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  1. pharmadog
  2. ›drugs
  3. ›Exparel
drug · small molecule
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bupivacaine

Marketedupdated 3mo ago
by Allay Therapeutics Inc🔗 ChEMBL
Approved
community read0 votes

🐶 often sniffed alongside

top 8
  • drugAlevatrix24 co-mentions · 24 sources
  • drugbupivacaine ER24 co-mentions · 24 sources
  • tagPain14 co-mentions · 14 sources
  • tagOrthopedics4 co-mentions · 3 sources
  • tagRecall3 co-mentions · 3 sources
  • drugadrenaline2 co-mentions · 2 sources
  • drugfentanyl CR2 co-mentions · 2 sources
  • drugfentanyl2 co-mentions · 2 sources

Small molecule drug with a maximum clinical stage of Approval (across all indications), with an approval for pain and hernia and 77 investigational indications.

targets

Sodium channel protein type 4 subunit alpha

all catalysts(14)

phase 1 2 completion · 2
Apr 30, 2026
phase 1 2 completion
3mo ago
Nakornping Hospital — bupivacaine (Phase I/II Trial Completion)
bupivacaine
→
Apr 30, 2026
phase 1 2 completion
3mo ago
Unity Health Toronto — bupivacaine (Phase I/II Trial Completion)
bupivacaine
→
phase 1 completion · 2
Apr 30, 2026
phase 1 completion
3mo ago
Makassed General Hospital — bupivacaine (Phase I Trial Completion)
bupivacaine
→
Apr 30, 2026
phase 1 completion
3mo ago
Phrae Hospital — bupivacaine (Phase I Trial Completion)
bupivacaine
→
phase 2 completion · 6
Apr 25, 2026
phase 2 completion
4mo ago
Karaman Training and Research Hospital — bupivacaine (Phase II Trial Completion)
bupivacaine
→
Apr 26, 2026
phase 2 completion
4mo ago
Bangalore Medical College and Research Institute — bupivacaine (Phase II Trial Completion)
bupivacaine
→
Apr 27, 2026
phase 2 completion
4mo ago
Chacha Nehru Bal Chikitsalaya — bupivacaine (Phase II Trial Completion)
bupivacaine
→
Apr 28, 2026
phase 2 completion
4mo ago
Umraniye Research Hospital — bupivacaine (Phase II Trial Completion)
bupivacaine
→
Apr 30, 2026
phase 2 completion
3mo ago
Veer Chandra Singh Garhwali Government Medical Science and Research Institute — bupivacaine (Phase II Trial Completion)
bupivacaine
→
Apr 30, 2026
phase 2 completion
3mo ago
Cantonal Hospital Authority — bupivacaine (Phase II Trial Completion)
bupivacaine
→
phase 2 initiation · 3
Apr 24, 2026
phase 2 initiation
4mo ago
Command Hospital Western Command — bupivacaine (Phase II Trial Initiation)
bupivacaine
→
Apr 27, 2026
phase 2 initiation
4mo ago
Ankara Etlik City Hospital — bupivacaine (Phase II Trial Initiation)
bupivacaine
→
Apr 29, 2026
phase 2 initiation
4mo ago
Government Medical College and Hospital Chandigarh — bupivacaine (Phase II Trial Initiation)
bupivacaine
→
phase 3 completion · 1
Apr 24, 2026
phase 3 completion
4mo ago
Shriners Hospitals for Children — bupivacaine ER (Phase III Trial Completion)
bupivacaine
→
view all 14 catalysts →

Trials studying bupivacaine

  • phase3Thoracic Epidural Analgesia vs Surgical Site Infiltration With Liposomal Bupivacaine Following Open Gynecologic Surgerycompletedn=106
  • phase2Sciatic Nerve Block With ALX006 in Subjects Undergoing Bunionectomyrecruitingn=60
  • N/AIntercostal Nerve Cryoablation Versus Epidural Analgesia for Nuss Repair of Pectus Excavatumcompletedn=50
  • phase2A Study of Bupivacaine Liposome Injection in the Treatment of Pain After Thoracoscopic Surgeryrecruitingn=96
  • phase2Pilot Herniorrhaphy Study for Postoperative Analgesiacompletedn=463
  • phase2Phase 2B Upper Extremity Nerve Block Studycompletedn=243
  • phase3Phase 3 Herniorrhaphy Study for Postoperative Analgesia (EPOCH 2)completedn=418
  • phase3Total Knee Arthroplasty (TKA) Study of HTX-011 in an Multimodal Analgesic Regimen (MMA) Regimencompletedn=116
more trials →

