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Last Updated: October 4, 2024

ENZALUTAMIDE - Generic Drug Details


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What are the generic drug sources for enzalutamide and what is the scope of freedom to operate?

Enzalutamide is the generic ingredient in two branded drugs marketed by Actavis Labs Fl Inc, Apotex, and Astellas, and is included in four 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 is one tentative approval for this compound.

Summary for ENZALUTAMIDE
Recent Clinical Trials for ENZALUTAMIDE

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

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

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 CAPSULE;ORAL 203415-001 Aug 31, 2012 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Apotex ENZALUTAMIDE enzalutamide CAPSULE;ORAL 209645-001 Apr 22, 2022 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 ⤷  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

Supplementary Protection Certificates for ENZALUTAMIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1893196 PA2013029 Lithuania ⤷  Sign Up PRODUCT NAME: ENZALUTAMIDUM; REGISTRATION NO/DATE: EU/1/13/846 20130621
1893196 CA 2013 00065 Denmark ⤷  Sign Up PRODUCT NAME: ENZALUTAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/846 20130625
1893196 PA2013029,C1893196 Lithuania ⤷  Sign Up PRODUCT NAME: ENZALUTAMIDUM; REGISTRATION NO/DATE: EU/1/13/846 20130625
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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