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Last Updated: March 19, 2024

XTANDI Drug Patent 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 two NDAs. There are four patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and eighty-three patent family members in thirty-four 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.

DrugPatentWatch® Generic Entry Outlook for Xtandi

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

There have been eight 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.

There is one tentative approval for the generic drug (enzalutamide), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for XTANDI
Drug Prices for XTANDI

See drug prices for XTANDI

Recent Clinical Trials for XTANDI

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

SponsorPhase
University of ChicagoPhase 2
Emory UniversityPhase 1
Xencor, Inc.Phase 1

See all XTANDI clinical trials

Paragraph IV (Patent) Challenges for XTANDI
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
XTANDI Tablets enzalutamide 40 mg and 80 mg 213674 1 2021-03-31
XTANDI Capsules enzalutamide 40 mg 203415 3 2016-08-31

US Patents and Regulatory Information for XTANDI

XTANDI is protected by eleven US patents and one FDA Regulatory Exclusivity.

Patents protecting XTANDI


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Diarylhydantoin compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Treatment of hyperproliferative disorders with diarylhydantoin compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER WHO HAVE PREVIOUSLY RECEIVED DOCETAXEL

Treatment of hyperproliferative disorders with diarylhydantoin compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (CRPC).

Treatment of hyperproliferative disorders with diarylhydantoin compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER

Treatment of hyperproliferative disorders with diarylhydantoin compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PATIENTS WITH CASTRATION-RESISTANT PROSTATE CANCER (CRPC)

Treatment of hyperproliferative disorders with diarylhydantoin compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PATIENTS WITH NON-METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (NMCSPC) WITH BIOCHEMICAL RECURRENCE (BCR) AT HIGH RISK FOR METASTASIS

Treatment of hyperproliferative disorders with diarylhydantoin compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PATIENTS WITH CASTRATION-RESISTANT PROSTATE CANCER (CRPC)

Treatment of hyperproliferative disorders with diarylhydantoin compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (CRPC).

Treatment of hyperproliferative disorders with diarylhydantoin compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER

Treatment of hyperproliferative disorders with diarylhydantoin compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PATIENTS WITH NON-METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (NMCSPC) WITH BIOCHEMICAL RECURRENCE (BCR) AT HIGH RISK FOR METASTASIS

FDA Regulatory Exclusivity protecting XTANDI

TREATMENT OF PATIENTS WITH NON-METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (NMCSPC) WITH BIOCHEMICAL RECURRENCE AT HIGH RISK FOR METASTASIS
Exclusivity Expiration: ⤷  Try a Trial

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 TABLET;ORAL 213674-002 Aug 4, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Astellas XTANDI enzalutamide TABLET;ORAL 213674-002 Aug 4, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Astellas XTANDI enzalutamide CAPSULE;ORAL 203415-001 Aug 31, 2012 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for XTANDI

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Astellas Pharma Europe B.V. Xtandi enzalutamide EMEA/H/C/002639
Xtandi is indicated for:the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (see section 5.1).the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1).the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1).the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.
Authorised no no no 2013-06-21 2013-04-26
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for XTANDI

When does loss-of-exclusivity occur for XTANDI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 06248109
Estimated Expiration: ⤷  Try a Trial

Patent: 07245022
Estimated Expiration: ⤷  Try a Trial

Austria

Patent: 41571
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0610359
Estimated Expiration: ⤷  Try a Trial

Patent: 0709682
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 08436
Estimated Expiration: ⤷  Try a Trial

Patent: 48139
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1222922
Estimated Expiration: ⤷  Try a Trial

Patent: 1460467
Estimated Expiration: ⤷  Try a Trial

Patent: 2584712
Estimated Expiration: ⤷  Try a Trial

Patent: 2755318
Estimated Expiration: ⤷  Try a Trial

Patent: 5037273
Estimated Expiration: ⤷  Try a Trial

Patent: 0003114
Estimated Expiration: ⤷  Try a Trial

Patent: 6003328
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0120323
Estimated Expiration: ⤷  Try a Trial

