Minocycline
As of the edition of 20 October 2026, Minocycline is a small molecule: marketed, first approved in 1973 (ES); 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 1982
- Kind
- Small molecule
- Brand name
- Minocin
- First approved
- 1 May 1973 (ES)
- Approvals on record
- 30 in 3 regions
- Holder of the most recent approval
- Coronado Biosciences; 8 holders in all
- Registered trials
- 174, 20 stopped early
- Disease areas
- Nervous system; Mental health; Heart and blood vessels; Cancer; Skin and connective tissue; Inherited and neonatal
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.
Coronado Biosciences 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.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 25 | 17 | 2 | 1 |
| Phase 1 | 24 | 14 | 1 | 4 |
| Phase 2 | 61 | 41 | 5 | 10 |
| Phase 3 | 25 | 10 | 6 | 3 |
| Phase 4 | 39 | 22 | 6 | 2 |
| All trials | 174 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| OraPharma | Later holder and Lead sponsor of trials | 2001 to now |
| Daiichi Sankyo | Later holder and Lead sponsor of trials | 2002 to now |
| Medicis Pharmaceutical | Later holder | 2006 to now |
| Triax Pharmaceuticals | Acquired holder | 2006 to now |
| Pfizer | Later holder and Lead sponsor of trials | 2007 to now |
| Dr. Reddy's | Later holder | 2017 to now |
| Novan | Acquired holder | 2019 to now |
| Bausch Health | Acquired holder | 2019 to now |
| Coronado Biosciences | Acquired holder and Lead sponsor of trials | 2020 to now |
| Rempex Pharmaceuticals Inc A Wholly Owned Sub Of Melinta Therapeutics | Acquired holder | 2021 to now |