TheraRadar
Data updated: May 26, 2026

EXPAREL (bupivacaine)

Trial Activity: Mature 11 active trials
Pain Approved 2011-10-28

Exparel is an amide local anesthetic used to manage pain following surgical procedures. It helps patients aged six and older when injected directly into the surgical site to provide local relief. For adult patients, it is also used to provide regional pain control through specific nerve blocks targeting the shoulder, lower leg, or thigh.

Source: FDA Label • PACIRA PHARMS INC • Amide Local Anesthetic
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How EXPAREL Works

This medication works by preventing the generation and conduction of nerve impulses. It increases the electrical threshold required for nerve excitation and slows the signal's travel, resulting in a predictable loss of sensation that begins with pain and temperature.

Source: FDA Label

Development Insights

Pacira Pharmaceuticals, Inc conducting 18 trials (28%)
75 indications explored (Broad Platform)
→ pain, postoperative (12 trials)
→ pain (10 trials)
→ postoperative pain (4 trials)
4
Indications
--
Phase 3 Trials
14
Years on Market

Details

Status
Prescription
First Approved
2011-10-28
Patent Cliff
2044

Pro Metrics

Patent cliff and revenue data

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Routes
INJECTION
Dosage Forms
INJECTABLE, LIPOSOMAL

Companies

PACIRA PHARMS INC
Active Ingredient: BUPIVACAINE

EXPAREL Approval History

2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
46 FDA actions from 2011 to 2023 · 3 indication expansions
Nov 2023 SUPPL
Label · Labeling
FDA Letter Label
Nov 2023 SUPPL
Efficacy
FDA Letter Label
Apr 2021 SUPPL
Mfg · Manufacturing (CMC)

What EXPAREL Treats

1 indications

EXPAREL is approved for 1 conditions since its original approval in 2011. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Pain
Source: FDA Label

EXPAREL Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

XIFYRM
AZURITY
2025 1 indic.
PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
Dr. Reddy's
2025 8 indic.
Unlock 8 more competitors across all three rings.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to EXPAREL

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

ACUVAIL
KETOROLAC TROMETHAMINE
1 shared
AbbVie
Shared indications:
Pain
BELBUCA
BUPRENORPHINE HYDROCHLORIDE
1 shared
BDSI
Shared indications:
Pain
BUPRENORPHINE
BUPRENORPHINE
1 shared
DIFGEN PHARMS
Shared indications:
Pain
View all 20 similar drugs Pro
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Clinical Trial Registry

