Ibrutinib
As of the edition of 20 October 2026, Ibrutinib is a small molecule: marketed, first approved in 2013 (US); acts on BTK; US protection ends in 2033.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2019
- Kind
- Small molecule
- Brand name
- Imbruvica
- First approved
- 13 November 2013 (US)
- Approvals on record
- 22 in 5 regions
- Holder of the most recent approval
- Johnson & Johnson; 5 holders in all
- Registered trials
- 336, 56 stopped early
- Disease areas
- Cancer; Blood and lymph; Immune system; Heart and blood vessels; Lungs and airways; Infections
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 AbbVie.
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 product98 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
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Ibrutinib.
See the 2 companies 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 | 12 | 6 | 2 | 0 |
| Phase 1 | 83 | 42 | 20 | 21 |
| Phase 2 | 202 | 91 | 60 | 33 |
| Phase 3 | 35 | 19 | 10 | 2 |
| Phase 4 | 4 | 2 | 2 | 0 |
| All trials | 336 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| AbbVie | Originator and Lead sponsor of trials | 2009 to now |
| Johnson & Johnson | Applicant and Lead sponsor of trials | 2012 to now |