Dabrafenib
As of the edition of 20 October 2026, Dabrafenib is a small molecule: marketed, first approved in 2013 (US); acts on BRAF; US protection ends in 2030.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2016
- Kind
- Small molecule
- Brand name
- Tafinlar
- First approved
- 29 May 2013 (US)
- Approvals on record
- 14 in 4 regions
- Holder of the most recent approval
- Novartis; 2 holders in all
- Registered trials
- 157, 31 stopped early
- Disease areas
- Cancer; Skin and connective tissue; Blood and lymph; Hormones; Lungs and airways; Nervous system
US protection
US protection ends in 2030.
The last listed US drug-substance patent ends in 2030. The application that gives this date is held by Novartis.
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 product39 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 on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Dabrafenib.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| BRAF | Serine/threonine-protein kinase B-raf | P15056 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 20 | 8 | 5 | 1 |
| Phase 1 | 34 | 15 | 4 | 13 |
| Phase 2 | 87 | 29 | 32 | 16 |
| Phase 3 | 13 | 6 | 5 | 1 |
| Phase 4 | 3 | 0 | 3 | 0 |
| All trials | 157 |