Vancomycin
As of the edition of 20 October 2026, Vancomycin is a small molecule: marketed, first approved in 1986 (US); no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2025
- Kind
- Small molecule
- Brand name
- Vancocin Hydrochloride
- First approved
- 15 April 1986 (US)
- Approvals on record
- 36 in 5 regions
- Holder of the most recent approval
- Zhejiang Novus Pharmaceuticals; 11 holders in all
- Registered trials
- 214, 30 stopped early
- Disease areas
- Infections; Digestive system; Lungs and airways; Cancer; Heart and blood vessels; Injuries
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 58 | 29 | 8 | 7 |
| Phase 1 | 30 | 16 | 7 | 2 |
| Phase 2 | 43 | 17 | 14 | 9 |
| Phase 3 | 33 | 13 | 9 | 4 |
| Phase 4 | 50 | 23 | 9 | 8 |
| All trials | 214 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Baxter Healthcare | Applicant and Acquired holder | 2003 to now |
| ANI Pharmaceuticals | Acquired holder | 2014 to now |
| Viatris | Later holder | 2018 to now |
| Azurity Pharmaceuticals | Acquired holder | 2020 to now |
| Zhejiang Novus Pharmaceuticals | Later holder | 2023 to now |
| Hikma Pharmaceuticals | Acquired holder | 2025 to now |
| Shionogi | Applicant | |
| Eli Lilly | Originator | 1986 to 2014 |