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ZYTIGA Drug Profile

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Zytiga is a drug marketed by Janssen Biotech and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-one patent family members in twenty-five countries.

The generic ingredient in ZYTIGA is abiraterone acetate. There are nineteen 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

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Drug Prices: :see details

Clinical Trials for: ZYTIGA

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Biotech
ZYTIGA
abiraterone acetate
TABLET;ORAL202379-001Apr 28, 2011RXYes5,604,213Dec 13, 2016YY
Janssen Biotech
ZYTIGA
abiraterone acetate
TABLET;ORAL202379-001Apr 28, 2011RXYes8,822,438Aug 24, 2027
Janssen Biotech
ZYTIGA
abiraterone acetate
TABLET;ORAL202379-001Apr 28, 2011RXYesApr 28, 2016
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Paragraph IV activity for: ZYTIGA

Drugname Dosage Strength RLD Submissiondate
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<disabled in preview>
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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
Australia3758493<disabled in preview>
World Intellectual Property Organization (WIPO)2008024484<disabled in preview>
European Patent Office0633893<disabled in preview>
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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
12/003Ireland<disabled>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
00508Netherlands<disabled>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:
0633893/01Switzerland<disabled>PRODUCT NAME: ABIRATERONI ACETAS; REGISTRATION NUMBER/DATE: SWISSMEDIC 62084 20.09.2011
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