Abiraterone acetate is available under different product names depending on country, manufacturer and regulatory authorization.
Zytiga
Zytiga is the established reference medicine containing abiraterone acetate. The EMA identifies Zytiga as an abiraterone acetate product authorized for specified prostate cancer indications in combination with prednisone or prednisolone.
Generic abiraterone products
Regulatory authorities have authorized generic abiraterone products in various jurisdictions. For example, the EMA identifies Abiraterone Accord and Abiraterone Mylan as generic medicines containing abiraterone acetate and describes their bioequivalence to Zytiga.
| Product category | Active substance | Relationship |
|---|---|---|
| Zytiga | Abiraterone acetate | Reference medicine |
| Authorized generic | Abiraterone acetate | Generic/reference relationship depends on jurisdiction |
| Abiraterone 250 mg product | Abiraterone acetate | Product-specific documentation required |
A brand name alone does not establish who manufactured a particular package.
Important distinction
The following should be treated as separate concepts:
- Active ingredient: abiraterone acetate
- Reference medicine: Zytiga
- Generic medicine: authorized product containing the same active substance
- Manufacturer: company manufacturing the particular product
- Marketing authorization holder: entity responsible for authorization in a jurisdiction
- Distributor: supply-chain entity