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Last Updated: January 25, 2021

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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 two NDAs. 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-eight 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
Novartis PharmaceuticalsPhase 3
POINT BiopharmaPhase 3
AmgenPhase 1

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 TABLET;ORAL 213674-001 Aug 4, 2020 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Astellas XTANDI enzalutamide TABLET;ORAL 213674-002 Aug 4, 2020 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 TABLET;ORAL 213674-001 Aug 4, 2020 RX Yes No   Start Trial   Start Trial   Start Trial
Astellas XTANDI enzalutamide TABLET;ORAL 213674-001 Aug 4, 2020 RX Yes No   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 C20130036 00106 Estonia   Start Trial PRODUCT NAME: ENSALUTAMIID;REG NO/DATE: K(2013)4019 (LOPLIK) 25.06.2013
1893196 CR 2013 00065 Denmark   Start Trial PRODUCT NAME: ENZALUTAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/846 20130625
1893196 C300632 Netherlands   Start Trial PRODUCT NAME: ENZALUTAMIDE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/13/846 20130621
1893196 13C0071 France   Start Trial PRODUCT NAME: ENZALUTAMIDE OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/846 20130625
1893196 70/2013 Austria   Start Trial PRODUCT NAME: ENZALUTAMID; REGISTRATION NO/DATE: EU/1/13/836 20130621
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Medtronic
Colorcon
Johnson and Johnson
Express Scripts
Boehringer Ingelheim

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