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Last Updated: January 19, 2022

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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. Nineteen 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
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Recent Clinical Trials for ZYTIGA

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SponsorPhase
University of Texas Southwestern Medical CenterPhase 2
Feinstein Institute for Medical ResearchPhase 2
University of MichiganPhase 2

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Paragraph IV (Patent) Challenges for ZYTIGA
Tradename Dosage Ingredient NDA Submissiondate
ZYTIGA TABLET;ORAL abiraterone acetate 202379 2017-08-23
ZYTIGA TABLET;ORAL abiraterone acetate 202379 2015-04-28

US Patents and Regulatory Information for ZYTIGA

ZYTIGA is protected by zero US patents and one FDA Regulatory Exclusivity.

FDA Regulatory Exclusivity protecting ZYTIGA

ABIRATERONE ACETATE IN COMBINATION WITH PREDNISONE FOR THE TREATMENT OF PATIENTS WITH METASTATIC HIGH-RISK CASTRATION-SENSITIVE PROSTATE CANCER
Exclusivity Expiration: ⤷  Try it Free

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 ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Janssen Biotech ZYTIGA abiraterone acetate TABLET;ORAL 202379-002 Apr 14, 2017 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 ZYTIGA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0633893 1190040-4 Sweden ⤷  Try it Free PRODUCT NAME: ABIRATERON OCH SYRAADDITIONSSALTER OCH 3-ESTRAR DAERAV, SPECIELLT ABIRATERON-ACETAT; REG. NO/DATE: EU/1/11/714/001 20110905
0633893 CA 2011 00035 Denmark ⤷  Try it Free
0633893 11C0055 France ⤷  Try it Free 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 C00633893/01 Switzerland ⤷  Try it Free PRODUCT NAME: ABIRATERONI ACETAS; REGISTRATION NUMBER/DATE: SWISSMEDIC 62084 20.09.2011
0633893 2012/003 Ireland ⤷  Try it Free 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 C300508 Netherlands ⤷  Try it Free 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 91911 Luxembourg ⤷  Try it Free 91911, EXPIRES: 20180315
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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