Patent: 0150437
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 12798
Estimated Expiration: ⤷  Try a Trial

Patent: 16426
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 93196
Estimated Expiration: ⤷  Try a Trial

Patent: 44085
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 93196
Estimated Expiration: ⤷  Try a Trial

Patent: 13187
Estimated Expiration: ⤷  Try a Trial

Patent: 39196
Estimated Expiration: ⤷  Try a Trial

Patent: 44085
Estimated Expiration: ⤷  Try a Trial

Patent: 61871
Estimated Expiration: ⤷  Try a Trial

Patent: 20706
Estimated Expiration: ⤷  Try a Trial

Patent: 06162
Estimated Expiration: ⤷  Try a Trial

Patent: 70721
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 12856
Estimated Expiration: ⤷  Try a Trial

Patent: 24612
Estimated Expiration: ⤷  Try a Trial

Patent: 69321
Estimated Expiration: ⤷  Try a Trial

Patent: 77691
Estimated Expiration: ⤷  Try a Trial

Patent: 17103
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 300076
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 7328
Estimated Expiration: ⤷  Try a Trial

Patent: 4438
Estimated Expiration: ⤷  Try a Trial

Patent: 8880
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 44737
Estimated Expiration: ⤷  Try a Trial

Patent: 38753
Estimated Expiration: ⤷  Try a Trial

Patent: 50780
Estimated Expiration: ⤷  Try a Trial

Patent: 50217
Estimated Expiration: ⤷  Try a Trial

Patent: 34670
Estimated Expiration: ⤷  Try a Trial

Patent: 13535
Estimated Expiration: ⤷  Try a Trial

Patent: 08540523
Estimated Expiration: ⤷  Try a Trial

Patent: 09531449
Estimated Expiration: ⤷  Try a Trial

Patent: 11068653
Estimated Expiration: ⤷  Try a Trial

Patent: 12211190
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Patent: 12236843
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Patent: 13136642
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Patent: 15098497
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Patent: 15117244
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Patent: 16183200
Estimated Expiration: ⤷  Try a Trial

Patent: 17031223
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Patent: 17031224
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Patent: 18100292
Estimated Expiration: ⤷  Try a Trial

Patent: 19218352
Estimated Expiration: ⤷  Try a Trial

Patent: 21035970
Estimated Expiration: ⤷  Try a Trial

Patent: 22101657
Estimated Expiration: ⤷  Try a Trial

Patent: 23075313
Estimated Expiration: ⤷  Try a Trial

Luxembourg

Patent: 338
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 6924
Estimated Expiration: ⤷  Try a Trial

Patent: 07014132
Estimated Expiration: ⤷  Try a Trial

Patent: 08012492
Estimated Expiration: ⤷  Try a Trial

Patent: 19015200
Estimated Expiration: ⤷  Try a Trial

Patent: 22009759
Estimated Expiration: ⤷  Try a Trial

Montenegro

Patent: 992
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 4223
Estimated Expiration: ⤷  Try a Trial

Patent: 2374
Estimated Expiration: ⤷  Try a Trial

Patent: 1119
Estimated Expiration: ⤷  Try a Trial

Patent: 6260
Estimated Expiration: ⤷  Try a Trial

Patent: 0368
Estimated Expiration: ⤷  Try a Trial

Patent: 0355
Estimated Expiration: ⤷  Try a Trial

Patent: 1414
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 9997
Estimated Expiration: ⤷  Try a Trial

Patent: 1071
Estimated Expiration: ⤷  Try a Trial

Patent: 2490
Estimated Expiration: ⤷  Try a Trial

Patent: 17019
Estimated Expiration: ⤷  Try a Trial

Patent: 076401
Estimated Expiration: ⤷  Try a Trial

Patent: 084480
Estimated Expiration: ⤷  Try a Trial

Patent: 161996
Estimated Expiration: ⤷  Try a Trial

Patent: 170919
Estimated Expiration: ⤷  Try a Trial

Patent: 180225
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 93196
Estimated Expiration: ⤷  Try a Trial

