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 eleven patents protecting this drug and one Paragraph IV challenge.
This drug has two hundred and eighty-seven 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 seven 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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Summary for ERLEADA
| International Patents: | 287 |
| US Patents: | 11 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 84 |
| Clinical Trials: | 22 |
| Patent Applications: | 579 |
| 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 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
| Sponsor | Phase |
|---|---|
| University of Washington | Phase 2 |
| Jonsson Comprehensive Cancer Center | Phase 2 |
| National Cancer Institute (NCI) | Phase 1 |
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 fifteen US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of ERLEADA is ⤷ Subscribe.
This potential generic entry date is based on patent ⤷ Subscribe.
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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
Patented Use: TREATMENT IN COMBINATION WITH ORCHIECTOMY OF NON-METASTATIC, CASTRATION-RESISTANT PROSTATE CANCER (NMCRPC)
Patent Number: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
Patented Use: TREATMENT OF METASTATIC CASTRATION SENSITIVE PROSTATE CANCER
Androgen receptor modulator for the treatment of prostate cancer and androgen receptor-associated diseases
Patent Number: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
Patented Use: TREATMENT OF METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (MCSPC)
Substituted diazaspiroalkanes as androgen receptor modulators
Patent Number: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
Crystalline forms of an androgen receptor modulator
Patent Number: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
Patented Use: TREATMENT OF METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (MCSPC)
Crystalline forms of an androgen receptor modulator
Patent Number: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
Patented Use: TREATMENT OF NON-METASTATIC, CASTRATION-RESISTANT PROSTATE CANCER (NM-CRPC)
Substituted diazaspiroalkanes as androgen receptor modulators
Patent Number: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
Patent Number: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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 | 210951-002 | Feb 17, 2023 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
| Janssen Biotech | ERLEADA | apalutamide | TABLET;ORAL | 210951-001 | Feb 14, 2018 | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | |||
| Janssen Biotech | ERLEADA | apalutamide | TABLET;ORAL | 210951-002 | Feb 17, 2023 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
| Janssen Biotech | ERLEADA | apalutamide | TABLET;ORAL | 210951-001 | Feb 14, 2018 | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
