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Serving 500+ biopharmaceutical companies globally:

Fuji
McKinsey
US Department of Justice
Dow
Colorcon
US Army
Accenture
Baxter
AstraZeneca
Chubb

Generated: August 17, 2017

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XTANDI Drug Profile

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What is the patent landscape for Xtandi, 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 ninety-five patent family members in twenty-five 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.

Summary for Tradename: XTANDI

Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list68
Clinical Trials: see list89
Patent Applications: see list78
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:XTANDI at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astellas
XTANDI
enzalutamide
CAPSULE;ORAL203415-001Aug 31, 2012RXYesYes► Subscribe► SubscribeYY ► Subscribe
Astellas
XTANDI
enzalutamide
CAPSULE;ORAL203415-001Aug 31, 2012RXYesYes► Subscribe► Subscribe ► Subscribe
Astellas
XTANDI
enzalutamide
CAPSULE;ORAL203415-001Aug 31, 2012RXYesYes► Subscribe► Subscribe ► Subscribe
Astellas
XTANDI
enzalutamide
CAPSULE;ORAL203415-001Aug 31, 2012RXYesYes► Subscribe► Subscribe► Subscribe
Astellas
XTANDI
enzalutamide
CAPSULE;ORAL203415-001Aug 31, 2012RXYesYes► Subscribe► Subscribe► Subscribe
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Paragraph IV activity 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
Canada2648139► Subscribe
Norway2017019► Subscribe
Cyprus1116426► Subscribe
South Korea20150008506► Subscribe
South Korea20120102140► 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
9 50005-2013Slovakia► SubscribePRODUCT NAME: ENZALUTAMID; REGISTRATION NO/DATE: EU/1/13/846 20130621
00632Netherlands► SubscribePRODUCT NAME: ENZALUTAMIDE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/13/846 20130621
2013029Lithuania► SubscribePRODUCT NAME: ENZALUTAMIDUM; REGISTRATION NO/DATE: EU/1/13/846 20130621
2013000155Germany► SubscribePRODUCT NAME: ENZALUTAMID ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ HIERVON; REGISTRATION NO/DATE: EU/1/13/846 20130621
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Julphar
Queensland Health
Citi
Cipla
AstraZeneca
Healthtrust
Baxter
Cerilliant
Fish and Richardson
Mallinckrodt

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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