Tenofovir disoproxil
As of the edition of 20 October 2026, Tenofovir disoproxil is a small molecule: marketed, first approved in 2001 (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 2018
- Kind
- Small molecule
- Brand name
- Viread
- First approved
- 26 October 2001 (US)
- Approvals on record
- 30 in 5 regions
- Holder of the most recent approval
- Macleods Pharmaceuticals; 11 holders in all
- Registered trials
- 351, 36 stopped early
- Disease areas
- Infections; Urinary and reproductive; Immune system; Digestive system; Cancer; Mental health
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 | 78 | 38 | 8 | 11 |
| Phase 1 | 45 | 37 | 2 | 4 |
| Phase 2 | 70 | 52 | 7 | 10 |
| Phase 3 | 70 | 50 | 10 | 5 |
| Phase 4 | 88 | 63 | 7 | 6 |
| All trials | 351 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Gilead Sciences | Applicant, Acquired holder, Later holder and Lead sponsor of trials | 2000 to now |
| Merck & Co. | Applicant and Lead sponsor of trials | 2006 to now |
| GSK | Later holder and Lead sponsor of trials | 2011 to now |
| Japan Tobacco | Applicant | 2013 to now |