Patent: 44085
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 93196
Estimated Expiration: ⤷  Try a Trial

Patent: 44085
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 48096
Estimated Expiration: ⤷  Try a Trial

Patent: 49993
Estimated Expiration: ⤷  Try a Trial

Patent: 38833
Estimated Expiration: ⤷  Try a Trial

Patent: 68972
Estimated Expiration: ⤷  Try a Trial

Patent: 07146462
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Patent: 08142728
Estimated Expiration: ⤷  Try a Trial

Patent: 12101095
Estimated Expiration: ⤷  Try a Trial

Patent: 17142159
Estimated Expiration: ⤷  Try a Trial

Patent: 18135606
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 274
Estimated Expiration: ⤷  Try a Trial

Patent: 967
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 0809
Estimated Expiration: ⤷  Try a Trial

Patent: 201408699T
Estimated Expiration: ⤷  Try a Trial

Patent: 201703816S
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 93196
Estimated Expiration: ⤷  Try a Trial

Patent: 44085
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 0710870
Estimated Expiration: ⤷  Try a Trial

Patent: 0809098
Estimated Expiration: ⤷  Try a Trial

Patent: 1201793
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1169832
Estimated Expiration: ⤷  Try a Trial

Patent: 1332889
Estimated Expiration: ⤷  Try a Trial

Patent: 1332924
Estimated Expiration: ⤷  Try a Trial

Patent: 1431407
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Patent: 1456722
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Patent: 1515335
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Patent: 1519705
Estimated Expiration: ⤷  Try a Trial

Patent: 1579701
Estimated Expiration: ⤷  Try a Trial

Patent: 1600230
Estimated Expiration: ⤷  Try a Trial

Patent: 1782236
Estimated Expiration: ⤷  Try a Trial

Patent: 2020721
Estimated Expiration: ⤷  Try a Trial

Patent: 2324567
Estimated Expiration: ⤷  Try a Trial

Patent: 2481886
Estimated Expiration: ⤷  Try a Trial

Patent: 080014039
Estimated Expiration: ⤷  Try a Trial

Patent: 090009215
Estimated Expiration: ⤷  Try a Trial

Patent: 110041580
Estimated Expiration: ⤷  Try a Trial

Patent: 120102140
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Patent: 120102147
Estimated Expiration: ⤷  Try a Trial

Patent: 130060369
Estimated Expiration: ⤷  Try a Trial

Patent: 140041831
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Patent: 140141676
Estimated Expiration: ⤷  Try a Trial

Patent: 150008506
Estimated Expiration: ⤷  Try a Trial

Patent: 150086567
Estimated Expiration: ⤷  Try a Trial

Patent: 160027254
Estimated Expiration: ⤷  Try a Trial

Patent: 170107585
Estimated Expiration: ⤷  Try a Trial

Patent: 190104244
Estimated Expiration: ⤷  Try a Trial

Patent: 210136161
Estimated Expiration: ⤷  Try a Trial

Patent: 230003445
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 78778
Estimated Expiration: ⤷  Try a Trial

Patent: 35179
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering XTANDI around the world.

Country Patent Number Title Estimated Expiration
Japan 2013136642 DIARYLTHIOHYDANTOIN COMPOUNDS ⤷  Try a Trial
South Korea 20110041580 DIARYLHYDANTOIN COMPOUNDS ⤷  Try a Trial
Norway 20076401 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for XTANDI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1893196 2013/061 Ireland ⤷  Try a Trial PRODUCT NAME: ENZALUTAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/846 20130625
1893196 PA2013029,C1893196 Lithuania ⤷  Try a Trial PRODUCT NAME: ENZALUTAMIDUM; REGISTRATION NO/DATE: EU/1/13/846 20130625
1893196 13C0071 France ⤷  Try a Trial PRODUCT NAME: ENZALUTAMIDE OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/846 20130625
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.