Apalutamide
As of the edition of 20 October 2026, Apalutamide is a small molecule: marketed, first approved in 2018 (US); acts on AR; 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
- Erleada
- First approved
- 14 February 2018 (US)
- Approvals on record
- 10 in 6 regions
- Holder of the most recent approval
- Johnson & Johnson; 6 holders in all
- Registered trials
- 124, 13 stopped early
- Disease areas
- Cancer; Urinary and reproductive; Inherited and neonatal; Nervous system; Blood and lymph; Lungs and airways
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 Johnson & Johnson.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
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Target
| Gene | Protein | UniProt |
|---|---|---|
| AR | Androgen receptor | P10275 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 18 | 10 | 5 | 0 |
| Phase 1 | 27 | 16 | 9 | 2 |
| Phase 2 | 55 | 17 | 26 | 8 |
| Phase 3 | 22 | 1 | 18 | 3 |
| Phase 4 | 2 | 1 | 0 | 0 |
| All trials | 124 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Johnson & Johnson | Originator, Applicant and Lead sponsor of trials | 2014 to now |