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Serving leading biopharmaceutical companies globally:

Moodys
Teva
UBS
Cipla
Farmers Insurance
Chubb
Baxter
Chinese Patent Office
Johnson and Johnson
Cantor Fitzgerald

Generated: December 17, 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 two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Abiraterone acetate has seventy patent family members in twenty-six countries and eight supplementary protection certificates in eight countries.

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

Medical Subject Heading (MeSH) Categories for abiraterone acetate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen BiotechZYTIGAabiraterone acetateTABLET;ORAL202379-002Apr 14, 2017RXYesNo► Subscribe► Subscribe► Subscribe
Janssen BiotechZYTIGAabiraterone acetateTABLET;ORAL202379-001Apr 28, 2011RXYesYes► Subscribe► Subscribe► Subscribe
Janssen BiotechZYTIGAabiraterone acetateTABLET;ORAL202379-001Apr 28, 2011RXYesYes► Subscribe► SubscribeYY► 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 BiotechZYTIGAabiraterone acetateTABLET;ORAL202379-001Apr 28, 2011► Subscribe► 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
World Intellectual Property Organization (WIPO)9509178► Subscribe
New Zealand597830► Subscribe
New Zealand273367► Subscribe
Australia2007287098► Subscribe
United Kingdom9224880► Subscribe
World Intellectual Property Organization (WIPO)9320097► Subscribe
Cyprus1115477► Subscribe
Israel197211► Subscribe
Israel227746► Subscribe
European Patent Office2061561► 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
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
0633893/01Switzerland► SubscribePRODUCT NAME: ABIRATERONI ACETAS; REGISTRATION NUMBER/DATE: SWISSMEDIC 62084 20.09.2011
2011 00035Denmark► Subscribe
90040-4Sweden► SubscribePRODUCT NAME: ABIRATERON OCH SYRAADDITIONSSALTER OCH 3-ESTRAR DAERAV, SPECIELLT ABIRATERON-ACETAT; REG. 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:
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
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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Harvard Business School
McKinsey
Express Scripts
Merck
Queensland Health
Healthtrust
Moodys
US Department of Justice
Chinese Patent Office

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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