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Last Updated: May 24, 2022

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 three patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and thirty-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.

DrugPatentWatch® Generic Entry Outlook for Xtandi

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

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

Recent Clinical Trials for XTANDI

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

SponsorPhase
Nuvation Bio Inc.Phase 1/Phase 2
Fudan UniversityPhase 2
Clarus TherapeuticsPhase 2

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 eight US patents and one FDA Regulatory Exclusivity.

Patents protecting XTANDI

Diarylhydantoin compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Treatment of hyperproliferative disorders with diarylhydantoin compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (CRPC).

Treatment of hyperproliferative disorders with diarylhydantoin compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER

Treatment of hyperproliferative disorders with diarylhydantoin compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PATIENTS WITH CASTRATION-RESISTANT PROSTATE CANCER (CRPC)

Treatment of hyperproliferative disorders with diarylhydantoin compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PATIENTS WITH CASTRATION-RESISTANT PROSTATE CANCER (CRPC)

Treatment of hyperproliferative disorders with diarylhydantoin compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (CRPC).

Treatment of hyperproliferative disorders with diarylhydantoin compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER

FDA Regulatory Exclusivity protecting XTANDI

TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (MCSPC)
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Astellas XTANDI enzalutamide TABLET;ORAL 213674-002 Aug 4, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Astellas XTANDI enzalutamide TABLET;ORAL 213674-001 Aug 4, 2020 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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: See Plans and Pricing

Patent: 07245022
Estimated Expiration: See Plans and Pricing

Austria

Patent: 1571
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0610359
Estimated Expiration: See Plans and Pricing

Patent: 0709682
Estimated Expiration: See Plans and Pricing

Canada

Patent: 08436
Estimated Expiration: See Plans and Pricing

Patent: 48139
Estimated Expiration: See Plans and Pricing

China

Patent: 1222922
Estimated Expiration: See Plans and Pricing

Patent: 1460467
Estimated Expiration: See Plans and Pricing

Patent: 2584712
Estimated Expiration: See Plans and Pricing

Patent: 2755318
Estimated Expiration: See Plans and Pricing

Patent: 5037273
Estimated Expiration: See Plans and Pricing

Patent: 0003114
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0120323
Estimated Expiration: See Plans and Pricing

Patent: 0150437
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 12798
Estimated Expiration: See Plans and Pricing

Patent: 16426
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 93196
Estimated Expiration: See Plans and Pricing

Patent: 44085
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 93196
Estimated Expiration: See Plans and Pricing

Patent: 13187
Estimated Expiration: See Plans and Pricing

Patent: 39196
Estimated Expiration: See Plans and Pricing

Patent: 44085
Estimated Expiration: See Plans and Pricing

Patent: 61871
Estimated Expiration: See Plans and Pricing

Patent: 20706
Estimated Expiration: See Plans and Pricing

Patent: 06162
Estimated Expiration: See Plans and Pricing

Patent: 70721
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 12856
Estimated Expiration: See Plans and Pricing

Patent: 24612
Estimated Expiration: See Plans and Pricing

Patent: 69321
Estimated Expiration: See Plans and Pricing

Patent: 77691
Estimated Expiration: See Plans and Pricing

Patent: 17103
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 300076
Estimated Expiration: See Plans and Pricing

Israel

Patent: 7328
Estimated Expiration: See Plans and Pricing

Patent: 4438
Estimated Expiration: See Plans and Pricing

Patent: 3812
Estimated Expiration: See Plans and Pricing

Patent: 3815
Estimated Expiration: See Plans and Pricing

Patent: 8880
Estimated Expiration: See Plans and Pricing

Japan

Patent: 44737
Estimated Expiration: See Plans and Pricing

Patent: 38753
Estimated Expiration: See Plans and Pricing

Patent: 50780
Estimated Expiration: See Plans and Pricing

Patent: 50217
Estimated Expiration: See Plans and Pricing

Patent: 34670
Estimated Expiration: See Plans and Pricing

Patent: 13535
Estimated Expiration: See Plans and Pricing

Patent: 08540523
Estimated Expiration: See Plans and Pricing

Patent: 09531449
Estimated Expiration: See Plans and Pricing

Patent: 11068653
Estimated Expiration: See Plans and Pricing

Patent: 12211190
Estimated Expiration: See Plans and Pricing

Patent: 12236843
Estimated Expiration: See Plans and Pricing

Patent: 13136642
Estimated Expiration: See Plans and Pricing

Patent: 15098497
Estimated Expiration: See Plans and Pricing

Patent: 15117244
Estimated Expiration: See Plans and Pricing

Patent: 16183200
Estimated Expiration: See Plans and Pricing

Patent: 17031223
Estimated Expiration: See Plans and Pricing

Patent: 17031224
Estimated Expiration: See Plans and Pricing

Patent: 18100292
Estimated Expiration: See Plans and Pricing

Patent: 19218352
Estimated Expiration: See Plans and Pricing

Patent: 21035970
Estimated Expiration: See Plans and Pricing

Luxembourg

Patent: 338
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 6924
Estimated Expiration: See Plans and Pricing