338 trials
Trial Sponsor ID Phase Status Title
NCT07340801 R 762 Ph 4 completed Inter-semispinal Fascial Plane Block (ISPB) Versus Erector Spinae Plane Block (ESPB) in Posterior Cervical Spine Surgery
NCT04864210 results posted 201901777 Ph 2 completed Video-assisted Thoracoscopic Surgery - Exparel Study
NCT05900427 EH23-069 Ph 4 terminated Effects on Postoperative Pain of Liposomal Bupivacaine in Interscalene Blocks for Total Shoulder Arthroplasty Patients
NCT05494645 SLRI-2022-24 Ph 4 completed Exparel Use in Peripheral Nerve Blocks and Local Infiltration for Foot and Ankle Surgery
NCT03781388 results posted Pro00101530 Ph 4 completed ED90 for Hyperbaric Bupivacaine in Super Obese Parturients
NCT05391971 22-00374 Ph 4 active not recruiting Effects of Stellate Ganglion Block in Post-traumatic Stress Disorder
NCT06743919 OSCTAP Cholecystectomy Ph 4 completed Adding Magnesium Sulfate or Dexmedetomidine to Bupivacaine in Oblique Subcostal Tap Block for Laparoscopic Cholecystectomy: A Randomized Double -Blind Controlled Study
NCT07469826 F.2-81/22-GENL/275/JPMC Ph 3 completed Bupivacaine Alone vs Bupivacaine With Tramadol in Local Anesthesia Procedures
NCT07467356 RC 18-2-2026 Ph 3 recruiting Anterior Iliopsoas Space Block Versus PENG Block on Ease of Positioning for Spinal Anathesia in Patients Undergoing Hip Surgeries
NCT07465185 RC 17-2-2026 Ph 2 recruiting Intrathecal Bupivacaine With or Without Dexmetomidine for Cesserian Delivery
NCT06784180 23-3302 Ph 4 withdrawn Intrathecal Hydromorphone vs Intrathecal Morphine to Treat Post Cesarean Pain in Patients With Opioid Use Disorder Taking Buprenorphine
NCT06559215 STU-2024-0773 Ph 2 recruiting Evaluation of Pain Management After Surgery When Using Exparel in the Pediatric Population
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
NCT07430085 2025-344 Ph 4 not yet recruiting Post-Operative Pain Relief: Zynrelef or Periarticular Injections in RATKA
NCT07212114 STUDY00008684 2025P010479 Ph 3 recruiting Efficacy of EXPAREL vs. Bupivacaine
NCT07280195 202509174 Ph 4 enrolling by invitation ZYNRELEF vs Continuous Catheter for Pain Management Following Shoulder Arthroplasty
NCT06002152 QoR-SCPB 2000035991 No NIH funding Ph 2 completed Superficial Cervical Plexus Block and Quality of Recovery After Thyroidectomy
NCT06411795 ANES-2023-31918 NCI-2024-02287, ANES-2023-31918 Ph 2 recruiting Rectus Sheath Block With Liposomal Bupivacaine Versus Thoracic Epidural Analgesia for Pain Control Following Pancreatoduodenectomy
NCT06997016 Baylor IRB #025-220 Ph 4 enrolling by invitation Enhanced Recovery After Surgery (ERAS) in Live Donor Kidney Transplant Recipients
NCT06908837 2024-520204-26-00 Ph 4 completed Effects of 10 Versus 20 mL Local Anesthetic for Popliteal Plexus Block on Opioid Consumption, Pain, and Patient-Reported Outcomes After Total Knee Arthroplasty
NCT07194694 DEX\KET in TAP MD 42 Ph 3 completed Dexmedetomidine vs Ketamine as Adjuvants to Bupivacaine in Transversus Abdominus Plane Block in Inguinal Hernioplasty
NCT07092566 IRB00133736 ONC-GU-2404 Ph 3 recruiting R.E.C.K vs Exparel in Robotic Nephrectomy
NCT02381353 14-007145 Ph 4 active not recruiting Exparel Injection for Postoperative Orbital Pain
NCT07329582 2023/00591 Ph 4 active not recruiting Hyperbaric Bupivacaine Versus Hyperbaric Prilocaine in Spinal Anaesthesia
NCT06271265 402-C-125 Ph 1 recruiting Study to Evaluate the Pharmacokinetics and Safety of EXPAREL for Postoperative Analgesia in Subjects Undergoing Cardiac Surgery
NCT04575688 PvP 19-06453-FB Ph 4 enrolling by invitation Periarticular Injection Versus Popliteal Block
NCT07276906 NOA 2387143-1 Ph 4 not yet recruiting Comparing Intramuscular Fentanyl and Ketorolac With Nerve of Arnold (NOA) Block for Bilateral Myringotomy
NCT03599635 results posted ANES-2017-25584 Ph 4 completed Pec Infiltration With Liposomal Bupivacaine for Breast Surgery
NCT04272086 GCO 19-1807 Ph 4 completed Utility of Liposomal Bupivacaine Transversus Abdominal Plane Block for Open Myomectomy
NCT06635889 IRB24-1600 Ph 2 recruiting Intravesical Bupivacaine on Post-Operative Ureteroscopy Pain
NCT06574022 UCCC-BRE-23-01 Ph 4 recruiting Post-mastectomy Recovery: Comparing Preoperative PECS-II Blocks With Intraoperative Pectoral Blocks
NCT07221019 NCR256547 Ph 4 recruiting Single Shot Exparel vs Catheters in Lower Extremity Trauma
NCT03827291 results posted PRO00091425 Ph 4 completed QL Block With Exparel in Colectomy
NCT06989866 NMCP.2024.0031 Ph 3 enrolling by invitation RCT to Test Regional Anesthesia Effect on Decreased Opiate Use
NCT05171179 STU00214187 Ph 3 completed The Use of Pecs Blocks in Combination With Exparel in Breast Reconstruction Surgery
NCT04979338 STUDY00000879 Ph 3 recruiting Development of Effective, Opioid Sparing Techniques for Peri-operative Pain Management of Transgender Patients Undergoing Gender Affirming Surgeries
NCT05285566 21-008473 Ph 4 recruiting Pain Control for Undergoing Costal Cartilage Harvesting
NCT02128646 results posted STUDY00000101 Ph 4 completed Liposomal Bupivacaine (Exparel) for Postoperative Pain Control for Open and Laparoscopic Abdominal Hernia Repair
NCT07146685 RPRCT 302714 Ph 4 not yet recruiting Effect of Local Anesthetic Concentration on Rebound Pain: A Randomized Control Study
NCT06291727 Prisma Upstate Ph 4 completed Mepivacaine vs Bupivacaine Spinal Anesthesia for TKA
NCT03351348 17-576 Ph 3 recruiting Bupivacaine vs Placebo for Unilateral Mastectomy Surgical Site Post-operative Pain Control
NCT05425979 22-000140 Ph 4 enrolling by invitation Mepivacaine Versus Bupivacaine Onset Time in Ultrasound-guided Ankle Blocks
NCT05017246 results posted 202105007 Ph 2 terminated Comparing Intrathecal Morphine and Intraoperative Lidocaine Infusion to Epidural Anesthesia With Postoperative PCA for Patients Undergoing Exploratory Laparotomy
NCT05732532 22-007855 Ph 4 completed Steroids in Occipital Nerve Block for Treatment of Headache
NCT06165679 N-439-2023 Ph 3 completed Effect of Prilocaine vs Bupivacaine on Hemodynamics in Spinal Anesthesia for Geriatric Patients
NCT07023991 FMASU MS113/2025 Ph 1 enrolling by invitation Dexmedetomidine Added to Bupivacaine for ESP Block in Children Undergoing Lower Abdominal Surgeries
NCT07013955 FESS (Function 1465/02/2025 Ph 3 enrolling by invitation Comparative Study Between the Effect of Dexmedetomidine ,Midazolam or Bupivacaine Packing During FESS on Surgical Field Visualization
NCT03737292 10129 Ph 4 recruiting Liposomal Bupivacaine Versus Plain Bupivacaine After Intercostal Injections For Pain Management After Thoracoscopy
NCT05972681 PAIN 2023-14825 Ph 4 recruiting The PAIN (Pelvic Area Injection for Numbness) Study
NCT05357690 22-001106 Ph 2, Ph 3 recruiting A Study of Stellate Ganglion Block for Prevention of Atrial Fibrillation

