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Covington
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Generated: April 25, 2019

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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 fifteen patent family members in twenty-six 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.

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
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
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 (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

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1893196 122013000155 Germany ➤ Try a Free Trial PRODUCT NAME: ENZALUTAMID ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ HIERVON; REGISTRATION NO/DATE: EU/1/13/846 20130621
1893196 92338 Luxembourg ➤ Try a Free Trial PRODUCT NAME: ENZALUTAMIDE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES (XTANDI); FIRST REGISTRATION DATE: 20130625
1893196 491 Finland ➤ Try a Free Trial
1893196 CA 2013 00065 Denmark ➤ Try a Free Trial PRODUCT NAME: ENZALUTAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/846 20130625
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
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Chubb
Deloitte
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Merck

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