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Last Updated: January 27, 2023

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, Glenmark Pharms, Hikma, MSN, Mylan, Novugen, Qilu, Rising, Teva Pharms Usa, Wockhardt Bio Ag, Sun Pharm, and Janssen Biotech, and is included in fifteen 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-two drug master file entries for abiraterone acetate. Twenty-three suppliers are listed for this compound.

Drug Prices for abiraterone acetate

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Recent Clinical Trials for abiraterone acetate

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SponsorPhase
Zhongnan HospitalPhase 2/Phase 3
Johns Hopkins Bloomberg School of Public HealthPhase 2
Anticancer Fund, BelgiumPhase 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 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
Novugen ABIRATERONE ACETATE abiraterone acetate TABLET;ORAL 215947-002 Jan 5, 2022 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Glenmark Pharms ABIRATERONE ACETATE abiraterone acetate TABLET;ORAL 209227-002 May 19, 2022 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amneal Pharms ABIRATERONE ACETATE abiraterone acetate TABLET;ORAL 208327-002 Dec 23, 2020 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Rising ABIRATERONE ACETATE abiraterone acetate TABLET;ORAL 208371-001 Feb 25, 2019 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Dr Reddys ABIRATERONE ACETATE abiraterone acetate TABLET;ORAL 208416-001 May 18, 2020 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Hong Kong 1219457 乙酸阿比特龍酯製劑 (ABIRATERONE ACETATE FORMULATION) See Plans and Pricing
Taiwan 201943408 Abiraterone acetate formulation See Plans and Pricing
Poland 2969227 See Plans and Pricing
Japan 2017528457 酢酸アビラテロン製剤及び使用方法 See Plans and Pricing
Tunisia 2018000318 ABIRATERONE ACETATE FORMULATION AND METHODS OF USE. See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for abiraterone acetate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0633893 SPC/GB11/063 United Kingdom See Plans and Pricing 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 See Plans and Pricing 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 See Plans and Pricing 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:

Baxter
McKinsey
Harvard Business School
Medtronic
Moodys
Merck

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