Bupivacaine
As of the edition of 20 October 2026, Bupivacaine is a small molecule: marketed, first approved in 1968 (ES); acts on SCN4A; no US protection of its own is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2020
- Kind
- Small molecule
- Brand name
- Sensorcaine
- First approved
- 1 April 1968 (ES)
- Approvals on record
- 43 in 5 regions
- Holder of the most recent approval
- Heron Therapeutics; 11 holders in all
- Withdrawn from market
- 5 October 2023 (in some regions)
- Registered trials
- 1,013, 129 stopped early
- Disease areas
- Nervous system; Injuries; Bones, joints and muscles; Cancer; Urinary and reproductive; Heart and blood vessels
US protection
No US protection of its own is listed.
The FDA registers list no drug-substance patent or exclusivity of its own that counts for this drug.
Heron Therapeutics holds a later exclusivity on its own new formulation or combination product, ending 2027; it does not protect the original drug.
This is the US only.
Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Bupivacaine.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| SCN4A | Sodium channel protein type 4 subunit alpha | P35499 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 355 | 205 | 72 | 19 |
| Phase 1 | 71 | 46 | 9 | 8 |
| Phase 2 | 83 | 38 | 16 | 16 |
| Phase 3 | 116 | 58 | 19 | 18 |
| Phase 4 | 388 | 212 | 66 | 68 |
| All trials | 1,013 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Applicant and Acquired holder | 2000 to now |
| Durect | Later holder and Lead sponsor of trials | 2006 to now |
| Pacira Pharmaceuticals | Applicant, Later holder and Lead sponsor of trials | 2007 to now |
| Fresenius Kabi | Acquired holder | 2013 to now |
| Baxter Healthcare | Later holder | 2019 to now |
| Innocoll Pharmaceuticals | Later holder | 2020 to now |
| Abbott | Later holder | |
| Astra | Later holder | |
| Sanofi | Earlier holder |