Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

Baxter
AstraZeneca
Medtronic
Mallinckrodt
Boehringer Ingelheim
Moodys

Last Updated: November 30, 2022

Enzalutamide - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


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, and Astellas, and is included in four 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-four patent family members in twenty-eight 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.

Recent Clinical Trials for enzalutamide

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

SponsorPhase
MacroGenicsPhase 2/Phase 3
Anticancer Fund, BelgiumPhase 2
dr. Tom van der HullePhase 2

See all enzalutamide clinical trials

Generic filers with tentative approvals for ENZALUTAMIDE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing80MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing40MGTABLET;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 213674-001 Aug 4, 2020 RX Yes No 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
Apotex ENZALUTAMIDE enzalutamide CAPSULE;ORAL 209645-001 Apr 22, 2022 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Astellas XTANDI enzalutamide CAPSULE;ORAL 203415-001 Aug 31, 2012 AB RX Yes Yes 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

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 491 Finland See Plans and Pricing
1893196 2013C/074 Belgium See Plans and Pricing PRODUCT NAME: ENZALUTAMIDE (ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/13/846 20130625
1893196 169 50005-2013 Slovakia See Plans and Pricing PRODUCT NAME: ENZALUTAMID; REGISTRATION NO/DATE: EU/1/13/846 20130621
1893196 CA 2013 00065 Denmark See Plans and Pricing PRODUCT NAME: ENZALUTAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/846 20130625
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Medtronic
Colorcon
Johnson and Johnson
Express Scripts
Boehringer Ingelheim

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.