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Serving leading biopharmaceutical companies globally:

Express Scripts
US Army
Chubb
Boehringer Ingelheim
Daiichi Sankyo
Dow
Baxter
Queensland Health
Citi
Harvard Business School

Generated: December 17, 2017

DrugPatentWatch Database Preview

XTANDI Drug Profile

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When do Xtandi patents expire, and when can generic versions of Xtandi launch?

Xtandi is a drug marketed by Astellas and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and six patent family members in twenty-five countries and fourteen supplementary protection certificates in twelve countries.

The generic ingredient in XTANDI is enzalutamide. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the enzalutamide profile page.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
AstellasXTANDIenzalutamideCAPSULE;ORAL203415-001Aug 31, 2012RXYesYes► Subscribe► SubscribeYY► Subscribe
AstellasXTANDIenzalutamideCAPSULE;ORAL203415-001Aug 31, 2012RXYesYes► Subscribe► Subscribe► Subscribe
AstellasXTANDIenzalutamideCAPSULE;ORAL203415-001Aug 31, 2012RXYesYes► Subscribe► Subscribe► Subscribe
AstellasXTANDIenzalutamideCAPSULE;ORAL203415-001Aug 31, 2012RXYesYes► Subscribe► Subscribe► Subscribe
AstellasXTANDIenzalutamideCAPSULE;ORAL203415-001Aug 31, 2012RXYesYes► Subscribe► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for XTANDI

Drugname Dosage Strength RLD Submissiondate
enzalutamideCapsules40 mgXtandi8/31/2016

Non-Orange Book Patents for Tradename: XTANDI

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
8,110,594Diarylthiohydantoin compounds► Subscribe
8,648,105Diarylthiohydantoin compounds► 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: XTANDI

Country Document Number Estimated Expiration
Russian Federation2007146462► Subscribe
Japan2008540523► Subscribe
Japan2012236843► Subscribe
Mexico2008012492► Subscribe
New Zealand591119► Subscribe
Norway20076401► Subscribe
South Korea20150008506► Subscribe
Luxembourg92338► Subscribe
Hong Kong1124612► Subscribe
European Patent Office3020706► 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: XTANDI

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2013029,C1893196Lithuania► SubscribePRODUCT NAME: ENZALUTAMIDUM; REGISTRATION NO/DATE: EU/1/13/846 20130625
2013 00065Denmark► SubscribePRODUCT NAME: ENZALUTAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/846 20130625
9 50005-2013Slovakia► SubscribePRODUCT NAME: ENZALUTAMID; REGISTRATION NO/DATE: EU/1/13/846 20130621
338Luxembourg► SubscribePRODUCT NAME: ENZALUTAMIDE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES (XTANDI); FIRST REGISTRATION DATE: 20130625
0130036 00106Estonia► SubscribePRODUCT NAME: ENSALUTAMIID;REG NO/DATE: K(2013)4019 (LOPLIK) 25.06.2013
2013 00065Denmark► SubscribePRODUCT NAME: ENZALUTAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/846 20130625
90060-0Sweden► SubscribePRODUCT NAME: ENZALUTAMID OCH FARMACEUTISKT ACCEPTABLA SALTER DAERAV; REG. NO/DATE: EU/1/13/846 20130621
1893196/01Switzerland► SubscribePRODUCT NAME: ENZALUTAMID; REGISTRATION NO/DATE: SWISSMEDIC 63040 03.12.2013
13/061Ireland► SubscribePRODUCT NAME: ENZALUTAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/846 20130625
1Finland► Subscribe
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Serving leading biopharmaceutical companies globally:

Citi
Queensland Health
Federal Trade Commission
Harvard Business School
Chinese Patent Office
Novartis
Johnson and Johnson
Mallinckrodt
Colorcon
Deloitte

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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