DrugPatentWatch Database Preview

XTANDI Drug Profile

« Back to Dashboard

When do Xtandi patents expire, and when can generic versions of Xtandi launch?

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 fifteen patent family members in twenty-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.

Summary for XTANDI

International Patents:	115
US Patents:	3
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	88
Clinical Trials:	102
Patent Applications:	135
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for XTANDI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for XTANDI
Prior Art and Litigation Support	Order Prior Art and Litigation support for XTANDI
DailyMed Link:	XTANDI at DailyMed

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.

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

Synonyms for XTANDI

4-(3-(4-Cyano-3-(trifluoromethyl)phenyl)-5,5-dimethyl-4-oxo-2-thioxoimidazolidin-1-yl)-2-fluoro-N-me

4-(3-(4-cyano-3-(trifluoromethyl)phenyl)-5,5-dimethyl-4-oxo-2-thioxoimidazolidin-1-yl)-2-fluoro-N-methylbenzamide

4-[3-[4-cyano-3-(trifluoromethyl)phenyl]-5,5-dimethyl-4-oxo-2-thioxo-imidazolidin-1-yl]-2-fluoro-N-methyl-benzamide

4-{3-[4-cyano-3-(trifluoromethyl)phenyl]-5,5-dimethyl-4-oxo-2-sulfanylideneimidazolidin-1-yl}-2-fluoro-N-methylbenzamide

4-{3-[4-cyano-3-(trifluoromethyl)phenyl]-5,5-dimethyl-4-oxo-2-thioxoimidazolidin-1-yl}-2-fluoro-N-methylbenzamide

915087-33-1

93T0T9GKNU

A25302

AB0008149

AB01565849_02

ABP000459

AC-26924

ACN-026804

AK-72825

AKOS015851022

AMX10212

AN-16279

ANW-54164

AOB87731

API0007596

AS-17047

ASP-9785

AX8165432

BBL102957

BC660065

BCP9000901

BCPP000169

BDBM50425732

Benzamide, 4-(3-(4-cyano-3-(trifluoromethyl)phenyl)-5,5-dimethyl-4-oxo-2-thioxo-1-imidazolidinyl)-2-fluoro-N-methyl-

Benzamide,4-[3-[4-cyano-3-(trifluoromethyl)phenyl]-5,5-dimethyl-4-oxo-2-thioxo-1-imidazolidinyl]-2-fluoro-N-methyl-

BR-72825

BRD-K56851771-001-01-9

C21H16F4N4O2S

CHEBI:68534

CHEMBL1082407

CJ-18592

CS-0317

CTK8B6725

D10218

DB08899

Enzalutamide

Enzalutamide (JAN/USAN)

Enzalutamide (MDV3100)

Enzalutamide [USAN:INN]

EX-A046

FT-0670957

GTPL6812

HMS3654L07

HY-70002

J-519668

KB-53497

KS-0000079W

MDV 3100

MDV-3100

MDV-3100, 915087-33-1

MDV3100

MDV3100 (Enzalutamide)

MDV3100 Enzalutamide

MDV3100, AldrichCPR

MDV3100/MDV-3100

MLS006010067

MolPort-009-679-470

n-methyl-4-[3-(4-cyano-3-trifluoromethylphenyl)-5,5-dimethyl-4-oxo-2-thioxoimidazolidin-1-yl]-2-fluo

NC-54

NCGC00263120-01

PubChem19320

QCR-130

RL05765

S-3847

s1250

SB20413

SC-69109

SCHEMBL189749

SMR004701227

SR-01000941580

SR-01000941580-1

ST24028748

STL556766

SW219288-1

TC-142909

Tube704

UNII-93T0T9GKNU

W9480

WXCXUHSOUPDCQV-UHFFFAOYSA-N

Xtandi (TN)

ZINC34806477

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
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

Paragraph IV (Patent) Challenges for XTANDI

Drugname	Dosage	Strength	RLD	Date
	Capsules	40 mg

International Patents for XTANDI

Country	Patent Number	Estimated Expiration
Japan	2008540523
New Zealand	591119
South Korea	20140141676
Singapore	10201703816S

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	92338	Luxembourg		PRODUCT NAME: ENZALUTAMIDE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES (XTANDI); FIRST REGISTRATION DATE: 20130625
1893196	491	Finland
1893196	CA 2013 00065	Denmark		PRODUCT NAME: ENZALUTAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/846 20130625