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Last Updated: January 24, 2020

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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 twenty-three patent family members in twenty-eight 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.

US ANDA Litigation and Generic Entry Outlook for Xtandi

Xtandi was eligible for patent challenges on August 31, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 13, 2027. This may change due to patent challenges or generic licensing.

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for XTANDI
Drug Prices for XTANDI

See drug prices 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.

Recent Clinical Trials for XTANDI

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

SponsorPhase
Clovis Oncology, Inc.Phase 1
BayerPhase 2
Zenith EpigeneticsPhase 1/Phase 2

See all XTANDI clinical trials

Recent Litigation for XTANDI

Identify potential future generic entrants

District Court Litigation
Case NameDate
Astellas Pharma Inc. v. Eugia Pharma Specialities Ltd.2018-05-17
Degui Chen v. Michael E. Jung2018-03-12
Astellas Pharma Inc. v. Roxane Laboratories, Inc.2017-05-09

See all XTANDI litigation

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
Paragraph IV (Patent) Challenges for XTANDI
Tradename Dosage Ingredient NDA Submissiondate
XTANDI CAPSULE;ORAL enzalutamide 203415 2016-08-31

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

Supplementary Protection Certificates for XTANDI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1893196 CR 2013 00065 Denmark   Start Trial PRODUCT NAME: ENZALUTAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/846 20130625
1893196 C 2013 041 Romania   Start Trial 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 PA2013029 Lithuania   Start Trial PRODUCT NAME: ENZALUTAMIDUM; REGISTRATION NO/DATE: EU/1/13/846 20130621
1893196 2013/061 Ireland   Start Trial PRODUCT NAME: ENZALUTAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/846 20130625
1893196 491 Finland   Start Trial
1893196 CA 2013 00065 Denmark   Start Trial PRODUCT NAME: ENZALUTAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/846 20130625
1893196 169 50005-2013 Slovakia   Start Trial PRODUCT NAME: ENZALUTAMID; REGISTRATION NO/DATE: EU/1/13/846 20130621
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Merck
Colorcon
AstraZeneca
Medtronic
Mallinckrodt

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