You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 28, 2024

Abiraterone acetate - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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

See drug prices for abiraterone acetate

Recent Clinical Trials for abiraterone acetate

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

SponsorPhase
Mayo ClinicPhase 2
Zhongnan HospitalPhase 2/Phase 3
Johns Hopkins Bloomberg School of Public HealthPhase 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
Janssen Biotech AKEEGA abiraterone acetate; niraparib tosylate TABLET;ORAL 216793-001 Aug 11, 2023 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Janssen Biotech AKEEGA abiraterone acetate; niraparib tosylate TABLET;ORAL 216793-001 Aug 11, 2023 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Janssen Biotech AKEEGA abiraterone acetate; niraparib tosylate TABLET;ORAL 216793-001 Aug 11, 2023 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva Pharms Usa ABIRATERONE ACETATE abiraterone acetate TABLET;ORAL 210726-001 Jan 26, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 1220162 乙酸阿比特龍酯製劑 (ABIRATERONE ACETATE FORMULATION) ⤷  Try a Trial
Mexico 2017003525 FORMULACION DE ACETATO DE ABIRATERONA Y METODOS DE USO. (ABIRATERONE ACETATE FORMULATION AND METHODS OF USE.) ⤷  Try a Trial
Spain 2741800 ⤷  Try a Trial
Colombia 2017002472 Formulación de acetato de abiraterona ⤷  Try a Trial
>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 ⤷  Try a 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 SPC/GB11/063 United Kingdom ⤷  Try a 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 ⤷  Try a 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

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.