Adefovir dipivoxil
As of the edition of 20 October 2026, Adefovir dipivoxil is a small molecule: marketed, first approved in 2002 (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 2002
- Kind
- Small molecule
- Brand name
- Hepsera
- First approved
- 20 September 2002 (US)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- Gilead Sciences; 2 holders in all
- Withdrawn from market
- 31 December 2022 (in some regions)
- Registered trials
- 54, 6 stopped early
- Disease areas
- Infections; Digestive system; Immune system; Urinary and reproductive; Cancer
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 | 12 | 7 | 0 | 2 |
| Phase 1 | 6 | 6 | 0 | 0 |
| Phase 2 | 15 | 12 | 0 | 2 |
| Phase 3 | 10 | 8 | 0 | 1 |
| Phase 4 | 11 | 7 | 0 | 1 |
| All trials | 54 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Gilead Sciences | Acquired holder and Lead sponsor of trials | 2002 to now |
| GSK | Applicant and Lead sponsor of trials | 2004 to now |