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Last Updated: March 28, 2024

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ERLEADA Drug Patent Profile


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When do Erleada patents expire, and when can generic versions of Erleada launch?

Erleada is a drug marketed by Janssen Biotech and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and sixty-four patent family members in forty-six countries.

The generic ingredient in ERLEADA is apalutamide. One supplier is listed for this compound. Additional details are available on the apalutamide profile page.

DrugPatentWatch® Generic Entry Outlook for Erleada

Erleada was eligible for patent challenges on February 14, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 4, 2033. This may change due to patent challenges or generic licensing.

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for ERLEADA
Drug Prices for ERLEADA

See drug prices for ERLEADA

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ERLEADA
Generic Entry Date for ERLEADA*:
Constraining patent/regulatory exclusivity:
NDA:
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 ERLEADA

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

SponsorPhase
National Cancer Institute (NCI)Phase 1
University of CambridgePhase 3
Janssen-Cilag Ltd.Phase 3

See all ERLEADA clinical trials

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

US Patents and Regulatory Information for ERLEADA

ERLEADA is protected by fourteen US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ERLEADA is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting ERLEADA

Anti-androgens for the treatment of non-metastatic castrate-resistant prostate cancer
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT IN COMBINATION WITH A GNRH AGONIST OF NON-METASTATIC, CASTRATION-RESISTANT PROSTATE CANCER (NM-CRPC)

Anti-androgens for the treatment of non-metastatic castrate-resistant prostate cancer
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT IN COMBINATION WITH A GNRH AGONIST OF HIGH RISK NON-METASTATIC, CASTRATION-RESISTANT PROSTATE CANCER (NM-CRPC)

Anti-androgens for the treatment of non-metastatic castration-resistant prostate cancer
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT IN COMBINATION WITH ANDROGEN DEPRIVATION THERAPY OF NON-METASTATIC, CASTRATION-RESISTANT PROSTATE CANCER (NMCRPC) THAT IMPROVES METASTASIS FREE SURVIVAL

Anti-androgens for the treatment of non-metastatic castrate-resistant prostate cancer
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT IN COMBINATION WITH ORCHIECTOMY OF NON-METASTATIC, CASTRATION-RESISTANT PROSTATE CANCER (NMCRPC)

Androgen receptor modulator for the treatment of prostate cancer and androgen receptor-associated diseases
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (MCSPC)

Androgen receptor modulator for the treatment of prostate cancer and androgen receptor-associated diseases
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF NON-METASTATIC, CASTRATION-RESISTANT PROSTATE CANCER (NM-CRPC)

Androgen receptor modulator for the treatment of prostate cancer and androgen receptor-associated diseases
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF NON-METASTATIC, CASTRATION-RESISTANT PROSTATE CANCER (NM-CRPC)

Androgen receptor modulator for the treatment of prostate cancer and androgen receptor-associated diseases
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (MCSPC)

Substituted diazaspiroalkanes as androgen receptor modulators
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Crystalline forms of an androgen receptor modulator
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (MCSPC)

Crystalline forms of an androgen receptor modulator
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF NON-METASTATIC, CASTRATION-RESISTANT PROSTATE CANCER (NM-CRPC)

Anti-androgens for the treatment of non-metastatic castrate-resistant prostate cancer
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF NON-METASTATIC, CASTRATION-RESISTANT PROSTATE CANCER (NM-CRPC)

Substituted diazaspiroalkanes as androgen receptor modulators
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT IN COMBINATION WITH A GNRH AGONIST OF NON-METASTATIC, CASTRATION-RESISTANT PROSTATE CANCER (NM-CRPC)

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 No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Janssen Biotech ERLEADA apalutamide TABLET;ORAL 210951-002 Feb 17, 2023 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Janssen Biotech ERLEADA apalutamide TABLET;ORAL 210951-002 Feb 17, 2023 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 No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Janssen Biotech ERLEADA apalutamide TABLET;ORAL 210951-002 Feb 17, 2023 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 ERLEADA

