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Serving leading biopharmaceutical companies globally:

Dow
US Department of Justice
Novartis
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Daiichi Sankyo
QuintilesIMS
Deloitte
Covington

Generated: November 18, 2017

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Enzalutamide - Generic Drug Details

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What are the generic sources for enzalutamide and what is the scope of enzalutamide freedom to operate?

Enzalutamide
is the generic ingredient in one branded drug marketed by Astellas 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.

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

There are nine drug master file entries for enzalutamide. One supplier is listed for this compound.
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► Subscribe ► Subscribe
Astellas
XTANDI
enzalutamide
CAPSULE;ORAL203415-001Aug 31, 2012RXYesYes► Subscribe► Subscribe► Subscribe
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
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Non-Orange Book Patents for Generic Ingredient: enzalutamide

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 Ingredient: enzalutamide

Country Document Number Estimated Expiration
Australia2006248109► Subscribe
Japan2017031224► Subscribe
Norway341071► Subscribe
South Korea101332889► Subscribe
Denmark1893196► Subscribe
Singapore10201408699T► Subscribe
South Korea20120102140► Subscribe
Japan2015098497► Subscribe
New Zealand710355► Subscribe
CroatiaP20150437► 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: ENZALUTAMIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
2013029Lithuania► SubscribePRODUCT NAME: ENZALUTAMIDUM; REGISTRATION NO/DATE: EU/1/13/846 20130621
338Luxembourg► SubscribePRODUCT NAME: ENZALUTAMIDE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES (XTANDI); FIRST REGISTRATION DATE: 20130625
2013029,C1893196Lithuania► SubscribePRODUCT NAME: ENZALUTAMIDUM; REGISTRATION NO/DATE: EU/1/13/846 20130625
1893196/01Switzerland► SubscribePRODUCT NAME: ENZALUTAMID; REGISTRATION NO/DATE: SWISSMEDIC 63040 03.12.2013
90060-0Sweden► SubscribePRODUCT NAME: ENZALUTAMID OCH FARMACEUTISKT ACCEPTABLA SALTER DAERAV; REG. NO/DATE: EU/1/13/846 20130621
0130036 00106Estonia► SubscribePRODUCT NAME: ENSALUTAMIID;REG NO/DATE: K(2013)4019 (LOPLIK) 25.06.2013
00632Netherlands► SubscribePRODUCT NAME: ENZALUTAMIDE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/13/846 20130621
2013 00065Denmark► SubscribePRODUCT NAME: ENZALUTAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/846 20130625
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Serving leading biopharmaceutical companies globally:

Citi
Julphar
Fuji
Merck
Deloitte
McKinsey
US Army
Farmers Insurance
Fish and Richardson
QuintilesIMS

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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