| Janssen Biotech | ERLEADA | apalutamide | TABLET;ORAL | 210951-002 | Feb 17, 2023 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
| Janssen Biotech | ERLEADA | apalutamide | TABLET;ORAL | 210951-001 | Feb 14, 2018 | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
| Janssen Biotech | ERLEADA | apalutamide | TABLET;ORAL | 210951-002 | Feb 17, 2023 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
| >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
Patent: Crystalline forms of an androgen receptor modulator
Estimated Expiration: ⤷ Subscribe
Patent: 17200298
Patent: Crystalline forms of an androgen receptor modulator
Estimated Expiration: ⤷ Subscribe
Patent: 17279807
Patent: Crystalline forms of an androgen receptor modulator
Estimated Expiration: ⤷ Subscribe
Brazil
Patent: 2014030678
Patent: formas cristalinas de um modulador de receptor de androgênio
Estimated Expiration: ⤷ Subscribe
Canada
Patent: 75767
Patent: FORMES CRISTALLINES D'UN MODULATEUR DU RECEPTEUR DES ANDROGENES (CRYSTALLINE FORMS OF AN ANDROGEN RECEPTOR MODULATOR)
Estimated Expiration: ⤷ Subscribe
Patent: 08345
Patent: FORMES CRISTALLINES D'UN MODULATEUR DE RECEPTEUR D'ANDROGENE (CRYSTALLINE FORMS OF AN ANDROGEN RECEPTOR MODULATOR)
Estimated Expiration: ⤷ Subscribe
Patent: 55660
Patent: FORMES CRISTALLINES D'UN MODULATEUR DE RECEPTEUR D'ANDROGENE (CRYSTALLINE FORMS OF AN ANDROGEN RECEPTOR MODULATOR)
Estimated Expiration: ⤷ Subscribe
Patent: 14726
Patent: FORMES CRISTALLINES D'UN MODULATEUR DE RECEPTEUR D'ANDROGENE (CRYSTALLINE FORMS OF AN ANDROGEN RECEPTOR MODULATOR)
Estimated Expiration: ⤷ Subscribe
Chile
Patent: 14003331
Patent: Formas cristalinas de un modulador de receptor de androgeno
Estimated Expiration: ⤷ Subscribe
China
Patent: 4619692
Patent: Crystalline forms of an androgen receptor modulator
Estimated Expiration: ⤷ Subscribe
Patent: 5693692
Patent: 雄激素受体调节剂的晶形
Estimated Expiration: ⤷ Subscribe
Patent: 3135892
Patent: 雄激素受体调节剂的晶形 (Crystalline form of androgen receptor modulator)
Estimated Expiration: ⤷ Subscribe
Colombia
Patent: 40407
Patent: Formas cristalinas de un modulador del receptor androgénico
Estimated Expiration: ⤷ Subscribe
Costa Rica
Patent: 140549
Patent: FORMAS CRISTALINAS DE UN MODULADOR DEL RECEPTOR ANDROGÉNICO
Estimated Expiration: ⤷ Subscribe
Patent: 190331
Patent: UNA FORMA CRISTALINA A DE UN MODULADOR DEL RECEPTOR ANDROGÉNICO (Divisional 2014-0549) (CRYSTALLINE FORMS OF AN ANDROGEN RECEPTOR MODULATOR)
Estimated Expiration: ⤷ Subscribe
Croatia
Patent: 0180902
Estimated Expiration: ⤷ Subscribe
Patent: 0201387
Estimated Expiration: ⤷ Subscribe
Patent: 0210909
Estimated Expiration: ⤷ Subscribe
Cyprus
Patent: 20393
Estimated Expiration: ⤷ Subscribe
Patent: 23427
Estimated Expiration: ⤷ Subscribe
Patent: 24831
Estimated Expiration: ⤷ Subscribe
Denmark
Patent: 58985
Estimated Expiration: ⤷ Subscribe
Patent: 48553
Estimated Expiration: ⤷ Subscribe
Patent: 33792
Estimated Expiration: ⤷ Subscribe
Ecuador
Patent: 14030098
Patent: FORMAS CRISTALINAS DE UN MODULADOR DEL RECEPTOR ANDROGÉNICO
Estimated Expiration: ⤷ Subscribe
