FDA Orange Book · active-ingredient family
Abiraterone acetate
Abiraterone acetate: 2 brands, 15 generics; first approved Apr 28, 2011; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 15 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
2
Generics (ANDA)
15
Listed patents
2
Next patent expiry
Mar 17, 2034
in 7 yr 8 mo
Brand (NDA) products
Originator applications
Generic (ANDA) products (15)
Abbreviated applications
- ABIRATERONE ACETATEFLORIDAANDA 2150862023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AB - ABIRATERONE ACETATETEVA PHARMS USAANDA 2107262023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued — - ABIRATERONE ACETATETEVA PHARMS USAANDA 2122062022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET ORAL Discontinued — - ABIRATERONE ACETATENOVUGENANDA 21594720222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB - ABIRATERONE ACETATEDR REDDYSANDA 20841620202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB - ABIRATERONE ACETATEGLENMARK SPECLTANDA 20922720192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB - ABIRATERONE ACETATEQILUANDA 21246220192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB - ABIRATERONE ACETATEMSNANDA 21068620192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB - ABIRATERONE ACETATEWOCKHARDT BIO AGANDA 2083802019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB - ABIRATERONE ACETATERISINGANDA 2083712019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB - ABIRATERONE ACETATEAMNEAL PHARMSANDA 20832720192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB - ABIRATERONE ACETATEAPOTEXANDA 2084532018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB - ABIRATERONE ACETATEHIKMAANDA 2083392018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB - ABIRATERONE ACETATEMYLANANDA 20844620182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB - ABIRATERONE ACETATETEVA PHARMS USAANDA 2084322018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 9889144 | in 7 yr 8 mo | Product | |
| 10292990 | in 7 yr 11 mo | U-2535 |
Approval history
FDA approval span
First approval
15 yr 6 mo ago
Most recent approval
2 yr 4 mo ago
Approvals span 2011–2024 across 17 FDA applications.
Brand (NDA) 212%
Generic (ANDA) 1588%
Abiraterone acetate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
