XTANDI Drug Patent Profile

Which patents cover Xtandi, and what generic alternatives are available?

Xtandi is a drug marketed by Astellas and is included in two NDAs. There are three patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and thirty-six patent family members in twenty-eight countries.

The generic ingredient in XTANDI is enzalutamide. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the enzalutamide profile page.

DrugPatentWatch^® Generic Entry Outlook for Xtandi

Xtandi was eligible for patent challenges on August 31, 2016.

There have been eight 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.

There is one tentative approval for the generic drug (enzalutamide), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for XTANDI

International Patents:	136
US Patents:	3
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	121
Clinical Trials:	150
Patent Applications:	2,309
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for XTANDI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for XTANDI
What excipients (inactive ingredients) are in XTANDI?	XTANDI excipients list
DailyMed Link:	XTANDI at DailyMed

See drug prices for XTANDI

Recent Clinical Trials for XTANDI

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Chicago	Phase 2
Emory University	Phase 1
Xencor, Inc.	Phase 1

See all XTANDI clinical trials

Pharmacology for XTANDI

Drug Class	Androgen Receptor Inhibitor
Mechanism of Action	Androgen Receptor Antagonists Cytochrome P450 2C19 Inducers Cytochrome P450 2C9 Inducers Cytochrome P450 3A4 Inducers

Anatomical Therapeutic Chemical (ATC) Classes for XTANDI

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

Paragraph IV (Patent) Challenges for XTANDI

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
XTANDI	Tablets	enzalutamide	40 mg and 80 mg	213674	1	2021-03-31
XTANDI	Capsules	enzalutamide	40 mg	203415	3	2016-08-31

US Patents and Regulatory Information for XTANDI

XTANDI is protected by eight US patents.

Patents protecting XTANDI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astellas	XTANDI	enzalutamide	CAPSULE;ORAL	203415-001	Aug 31, 2012		RX	Yes	Yes
Astellas	XTANDI	enzalutamide	TABLET;ORAL	213674-002	Aug 4, 2020		RX	Yes	Yes			Y	Y
Astellas	XTANDI	enzalutamide	CAPSULE;ORAL	203415-001	Aug 31, 2012		RX	Yes	Yes			Y	Y
Astellas	XTANDI	enzalutamide	TABLET;ORAL	213674-002	Aug 4, 2020		RX	Yes	Yes
Astellas	XTANDI	enzalutamide	TABLET;ORAL	213674-002	Aug 4, 2020		RX	Yes	Yes

EU/EMA Drug Approvals for XTANDI

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Astellas Pharma Europe B.V.	Xtandi	enzalutamide	EMEA/H/C/002639 Xtandi is indicated for:the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (see section 5.1).the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1).the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1).the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.	Authorised	no	no	no	2013-06-21	2013-04-26

International Patents for XTANDI

When does loss-of-exclusivity occur for XTANDI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Austria

Brazil

Canada

China

Croatia

Cyprus

Denmark

European Patent Office

Hong Kong

Hungary

Israel

Japan

Luxembourg

Mexico

Montenegro

New Zealand

Norway

Poland

Portugal

Russian Federation

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

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 XTANDI around the world.

Country	Patent Number	Title	Estimated Expiration
Serbia	53967	DIARIL HIDANTOIN JEDINJENJA KAO ANTAGONISTI RECEPTORA ANDROGENA ZA LEČENJE RAKA (DIARYLHYDANTOIN COMPOUNDS AS ANDROGEN RECEPTOR ANTAGONISTS FOR TREATMENT OF CANCER)
Japan	2023075313	ジアリールヒダントイン化合物
South Korea	20150086567	디아릴히단토인 화합물 (DIARYLHYDANTOIN COMPOUNDS)
European Patent Office	3106162	COMPOSES DIARYLHYDANTOINES EN TANT QU'ANTAGONISTES DU RECEPTEUR D'ANDROGENE POUR LE TRAITEMENT DU CANCER (DIARYLHYDANTOIN COMPOUNDS AS ANDROGEN RECEPTOR ANTAGONISTS FOR TREATMENT OF CANCER)
Slovenia	2444085

Supplementary Protection Certificates for XTANDI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1893196	C01893196/01	Switzerland		PRODUCT NAME: ENZALUTAMID; REGISTRATION NO/DATE: SWISSMEDIC 63040 03.12.2013
1893196	SPC/GB13/079	United Kingdom		PRODUCT NAME: ENZLUTAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/13/846 20130625
1893196	CR 2013 00065	Denmark		PRODUCT NAME: ENZALUTAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/846 20130625
1893196	CA 2013 00065	Denmark		PRODUCT NAME: ENZALUTAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/846 20130625
1893196	2013/061	Ireland		PRODUCT NAME: ENZALUTAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/846 20130625