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Last Updated: September 24, 2020

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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 three patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Abiraterone acetate has eighty-three patent family members in thirty-two countries.

There are twenty-five drug master file entries for abiraterone acetate. Seventeen 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
ExelixisPhase 1
Washington University School of MedicinePhase 1
Bristol-Myers SquibbPhase 1

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
Rising ABIRATERONE ACETATE abiraterone acetate TABLET;ORAL 208371-001 Feb 25, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Glenmark Pharms ABIRATERONE ACETATE abiraterone acetate TABLET;ORAL 209227-001 Oct 16, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Sun Pharma Global YONSA abiraterone acetate TABLET;ORAL 210308-001 May 22, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Mylan ABIRATERONE ACETATE abiraterone acetate TABLET;ORAL 208446-001 Oct 31, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Janssen Biotech ZYTIGA abiraterone acetate TABLET;ORAL 202379-001 Apr 28, 2011 AB RX Yes No   Start Trial   Start Trial   Start Trial
Janssen Biotech ZYTIGA abiraterone acetate TABLET;ORAL 202379-002 Apr 14, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start 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   Start Trial PRODUCT NAME: ABIRATERONE AND ACID ADDITION SALTS AND 3-ESTERS THEREOF ESPECIALLY ABIRATERONE ACETATE; REGISTERED: UK EU/1/11/714/001 20110905
0633893 11C0055 France   Start 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
0633893 2012/003 Ireland   Start 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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