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Last Updated: December 10, 2024

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, Apotex, Zydus Pharms, and Astellas, and is included in five NDAs. There are four 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 eighty-four patent family members in thirty-four countries.

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

Summary for enzalutamide
Recent Clinical Trials for enzalutamide

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

SponsorPhase
University of OklahomaPhase 1
Orion Corporation, Orion PharmaPhase 3
Merck Sharp & Dohme LLCPhase 3

See all enzalutamide clinical trials

Generic filers with tentative approvals for ENZALUTAMIDE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up80MGTABLET;ORAL
⤷  Sign Up⤷  Sign Up40MGTABLET;ORAL
⤷  Sign Up⤷  Sign Up80MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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 TABLET;ORAL 213674-002 Aug 4, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Astellas XTANDI enzalutamide TABLET;ORAL 213674-001 Aug 4, 2020 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Astellas XTANDI enzalutamide TABLET;ORAL 213674-002 Aug 4, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Actavis Labs Fl Inc ENZALUTAMIDE enzalutamide CAPSULE;ORAL 209614-001 May 14, 2021 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Astellas XTANDI enzalutamide TABLET;ORAL 213674-002 Aug 4, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Astellas XTANDI enzalutamide CAPSULE;ORAL 203415-001 Aug 31, 2012 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for enzalutamide

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Astellas Pharma Europe B.V. Xtandi enzalutamide EMEA/H/C/002639
Xtandi is indicated for:the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (see section 5.1).the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1).the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1).the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.
Authorised no no no 2013-06-21 2013-04-26
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for enzalutamide

Country Patent Number Title Estimated Expiration
European Patent Office 3971167 FORMULATIONS D'ENZALUTAMIDE (FORMULATIONS OF ENZALUTAMIDE) ⤷  Sign Up
Israel 258880 תרכובות של דיארילהידנתוין (Diarylhydantoin compounds) ⤷  Sign Up
Mexico 2022009759 EL USO DE 1-(4-CIANO-3-TRIFLUOROMETIL-FENIL)-3-[7-(4-CIANO-3-TRIFL UOROMETIL-FENIL)-6-TIOXO-5-P-TOLILO-5,7-DIAZAESPIRO[3.4]OCT-8-ILI DENO]-TIOUREA. (DIARYLHYDANTOIN COMPOUNDS.) ⤷  Sign Up
South Africa 200710870 DIARYLHYDANTOIN COMPOUNDS ⤷  Sign Up
South Korea 101579701 ⤷  Sign Up
Mexico 2007014132 COMPUESTOS DE DIARILHIDANTOINA. (DIARYLHYDANTOIN COMPOUNDS.) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for enzalutamide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1893196 C 2013 041 Romania ⤷  Sign Up PRODUCT NAME: ENZALUTAMIDA SAU O SARE ACCEPTABILA FARMACEUTIC AACESTEIA; NATIONAL AUTHORISATION NUMBER: EU/1/13/846; DATE OF NATIONAL AUTHORISATION: 20130621; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/846; DATE OF FIRST AUTHORISATION IN EEA: 20130621
1893196 C300632 Netherlands ⤷  Sign Up PRODUCT NAME: ENZALUTAMIDE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/13/846 20130621
1893196 2013/061 Ireland ⤷  Sign Up PRODUCT NAME: ENZALUTAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/846 20130625
1893196 SPC/GB13/079 United Kingdom ⤷  Sign Up PRODUCT NAME: ENZLUTAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/13/846 20130625
1893196 122013000155 Germany ⤷  Sign Up PRODUCT NAME: ENZALUTAMID ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ HIERVON; REGISTRATION NO/DATE: EU/1/13/846 20130621
1893196 70/2013 Austria ⤷  Sign Up 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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