Tigecycline
As of the edition of 20 October 2026, Tigecycline is a small molecule: marketed, first approved in 2005 (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 2012
- Kind
- Small molecule
- Brand name
- Tygacil
- First approved
- 15 June 2005 (US)
- Approvals on record
- 9 in 6 regions
- Holder of the most recent approval
- Amneal Pharmaceuticals; 6 holders in all
- Registered trials
- 48, 4 stopped early
- Disease areas
- Infections; Lungs and airways; Skin and connective tissue; Digestive system; Nervous system; Blood and lymph
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 | 17 | 11 | 3 | 0 |
| Phase 1 | 5 | 4 | 0 | 0 |
| Phase 2 | 5 | 2 | 2 | 1 |
| Phase 3 | 16 | 11 | 2 | 3 |
| Phase 4 | 5 | 4 | 0 | 0 |
| All trials | 48 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Originator, Applicant and Lead sponsor of trials | 2002 to now |
| Fresenius Kabi | Later holder | 2016 to now |
| Accord Healthcare | Later holder | 2018 to now |
| Amneal Pharmaceuticals | Later holder | 2018 to now |