EMA · European Union
bupivacaine — EMA regulatory status
bupivacaine (EXPAREL LIPOSOMAL) regulatory status in the European Union is tracked from public EMA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: EMA approved.
Status snapshot
- Status
- EMA approved
- Brand
- EXPAREL LIPOSOMAL
- Originator
- Pacira Ireland Limited
- Mechanism
- Sodium channel protein type IV alpha subunit blocker
- Target
- Sodium channel protein type 4 subunit alpha
- Structured fields
- 8
Sponsor / originator context: Pacira Ireland Limited. Pipeline programs and exclusivity signals below are joined from ClinicalTrials.gov-linked projects and USPTO/EPO patent rows associated with this INN.
Pharmacology context used for competitive intelligence: Sodium channel protein type IV alpha subunit blocker. Target: Sodium channel protein type 4 subunit alpha. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — EMA: approved.
Linked evidence on this spoke: 80 published clinical programs and 12 related patent records. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| EMA | European Union | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| Bupivacaine | Phase 3 | United Therapeutics Europe | NCT06989866 |
| Bupivacaine | Phase 3 | Pacira Ireland | NCT02740114 |
| Bupivacaine HCl | Phase 3 | Pacira Ireland | NCT00485433, NCT00485693 |
| Bupivacaine HCl | Phase 3 | Pacira Ireland | NCT00744848 |
| Bupivacaine Liposome Injection | Phase 3 | United Therapeutics Europe | NCT02341079 |
| Bupivacaine liposome | Phase 3 | Pacira Ireland | NCT02517905 |
| Bupivacaine liposome injectable suspension 266 mg | Phase 3 | Pacira Ireland | NCT05157841 |
| EXPAREL | Phase 3 | Pacira Ireland | NCT07212114 |
| EXPAREL 13.3Mg/mL Suspension for Injection | Phase 3 | Pacira Ireland | NCT03954639 |
| EXPAREL 266 mg | Phase 3 | Pacira Ireland | NCT01802411 |
| Exparel | Phase 3 | Pacira Ireland | NCT06350981 |
| Exparel | Phase 3 | Pacira Ireland | NCT03428984, NCT03485014 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 12370142 | Manufacturing of bupivacaine multivesicular liposomes | US |
| 12364764 | Sustained release thermosetting gels comprising sodium channel blockers and the methods of making same | US |
| 12318483 | Manufacturing of bupivacaine multivesicular liposomes | US |
| 12296047 | Manufacturing of bupivacaine multivesicular liposomes | US |
| 12285419 | Bupivacaine multivesicular liposome formulations and uses thereof | US |
| 12280149 | Manufacturing of bupivacaine multivesicular liposomes | US |
| 12251472 | Manufacturing of bupivacaine multivesicular liposomes | US |
| 12251468 | Manufacturing of bupivacaine multivesicular liposomes | US |
| 12246092 | Manufacturing of bupivacaine multivesicular liposomes | US |
| 12226610 | Treatment of pain associated with total knee arthroplasty with sustained-release liposomal anesthetic compositions | US |
| 12178909 | Manufacturing of bupivacaine multivesicular liposomes | US |
| 12156940 | Manufacturing of bupivacaine multivesicular liposomes | US |
Related hubs
FAQ
What is the EMA approval status of bupivacaine?
bupivacaine currently shows EMA approved in our European Union regulatory index. Confirm on the official EMA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get bupivacaine regulatory data?
Status fields are joined from public sources (openFDA / EMA / regional agencies), ClinicalTrials.gov-linked programs, and patent registries. See /about/data-sources for attribution.
How many clinical programs are linked to bupivacaine?
This spoke lists 80 published programs associated with bupivacaine in our pipeline index.