Patent: 07014132
Estimated Expiration: See Plans and Pricing

Patent: 08012492
Estimated Expiration: See Plans and Pricing

Patent: 19015200
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 992
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 4223
Estimated Expiration: See Plans and Pricing

Patent: 2374
Estimated Expiration: See Plans and Pricing

Patent: 1119
Estimated Expiration: See Plans and Pricing

Patent: 6260
Estimated Expiration: See Plans and Pricing

Patent: 0368
Estimated Expiration: See Plans and Pricing

Patent: 0355
Estimated Expiration: See Plans and Pricing

Patent: 1414
Estimated Expiration: See Plans and Pricing

Norway

Patent: 9997
Estimated Expiration: See Plans and Pricing

Patent: 1071
Estimated Expiration: See Plans and Pricing

Patent: 2490
Estimated Expiration: See Plans and Pricing

Patent: 17019
Estimated Expiration: See Plans and Pricing

Patent: 076401
Estimated Expiration: See Plans and Pricing

Patent: 084480
Estimated Expiration: See Plans and Pricing

Patent: 161996
Estimated Expiration: See Plans and Pricing

Patent: 170919
Estimated Expiration: See Plans and Pricing

Patent: 180225
Estimated Expiration: See Plans and Pricing

Poland

Patent: 93196
Estimated Expiration: See Plans and Pricing

Patent: 44085
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 93196
Estimated Expiration: See Plans and Pricing

Patent: 44085
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 48096
Estimated Expiration: See Plans and Pricing

Patent: 49993
Estimated Expiration: See Plans and Pricing

Patent: 38833
Estimated Expiration: See Plans and Pricing

Patent: 68972
Estimated Expiration: See Plans and Pricing

Patent: 07146462
Estimated Expiration: See Plans and Pricing

Patent: 08142728
Estimated Expiration: See Plans and Pricing

Patent: 12101095
Estimated Expiration: See Plans and Pricing

Patent: 17142159
Estimated Expiration: See Plans and Pricing

Patent: 18135606
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 274
Estimated Expiration: See Plans and Pricing

Patent: 967
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 0809
Estimated Expiration: See Plans and Pricing

Patent: 201408699T
Estimated Expiration: See Plans and Pricing

Patent: 201703816S
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 93196
Estimated Expiration: See Plans and Pricing

Patent: 44085
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0710870
Estimated Expiration: See Plans and Pricing

Patent: 0809098
Estimated Expiration: See Plans and Pricing

Patent: 1201793
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1169832
Estimated Expiration: See Plans and Pricing

Patent: 1332889
Estimated Expiration: See Plans and Pricing

Patent: 1332924
Estimated Expiration: See Plans and Pricing

Patent: 1431407
Estimated Expiration: See Plans and Pricing

Patent: 1456722
Estimated Expiration: See Plans and Pricing

Patent: 1515335
Estimated Expiration: See Plans and Pricing

Patent: 1519705
Estimated Expiration: See Plans and Pricing

Patent: 1579701
Estimated Expiration: See Plans and Pricing

Patent: 1600230
Estimated Expiration: See Plans and Pricing

Patent: 1782236
Estimated Expiration: See Plans and Pricing

Patent: 2020721
Estimated Expiration: See Plans and Pricing

Patent: 2324567
Estimated Expiration: See Plans and Pricing

Patent: 080014039
Estimated Expiration: See Plans and Pricing

Patent: 090009215
Estimated Expiration: See Plans and Pricing

Patent: 110041580
Estimated Expiration: See Plans and Pricing

Patent: 120102140
Estimated Expiration: See Plans and Pricing

Patent: 120102147
Estimated Expiration: See Plans and Pricing

Patent: 130060369
Estimated Expiration: See Plans and Pricing

Patent: 140041831
Estimated Expiration: See Plans and Pricing

Patent: 140141676
Estimated Expiration: See Plans and Pricing

Patent: 150008506
Estimated Expiration: See Plans and Pricing

Patent: 150086567
Estimated Expiration: See Plans and Pricing

Patent: 160027254
Estimated Expiration: See Plans and Pricing

Patent: 170107585
Estimated Expiration: See Plans and Pricing

Patent: 190104244
Estimated Expiration: See Plans and Pricing

Patent: 210136161
Estimated Expiration: See Plans and Pricing

Spain

Patent: 78778
Estimated Expiration: See Plans and Pricing

Patent: 35179
Estimated Expiration: See Plans and Pricing

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
South Korea 20150086567 디아릴히단토인 화합물 (DIARYLHYDANTOIN COMPOUNDS) See Plans and Pricing
South Korea 20210136161 디아릴히단토인 화합물 (DIARYLHYDANTOIN COMPOUNDS) See Plans and Pricing
Croatia P20120323 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for XTANDI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1893196 13C0071 France See Plans and Pricing PRODUCT NAME: ENZALUTAMIDE OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/846 20130625
1893196 169 50005-2013 Slovakia See Plans and Pricing PRODUCT NAME: ENZALUTAMID; REGISTRATION NO/DATE: EU/1/13/846 20130621
1893196 CR 2013 00065 Denmark See Plans and Pricing 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

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

Serving leading biopharmaceutical companies globally:

McKinsey
Merck
Mallinckrodt
Express Scripts
McKesson
Moodys

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.