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Last Updated: June 10, 2023

Apalutamide - Generic Drug Details


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What are the generic sources for apalutamide and what is the scope of patent protection?

Apalutamide is the generic ingredient in one branded drug marketed by Janssen Biotech and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Apalutamide has two hundred and fifty-seven patent family members in forty-four countries.

One supplier is listed for this compound.

Summary for apalutamide
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for apalutamide
Generic Entry Date for apalutamide*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for apalutamide

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

SponsorPhase
Merck Sharp & Dohme LLCPhase 2
Prostate Cancer FoundationPhase 2
University of CincinnatiPhase 2

See all apalutamide clinical trials

Paragraph IV (Patent) Challenges for APALUTAMIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ERLEADA Tablets apalutamide 60 mg 210951 5 2022-02-14

US Patents and Regulatory Information for apalutamide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Biotech ERLEADA apalutamide TABLET;ORAL 210951-001 Feb 14, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Janssen Biotech ERLEADA apalutamide TABLET;ORAL 210951-001 Feb 14, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Janssen Biotech ERLEADA apalutamide TABLET;ORAL 210951-001 Feb 14, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Janssen Biotech ERLEADA apalutamide TABLET;ORAL 210951-001 Feb 14, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Janssen Biotech ERLEADA apalutamide TABLET;ORAL 210951-001 Feb 14, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Janssen Biotech ERLEADA apalutamide TABLET;ORAL 210951-001 Feb 14, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 apalutamide

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Janssen-Cilag International NV Erleada apalutamide EMEA/H/C/004452
Erleada is indicated:in adult men for the treatment of non metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease.in adult men for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT).
Authorised no no no 2019-01-14
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for apalutamide

Country Patent Number Title Estimated Expiration
Japan 2020536965 非転移性去勢抵抗性前立腺癌の治療のための抗アンドロゲン剤 ⤷  Try a Trial
Philippines 12018502569 ANTI-ANDROGENS FOR THE TREATMENT OF NON-METASTATIC CASTRATE-RESISTANT PROSTATE CANCER ⤷  Try a Trial
Poland 2656842 ⤷  Try a Trial
Japan 7257692 ⤷  Try a Trial
Canada 3079135 ANTI-ANDROGENES DESTINES AU TRAITEMENT DU CANCER DE LA PROSTATE RESISTANT A LA CASTRATION, NON METASTATIQUE (ANTI-ANDROGENS FOR THE TREATMENT OF NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER) ⤷  Try a Trial
Croatia P20201387 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for apalutamide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2368550 1990032-3 Sweden ⤷  Try a Trial PRODUCT NAME: APALUTAMIDE; REG. NO/DATE: EU/1/1342 20190116
3533792 CA 2021 00041 Denmark ⤷  Try a Trial PRODUCT NAME: APALUTAMID; REG. NO/DATE: EU/1/18/1342 20190116
2368550 2019/032 Ireland ⤷  Try a Trial PRODUCT NAME: APALUTAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/18/1342 20190114
2368550 2019C/529 Belgium ⤷  Try a Trial PRODUCT NAME: APALUTAMIDE OU UN SEL PHARMACOLOGIQUEMENT ADMISSIBLE DE CELLES-CI; AUTHORISATION NUMBER AND DATE: EU/1/18/1342 20190116
3533792 C202130058 Spain ⤷  Try a Trial PRODUCT NAME: APALUTAMIDA; NATIONAL AUTHORISATION NUMBER: EU/1/18/1342; DATE OF AUTHORISATION: 20190114; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1342; DATE OF FIRST AUTHORISATION IN EEA: 20190114
3533792 301144 Netherlands ⤷  Try a Trial PRODUCT NAME: APALUTAMIDE; REGISTRATION NO/DATE: EU/1/18/1342 20190116
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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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.