Clotrimazole
As of the edition of 20 October 2026, Clotrimazole is a small molecule: marketed, first approved in 1973 (CH); 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 2015
- Kind
- Small molecule
- Brand name
- Lotrimin
- First approved
- 16 July 1973 (CH)
- Approvals on record
- 49 in 6 regions
- Holder of the most recent approval
- Carwin Pharmaceutical Associates; 11 holders in all
- Registered trials
- 28, 2 stopped early
- Disease areas
- Infections; Urinary and reproductive; Pregnancy and women's health; Skin and connective tissue; Ear, nose and throat; Immune system
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.
Carwin Pharmaceutical Associates holds a later exclusivity on its own new formulation or combination product, ending 2037; it does not protect the original drug.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 8 | 6 | 0 | 0 |
| Phase 1 | 2 | 2 | 0 | 0 |
| Phase 2 | 4 | 2 | 1 | 0 |
| Phase 3 | 10 | 5 | 2 | 1 |
| Phase 4 | 4 | 2 | 1 | 1 |
| All trials | 28 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bayer | Applicant, Later holder and Lead sponsor of trials | 1973 to now |
| Organon | Later holder and Lead sponsor of trials | 1986 to now |
| Schering Plough Healthcare | Acquired holder | 2003 to now |
| Carwin Pharmaceutical Associates | Later holder | 2025 to now |
| Sun Pharma | Acquired holder | 2025 to now |
| Merck & Co. | Applicant |