Eurasian Patent Organization
Patent: 8791
Patent: КРИСТАЛЛИЧЕСКАЯ ФОРМА МОДУЛЯТОРА АНДРОГЕННЫХ РЕЦЕПТОРОВ (CRYSTALLINE FORM OF AN ANDROGEN RECEPTOR MODULATOR)
Estimated Expiration: ⤷ Subscribe
Patent: 3956
Patent: КРИСТАЛЛИЧЕСКАЯ ФОРМА А 4-[7-(6-ЦИАНО-5-ТРИФТОРМЕТИЛПИРИДИН-3-ИЛ)-8-ОКСО-6-ТИОКСО-5,7- ДИАЗАСПИРО[3.4]ОКТ-5-ИЛ]-2-ФТОР-N-МЕТИЛБЕНЗАМИДА ДЛЯ ЛЕЧЕНИЯ ЗАБОЛЕВАНИЯ ИЛИ СОСТОЯНИЯ, СВЯЗАННОГО С АКТИВНОСТЬЮ АНДРОГЕННЫХ РЕЦЕПТОРОВ, ВКЛЮЧАЯ РАК ПРОСТАТЫ (CRYSTALLINE FORM OF 4-[7-(6-CYANO-5-TRIFLUOROMETHYLPYRIDIN-3-YL)-8-OXO-6-THIOXO-5,7-DIAZASPIRO[3.4]OCT-5-YL]-2-FLUORO-N-METHYLBENZAMIDE FOR TREATING A DISEASE OR CONDITION ASSOCIATED WITH ANDROGEN RECEPTOR ACTIVITY, INCLUDING PROSTATE CANCER)
Estimated Expiration: ⤷ Subscribe
Patent: 1492272
Patent: КРИСТАЛЛИЧЕСКИЕ ФОРМЫ МОДУЛЯТОРА АНДРОГЕННЫХ РЕЦЕПТОРОВ
Estimated Expiration: ⤷ Subscribe
Patent: 1791592
Patent: КРИСТАЛЛИЧЕСКИЕ ФОРМЫ МОДУЛЯТОРА АНДРОГЕННЫХ РЕЦЕПТОРОВ
Estimated Expiration: ⤷ Subscribe
Patent: 1992010
Patent: КРИСТАЛЛИЧЕСКАЯ ФОРМА А 4-[7-(6-ЦИАНО-5-ТРИФТОРМЕТИЛПИРИДИН-3-ИЛ)-8-ОКСО-6-ТИОКСО-5,7-ДИАЗАСПИРО[3.4]ОКТ-5-ИЛ]-2-ФТОР-N-МЕТИЛБЕНЗАМИДА ДЛЯ ЛЕЧЕНИЯ ЗАБОЛЕВАНИЯ ИЛИ СОСТОЯНИЯ, СВЯЗАННОГО С АКТИВНОСТЬЮ АНДРОГЕННЫХ РЕЦЕПТОРОВ, ВКЛЮЧАЯ РАК ПРОСТАТЫ
Estimated Expiration: ⤷ Subscribe
European Patent Office
Patent: 58985
Patent: FORMES CRISTALLINES D'UN MODULATEUR DU RÉCEPTEUR DES ANDROGÈNES (CRYSTALLINE FORMS OF AN ANDROGEN RECEPTOR MODULATOR)
Estimated Expiration: ⤷ Subscribe
Patent: 48553
Patent: FORMES CRISTALLINES D'UN MODULATEUR DE RÉCEPTEUR D'ANDROGÈNE (CRYSTALLINE FORMS OF AN ANDROGEN RECEPTOR MODULATOR)
Estimated Expiration: ⤷ Subscribe
Patent: 33792
Patent: FORMES CRISTALLINES D'UN MODULATEUR DE RÉCEPTEUR D'ANDROGÈNE (CRYSTALLINE FORMS OF AN ANDROGEN RECEPTOR MODULATOR)
Estimated Expiration: ⤷ Subscribe
Patent: 22629
Patent: FORMES CRISTALLINES D'UN MODULATEUR DE RÉCEPTEUR D'ANDROGÈNE (CRYSTALLINE FORMS OF AN ANDROGEN RECEPTOR MODULATOR)
Estimated Expiration: ⤷ Subscribe
France
Patent: C1050
Estimated Expiration: ⤷ Subscribe
Guatemala
Patent: 1400283
Patent: FORMAS CRISTALINAS DE UN MODULADOR DEL RECEPTOR ANDROGÉNICO
Estimated Expiration: ⤷ Subscribe
Hong Kong
Patent: 10175
Patent: 雄激素受體調節劑的晶形 (CRYSTALLINE FORMS OF AN ANDROGEN RECEPTOR MODULATOR)
Estimated Expiration: ⤷ Subscribe
Patent: 26066
Patent: 雄激素受體調節劑的晶形 (CRYSTALLINE FORMS OF AN ANDROGEN RECEPTOR MODULATOR)
Estimated Expiration: ⤷ Subscribe
Hungary
Patent: 38082
Estimated Expiration: ⤷ Subscribe
Patent: 50357
Estimated Expiration: ⤷ Subscribe
Patent: 54595
Estimated Expiration: ⤷ Subscribe
Patent: 100047
Estimated Expiration: ⤷ Subscribe
India
Patent: 084DEN2014
Estimated Expiration: ⤷ Subscribe
Israel
Patent: 9738
Patent: צורות גבישיות של מאפנן קולטן אנדרוגן (Crystalline forms of an androgen receptor modulator)
Estimated Expiration: ⤷ Subscribe
Patent: 7608
Patent: צורות גבישיות של מאפנן קולטן אנדרוגן (Crystalline forms of an androgen receptor modulator)
Estimated Expiration: ⤷ Subscribe
Patent: 5413
