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Last Updated: October 22, 2021

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Abiraterone acetate - Generic Drug Details

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What are the generic sources for abiraterone acetate and what is the scope of patent protection?

Abiraterone acetate is the generic ingredient in three branded drugs marketed by Amneal Pharms, Apotex, Dr Reddys Labs Ltd, Glenmark Pharms, Hikma, MSN, Mylan, Qilu, Rising, Teva Pharms Usa, Wockhardt Bio Ag, Sun Pharma Global, and Janssen Biotech, and is included in thirteen NDAs. There are two patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Abiraterone acetate has fifty-three patent family members in twenty-six countries.

There are twenty-five drug master file entries for abiraterone acetate. Nineteen suppliers are listed for this compound.

Drug Prices for abiraterone acetate

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Recent Clinical Trials for abiraterone acetate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Antares Pharma Inc.Phase 1
Syneos HealthPhase 1
Jiangsu HengRui Medicine Co., Ltd.Phase 2

See all abiraterone acetate clinical trials

Medical Subject Heading (MeSH) Categories for abiraterone acetate
Paragraph IV (Patent) Challenges for ABIRATERONE ACETATE
Tradename Dosage Ingredient NDA Submissiondate
YONSA TABLET;ORAL abiraterone acetate 210308 2018-07-23
ZYTIGA TABLET;ORAL abiraterone acetate 202379 2017-08-23
ZYTIGA TABLET;ORAL abiraterone acetate 202379 2015-04-28

US Patents and Regulatory Information for abiraterone acetate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Qilu ABIRATERONE ACETATE abiraterone acetate TABLET;ORAL 212462-002 Jun 25, 2021 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Glenmark Pharms ABIRATERONE ACETATE abiraterone acetate TABLET;ORAL 209227-001 Oct 16, 2019 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Qilu ABIRATERONE ACETATE abiraterone acetate TABLET;ORAL 212462-001 Sep 27, 2019 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Amneal Pharms ABIRATERONE ACETATE abiraterone acetate TABLET;ORAL 208327-002 Dec 23, 2020 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Mylan ABIRATERONE ACETATE abiraterone acetate TABLET;ORAL 208446-001 Oct 31, 2018 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for abiraterone acetate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0633893 SPC/GB11/063 United Kingdom ⤷  Free Forever Trial PRODUCT NAME: ABIRATERONE AND ACID ADDITION SALTS AND 3-ESTERS THEREOF ESPECIALLY ABIRATERONE ACETATE; REGISTERED: UK EU/1/11/714/001 20110905
0633893 2012/003 Ireland ⤷  Free Forever Trial PRODUCT NAME: ZYTIGA (ABIRATERONE) "ABIRATERONE AND ACID ADDITION SALTS AND 3-ESTERS THEREOF, ESPECIALLY ABIRATERONE ACETATE"; REGISTRATION NO/DATE: EU/1/11/714/001 20110905
0633893 11C0055 France ⤷  Free Forever Trial PRODUCT NAME: ABIRATERONE, SES SELS D'ADDITION D'ACIDE ET 3-ESTERS, EN PARTICULIER ACETATE D'ABIRATERONE; REGISTRATION NO/DATE: EU/1/11/714/001 20110905
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
McKinsey
Harvard Business School
Medtronic
Moodys
Merck

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