Acalabrutinib
As of the edition of 20 October 2026, Acalabrutinib is a small molecule: marketed, first approved in 2017 (US); acts on BTK; US protection ends in 2036.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2023
- Kind
- Small molecule
- Brand name
- Calquence
- First approved
- 31 October 2017 (US)
- Approvals on record
- 11 in 5 regions
- Holder of the most recent approval
- AstraZeneca
- Registered trials
- 146, 13 stopped early
- Disease areas
- Cancer; Blood and lymph; Immune system; Heart and blood vessels; Infections; Lungs and airways
US protection
US protection ends in 2036.
The last listed US drug-substance patent ends in 2036. The application that gives this date is held by AstraZeneca.
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 Acalabrutinib.
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 |
|---|---|---|
| BTK | Tyrosine-protein kinase BTK | Q06187 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 7 | 2 | 4 | 0 |
| Phase 1 | 27 | 18 | 7 | 2 |
| Phase 2 | 95 | 20 | 64 | 10 |
| Phase 3 | 16 | 2 | 13 | 1 |
| Phase 4 | 1 | 1 | 0 | 0 |
| All trials | 146 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| AstraZeneca | Originator and Lead sponsor of trials | 2017 to now |