Patent: צורות גבישיות של מאפנן קולטן אנדרוגן (Crystalline forms of an androgen receptor modulator)
Estimated Expiration: ⤷ Subscribe
Japan
Patent: 82209
Estimated Expiration: ⤷ Subscribe
Patent: 45821
Estimated Expiration: ⤷ Subscribe
Patent: 15518890
Patent: アンドロゲン受容体変調剤の結晶質形態
Estimated Expiration: ⤷ Subscribe
Patent: 17178923
Patent: アンドロゲン受容体変調剤の結晶質形態 (CRYSTALLINE FORMS OF ANDROGEN RECEPTOR MODULATOR)
Estimated Expiration: ⤷ Subscribe
Patent: 18141009
Patent: アンドロゲン受容体変調剤の結晶質形態 (CRYSTALLINE FORMS OF ANDROGEN RECEPTOR MODULATOR)
Estimated Expiration: ⤷ Subscribe
Lithuania
Patent: 2021525
Estimated Expiration: ⤷ Subscribe
Patent: 58985
Estimated Expiration: ⤷ Subscribe
Patent: 48553
Estimated Expiration: ⤷ Subscribe
Patent: 33792
Estimated Expiration: ⤷ Subscribe
Malaysia
Patent: 7500
Patent: CRYSTALLINE FORMS OF AN ANDROGEN RECEPTOR MODULATOR
Estimated Expiration: ⤷ Subscribe
Mexico
Patent: 6754
Patent: FORMAS CRISTALINAS DE UN MODULADOR DEL RECEPTOR ANDROGENICO. (CRYSTALLINE FORMS OF AN ANDROGEN RECEPTOR MODULATOR.)
Estimated Expiration: ⤷ Subscribe
Patent: 14015005
Patent: FORMAS CRISTALINAS DE UN MODULADOR DEL RECEPTOR ANDROGENICO. (CRYSTALLINE FORMS OF AN ANDROGEN RECEPTOR MODULATOR.)
Estimated Expiration: ⤷ Subscribe
Montenegro
Patent: 081
Patent: MODULATORA RECEPTORA ANDROGENA PATENTNI ZAHTEVI (CRYSTALLINE FORMS OF AN ANDROGEN RECEPTOR MODULATOR)
Estimated Expiration: ⤷ Subscribe
Patent: 815
Patent: KRISTALNI OBLICI MODULATORA RECEPTORA ANDROGENA (CRYSTALLINE FORMS OF AN ANDROGEN RECEPTOR MODULATOR)
Estimated Expiration: ⤷ Subscribe
New Zealand
Patent: 2203
Patent: Crystalline forms of an androgen receptor modulator
Estimated Expiration: ⤷ Subscribe
Patent: 7683
Patent: Crystalline forms of an androgen receptor modulator
Estimated Expiration: ⤷ Subscribe
Nicaragua
Patent: 1400142
Patent: FORMAS CRISTALINAS DE UN MODULADOR DEL RECEPTOR DE ANDROGENOS
Estimated Expiration: ⤷ Subscribe
Norway
Patent: 21046
Estimated Expiration: ⤷ Subscribe
Peru
Patent: 150631
Patent: FORMAS CRISTALINAS DE UN MODULADOR DEL RECEPTOR ANDROGENICO
Estimated Expiration: ⤷ Subscribe
Patent: 200725
Patent: FORMAS CRISTALINAS DEL MODULADOR RECEPTOR DE ANDROGENO: 4-[7-(6-CIANO-5-TRIFLUOROMETILPIRIDIN-3-IL)-8-OXO-6-TIOXO-5,7-DIAZAESPIRO[3,4]OCT-5-IL]-2-FLUORO-N-METILBENZAMIDA) (APALUTAMIDA)
Estimated Expiration: ⤷ Subscribe
Philippines
Patent: 014502714
Patent: CRYSTALLINE FORMS OF AN ANDROGEN RECEPTOR MODULATOR
Estimated Expiration: ⤷ Subscribe
Patent: 016501470
Patent: CRYSTALLINE FORMS OF AN ANDROGEN RECEPTOR MODULATOR
Estimated Expiration: ⤷ Subscribe
Poland
Patent: 58985
Estimated Expiration: ⤷ Subscribe
Patent: 48553
Estimated Expiration: ⤷ Subscribe
Patent: 33792
Estimated Expiration: ⤷ Subscribe
Portugal
Patent: 58985
Estimated Expiration: ⤷ Subscribe
Patent: 48553
Estimated Expiration: ⤷ Subscribe
Patent: 33792
Estimated Expiration: ⤷ Subscribe
Serbia
Patent: 370
Patent: KRISTALNI OBLICI MODULATORA RECEPTORA ANDROGENA (CRYSTALLINE FORMS OF AN ANDROGEN RECEPTOR MODULATOR)
Estimated Expiration: ⤷ Subscribe
Patent: 617
Patent: KRISTALNI OBLICI MODULATORA RECEPTORA ANDROGENA (CRYSTALLINE FORMS OF AN ANDROGEN RECEPTOR MODULATOR)
Estimated Expiration: ⤷ Subscribe
Patent: 988
Patent: KRISTALNI OBLICI MODULATORA RECEPTORA ANDROGENA (CRYSTALLINE FORMS OF AN ANDROGEN RECEPTOR MODULATOR)
Estimated Expiration: ⤷ Subscribe
Singapore
Patent: 201610248S
Patent: CRYSTALLINE FORMS OF AN ANDROGEN RECEPTOR MODULATOR
Estimated Expiration: ⤷ Subscribe
Patent: 201610249T
Patent: CRYSTALLINE FORMS OF AN ANDROGEN RECEPTOR MODULATOR
Estimated Expiration: ⤷ Subscribe
Patent: 201408140Q
Patent: CRYSTALLINE FORMS OF AN ANDROGEN RECEPTOR MODULATOR
Estimated Expiration: ⤷ Subscribe
Slovenia
Patent: 58985
Estimated Expiration: ⤷ Subscribe
Patent: 48553
Estimated Expiration: ⤷ Subscribe
Patent: 33792
Estimated Expiration: ⤷ Subscribe
South Africa
Patent: 1500076
Patent: CRYSTALLINE FORMS OF ANDROGEN RECEPTOR MODULATOR
Estimated Expiration: ⤷ Subscribe
South Korea
Patent: 2062024
Estimated Expiration: ⤷ Subscribe
Patent: 2195916
Estimated Expiration: ⤷ Subscribe
Patent: 150021993
Patent: CRYSTALLINE FORMS OF AN ANDROGEN RECEPTOR MODULATOR
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Patent: 190132543
Patent: 안드로겐 수용체 조절제의 결정 형태 (CRYSTALLINE FORMS OF AN ANDROGEN RECEPTOR MODULATOR)
Estimated Expiration: ⤷ Subscribe
Spain
Patent: 70683
Estimated Expiration: ⤷ Subscribe
Patent: 09738
Estimated Expiration: ⤷ Subscribe
Patent: 75932
Estimated Expiration: ⤷ Subscribe
Taiwan
Patent: 32732
Estimated Expiration: ⤷ Subscribe
Patent: 1402561
Patent: Crystalline forms of an androgen receptor modulator
Estimated Expiration: ⤷ Subscribe
Turkey
Patent: 1808939
Estimated Expiration: ⤷ Subscribe
Ukraine
Patent: 5665
Patent: КРИСТАЛІЧНІ ФОРМИ МОДУЛЯТОРА АНДРОГЕННОГО РЕЦЕПТОРА (CRYSTALLINE FORMS OF AN ANDROGEN RECEPTOR MODULATOR)
Estimated Expiration: ⤷ Subscribe
Patent: 3142
Patent: КРИСТАЛІЧНІ ФОРМИ МОДУЛЯТОРА АНДРОГЕННОГО РЕЦЕПТОРА
Estimated Expiration: ⤷ Subscribe
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 | 2016011315 | 前立腺癌およびアンドロゲン受容体関連病態の治療のためのアンドロゲン受容体の調節剤 (ANDROGEN RECEPTOR MODULATOR FOR TREATMENT OF PROSTATE CANCER AND ANDROGEN RECEPTOR-ASSOCIATED DISEASES) | ⤷ Subscribe |
| South Korea | 102210825 | ⤷ Subscribe | |
| Lithuania | 3305285 | ⤷ Subscribe | |
| Eurasian Patent Organization | 202192097 | АНТИАНДРОГЕНЫ ДЛЯ ЛЕЧЕНИЯ МЕТАСТАТИЧЕСКОГО КАСТРАЦИОННО-ЧУВСТВИТЕЛЬНОГО РАКА ПРЕДСТАТЕЛЬНОЙ ЖЕЛЕЗЫ | ⤷ Subscribe |
| European Patent Office | 4438126 | ⤷ Subscribe | |
| South Korea | 20150070192 | 비전이성 거세 저항성 전립선암 치료용 항안드로겐 (ANTI-ANDROGENS FOR THE TREATMENT OF NON-METASTATIC CASTRATE-RESISTANT PROSTATE CANCER) | ⤷ Subscribe |
| Mexico | 2023005997 | ⤷ Subscribe | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ERLEADA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3533792 | CA 2021 00041 | Denmark | ⤷ Subscribe | PRODUCT NAME: APALUTAMID; REG. NO/DATE: EU/1/18/1342 20190116 |
| 3533792 | 43/2021 | Austria | ⤷ Subscribe | PRODUCT NAME: APALUTAMID; REGISTRATION NO/DATE: EU/1/18/1342 (MITTEILUNG) 20190116 |
| 3533792 | LUC00236 | Luxembourg | ⤷ Subscribe | PRODUCT NAME: APALUTAMIDE; AUTHORISATION NUMBER AND DATE: EU/1/18/1342 20190116 |
| 3533792 | 132021000000170 | Italy | ⤷ Subscribe | PRODUCT NAME: APALUTAMIDE(ERLEADA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1342, 20190116 |
| 3533792 | C202130058 | Spain | ⤷ Subscribe | 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 |
| 2368550 | 1990032-3 | Sweden | ⤷ Subscribe | PRODUCT NAME: APALUTAMIDE; REG. NO/DATE: EU/1/1342 20190116 |
| 2368550 | PA2019512,C2368550 | Lithuania | ⤷ Subscribe | 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 |
ERLEADA Market dynamics and financial trajectory Experimental
Market Dynamics and Financial Trajectory for ERLEADA
Introduction to ERLEADA
ERLEADA, also known as apalutamide, is an androgen receptor inhibitor developed by Johnson & Johnson (J&J) for the treatment of prostate cancer. It has been approved for patients with non-metastatic castration-resistant prostate cancer and is also being evaluated for other indications within the prostate cancer treatment spectrum[4].
Approval and Regulatory Milestones
ERLEADA received its initial approval from Health Canada in July 2018 for the treatment of patients with non-metastatic castration-resistant prostate cancer. This approval was based on the SPARTAN Phase III clinical trial, which demonstrated a significant reduction in the risk of distant metastases or death compared to placebo plus androgen deprivation therapy (ADT)[4].
Clinical Efficacy and Safety
The SPARTAN trial showed that ERLEADA plus ADT decreased the risk of distant metastases or death by 70% compared to placebo plus ADT. The median metastasis-free survival was 2 years longer in patients treated with ERLEADA. The safety profile of ERLEADA has been consistent with previous reports, with treatment-emergent adverse events reported by 99.1% of patients, although most were not severe[4].
Market Position and Competition
ERLEADA enters a market dominated by other prostate cancer therapies, notably J&J's own Zytiga (abiraterone acetate) and Astellas and Pfizer's Xtandi (enzalutamide). Zytiga, once a significant revenue generator for J&J, has faced generic competition since the fourth quarter of 2018, leading to a decline in its market share and sales. For instance, Zytiga's share of total U.S. prescriptions dropped from 56% to 31% between October and January 2019 due to generic competition[1].
Competitive Landscape: Xtandi
Xtandi, approved for both metastatic and non-metastatic prostate cancer, poses a significant competitive challenge to ERLEADA. Xtandi received a label expansion in 2018, making it the only oral medication available for both metastatic and non-metastatic prostate cancer. Pfizer reported $699 million in revenue from Xtandi in 2018, up from $590 million in 2017. Xtandi's market share in the non-metastatic, castrate-resistant setting was quadruple that of ERLEADA's six months after its approval[1].
