Doravirine
As of the edition of 20 October 2026, Doravirine is a small molecule: marketed, first approved in 2018 (US); US protection ends in 2032.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2024
- Kind
- Small molecule
- Brand name
- Delstrigo
- First approved
- 30 August 2018 (US)
- Approvals on record
- 13 in 6 regions
- Holder of the most recent approval
- Merck & Co.
- Registered trials
- 53, 1 stopped early
- Disease areas
- Urinary and reproductive; Infections; Immune system; Pregnancy and women's health; Nutrition and metabolism; Bones, joints and muscles
US protection
US protection ends in 2032.
The last listed US drug-substance patent ends in 2032. The application that gives this date is held by Merck & Co..
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 product9 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 9 listings behind itRequest access. Nothing is shown until you do.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 6 | 3 | 0 | 1 |
| Phase 1 | 11 | 11 | 0 | 0 |
| Phase 2 | 11 | 7 | 4 | 0 |
| Phase 3 | 13 | 7 | 5 | 0 |
| Phase 4 | 12 | 4 | 5 | 0 |
| All trials | 53 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Merck & Co. | Originator and Lead sponsor of trials | 2011 to now |