Brigatinib
As of the edition of 20 October 2026, Brigatinib is a small molecule: marketed, first approved in 2017 (US); acts on ALK and EGFR; US protection ends in 2035.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2021
- Kind
- Small molecule
- Brand name
- Alunbrig
- First approved
- 28 April 2017 (US)
- Approvals on record
- 11 in 5 regions
- Holder of the most recent approval
- Takeda
- Registered trials
- 35, 9 stopped early
- Disease areas
- Cancer; Lungs and airways; Blood and lymph; Immune system; Nervous system; Digestive system
US protection
US protection ends in 2035.
The last listed US drug-substance patent ends in 2035. The application that gives this date is held by Takeda.
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.
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Companies that need a new molecule because of this drug
1 company-target row on route B because of this drug.
Companies on route B for this drug
In the product1 company-target row is on route B because of Brigatinib.
See the 1 company-target row on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 7 | 3 | 3 | 0 |
| Phase 1 | 5 | 2 | 2 | 1 |
| Phase 2 | 21 | 5 | 5 | 8 |
| Phase 3 | 2 | 2 | 0 | 0 |
| All trials | 35 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Takeda | Originator, Applicant and Lead sponsor of trials | 2017 to now |