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
Summary for ERLEADA
International Patents: | 249 |
US Patents: | 9 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 76 |
Clinical Trials: | 19 |
Patent Applications: | 675 |
Drug Prices: | Drug price information for ERLEADA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ERLEADA |
What excipients (inactive ingredients) are in ERLEADA? | ERLEADA excipients list |
DailyMed Link: | ERLEADA at DailyMed |


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
Sponsor | Phase |
---|---|
University of Cambridge | Phase 3 |
Janssen-Cilag Ltd. | Phase 3 |
Cambridge University Hospitals NHS Foundation Trust | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for ERLEADA
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 |