FDA Orange Book
Generic for Zytiga
Zytiga contains abiraterone acetate. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Zytiga is abiraterone acetate. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Zytiga products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 250MG | Marketed (Rx) | AB | 11 | AB |
| tablet, oral | 500MG | Marketed (Rx) | AB | 8 | AB |
NDA 202379, held by JANSSEN BIOTECH INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic abiraterone acetate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| APOTEX INC | 208453 | AB (A-rated, therapeutically equivalent) | October 31, 2018 | 250MG |
| HIKMA PHARMACEUTICALS LLC | 208339 | AB (A-rated, therapeutically equivalent) | October 31, 2018 | 250MG |
| MYLAN PHARMACEUTICALS INC | 208446 | AB (A-rated, therapeutically equivalent) | October 31, 2018 | 250MG, 500MG |
| AMNEAL PHARMACEUTICALS OF NEW YORK LLC | 208327 | AB (A-rated, therapeutically equivalent) | January 7, 2019 | 250MG, 500MG |
| RISING PHARMA HOLDINGS INC | 208371 | AB (A-rated, therapeutically equivalent) | February 25, 2019 | 250MG |
| WOCKHARDT BIO AG | 208380 | AB (A-rated, therapeutically equivalent) | February 27, 2019 | 250MG |
| MSN LABORATORIES PRIVATE LTD | 210686 | AB (A-rated, therapeutically equivalent) | July 10, 2019 | 250MG, 500MG |
| QILU PHARMACEUTICAL CO LTD | 212462 | AB (A-rated, therapeutically equivalent) | September 27, 2019 | 250MG, 500MG |
| GLENMARK SPECIALTY SA | 209227 | AB (A-rated, therapeutically equivalent) | October 16, 2019 | 250MG, 500MG |
| DR REDDYS LABORATORIES LTD | 208416 | AB (A-rated, therapeutically equivalent) | May 18, 2020 | 250MG, 500MG |
| NOVUGEN ONCOLOGY SDN BHD | 215947 | AB (A-rated, therapeutically equivalent) | January 5, 2022 | 250MG, 500MG |
| REGCON HOLDINGS LLC | 215086 | AB (A-rated, therapeutically equivalent) | March 23, 2023 | 500MG |
Zytiga NDC codes
Questions
Is there a generic for Zytiga?
Yes. The generic name for Zytiga is abiraterone acetate. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Zytiga?
The active ingredient in Zytiga is abiraterone acetate, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.
More on Zytiga and Abiraterone Acetate
- What is Abiraterone Acetate used for?FDA label uses
- Is Abiraterone Acetate a controlled substance?Federal schedule
- Generic for YonsaFDA Orange Book
- Cytochrome P450 17A1 Inhibitors listFDA drug class
- Zytiga Medicare Part D coverageBy plan and state
- NDC 57894-150Zytiga NDC record
- NDC 57894-195Zytiga NDC record