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 ERLEADA

When does loss-of-exclusivity occur for ERLEADA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 13271751
Estimated Expiration: ⤷  Try a Trial

Patent: 17200298
Estimated Expiration: ⤷  Try a Trial

Patent: 17279807
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2014030678
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 75767
Estimated Expiration: ⤷  Try a Trial

Patent: 08345
Estimated Expiration: ⤷  Try a Trial

Patent: 55660
Estimated Expiration: ⤷  Try a Trial

Patent: 14726
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 14003331
Estimated Expiration: ⤷  Try a Trial

China

Patent: 4619692
Estimated Expiration: ⤷  Try a Trial

Patent: 5693692
Estimated Expiration: ⤷  Try a Trial

Patent: 3135892
Estimated Expiration: ⤷  Try a Trial

Colombia

Patent: 40407
Estimated Expiration: ⤷  Try a Trial

Costa Rica

Patent: 140549
Estimated Expiration: ⤷  Try a Trial

Patent: 190331
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0180902
Estimated Expiration: ⤷  Try a Trial

Patent: 0201387
Estimated Expiration: ⤷  Try a Trial

Patent: 0210909
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 20393
Estimated Expiration: ⤷  Try a Trial

Patent: 23427
Estimated Expiration: ⤷  Try a Trial

Patent: 24831
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 58985
Estimated Expiration: ⤷  Try a Trial

Patent: 48553
Estimated Expiration: ⤷  Try a Trial

Patent: 33792
Estimated Expiration: ⤷  Try a Trial

Ecuador

Patent: 14030098
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 8791
Estimated Expiration: ⤷  Try a Trial

Patent: 3956
Estimated Expiration: ⤷  Try a Trial

Patent: 1492272
Estimated Expiration: ⤷  Try a Trial

Patent: 1791592
Estimated Expiration: ⤷  Try a Trial

Patent: 1992010
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 58985
Estimated Expiration: ⤷  Try a Trial

Patent: 48553
Estimated Expiration: ⤷  Try a Trial

Patent: 33792
Estimated Expiration: ⤷  Try a Trial

Patent: 22629
Estimated Expiration: ⤷  Try a Trial

France

Patent: C1050
Estimated Expiration: ⤷  Try a Trial

Guatemala

Patent: 1400283
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 10175
Estimated Expiration: ⤷  Try a Trial

Patent: 26066
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 38082
Estimated Expiration: ⤷  Try a Trial

Patent: 50357
Estimated Expiration: ⤷  Try a Trial

Patent: 54595
Estimated Expiration: ⤷  Try a Trial

Patent: 100047
Estimated Expiration: ⤷  Try a Trial

India

Patent: 084DEN2014
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 9738
Estimated Expiration: ⤷  Try a Trial

Patent: 7608
Estimated Expiration: ⤷  Try a Trial

Patent: 5413
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 82209
Estimated Expiration: ⤷  Try a Trial

Patent: 45821
Estimated Expiration: ⤷  Try a Trial

Patent: 15518890
Estimated Expiration: ⤷  Try a Trial

Patent: 17178923
Estimated Expiration: ⤷  Try a Trial

Patent: 18141009
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 2021525
Estimated Expiration: ⤷  Try a Trial

Patent: 58985
Estimated Expiration: ⤷  Try a Trial

Patent: 48553
Estimated Expiration: ⤷  Try a Trial

Patent: 33792
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 7500
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 6754
Estimated Expiration: ⤷  Try a Trial

Patent: 14015005
Estimated Expiration: ⤷  Try a Trial

Montenegro

Patent: 081
Estimated Expiration: ⤷  Try a Trial

Patent: 815
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 2203
Estimated Expiration: ⤷  Try a Trial

Patent: 7683
Estimated Expiration: ⤷  Try a Trial

Nicaragua

Patent: 1400142
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 21046
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 150631
Estimated Expiration: ⤷  Try a Trial

