Brincidofovir
As of the edition of 20 October 2026, Brincidofovir is a small molecule: marketed, first approved in 2021 (US); US protection ends in 2034.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2023
- Kind
- Small molecule
- Brand name
- Tembexa
- First approved
- 4 June 2021 (US)
- Approvals on record
- 3 in 2 regions
- Holder of the most recent approval
- Emergent Biosolutions
- Registered trials
- 17, 7 stopped early
- Disease areas
- Infections; Blood and lymph; Cancer; Immune system; Nervous system; Pregnancy and women's health
US protection
US protection ends in 2034.
The last listed US drug-substance patent ends in 2034. The application that gives this date is held by Emergent Biosolutions.
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 product5 listings count towards this date. The exact date and each listing are in the product.
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Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 3 | 0 | 0 | 2 |
| Phase 1 | 2 | 2 | 0 | 0 |
| Phase 2 | 9 | 2 | 1 | 5 |
| Phase 3 | 3 | 2 | 1 | 0 |
| All trials | 17 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Emergent Biosolutions | Acquired holder | 2022 to now |
| Chimerix | Originator | 2021 to 2022 |