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Last Updated: August 3, 2020

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Enzalutamide - Generic Drug Details

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What are the generic drug sources for enzalutamide and what is the scope of patent protection?

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 twenty-five patent family members in twenty-eight countries.

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

Recent Clinical Trials for enzalutamide

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Hospital Sirio-LibanesPhase 2
Jiangxi Qingfeng Pharmaceutical Co. Ltd.Phase 1/Phase 2
Zenith EpigeneticsPhase 2

See all enzalutamide clinical trials

Paragraph IV (Patent) Challenges for ENZALUTAMIDE
Tradename Dosage Ingredient NDA Submissiondate
XTANDI CAPSULE;ORAL enzalutamide 203415 2016-08-31

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

Supplementary Protection Certificates for enzalutamide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1893196 2013C/074 Belgium   Start Trial PRODUCT NAME: ENZALUTAMIDE (ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/13/846 20130625
1893196 491 Finland   Start Trial
1893196 SPC/GB13/079 United Kingdom   Start Trial PRODUCT NAME: ENZLUTAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/13/846 20130625
1893196 PA2013029,C1893196 Lithuania   Start Trial PRODUCT NAME: ENZALUTAMIDUM; REGISTRATION NO/DATE: EU/1/13/846 20130625
1893196 2013/061 Ireland   Start Trial PRODUCT NAME: ENZALUTAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/846 20130625
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Harvard Business School
Moodys
Medtronic
Johnson and Johnson
Merck

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