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Enzalutamide - Generic Drug Details

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What are the generic sources for enzalutamide and what is the scope of freedom to operate?

Enzalutamide is the generic ingredient in one branded drug marketed by Astellas and is included in one NDA. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Enzalutamide has one hundred and twenty-three patent family members in twenty-eight countries.

There are nine drug master file entries for enzalutamide. One supplier is listed for this compound.

Summary for enzalutamide

International Patents:	123
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	9
Suppliers / Packagers:	1
Bulk Api Vendors:	96
Clinical Trials:	255
Patent Applications:	218
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for enzalutamide
DailyMed Link:	enzalutamide at DailyMed

Recent Clinical Trials for enzalutamide

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

Sponsor	Phase
PPD	Phase 2/Phase 3
Dr. Han Xu, President/CEO / PD / PI / Monitor / IRB Chair	Phase 2/Phase 3
Sir Mortimer B. Davis - Jewish General Hospital	Phase 2

See all enzalutamide clinical trials

Recent Litigation for enzalutamide

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Astellas Pharma Inc. v. Eugia Pharma Specialities Ltd.	2018-05-17
Astellas Pharma Inc. v. Roxane Laboratories, Inc.	2017-05-09
Astellas Pharma Inc. v. Apotex Inc.	2016-12-09

See all enzalutamide litigation

Pharmacology for enzalutamide

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 enzalutamide

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 (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

Xtandi (TN)

ZINC34806477

Paragraph IV (Patent) Challenges for ENZALUTAMIDE

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

US Patents and Regulatory Information for enzalutamide

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

International Patents for enzalutamide

Country	Patent Number	Estimated Expiration
Norway	341071
Russian Federation	2007146462
China	110003114
South Korea	20110041580
South Korea	102020721

Supplementary Protection Certificates for enzalutamide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1893196	C01893196/01	Switzerland		PRODUCT NAME: ENZALUTAMID; REGISTRATION NO/DATE: SWISSMEDIC 63040 03.12.2013
1893196	PA2013029,C1893196	Lithuania		PRODUCT NAME: ENZALUTAMIDUM; REGISTRATION NO/DATE: EU/1/13/846 20130625
1893196	C300632	Netherlands		PRODUCT NAME: ENZALUTAMIDE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION 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	491	Finland