Patent cliff

source: FDA Orange Book
first barrier falls
Nov 9, 2026
89 days

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (108)

  • Jul 2, 2044formulationUS 12156940
  • Jul 2, 2044formulationUS 12156940
  • Jul 2, 2044formulationUS 12251468
  • Jul 2, 2044formulationUS 12251468
  • Jul 2, 2044method-of-use (U-4152)US 12318483
  • Jul 2, 2044method-of-use (U-4152)US 12318483
  • Jul 2, 2044formulationUS 12370142
  • Jul 2, 2044formulationUS 12370142
  • Feb 2, 2043method-of-use (U-3841)US 11918565
  • Feb 2, 2043method-of-use (U-3841)US 11918565
  • Feb 2, 2043method-of-use (U-4150)US 12226610
  • Feb 2, 2043method-of-use (U-4150)US 12226610
  • Mar 17, 2042method-of-use (U-3840)US 11931459
  • Mar 17, 2042method-of-use (U-3839)US 11931459
  • Jan 22, 2041formulationUS 11033495
  • Jan 22, 2041formulationUS 11033495
  • Jan 22, 2041formulationUS 11179336
  • Jan 22, 2041formulationUS 11179336
  • Jan 22, 2041formulationUS 11278494
  • Jan 22, 2041formulationUS 11278494
  • Jan 22, 2041formulationUS 11304904
  • Jan 22, 2041formulationUS 11304904
  • Jan 22, 2041formulationUS 11311486
  • Jan 22, 2041formulationUS 11311486
  • Jan 22, 2041formulationUS 11357727
  • Jan 22, 2041formulationUS 11357727
  • Jan 22, 2041formulationUS 11426348
  • Jan 22, 2041formulationUS 11426348
  • Jan 22, 2041formulationUS 11452691
  • Jan 22, 2041formulationUS 11452691
  • Jan 22, 2041formulationUS 11819574
  • Jan 22, 2041formulationUS 11819574
  • Jan 22, 2041formulationUS 11819575
  • Jan 22, 2041formulationUS 11819575
  • Jan 22, 2041formulationUS 11925706
  • Jan 22, 2041formulationUS 11925706
  • Jan 22, 2041formulationUS 12144890
  • Jan 22, 2041formulationUS 12144890
  • Jan 22, 2041formulationUS 12151024
  • Jan 22, 2041formulationUS 12151024
  • Jan 22, 2041formulationUS 12296047
  • Jan 22, 2041formulationUS 12296047
  • Jan 12, 2041formulationUS 11400019
  • Jan 12, 2041method-of-use (U-3724)US 11771624
  • Apr 21, 2036method-of-use (U-3417)US 11844837
  • Apr 21, 2036method-of-use (U-3417)US 11844837
  • Apr 21, 2036method-of-use (U-3417)US 11844837
  • Apr 21, 2036method-of-use (U-3417)US 11844837
  • Apr 20, 2035method-of-use (U-3118)US 10098957
  • Apr 20, 2035method-of-use (U-3118)US 10098957
  • Apr 20, 2035method-of-use (U-3118)US 10098957
  • Apr 20, 2035method-of-use (U-3118)US 10098957
  • Apr 20, 2035formulationUS 10213510
  • Apr 20, 2035formulationUS 10213510
  • Apr 20, 2035formulationUS 10213510
  • Apr 20, 2035formulationUS 10213510
  • Apr 20, 2035formulationUS 10632199
  • Apr 20, 2035formulationUS 10632199
  • Apr 20, 2035formulationUS 10632199
  • Apr 20, 2035formulationUS 10632199
  • Apr 20, 2035formulationUS 10898575
  • Apr 20, 2035formulationUS 10898575
  • Apr 20, 2035formulationUS 10898575
  • Apr 20, 2035formulationUS 10898575
  • Apr 20, 2035formulationUS 10980886
  • Apr 20, 2035formulationUS 10980886
  • Apr 20, 2035formulationUS 10980886
  • Apr 20, 2035formulationUS 10980886
  • Apr 20, 2035formulationUS 11083730
  • Apr 20, 2035formulationUS 11083730
  • Apr 20, 2035formulationUS 11083730
  • Apr 20, 2035formulationUS 11083730
  • Apr 20, 2035formulationUS 11083797
  • Apr 20, 2035formulationUS 11083797
  • Apr 20, 2035formulationUS 11083797
  • Apr 20, 2035formulationUS 11083797
  • Apr 20, 2035method-of-use (U-3417)US 11413350
  • Apr 20, 2035method-of-use (U-3417)US 11413350
  • Apr 20, 2035method-of-use (U-3417)US 11413350
  • Apr 20, 2035method-of-use (U-3417)US 11413350
  • Apr 20, 2035formulationUS 9694079
  • Apr 20, 2035formulationUS 9694079
  • Apr 20, 2035formulationUS 9694079
  • Apr 20, 2035formulationUS 9694079
  • Apr 20, 2035formulationUS 9801945
  • Apr 20, 2035formulationUS 9801945
  • Apr 20, 2035formulationUS 9801945
  • Apr 20, 2035formulationUS 9801945
  • Mar 13, 2034formulationUS 10398686
  • Mar 13, 2034formulationUS 10398686
  • Mar 13, 2034formulationUS 10398686
  • Mar 13, 2034formulationUS 10398686
  • Mar 13, 2034method-of-use (U-3118)US 11253504
  • Mar 13, 2034method-of-use (U-3118)US 11253504
  • Mar 13, 2034method-of-use (U-3118)US 11253504
  • Mar 13, 2034method-of-use (U-3118)US 11253504
  • Mar 13, 2034formulationUS 9592227
  • Mar 13, 2034formulationUS 9592227
  • Mar 13, 2034formulationUS 9592227
  • Mar 13, 2034formulationUS 9592227
  • Mar 13, 2034formulationUS 9744163
  • Mar 13, 2034formulationUS 9744163
  • Mar 13, 2034formulationUS 9744163
  • Mar 13, 2034formulationUS 9744163
  • Mar 13, 2034method-of-use (U-3118)US 9913909
  • Mar 13, 2034method-of-use (U-3118)US 9913909
  • Mar 13, 2034method-of-use (U-3118)US 9913909
  • Mar 13, 2034method-of-use (U-3118)US 9913909

