Abiraterone acetate
As of the edition of 20 October 2026, Abiraterone acetate is a small molecule: marketed, first approved in 2011 (US); acts on CYP17A1; US protection ends in 2038.
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
- Zytiga
- First approved
- 28 April 2011 (US)
- Approvals on record
- 11 in 3 regions
- Holder of the most recent approval
- Johnson & Johnson; 4 holders in all
- Registered trials
- 195, 30 stopped early
- Disease areas
- Cancer; Urinary and reproductive; Pregnancy and women's health; Skin and connective tissue; Hormones; Inherited and neonatal
US protection
US protection ends in 2038.
The last listed US drug-substance patent ends in 2038. 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
In the product14 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 14 listings behind itRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| CYP17A1 | Steroid 17-alpha-hydroxylase/17,20 lyase | P05093 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 15 | 4 | 6 | 2 |
| Phase 1 | 38 | 23 | 7 | 7 |
| Phase 2 | 115 | 53 | 34 | 20 |
| Phase 3 | 23 | 8 | 13 | 1 |
| Phase 4 | 4 | 2 | 2 | 0 |
| All trials | 195 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Johnson & Johnson | Originator, Applicant and Lead sponsor of trials | 2011 to now |
| SUN Pharmaceutical Industries | Acquired holder and Lead sponsor of trials | 2016 to now |