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Serving 500+ biopharmaceutical companies globally:

Healthtrust
Teva
Julphar
Colorcon
Deloitte
Daiichi Sankyo
Novartis
Dow
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Express Scripts

Generated: June 22, 2017

DrugPatentWatch Database Preview

Abiraterone acetate - Generic Drug Details

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What are the generic drug sources for abiraterone acetate and what is the scope of abiraterone acetate patent protection?

Abiraterone acetate
is the generic ingredient in one branded drug marketed by Janssen Biotech and is included in one NDA. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Abiraterone acetate has sixty-five patent family members in twenty-six countries.

There are twenty-one drug master file entries for abiraterone acetate. One supplier is listed for this compound.

Summary for Generic Name: abiraterone acetate

Tradenames:1
Patents:3
Applicants:1
NDAs:1
Drug Master File Entries: see list21
Suppliers / Packagers: see list1
Bulk Api Vendors: see list48
Clinical Trials: see list951
Patent Applications: see list61
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:abiraterone acetate 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, 2011RXYesYes5,604,213► SubscribeYY ► Subscribe
Janssen Biotech
ZYTIGA
abiraterone acetate
TABLET;ORAL202379-001Apr 28, 2011RXYesYes8,822,438► Subscribe ► Subscribe
Janssen Biotech
ZYTIGA
abiraterone acetate
TABLET;ORAL202379-002Apr 14, 2017RXYesNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: abiraterone acetate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Biotech
ZYTIGA
abiraterone acetate
TABLET;ORAL202379-001Apr 28, 20115,604,213► Subscribe
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Non-Orange Book Patents for Generic Ingredient: abiraterone acetate

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 Ingredient: abiraterone acetate

Country Document Number Estimated Expiration
Germany69416419► Subscribe
Japan2742331► Subscribe
Hong Kong1002634► Subscribe
Israel197211► Subscribe
Australia2015221447► 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: ABIRATERONE ACETATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
911Luxembourg► Subscribe91911, EXPIRES: 20180315
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:
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
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
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Fuji
McKinsey
US Department of Justice
Covington
Novartis
Baxter
Julphar
Deloitte
AstraZeneca
Express Scripts

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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