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Last Updated: May 28, 2024

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 four branded drugs marketed by Amneal Pharms, Apotex, Dr Reddys, Florida, Glenmark Pharms, Hikma, MSN, Mylan, Novugen, Qilu, Rising, Teva Pharms Usa, Wockhardt Bio Ag, Sun Pharm, and Janssen Biotech, and is included in eighteen NDAs. There are ten patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

There are twenty-two drug master file entries for abiraterone acetate. Twenty-six 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
Mayo ClinicPhase 2
Johns Hopkins Bloomberg School of Public HealthPhase 2
Zhongnan HospitalPhase 2/Phase 3

See all abiraterone acetate clinical trials

Medical Subject Heading (MeSH) Categories for abiraterone acetate
Paragraph IV (Patent) Challenges for ABIRATERONE ACETATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
YONSA Tablets abiraterone acetate 125 mg 210308 1 2018-07-23
ZYTIGA Tablets abiraterone acetate 500 mg 202379 1 2017-08-23
ZYTIGA Tablets abiraterone acetate 250 mg 202379 13 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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Janssen Biotech AKEEGA abiraterone acetate; niraparib tosylate TABLET;ORAL 216793-002 Aug 11, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Msn ABIRATERONE ACETATE abiraterone acetate TABLET;ORAL 210686-001 Jul 10, 2019 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for abiraterone acetate

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Mylan Ireland Limited Abiraterone Mylan abiraterone acetate EMEA/H/C/005368
Abiraterone Mylan is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT).the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.
Authorised yes no no 2021-08-20
Krka, d.d., Novo mesto Abiraterone Krka abiraterone acetate EMEA/H/C/005649
Abiraterone Krka is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT) (see section 5.1)the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1)the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.
Authorised yes no no 2021-06-24
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for abiraterone acetate

Country Patent Number Title Estimated Expiration
South Korea 20170070025 아비라테론 아세테이트 제제 및 사용 방법 (ABIRATERONE ACETATE FORMULATION AND METHODS OF USE) ⤷  Sign Up
Brazil 112017003219 formulação de acetato de abiraterona e métodos de uso ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2016044701 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for abiraterone acetate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0633893 2012/003 Ireland ⤷  Sign Up 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 ⤷  Sign Up 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 SPC/GB11/063 United Kingdom ⤷  Sign Up PRODUCT NAME: ABIRATERONE AND ACID ADDITION SALTS AND 3-ESTERS THEREOF ESPECIALLY ABIRATERONE ACETATE; REGISTERED: UK EU/1/11/714/001 20110905
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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