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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Johnson and Johnson
Boehringer Ingelheim
Citi
US Department of Justice
Baxter
US Army
Daiichi Sankyo
Moodys

Generated: July 21, 2018

DrugPatentWatch Database Preview

Enzalutamide - Generic Drug Details

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What are the generic sources for enzalutamide and what is the scope of enzalutamide 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 nine patent family members in twenty-five countries.

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

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 ➤ Sign Up
Astellas XTANDI enzalutamide CAPSULE;ORAL 203415-001 Aug 31, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ 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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Non-Orange Book US Patents for enzalutamide

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 ➤ Sign Up
8,648,105 Diarylthiohydantoin compounds ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for enzalutamide

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2013 00065 Denmark ➤ Sign Up PRODUCT NAME: ENZALUTAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/846 20130625
1893196/01 Switzerland ➤ Sign Up PRODUCT NAME: ENZALUTAMID; REGISTRATION NO/DATE: SWISSMEDIC 63040 03.12.2013
C0071 France ➤ Sign Up PRODUCT NAME: ENZALUTAMIDE OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/846 20130625
2013000155 Germany ➤ Sign Up PRODUCT NAME: ENZALUTAMID ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ HIERVON; REGISTRATION NO/DATE: EU/1/13/846 20130621
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Daiichi Sankyo
Moodys
UBS
AstraZeneca
Colorcon
Citi
Chubb
Boehringer Ingelheim

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.