Bosutinib
As of the edition of 20 October 2026, Bosutinib is a small molecule: marketed, first approved in 2012 (US); acts on ABL1; US protection ends in 2031.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2014
- Kind
- Small molecule
- Brand name
- Bosulif
- First approved
- 4 September 2012 (US)
- Approvals on record
- 12 in 5 regions
- Holder of the most recent approval
- Pfizer; 3 holders in all
- Registered trials
- 65, 10 stopped early
- Disease areas
- Cancer; Blood and lymph; Skin and connective tissue; Immune system; Lungs and airways; Pregnancy and women's health
US protection
US protection ends in 2031.
The last listed US exclusivity ends in 2031. The application that gives this date is held by Pfizer.
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 product25 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 Bosutinib.
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 | 7 | 6 | 1 | 0 |
| Phase 1 | 29 | 25 | 0 | 3 |
| Phase 2 | 24 | 13 | 3 | 6 |
| Phase 3 | 3 | 2 | 1 | 0 |
| Phase 4 | 2 | 0 | 1 | 1 |
| All trials | 65 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Originator, Applicant and Lead sponsor of trials | 2004 to now |