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 seven patents protecting this drug and three Paragraph IV challenges.

This drug has one hundred and ninety-two patent family members in thirty-six 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 nine 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 are three tentative approvals for the generic drug (enzalutamide), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for XTANDI

International Patents:	192
US Patents:	7
Applicants:	1
NDAs:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for XTANDI

Paragraph IV (Patent) Challenges for XTANDI

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
XTANDI	Tablets	enzalutamide	120 mg and 160 mg	213674	1	2024-12-27
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 twenty-one US patents and one FDA Regulatory Exclusivity.

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	TABLET;ORAL	213674-002	Aug 4, 2020		RX	Yes	Yes	12,502,357
Astellas	XTANDI	enzalutamide	TABLET;ORAL	213674-002	Aug 4, 2020		RX	Yes	Yes	7,709,517		Y	Y
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	7,709,517		Y	Y

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:

Canada

Israel

Russian Federation

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
Cyprus	2013047
Mexico	363974	FORMULACIONES DE ENZALUTAMIDA. (FORMULATIONS OF ENZALUTAMIDE.)
Lithuania	3725778
China	102755318	Hyperproliferative disorders with diarylhydantoin compounds

Supplementary Protection Certificates for XTANDI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1893196	SPC/GB13/079	United Kingdom		PRODUCT NAME: ENZLUTAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/13/846 20130625
1893196	1390060-0	Sweden		PRODUCT NAME: ENZALUTAMID OCH FARMACEUTISKT ACCEPTABLA SALTER DAERAV; REG. NO/DATE: EU/1/13/846 20130621
1893196	C 2013 041	Romania		PRODUCT NAME: ENZALUTAMIDA SAU O SARE ACCEPTABILA FARMACEUTIC AACESTEIA; NATIONAL AUTHORISATION NUMBER: EU/1/13/846; DATE OF NATIONAL AUTHORISATION: 20130621; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/846; DATE OF FIRST AUTHORISATION IN EEA: 20130621
1893196	2013C/074	Belgium		PRODUCT NAME: ENZALUTAMIDE (ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/13/846 20130625