Lidocaine
As of the edition of 20 October 2026, Lidocaine is a small molecule: marketed, first approved in 1949 (CH); acts on SCN10A, SCN11A and SCN1A and 7 more; 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 2014
- Kind
- Small molecule
- Brand name
- Xylocaine
- First approved
- 25 January 1949 (CH)
- Approvals on record
- 105 in 8 regions
- Holder of the most recent approval
- DEPROCO INC; 41 holders in all
- Registered trials
- 964, 100 stopped early
- Disease areas
- Nervous system; Cancer; Urinary and reproductive; Bones, joints and muscles; Digestive system; Injuries
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.
MEDRx holds a later exclusivity on its own new formulation or combination product, ending 2028; it does not protect the original drug.
This is the US only.
Companies that need a new molecule because of this drug
2 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product2 company-target rows are on route B because of Lidocaine.
See the 2 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
| Gene | Protein | UniProt |
|---|---|---|
| SCN1A | Sodium channel protein type 1 subunit alpha | P35498 |
| SCN4A | Sodium channel protein type 4 subunit alpha | P35499 |
| SCN7A | Sodium channel protein type 7 subunit alpha | Q01118 |
| SCN5A | Sodium channel protein type 5 subunit alpha | Q14524 |
| SCN9A | Sodium channel protein type 9 subunit alpha | Q15858 |
| SCN2A | Sodium channel protein type 2 subunit alpha | Q99250 |
| SCN3A | Sodium channel protein type 3 subunit alpha | Q9NY46 |
| SCN11A | Sodium channel protein type 11 subunit alpha | Q9UI33 |
| SCN8A | Sodium channel protein type 8 subunit alpha | Q9UQD0 |
| SCN10A | Sodium channel protein type 10 subunit alpha | Q9Y5Y9 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 397 | 220 | 56 | 25 |
| Phase 1 | 74 | 49 | 10 | 8 |
| Phase 2 | 92 | 52 | 15 | 15 |
| Phase 3 | 147 | 100 | 16 | 13 |
| Phase 4 | 254 | 136 | 29 | 39 |
| All trials | 964 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Applicant and Acquired holder | 1973 to now |
| B. Braun Medical | Later holder | 1984 to now |
| Noven Therapeutics | Later holder | 1996 to now |
| Teikoku Pharma | Later holder | 1999 to now |
| IBSA Institut Biochimique | Applicant | 1999 to now |
| Abbott | Acquired holder and Later holder | 2003 to now |
| Amphastar Pharmaceuticals | Acquired holder | 2003 to now |
| AstraZeneca | Acquired holder | 2003 to now |
| International Medication System | Acquired holder | 2003 to now |
| Abraxis Pharmaceutical | Acquired holder | 2006 to now |
| Sanofi | Later holder and Lead sponsor of trials | 2007 to now |
| Anesiva | Later holder | 2007 to now |
| Akorn | Later holder | 2008 to now |
| MEDRx | Later holder and Lead sponsor of trials | 2010 to now |
| Powder Pharmaceuticals | Acquired holder | 2011 to now |
| SATO Pharmaceutical | Applicant | 2012 to now |
| Dentsply Pharmaceutical | Acquired holder | 2012 to now |
| Fresenius Kabi | Acquired holder | 2013 to now |
| Recordati | Applicant | 2013 to now |
| Scilex Pharmaceuticals | Later holder and Lead sponsor of trials | 2014 to now |
| Aché Laboratórios Farmacêuticos | Applicant | 2019 to now |
| Thea Pharma | Acquired holder | 2022 to now |
| Epic Pharma | Acquired holder | 2023 to now |
| Astra | Applicant | |
| Baxter Healthcare | Later holder | |
| Concentra Biosciences | Later holder | |
| Nitto Denko | Later holder |