Patent: 200725
Estimated Expiration: ⤷  Try a Trial

Philippines

Patent: 014502714
Estimated Expiration: ⤷  Try a Trial

Patent: 016501470
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 58985
Estimated Expiration: ⤷  Try a Trial

Patent: 48553
Estimated Expiration: ⤷  Try a Trial

Patent: 33792
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 58985
Estimated Expiration: ⤷  Try a Trial

Patent: 48553
Estimated Expiration: ⤷  Try a Trial

Patent: 33792
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 370
Estimated Expiration: ⤷  Try a Trial

Patent: 617
Estimated Expiration: ⤷  Try a Trial

Patent: 988
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 201610248S
Estimated Expiration: ⤷  Try a Trial

Patent: 201610249T
Estimated Expiration: ⤷  Try a Trial

Patent: 201408140Q
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 58985
Estimated Expiration: ⤷  Try a Trial

Patent: 48553
Estimated Expiration: ⤷  Try a Trial

Patent: 33792
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1500076
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 2062024
Estimated Expiration: ⤷  Try a Trial

Patent: 2195916
Estimated Expiration: ⤷  Try a Trial

Patent: 150021993
Estimated Expiration: ⤷  Try a Trial

Patent: 190132543
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 70683
Estimated Expiration: ⤷  Try a Trial

Patent: 09738
Estimated Expiration: ⤷  Try a Trial

Patent: 75932
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 32732
Estimated Expiration: ⤷  Try a Trial

Patent: 1402561
Estimated Expiration: ⤷  Try a Trial

Turkey

Patent: 1808939
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 5665
Estimated Expiration: ⤷  Try a Trial

Patent: 3142
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ERLEADA around the world.

Country Patent Number Title Estimated Expiration
Japan 2012092149 ANDROGEN RECEPTOR MODULATOR FOR THE TREATMENT OF PROSTATE CANCER AND ANDROGEN RECEPTOR-ASSOCIATED DISEASES ⤷  Try a Trial
European Patent Office 3777845 ANTI-ANDROGÈNES POUR LE TRAITEMENT DU CANCER DE LA PROSTATE RÉSISTANT À LA CASTRATION NON MÉTASTATIQUE (ANTI-ANDROGENS FOR THE TREATMENT OF NON-METASTATIC CASTRATE-RESISTANT PROSTATE CANCER) ⤷  Try a Trial
Eurasian Patent Organization 202090960 АНТИАНДРОГЕНЫ ДЛЯ ЛЕЧЕНИЯ НЕМЕТАСТАТИЧЕСКОГО КАСТРАЦИОННО-РЕЗИСТЕНТНОГО РАКА ПРЕДСТАТЕЛЬНОЙ ЖЕЛЕЗЫ ⤷  Try a Trial
Hungary E042037 ⤷  Try a Trial
Japan 5133975 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ERLEADA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2368550 C 2019 029 Romania ⤷  Try a Trial PRODUCT NAME: APALUTAMIDA SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTEIA; NATIONAL AUTHORISATION NUMBER: EU/1/18/1342; DATE OF NATIONAL AUTHORISATION: 20190114; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1342; DATE OF FIRST AUTHORISATION IN EEA: 20190114
3533792 122021000067 Germany ⤷  Try a Trial PRODUCT NAME: APALUTAMID; REGISTRATION NO/DATE: EU/1/18/1342 20190114
3533792 132021000000170 Italy ⤷  Try a Trial PRODUCT NAME: APALUTAMIDE(ERLEADA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1342, 20190116
2368550 CR 2019 00029 Denmark ⤷  Try a Trial PRODUCT NAME: APALUTAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/18/1342 20190116
3533792 LUC00236 Luxembourg ⤷  Try a Trial PRODUCT NAME: APALUTAMIDE; AUTHORISATION NUMBER AND DATE: EU/1/18/1342 20190116
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.