Nevirapine
As of the edition of 20 October 2026, Nevirapine is a small molecule: marketed, first approved in 1996 (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
- Viramune
- First approved
- 21 June 1996 (US)
- Approvals on record
- 6 in 2 regions
- Holder of the most recent approval
- Micro; 2 holders in all
- Registered trials
- 134, 7 stopped early
- Disease areas
- Infections; Urinary and reproductive; Immune system; Pregnancy and women's health; 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 | 26 | 25 | 0 | 1 |
| Phase 1 | 24 | 22 | 0 | 2 |
| Phase 2 | 25 | 22 | 1 | 2 |
| Phase 3 | 34 | 29 | 1 | 1 |
| Phase 4 | 25 | 22 | 0 | 1 |
| All trials | 134 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Boehringer Ingelheim | Originator and Lead sponsor of trials | 1996 to now |