Dolutegravir
As of the edition of 20 October 2026, Dolutegravir is a small molecule: marketed, first approved in 2013 (US); US protection ends in 2031.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2014
- Kind
- Small molecule
- Brand name
- Tivicay
- First approved
- 12 August 2013 (US)
- Approvals on record
- 27 in 5 regions
- Holder of the most recent approval
- GSK; 4 holders in all
- Registered trials
- 191, 16 stopped early
- Disease areas
- Infections; Immune system; Urinary and reproductive; Nutrition and metabolism; Nervous system; Digestive system
US protection
US protection ends in 2031.
The last listed US drug-substance patent ends in 2031. 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 product14 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 14 listings behind itRequest access. Nothing is shown until you do.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 26 | 20 | 2 | 1 |
| Phase 1 | 59 | 56 | 1 | 1 |
| Phase 2 | 30 | 17 | 5 | 5 |
| Phase 3 | 40 | 25 | 8 | 4 |
| Phase 4 | 36 | 19 | 5 | 5 |
| All trials | 191 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| GSK | Applicant, Later holder and Lead sponsor of trials | 2007 to now |