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XTANDI Drug Profile

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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 nine patent family members in twenty-five 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:	109
US Patents:	3
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	80
Clinical Trials:	93
Patent Applications:	113
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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

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

D0M1YR

D0QK5X

D10218

DB08899

Enzalutamide

Enzalutamide (AR inhibitor)

Enzalutamide (JAN/USAN)

Enzalutamide (MDV3100)

Enzalutamide [USAN:INN]

EX-A046

FT-0670957

GTPL6812

HE069450

HMS3654L07

HY-70002

J-519668

KB-53497

KS-0000079W

MDV 3100

MDV-3100

MDV-3100, 915087-33-1

MDV3100

MDV3100 (Enzalutamide)

MDV3100 Enzalutamide

MDV3100, 95%

MDV3100, AldrichCPR

MDV3100/MDV-3100

MDV3101

MFCD14155804

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

SC-69109

SCHEMBL189749

SMR004701227

SR-01000941580

SR-01000941580-1

ST24028748

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			Y	Y
Astellas	XTANDI	enzalutamide	CAPSULE;ORAL	203415-001	Aug 31, 2012		RX	Yes	Yes

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Paragraph IV (Patent) Challenges for XTANDI

Drugname	Dosage	Strength	RLD	Date
	Capsules	40 mg

Non-Orange Book US Patents for XTANDI

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
8,110,594	Diarylthiohydantoin compounds
8,648,105	Diarylthiohydantoin compounds

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International Patents for XTANDI

Country	Document Number	Estimated Expiration
Brazil	PI0610359
Japan	5350217
Japan	5138753
Hong Kong	1112856

Supplementary Protection Certificates for XTANDI

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0130036 00106	Estonia		PRODUCT NAME: ENSALUTAMIID;REG NO/DATE: K(2013)4019 (LOPLIK) 25.06.2013
2013 00065	Denmark		PRODUCT NAME: ENZALUTAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/846 20130625
C0071	France		PRODUCT NAME: ENZALUTAMIDE OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/846 20130625
13/061	Ireland		PRODUCT NAME: ENZALUTAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/846 20130625