Efavirenz
As of the edition of 20 October 2026, Efavirenz is a small molecule: marketed, first approved in 1998 (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 1998
- Kind
- Small molecule
- Brand name
- Sustiva
- First approved
- 17 September 1998 (US)
- Approvals on record
- 10 in 1 region
- Holder of the most recent approval
- Macleods Pharmaceuticals; 5 holders in all
- Withdrawn from market
- 30 September 2025 (in some regions)
- Registered trials
- 226, 13 stopped early
- Disease areas
- Infections; Urinary and reproductive; Immune system; Digestive system; Nutrition and metabolism; Skin and connective tissue
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 | 44 | 34 | 1 | 4 |
| Phase 1 | 52 | 46 | 2 | 1 |
| Phase 2 | 45 | 40 | 1 | 3 |
| Phase 3 | 44 | 38 | 1 | 0 |
| Phase 4 | 41 | 30 | 0 | 5 |
| All trials | 226 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bristol Myers Squibb | Acquired holder and Lead sponsor of trials | 2000 to now |