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-three 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 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 XTANDI

International Patents:	133
US Patents:	3
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	111
Clinical Trials:	140
Patent Applications:	2,437
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
Nuvation Bio Inc.	Phase 1/Phase 2
Fudan University	Phase 2
Clarus Therapeutics	Phase 2

See all XTANDI clinical trials

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 and one FDA Regulatory Exclusivity.

Patents protecting XTANDI

FDA Regulatory Exclusivity 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
Astellas	XTANDI	enzalutamide	TABLET;ORAL	213674-001	Aug 4, 2020		RX	Yes	No

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
South Korea	20150086567	디아릴히단토인 화합물 (DIARYLHYDANTOIN COMPOUNDS)
South Korea	20210136161	디아릴히단토인 화합물 (DIARYLHYDANTOIN COMPOUNDS)
Croatia	P20120323

Supplementary Protection Certificates for XTANDI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1893196	13C0071	France		PRODUCT NAME: ENZALUTAMIDE OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/846 20130625
1893196	169 50005-2013	Slovakia		PRODUCT NAME: ENZALUTAMID; REGISTRATION NO/DATE: EU/1/13/846 20130621
1893196	CR 2013 00065	Denmark		PRODUCT NAME: ENZALUTAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/846 20130625