Showing 50 of 338 trials

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Active Pipeline

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Ongoing clinical trials by development phase

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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

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.

EXPAREL FDA Label Details

Indications & Usage

FDA Label (PDF)

EXPAREL is indicated for the treatment of Pain.

View full patent landscape →
21 OB patents · 9 families · 54 international docs across 5 countries

EXPAREL Patents & Exclusivity

Latest Patent: Jul 2044
Exclusivity: Nov 2026

Patents (21 active)

US12318483 Expires Jul 2, 2044
US12370142 Expires Jul 2, 2044
US12251468 Expires Jul 2, 2044
US12156940 Expires Jul 2, 2044
US12226610 Expires Feb 2, 2043
US11918565 Expires Feb 2, 2043
US11931459 Expires Mar 17, 2042
US11452691 Expires Jan 22, 2041
US11819575 Expires Jan 22, 2041
US11033495 Expires Jan 22, 2041
US12144890 Expires Jan 22, 2041
US11179336 Expires Jan 22, 2041
US11426348 Expires Jan 22, 2041
US12296047 Expires Jan 22, 2041
US11357727 Expires Jan 22, 2041
US11311486 Expires Jan 22, 2041
US11278494 Expires Jan 22, 2041
US11304904 Expires Jan 22, 2041
US11819574 Expires Jan 22, 2041
US11925706 Expires Jan 22, 2041
US12151024 Expires Jan 22, 2041

Exclusivity

I-929 Until Nov 2026
I-929 Until Nov 2026
I-929 Until Nov 2026
I-929 Until Nov 2026
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for EXPAREL

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2044
  • • 96 active patents

Trial Analysis

  • • 65 total trials
  • • Stage: Mature

Competitive Landscape

  • • 20 similar drugs
  • • Same target/indication analysis
Unlock Full Intelligence

Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: NDA022496 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment