Abacavir
As of the edition of 20 October 2026, Abacavir is a small molecule: marketed, first approved in 1998 (US); US protection ends in 2029.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1999
- Kind
- Small molecule
- Brand name
- Ziagen
- First approved
- 17 December 1998 (US)
- Approvals on record
- 18 in 4 regions
- Holder of the most recent approval
- Pharmobedient Consulting; 5 holders in all
- Registered trials
- 141, 10 stopped early
- Disease areas
- Infections; Immune system; Urinary and reproductive; Nutrition and metabolism; Skin and connective tissue; Nervous system
US protection
US protection ends in 2029.
The last listed US drug-substance patent ends in 2029. The application that gives this date is held by GSK.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product8 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 8 listings behind itRequest access. Nothing is shown until you do.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 22 | 18 | 1 | 2 |
| Phase 1 | 19 | 18 | 1 | 0 |
| Phase 2 | 32 | 30 | 1 | 1 |
| Phase 3 | 40 | 32 | 1 | 3 |
| Phase 4 | 28 | 21 | 0 | 4 |
| All trials | 141 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| GSK | Originator, Applicant, Later holder and Lead sponsor of trials | 1994 to now |