Assyro AI

FDA Orange Book · active-ingredient family

Abiraterone acetate

Abiraterone acetate is approved as 2 brand and 15 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:YONSA · NDA 210308

2

Brand (NDA)

15

Generics (ANDA)

2

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
YONSARLDSUN PHARMNDA 210308—May 22, 2018
ZYTIGARLD×2JANSSEN BIOTECHNDA 202379ABApr 28, 2011

Generic (ANDA) products (15)

ProductApplicantApplicationTEApproved
ABIRATERONE ACETATEFLORIDAANDA 215086ABMar 23, 2023
ABIRATERONE ACETATETEVA PHARMS USAANDA 210726—Jan 26, 2023
ABIRATERONE ACETATETEVA PHARMS USAANDA 212206—Jun 24, 2022
ABIRATERONE ACETATE×2NOVUGENANDA 215947ABJan 05, 2022
ABIRATERONE ACETATE×2DR REDDYSANDA 208416ABMay 18, 2020
ABIRATERONE ACETATE×2GLENMARK SPECLTANDA 209227ABOct 16, 2019
ABIRATERONE ACETATE×2QILUANDA 212462ABSep 27, 2019
ABIRATERONE ACETATE×2MSNANDA 210686ABJul 10, 2019
ABIRATERONE ACETATEWOCKHARDT BIO AGANDA 208380ABFeb 27, 2019
ABIRATERONE ACETATERISINGANDA 208371ABFeb 25, 2019
ABIRATERONE ACETATE×2AMNEAL PHARMSANDA 208327ABJan 07, 2019
ABIRATERONE ACETATEAPOTEXANDA 208453ABOct 31, 2018
ABIRATERONE ACETATEHIKMAANDA 208339ABOct 31, 2018
ABIRATERONE ACETATE×2MYLANANDA 208446ABOct 31, 2018
ABIRATERONE ACETATETEVA PHARMS USAANDA 208432—Oct 31, 2018

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9889144Mar 17, 2034in 7 yr 10 mo
Product
10292990May 20, 2034in 8 yr
U-2535

Abiraterone acetate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo