ERLEADA Drug Patent Profile

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 fifty-nine patent family members in forty-five 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

Summary for ERLEADA

International Patents:	259
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	83
Clinical Trials:	20
Patent Applications:	724
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

See drug prices for ERLEADA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ERLEADA

NDA:

210951

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
National Cancer Institute (NCI)	Phase 1
Janssen-Cilag Ltd.	Phase 3
Cambridge University Hospitals NHS Foundation Trust	Phase 3

See all ERLEADA clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for ERLEADA

L02BB	Anti-androgens
L02B	HORMONE ANTAGONISTS AND RELATED AGENTS
L02	ENDOCRINE THERAPY
L	Antineoplastic and immunomodulating agents

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 and one FDA Regulatory Exclusivity.

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

FDA Regulatory Exclusivity protecting ERLEADA

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					Y
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951-002	Feb 17, 2023		RX	Yes	Yes			Y	Y
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951-002	Feb 17, 2023		RX	Yes	Yes
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951-001	Feb 14, 2018		RX	Yes	No
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951-002	Feb 17, 2023		RX	Yes	Yes
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951-002	Feb 17, 2023		RX	Yes	Yes			Y
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951-002	Feb 17, 2023		RX	Yes	Yes

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

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

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

France

Guatemala

Hong Kong

Hungary

India

Israel

Japan

Lithuania

Malaysia

Mexico

Montenegro

New Zealand

Nicaragua

Norway

Peru

Philippines

Poland

Portugal

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Turkey

Ukraine

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
Philippines	12018502569	ANTI-ANDROGENS FOR THE TREATMENT OF NON-METASTATIC CASTRATE-RESISTANT PROSTATE CANCER
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)
Denmark	2656841
Ukraine	124967	АНТИАНДРОГЕНИ ДЛЯ ЛІКУВАННЯ НЕМЕТАСТАТИЧНОГО КАСТРАЦІЙНО-РЕЗИСТЕНТНОГО РАКУ ПЕРЕДМІХУРОВОЇ ЗАЛОЗИ
European Patent Office	2368550	Modulateurs de récepteurs d'androgènes pour le traitement du cancer de la prostate et de maladies liées au récepteur de l'androgène (Androgen receptor modulator for the treatment of prostate cancer and androgen receptor-associated diseases)
Slovenia	2004181
Hungary	S2100047

Supplementary Protection Certificates for ERLEADA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3533792	43/2021	Austria		PRODUCT NAME: APALUTAMID; REGISTRATION NO/DATE: EU/1/18/1342 (MITTEILUNG) 20190116
3533792	C202130058	Spain		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		PRODUCT NAME: APALUTAMIDE; REG. NO/DATE: EU/1/1342 20190116
2368550	122019000060	Germany		PRODUCT NAME: APALUTAMID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1342 20190114
2368550	C 2019 029	Romania		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
2368550	C201930040	Spain		PRODUCT NAME: APALUTAMIDA O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; 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	PA2019512	Lithuania		PRODUCT NAME: APALUTAMIDAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/18/1342 20190114