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Last Updated: January 18, 2021

DrugPatentWatch Database Preview

ZYTIGA Drug 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. There is one patent protecting this drug and two Paragraph IV challenges.

This drug has thirty-eight patent family members in nineteen countries.

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

US ANDA Litigation and Generic Entry Outlook for Zytiga

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

  Start Trial

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
CelgenePhase 1
Myovant Sciences GmbHPhase 1
BayerPhase 4

See all ZYTIGA clinical trials

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

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   Start Trial   Start Trial   Start Trial
Janssen Biotech ZYTIGA abiraterone acetate TABLET;ORAL 202379-002 Apr 14, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Janssen Biotech ZYTIGA abiraterone acetate TABLET;ORAL 202379-002 Apr 14, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
>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 91911 Luxembourg   Start Trial 91911, EXPIRES: 20180315
0633893 1190040-4 Sweden   Start Trial PRODUCT NAME: ABIRATERON OCH SYRAADDITIONSSALTER OCH 3-ESTRAR DAERAV, SPECIELLT ABIRATERON-ACETAT; REG. NO/DATE: EU/1/11/714/001 20110905
0633893 C300508 Netherlands   Start Trial 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 2012/003 Ireland   Start 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Harvard Business School
Dow
Express Scripts
Colorcon
Moodys

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