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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Farmers Insurance
Harvard Business School
Baxter
Cantor Fitzgerald
Deloitte
Fuji
AstraZeneca
Teva
Chubb

Generated: January 16, 2018

DrugPatentWatch Database Preview

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 seven patent family members in twenty-five countries.

There are nine drug master file entries for enzalutamide. One supplier is listed for this compound.
Summary for enzalutamide

US Patents and Regulatory Information for enzalutamide

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;ORAL 203415-001 Aug 31, 2012 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Astellas XTANDI enzalutamide CAPSULE;ORAL 203415-001 Aug 31, 2012 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Astellas XTANDI enzalutamide CAPSULE;ORAL 203415-001 Aug 31, 2012 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Astellas XTANDI enzalutamide CAPSULE;ORAL 203415-001 Aug 31, 2012 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Astellas XTANDI enzalutamide CAPSULE;ORAL 203415-001 Aug 31, 2012 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for 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
8,110,594 Diarylthiohydantoin compounds ➤ Subscribe
8,648,105 Diarylthiohydantoin compounds ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for enzalutamide

Supplementary Protection Certificates for enzalutamide

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
338 Luxembourg ➤ Subscribe PRODUCT NAME: ENZALUTAMIDE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES (XTANDI); FIRST REGISTRATION DATE: 20130625
2013029,C1893196 Lithuania ➤ Subscribe PRODUCT NAME: ENZALUTAMIDUM; REGISTRATION NO/DATE: EU/1/13/846 20130625
2013029 Lithuania ➤ Subscribe PRODUCT NAME: ENZALUTAMIDUM; REGISTRATION NO/DATE: EU/1/13/846 20130621
2013 00065 Denmark ➤ Subscribe PRODUCT NAME: ENZALUTAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/846 20130625
0130036 00106 Estonia ➤ Subscribe PRODUCT NAME: ENSALUTAMIID;REG NO/DATE: K(2013)4019 (LOPLIK) 25.06.2013
2013 00065 Denmark ➤ Subscribe PRODUCT NAME: ENZALUTAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/846 20130625
9 50005-2013 Slovakia ➤ Subscribe PRODUCT NAME: ENZALUTAMID; REGISTRATION NO/DATE: EU/1/13/846 20130621
2013000155 Germany ➤ Subscribe PRODUCT NAME: ENZALUTAMID ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ HIERVON; REGISTRATION NO/DATE: EU/1/13/846 20130621
90060-0 Sweden ➤ Subscribe PRODUCT NAME: ENZALUTAMID OCH FARMACEUTISKT ACCEPTABLA SALTER DAERAV; REG. NO/DATE: EU/1/13/846 20130621
C0071 France ➤ Subscribe PRODUCT NAME: ENZALUTAMIDE OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/846 20130625
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Express Scripts
Deloitte
QuintilesIMS
Colorcon
Boehringer Ingelheim
UBS
Argus Health
US Army
Fish and Richardson

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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