATRIX-2 results posted INN-CB-016 Ph 3 completed Phase 3 Study of Efficacy and Safety of the XaraColl® Bupivacaine Implant After Hernioplasty

Showing 50 of 56 trials

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Active Pipeline

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

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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.

XARACOLL FDA Label Details

View full patent landscape →
2 OB patents · 2 families · 68 international docs across 22 countries

XARACOLL Patents & Exclusivity

Latest Patent: Jan 2033

Patents (2 active)

US11746141 Expires Jan 9, 2033
USRE47826 Expires May 20, 2029
Source: FDA Orange Book

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Patent Timeline

  • • Cliff: 2033
  • • 2 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

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Data Sources

FDA Approval: NDA209511 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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