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Last Updated: May 17, 2022

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 two branded drugs marketed by Actavis Labs Fl Inc and Astellas, and is included in three 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 thirty-three 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
Nuvation Bio Inc.Phase 1/Phase 2
Fudan UniversityPhase 2
Curium US LLCPhase 3

See all enzalutamide clinical trials

Paragraph IV (Patent) Challenges for ENZALUTAMIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
XTANDI Tablets enzalutamide 40 mg and 80 mg 213674 1 2021-03-31
XTANDI Capsules enzalutamide 40 mg 203415 3 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 See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Astellas XTANDI enzalutamide CAPSULE;ORAL 203415-001 Aug 31, 2012 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Astellas XTANDI enzalutamide TABLET;ORAL 213674-001 Aug 4, 2020 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Actavis Labs Fl Inc ENZALUTAMIDE enzalutamide CAPSULE;ORAL 209614-001 May 14, 2021 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for enzalutamide

Country Patent Number Title Estimated Expiration
Luxembourg 92338 See Plans and Pricing
Serbia 52274 JEDINJENJE DIARILHIDANTOINA (DIARZLHZDANTOIN COMPOUND) See Plans and Pricing
Japan 2017031224 ジアリールチオヒダントイン化合物 (DIARYLTHIOHYDANTOIN COMPOUNDS) See Plans and Pricing
Hong Kong 1177691 二芳基硫代乙內酰脲化合物 (DIARYLTHIOHYDANTOIN COMPOUNDS) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for enzalutamide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1893196 PA2013029,C1893196 Lithuania See Plans and Pricing PRODUCT NAME: ENZALUTAMIDUM; REGISTRATION NO/DATE: EU/1/13/846 20130625
1893196 92338 Luxembourg See Plans and Pricing PRODUCT NAME: ENZALUTAMIDE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES (XTANDI); FIRST REGISTRATION DATE: 20130625
1893196 PA2013029 Lithuania See Plans and Pricing PRODUCT NAME: ENZALUTAMIDUM; REGISTRATION NO/DATE: EU/1/13/846 20130621
1893196 70/2013 Austria See Plans and Pricing 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:

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