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Last Updated: November 21, 2024

ZYTIGA Drug Patent Profile


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Which patents cover Zytiga, and what generic alternatives are available?

Zytiga is a drug marketed by Janssen Biotech and is included in one NDA.

The generic ingredient in ZYTIGA is abiraterone acetate. There are twenty-five drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the abiraterone acetate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Zytiga

A generic version of ZYTIGA was approved as abiraterone acetate by APOTEX on October 31st, 2018.

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Drug patent expirations by year for ZYTIGA
Drug Prices for ZYTIGA

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Recent Clinical Trials for ZYTIGA

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

SponsorPhase
Merck Sharp & Dohme LLCPhase 3
Orion Corporation, Orion PharmaPhase 3
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB ChairPhase 2/Phase 3

See all ZYTIGA clinical trials

Paragraph IV (Patent) Challenges for ZYTIGA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
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 ZYTIGA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Biotech ZYTIGA abiraterone acetate TABLET;ORAL 202379-001 Apr 28, 2011 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Janssen Biotech ZYTIGA abiraterone acetate TABLET;ORAL 202379-002 Apr 14, 2017 AB RX Yes Yes ⤷  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 ZYTIGA

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 ZYTIGA

See the table below for patents covering ZYTIGA around the world.

Country Patent Number Title Estimated Expiration
Spain 2428634 ⤷  Sign Up
Japan H09502994 ⤷  Sign Up
Japan 2021038252 癌を治療するための方法及び組成物 (METHOD AND COMPOSITION FOR TREATING CANCER) ⤷  Sign Up
Japan H07505377 ⤷  Sign Up
Canada 2170286 SYNTHESE DE STEROIDES A BASE DE 17-(3-PYRIDYL) (SYNTHESIS OF 17-(3-PYRIDYL) STEROIDS) ⤷  Sign Up
New Zealand 273367 PREPARATION OF 3-HYDROXY (OR LOWER ACYLOXY)-16,17-ENE-17-(2-PYRIDYL)-SUBSTITUTED STEROIDS USING A PALLADIUM COMPLEX CATALYSED CROSS COUPLING REACTION ⤷  Sign Up
Cyprus 1115477 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ZYTIGA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 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 CA 2011 00035 Denmark ⤷  Sign Up
0633893 91911 Luxembourg ⤷  Sign Up 91911, EXPIRES: 20180315
0633893 1190040-4 Sweden ⤷  Sign Up PRODUCT NAME: ABIRATERON OCH SYRAADDITIONSSALTER OCH 3-ESTRAR DAERAV, SPECIELLT ABIRATERON-ACETAT; REG. NO/DATE: EU/1/11/714/001 20110905
0633893 C300508 Netherlands ⤷  Sign Up PRODUCT NAME: ABIRATERON ALSMEDE ZUURADDITIEZOUTEN EN 3-ESTERS ERVAN, IN HET BIJZONDER ABIRATERONACETAAT; NAT. REGISTRATION NO/DATE: EU/1/11/714/001 20110905; FIRST REGISTRATION:
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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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.