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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Farmers Insurance
Julphar
Merck
Queensland Health
Argus Health
Colorcon
Federal Trade Commission
Fish and Richardson

Generated: November 19, 2018

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XTANDI Drug Profile

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Which patents cover Xtandi, and what generic alternatives are available?

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.

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.

Drug patent expirations by year for XTANDI
Generic Entry Opportunity Date for XTANDI
Generic Entry Date for XTANDI*:
Constraining patent/regulatory exclusivity:
NDA:
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.

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 ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Astellas XTANDI enzalutamide CAPSULE;ORAL 203415-001 Aug 31, 2012 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Astellas XTANDI enzalutamide CAPSULE;ORAL 203415-001 Aug 31, 2012 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Astellas XTANDI enzalutamide CAPSULE;ORAL 203415-001 Aug 31, 2012 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
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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Paragraph IV (Patent) Challenges for XTANDI
Drugname Dosage Strength RLD Date
➤ Subscribe Capsules 40 mg ➤ Subscribe ➤ Try a Free Trial

Supplementary Protection Certificates for XTANDI

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1893196/01 Switzerland ➤ Try a Free Trial PRODUCT NAME: ENZALUTAMID; REGISTRATION NO/DATE: SWISSMEDIC 63040 03.12.2013
90060-0 Sweden ➤ Try a Free Trial PRODUCT NAME: ENZALUTAMID OCH FARMACEUTISKT ACCEPTABLA SALTER DAERAV; REG. NO/DATE: EU/1/13/846 20130621
2013 00065 Denmark ➤ Try a Free Trial PRODUCT NAME: ENZALUTAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/846 20130625
9 50005-2013 Slovakia ➤ Try a Free Trial PRODUCT NAME: ENZALUTAMID; REGISTRATION NO/DATE: EU/1/13/846 20130621
13/061 Ireland ➤ Try a Free Trial PRODUCT NAME: ENZALUTAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/846 20130625
2013029,C1893196 Lithuania ➤ Try a Free Trial PRODUCT NAME: ENZALUTAMIDUM; REGISTRATION NO/DATE: EU/1/13/846 20130625
338 Luxembourg ➤ Try a Free Trial PRODUCT NAME: ENZALUTAMIDE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES (XTANDI); FIRST REGISTRATION DATE: 20130625
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Farmers Insurance
Julphar
Merck
Queensland Health
Argus Health
Colorcon
Federal Trade Commission
Fish and Richardson

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.