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Enzalutamide - Generic Drug Details

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What are the generic drug sources for enzalutamide and what is the scope of enzalutamide patent protection?

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.

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

Summary for enzalutamide

US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	9
Suppliers / Packagers:	1
Bulk Api Vendors:	81
Clinical Trials:	188
Patent Applications:	180
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for enzalutamide
DailyMed Link:	enzalutamide at DailyMed

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
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 (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
Xtandi (TN)
ZINC34806477

US Patents and Regulatory Information for enzalutamide

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Glossary

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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	➤ Sign Up	➤ Sign Up				➤ Sign Up
Astellas	XTANDI	enzalutamide	CAPSULE;ORAL	203415-001	Aug 31, 2012		RX	Yes	Yes	➤ Sign Up	➤ Sign Up	Y	Y		➤ Sign Up
Astellas	XTANDI	enzalutamide	CAPSULE;ORAL	203415-001	Aug 31, 2012		RX	Yes	Yes	➤ Sign Up	➤ Sign Up				➤ Sign Up
Astellas	XTANDI	enzalutamide	CAPSULE;ORAL	203415-001	Aug 31, 2012		RX	Yes	Yes	➤ Sign Up	➤ Sign Up				➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration

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International Patents for enzalutamide

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Country	Document Number	Estimated Expiration
New Zealand	564223	➤ Sign Up
South Korea	101431407	➤ Sign Up
Norway	20084480	➤ Sign Up
South Korea	101332924	➤ Sign Up
Hong Kong	1124612	➤ Sign Up
Japan	5350217	➤ Sign Up
World Intellectual Property Organization (WIPO)	2007127010	➤ Sign Up
Country	Document Number	Estimated Expiration

Supplementary Protection Certificates for enzalutamide

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Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
90060-0	Sweden	➤ Sign Up	PRODUCT NAME: ENZALUTAMID OCH FARMACEUTISKT ACCEPTABLA SALTER DAERAV; REG. NO/DATE: EU/1/13/846 20130621
1	Finland	➤ Sign Up
2013 00065	Denmark	➤ Sign Up	PRODUCT NAME: ENZALUTAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/846 20130625
2013029,C1893196	Lithuania	➤ Sign Up	PRODUCT NAME: ENZALUTAMIDUM; REGISTRATION NO/DATE: EU/1/13/846 20130625
13/061	Ireland	➤ Sign Up	PRODUCT NAME: ENZALUTAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/846 20130625
2013 00065	Denmark	➤ Sign Up	PRODUCT NAME: ENZALUTAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/846 20130625
0130036 00106	Estonia	➤ Sign Up	PRODUCT NAME: ENSALUTAMIID;REG NO/DATE: K(2013)4019 (LOPLIK) 25.06.2013
Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description