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Serving leading biopharmaceutical companies globally:

Novartis
Cantor Fitzgerald
Citi
Healthtrust
Mallinckrodt
Merck
Queensland Health
US Department of Justice
US Army
UBS

Generated: October 23, 2017

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 and eight supplementary protection certificates in eight 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.

Summary for Tradename: ZYTIGA

US Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list48
Clinical Trials: see list63
Patent Applications: see list49
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:ZYTIGA at DailyMed
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;ORAL202379-001Apr 28, 2011RXYesYes► Subscribe► SubscribeYY ► Subscribe
Janssen Biotech
ZYTIGA
abiraterone acetate
TABLET;ORAL202379-001Apr 28, 2011RXYesYes► Subscribe► Subscribe ► Subscribe
Janssen Biotech
ZYTIGA
abiraterone acetate
TABLET;ORAL202379-002Apr 14, 2017RXYesNo► Subscribe► Subscribe ► Subscribe
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Expired Patents for Tradename: ZYTIGA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Biotech
ZYTIGA
abiraterone acetate
TABLET;ORAL202379-001Apr 28, 2011► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for ZYTIGA

Drugname Dosage Strength RLD Submissiondate
abiraterone acetateTablets500 mgZytiga8/23/2017
abiraterone acetateTablets250 mgZytiga4/28/2015

Non-Orange Book Patents for Tradename: 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
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: ZYTIGA

Country Document Number Estimated Expiration
Greece3029601► Subscribe
European Patent Office0721461► Subscribe
Spain2138618► Subscribe
Canada2132449► Subscribe
New Zealand597830► Subscribe
Australia3758493► Subscribe
Hong Kong1131577► Subscribe
Japan2012082215► Subscribe
CroatiaP20130961► Subscribe
Hong Kong1002634► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: ZYTIGA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB11/063United Kingdom► SubscribePRODUCT NAME: ABIRATERONE AND ACID ADDITION SALTS AND 3-ESTERS THEREOF ESPECIALLY ABIRATERONE ACETATE; REGISTERED: UK EU/1/11/714/001 20110905
911Luxembourg► Subscribe91911, EXPIRES: 20180315
12/003Ireland► SubscribePRODUCT NAME: ZYTIGA (ABIRATERONE) "ABIRATERONE AND ACID ADDITION SALTS AND 3-ESTERS THEREOF, ESPECIALLY ABIRATERONE ACETATE"; REGISTRATION NO/DATE: EU/1/11/714/001 20110905
0633893/01Switzerland► SubscribePRODUCT NAME: ABIRATERONI ACETAS; REGISTRATION NUMBER/DATE: SWISSMEDIC 62084 20.09.2011
90040-4Sweden► SubscribePRODUCT NAME: ABIRATERON OCH SYRAADDITIONSSALTER OCH 3-ESTRAR DAERAV, SPECIELLT ABIRATERON-ACETAT; REG. NO/DATE: EU/1/11/714/001 20110905
2011 00035Denmark► Subscribe
C0055France► SubscribePRODUCT 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
00508Netherlands► SubscribePRODUCT NAME: ABIRATERON ALSMEDE ZUURADDITIEZOUTEN EN 3-ESTERS ERVAN, IN HET BIJZONDER ABIRATERONACETAAT; NAT. REGISTRATION NO/DATE: EU/1/11/714/001 20110905; FIRST REGISTRATION:
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Healthtrust
McKinsey
Harvard Business School
QuintilesIMS
UBS
Mallinckrodt
Express Scripts
Accenture
Julphar

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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