Ponatinib
As of the edition of 20 October 2026, Ponatinib is a small molecule: marketed, first approved in 2012 (US); acts on ABL1; US protection ends in 2033.
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
- Iclusig
- First approved
- 14 December 2012 (US)
- Approvals on record
- 8 in 4 regions
- Holder of the most recent approval
- Takeda; 3 holders in all
- Registered trials
- 66, 17 stopped early
- Disease areas
- Cancer; Blood and lymph; Immune system; Lungs and airways; Digestive system; Skin and connective tissue
US protection
US protection ends in 2033.
The last listed US drug-substance patent ends in 2033. 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 product44 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 Ponatinib.
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 |
|---|---|---|
| ABL1 | Tyrosine-protein kinase ABL1 | P00519 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 10 | 3 | 2 | 2 |
| Phase 1 | 3 | 2 | 0 | 1 |
| Phase 2 | 47 | 15 | 15 | 11 |
| Phase 3 | 6 | 0 | 3 | 3 |
| All trials | 66 |