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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Novartis
Covington
Fish and Richardson
Fuji
Mallinckrodt
Farmers Insurance
Cipla
Chinese Patent Office
Julphar

Generated: January 17, 2018

DrugPatentWatch Database Preview

ZYTIGA Drug Profile

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Which patents cover Zytiga, and when can generic versions of Zytiga launch?

Zytiga is a drug marketed by Janssen Biotech and is included in one NDA. There are two patents protecting this drug and two Paragraph IV challenges.

This drug has seventy patent family members in twenty-six countries.

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

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

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Paragraph IV (Patent) Challenges for ZYTIGA
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 500 mg ➤ Subscribe 8/23/2017
➤ Subscribe Tablets 250 mg ➤ Subscribe 4/28/2015

Non-Orange Book US Patents for ZYTIGA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,618,807 Method for preparing 17-substituted steroids useful in cancer treatment ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for ZYTIGA

Supplementary Protection Certificates for ZYTIGA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00508 Netherlands ➤ Subscribe 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:
C/GB11/063 United Kingdom ➤ Subscribe PRODUCT NAME: ABIRATERONE AND ACID ADDITION SALTS AND 3-ESTERS THEREOF ESPECIALLY ABIRATERONE ACETATE; REGISTERED: UK EU/1/11/714/001 20110905
90040-4 Sweden ➤ Subscribe PRODUCT NAME: ABIRATERON OCH SYRAADDITIONSSALTER OCH 3-ESTRAR DAERAV, SPECIELLT ABIRATERON-ACETAT; REG. NO/DATE: EU/1/11/714/001 20110905
2011 00035 Denmark ➤ Subscribe
12/003 Ireland ➤ Subscribe 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
0633893/01 Switzerland ➤ Subscribe PRODUCT NAME: ABIRATERONI ACETAS; REGISTRATION NUMBER/DATE: SWISSMEDIC 62084 20.09.2011
C0055 France ➤ Subscribe 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
911 Luxembourg ➤ Subscribe 91911, EXPIRES: 20180315
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Queensland Health
US Department of Justice
Merck
Johnson and Johnson
Baxter
Dow
Covington
Accenture
US Army

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 verifification 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.

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