Financial Performance and Projections
Despite the competitive landscape, ERLEADA is expected to be a key growth driver for J&J. Although its sales have not been astronomical since its launch, supportive data from studies like the TITAN trial, which showed significant benefits in patients with metastatic, castration-sensitive prostate cancer, are expected to expand its label and boost sales. J&J's CFO, Joseph Wolk, emphasized the company's strategies to adapt payer contracts and outcomes-based pilots to highlight the benefits of ERLEADA[1].
Revenue Impact and Market Share
In the context of J&J's overall financial performance, ERLEADA's growth is crucial as the company navigates the decline of Zytiga's sales. J&J reported a 4% year-over-year growth in Zytiga sales in 2018, which was significantly lower than the previous year's growth due to generic competition. ERLEADA's potential to capture a larger market share, especially with its expanding indications, is seen as a way to mitigate these losses[1].
Payer Strategies and Outcomes-Based Models
J&J is focusing on evolving its payer strategies to better communicate the value of ERLEADA. This includes implementing outcomes-based contracts, which could provide a long-term solution by tying payments to the actual outcomes of the treatment. This approach is part of J&J's broader strategy to adapt to changing market dynamics and ensure the sustainability of its products[1].
Recent Clinical Data and Future Prospects
Recent Phase 2 data for ERLEADA plus ADT following radical prostatectomy showed promising results, with no confirmed biochemical recurrence after additional follow-up and a significant rate of serum testosterone recovery. These findings support the potential for ERLEADA in broader treatment settings, further solidifying its position in the prostate cancer market[3].
Financial Trajectory for J&J
In the fourth quarter and full-year 2023, J&J reported overall sales growth, with operational sales increasing by 7.2% and adjusted operational sales by 5.7%. While the company's financial performance is diversified across various therapeutic areas, the success of ERLEADA will be a critical component of its oncology portfolio's growth[5].
Key Takeaways
- Regulatory Approval: ERLEADA has been approved for non-metastatic castration-resistant prostate cancer and is under evaluation for other indications.
- Clinical Efficacy: ERLEADA has shown significant benefits in reducing the risk of distant metastases or death in clinical trials.
- Market Competition: ERLEADA faces competition from Zytiga and Xtandi, but its expanding label and supportive data position it for growth.
- Financial Impact: ERLEADA is expected to mitigate the decline in Zytiga sales and contribute to J&J's overall revenue growth.
- Payer Strategies: J&J is adapting its payer strategies, including outcomes-based models, to enhance ERLEADA's market position.
FAQs
Q: What is ERLEADA used for?
ERLEADA (apalutamide) is used for the treatment of patients with non-metastatic castration-resistant prostate cancer.
Q: How does ERLEADA compare to other prostate cancer treatments?
ERLEADA competes with other treatments like Zytiga (abiraterone acetate) and Xtandi (enzalutamide), but its expanding label and clinical data support its growth potential.
Q: What are the key findings from the TITAN trial?
The TITAN trial showed that patients taking ERLEADA plus ADT had significantly longer survival without cancer progression and death compared to those receiving ADT plus placebo.
Q: How is J&J addressing the decline in Zytiga sales?
J&J is focusing on ERLEADA as a key growth driver and adapting its payer strategies to highlight the benefits of its products.
Q: What are the future prospects for ERLEADA?
ERLEADA's future prospects include potential label expansions and increased market share, driven by supportive clinical data and evolving payer strategies.
Cited Sources
- Biopharma Dive: "J&J's Erleada has big shoes to fill, and a tough competitor to boot" - January 31, 2019.
- Royalty Pharma: "Royalty Pharma Reports Second Quarter 2023 Results" - August 8, 2023.
- Janssen: "Phase 2 data for ERLEADA® (apalutamide) plus androgen deprivation therapy following radical prostatectomy" - May 3, 2024.
- Health Canada: "Summary Basis of Decision for Erleada" - August 27, 2018.
- Johnson & Johnson: "Johnson & Johnson Reports Q4 and Full-Year 2023 Results" - January 23, 2024.
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