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 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

See drug prices for ERLEADA

DrugPatentWatch^® Estimated Generic Entry Opportunity 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
University of Cambridge	Phase 3
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 twelve US patents and two FDA Regulatory Exclusivities.

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	Yes
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951-001	Feb 14, 2018		RX	Yes	Yes			Y	Y
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951-001	Feb 14, 2018		RX	Yes	Yes
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951-001	Feb 14, 2018		RX	Yes	Yes

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

Guatemala

Hong Kong

Hungary

India

Israel

Japan

Lithuania

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
Canada	3114726	FORMES CRISTALLINES D'UN MODULATEUR DE RECEPTEUR D'ANDROGENE (CRYSTALLINE FORMS OF AN ANDROGEN RECEPTOR MODULATOR)
Lithuania	PA2019512
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)
Spain	2593379

Supplementary Protection Certificates for ERLEADA

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