Bedaquiline
As of the edition of 20 October 2026, Bedaquiline is a small molecule: marketed, first approved in 2012 (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 2018
- Kind
- Small molecule
- Brand name
- Sirturo
- First approved
- 28 December 2012 (US)
- Approvals on record
- 4 in 2 regions
- Holder of the most recent approval
- Johnson & Johnson; 3 holders in all
- Registered trials
- 74, 1 stopped early
- Disease areas
- Infections; Lungs and airways; Immune system; Urinary and reproductive
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 Johnson & Johnson.
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 product12 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 12 listings behind itRequest access. Nothing is shown until you do.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 7 | 3 | 2 | 0 |
| Phase 1 | 11 | 10 | 1 | 0 |
| Phase 2 | 29 | 19 | 6 | 1 |
| Phase 3 | 26 | 12 | 12 | 0 |
| Phase 4 | 1 | 0 | 0 | 0 |
| All trials | 74 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Johnson & Johnson | Originator, Applicant, Later holder and Lead sponsor of trials | 2005 to now |