Pretomanid
As of the edition of 20 October 2026, Pretomanid is a small molecule: marketed, first approved in 2019 (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 2020
- Kind
- Small molecule
- Brand name
- Dovprela
- First approved
- 14 August 2019 (US)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- Viatris; 2 holders in all
- Registered trials
- 41, 2 stopped early
- Disease areas
- Infections; Lungs and airways; Urinary and reproductive; Immune system; Pregnancy and women's health
US protection
US protection ends in 2031.
The last listed US exclusivity ends in 2031. The application that gives this date is held by Viatris.
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 product4 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 4 listings behind itRequest access. Nothing is shown until you do.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 3 | 2 | 1 | 0 |
| Phase 1 | 10 | 9 | 0 | 1 |
| Phase 2 | 17 | 9 | 6 | 1 |
| Phase 3 | 11 | 6 | 3 | 0 |
| All trials | 41 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Viatris | Acquired holder | 2019 to now |