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Last Updated: May 24, 2022

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 nine patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and forty-nine patent family members in forty-four 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 two 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 Generic Entry Opportunity 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
University of CambridgePhase 3
Janssen-Cilag Ltd.Phase 3
Cambridge University Hospitals NHS Foundation TrustPhase 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 twelve US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ERLEADA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (MCSPC)

Substituted diazaspiroalkanes as androgen receptor modulators
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Crystalline forms of an androgen receptor modulator
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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

Substituted diazaspiroalkanes as androgen receptor modulators
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting ERLEADA

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (MCSPC)
Exclusivity Expiration: 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
Janssen Biotech ERLEADA apalutamide TABLET;ORAL 210951-001 Feb 14, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Janssen Biotech ERLEADA apalutamide TABLET;ORAL 210951-001 Feb 14, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Janssen Biotech ERLEADA apalutamide TABLET;ORAL 210951-001 Feb 14, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Janssen Biotech ERLEADA apalutamide TABLET;ORAL 210951-001 Feb 14, 2018 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

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: See Plans and Pricing

Patent: 17200298
Estimated Expiration: See Plans and Pricing

Patent: 17279807
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2014030678
Estimated Expiration: See Plans and Pricing

Canada

Patent: 75767
Estimated Expiration: See Plans and Pricing

Patent: 08345
Estimated Expiration: See Plans and Pricing

Patent: 55660
Estimated Expiration: See Plans and Pricing

Patent: 14726
Estimated Expiration: See Plans and Pricing

Chile

Patent: 14003331
Estimated Expiration: See Plans and Pricing

China

Patent: 4619692
Estimated Expiration: See Plans and Pricing

Patent: 5693692
Estimated Expiration: See Plans and Pricing

Patent: 3135892
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 40407
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 140549
Estimated Expiration: See Plans and Pricing

Patent: 190331
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0180902
Estimated Expiration: See Plans and Pricing

Patent: 0201387
Estimated Expiration: See Plans and Pricing

Patent: 0210909
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 20393
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 58985
Estimated Expiration: See Plans and Pricing

Patent: 48553
Estimated Expiration: See Plans and Pricing

Patent: 33792
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 14030098
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 8791
Estimated Expiration: See Plans and Pricing

Patent: 3956
Estimated Expiration: See Plans and Pricing

Patent: 1492272
Estimated Expiration: See Plans and Pricing

Patent: 1791592
Estimated Expiration: See Plans and Pricing

Patent: 1992010
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 58985
Estimated Expiration: See Plans and Pricing

Patent: 48553
Estimated Expiration: See Plans and Pricing

Patent: 33792
Estimated Expiration: See Plans and Pricing

Patent: 22629
Estimated Expiration: See Plans and Pricing

Guatemala

Patent: 1400283
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 10175
Estimated Expiration: See Plans and Pricing

Patent: 26066
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 38082
Estimated Expiration: See Plans and Pricing

Patent: 50357
Estimated Expiration: See Plans and Pricing

Patent: 54595
Estimated Expiration: See Plans and Pricing

Patent: 100047
Estimated Expiration: See Plans and Pricing

India

Patent: 084DEN2014
Estimated Expiration: See Plans and Pricing

Israel

Patent: 6055
Estimated Expiration: See Plans and Pricing

Patent: 9738
Estimated Expiration: See Plans and Pricing

Patent: 7608
Estimated Expiration: See Plans and Pricing

Patent: 5413
Estimated Expiration: See Plans and Pricing

Japan

Patent: 82209
Estimated Expiration: See Plans and Pricing

Patent: 45821
Estimated Expiration: See Plans and Pricing

Patent: 15518890
Estimated Expiration: See Plans and Pricing

Patent: 17178923
Estimated Expiration: See Plans and Pricing

Patent: 18141009
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 2021525
Estimated Expiration: See Plans and Pricing

Patent: 58985
Estimated Expiration: See Plans and Pricing

Patent: 48553
Estimated Expiration: See Plans and Pricing

Patent: 33792
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 6754
Estimated Expiration: See Plans and Pricing

Patent: 14015005
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 081
Estimated Expiration: See Plans and Pricing

Patent: 815
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 2203
Estimated Expiration: See Plans and Pricing

Patent: 7683
Estimated Expiration: See Plans and Pricing

Nicaragua

Patent: 1400142
Estimated Expiration: See Plans and Pricing

Norway

Patent: 21046
Estimated Expiration: See Plans and Pricing

Peru

Patent: 150631
Estimated Expiration: See Plans and Pricing

Patent: 200725
Estimated Expiration: See Plans and Pricing

Philippines

Patent: 014502714
Estimated Expiration: See Plans and Pricing

Patent: 016501470
Estimated Expiration: See Plans and Pricing

Poland

Patent: 58985
Estimated Expiration: See Plans and Pricing

Patent: 48553
Estimated Expiration: See Plans and Pricing

Patent: 33792
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 58985
Estimated Expiration: See Plans and Pricing

Patent: 48553
Estimated Expiration: See Plans and Pricing

Patent: 33792
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 370
Estimated Expiration: See Plans and Pricing

Patent: 617
Estimated Expiration: See Plans and Pricing

Patent: 988
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 201610248S
Estimated Expiration: See Plans and Pricing

Patent: 201610249T
Estimated Expiration: See Plans and Pricing

Patent: 201408140Q
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 58985
Estimated Expiration: See Plans and Pricing

Patent: 48553
Estimated Expiration: See Plans and Pricing

Patent: 33792
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1500076
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 2062024
Estimated Expiration: See Plans and Pricing

Patent: 2195916
Estimated Expiration: See Plans and Pricing

Patent: 150021993
Estimated Expiration: See Plans and Pricing

Patent: 190132543
Estimated Expiration: See Plans and Pricing

Spain

Patent: 70683
Estimated Expiration: See Plans and Pricing

Patent: 09738
Estimated Expiration: See Plans and Pricing

Patent: 75932
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 32732
Estimated Expiration: See Plans and Pricing

Patent: 1402561
Estimated Expiration: See Plans and Pricing

Turkey

Patent: 1808939
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 5665
Estimated Expiration: See Plans and Pricing

Patent: 3142
Estimated Expiration: See Plans and Pricing

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
Canada 3114726 FORMES CRISTALLINES D'UN MODULATEUR DE RECEPTEUR D'ANDROGENE (CRYSTALLINE FORMS OF AN ANDROGEN RECEPTOR MODULATOR) See Plans and Pricing
Lithuania PA2019512 See Plans and Pricing
Hong Kong 1190928 用於治療前列腺癌和與雄激素受體相關的疾病的雄激素受體調節劑 (ANDROGEN RECEPTOR MODULATOR FOR THE TREATMENT OF PROSTATE CANCER AND ANDROGEN RECEPTOR-ASSOCIATED DISEASES) See Plans and Pricing
Spain 2593379 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ERLEADA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3533792 LUC00236 Luxembourg See Plans and Pricing PRODUCT NAME: APALUTAMIDE; AUTHORISATION NUMBER AND DATE: EU/1/18/1342 20190116
2368550 35/2019 Austria See Plans and Pricing PRODUCT NAME: APALUTAMID; REGISTRATION NO/DATE: EU/1/18/1342 (MITTEILUNG) 20190116
2368550 CR 2019 00029 Denmark See Plans and Pricing PRODUCT NAME: APALUTAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/18/1342 20190116
2368550 PA2019512,C2368550 Lithuania See Plans and Pricing PRODUCT NAME: APALUTAMIDAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/18/1342 20190114
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Express Scripts
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Mallinckrodt
Moodys
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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.