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XTANDI Drug Profile

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

Xtandi is a drug marketed by Astellas and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and twenty-five 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.

US ANDA Litigation and Generic Entry Outlook for Xtandi

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

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 13, 2027. 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 XTANDI

International Patents:	125
US Patents:	3
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	99
Clinical Trials:	121
Patent Applications:	165
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for XTANDI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for XTANDI
DailyMed Link:	XTANDI at DailyMed

See drug prices for XTANDI

Generic Entry Opportunity Date for XTANDI

NDA:

203415

Dosage:

CAPSULE;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 XTANDI

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

Sponsor	Phase
Oncology Institute of Southern Switzerland	Phase 2
MedSIR	Phase 2
Institute for Research in Biomedicine	Phase 2

See all XTANDI clinical trials

Pharmacology for XTANDI

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

Paragraph IV (Patent) Challenges for XTANDI

Tradename	Dosage	Ingredient	NDA	Submissiondate
XTANDI	CAPSULE;ORAL	enzalutamide	203415	2016-08-31

US Patents and Regulatory Information for 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	CAPSULE;ORAL	203415-001	Aug 31, 2012		RX	Yes	Yes			Y	Y
Astellas	XTANDI	enzalutamide	CAPSULE;ORAL	203415-001	Aug 31, 2012		RX	Yes	Yes
Astellas	XTANDI	enzalutamide	CAPSULE;ORAL	203415-001	Aug 31, 2012		RX	Yes	Yes

International Patents for XTANDI

Country	Patent Number	Estimated Expiration
Japan	2012236843
Canada	2648139
Norway	341071
South Korea	20150008506

Supplementary Protection Certificates for XTANDI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1893196	122013000155	Germany		PRODUCT NAME: ENZALUTAMID ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ HIERVON; REGISTRATION NO/DATE: EU/1/13/846 20130621
1893196	PA2013029,C1893196	Lithuania		PRODUCT NAME: ENZALUTAMIDUM; REGISTRATION NO/DATE: EU/1/13/846 20130625
1893196	SPC/GB13/079	United Kingdom		PRODUCT NAME: ENZLUTAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/13/846 20130625
1893196	70/2013	Austria		PRODUCT NAME: ENZALUTAMID; REGISTRATION NO/DATE: EU/1/13/836 20130621