FDA exclusivities (6)

  • Jan 23, 2027I-933Indication (3y)164d
  • Jan 23, 2027I-933Indication (3y)164d
  • Jan 23, 2027I-933Indication (3y)164d
  • Jan 23, 2027I-933Indication (3y)164d
  • Nov 9, 2026I-929Indication (3y)89d
  • Nov 9, 2026I-929Indication (3y)89d

News(5)

  • Convenience Kit Correction: Medline Issues Correction for Kits Containing Huons Lidocaine Hydrochloride and Bupivacaine Hydrochloride in Dextrose Injection
    Medline is correcting affected convenience kits by removing recalled Lidocaine Hydrochloride and Bupivacaine Hydrochloride in Dextrose Injection components from affected convenience kits.
    fda_medwatch · 9d ago
  • Convenience Kit Correction: Argon Medical Issues Correction for Convenience Kits Containing Spectra Medical Device Lidocaine Ampules
    Argon Medical is correcting affected convenience kits by removing included Spectra Medical Devices Lidocaine Ampules.
    fda_medwatch · 13d ago
  • The FDA’s 505(b)(2) pathway is an underestimated engine of value creation
    The biopharma industry would do well to re-embrace the 505(b)(2) path, which allows sponsors to draw on previous findings around an existing drug even as they propose modifications to it.
    biospace · 21d ago
  • Convenience Kit Correction: Arrow International Issues Correction for Convenience Kits Containing Recalled Huons Lidocaine and Bupivacaine and Saline
    Saline, Lidocaine and Bupivacaine from affected convenience kits should not be used.
    fda_medwatch · 27d ago
  • Convenience Kit Recall: B. Braun Medical, Inc. Removes Spinal Anesthesia Kits Containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP
    B. Braun is removing affected convenience kits containing recalled Bupivacaine Hydrochloride in Dextrose Injection components
    fda_medwatch · 27d ago
brand
Exparel
trade names
Anekain, Bupivacaine component of zynrelef, Exparel, Exparel liposomal, Posimir
generic
bupivacaine
MOA
Sodium channel protein type IV alpha subunit blocker
indication
Post-Operative Pain
phase
marketed
Data sources
ClinicalTrials.gov · OpenTargets
last refreshed 50m ago
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