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Last Updated: June 1, 2024

xtandi Drug Patent Profile


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Which patents cover Xtandi, and when can generic versions of Xtandi launch?

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-four 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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Summary for xtandi
International Patents:184
US Patents:4
Applicants:1
NDAs:2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 122
Clinical Trials: 150
Patent Applications: 2,309
Formulation / Manufacturing:see details
Drug Prices: Drug price information for xtandi
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for xtandi
What excipients (inactive ingredients) are in xtandi?xtandi excipients list
DailyMed Link:xtandi at DailyMed
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

Pharmacology for xtandi
Drug ClassAndrogen Receptor Inhibitor
Mechanism of ActionAndrogen Receptor Antagonists
Cytochrome P450 2C19 Inducers
Cytochrome P450 2C9 Inducers
Cytochrome P450 3A4 Inducers
Anatomical Therapeutic Chemical (ATC) Classes for xtandi
L02BB Anti-androgens
L02B HORMONE ANTAGONISTS AND RELATED AGENTS
L02 ENDOCRINE THERAPY
L Antineoplastic and immunomodulating agents
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


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Diarylhydantoin compounds
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Treatment of hyperproliferative disorders with diarylhydantoin compounds
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Patented Use: THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER WHO HAVE PREVIOUSLY RECEIVED DOCETAXEL

Treatment of hyperproliferative disorders with diarylhydantoin compounds
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Patented Use: THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (CRPC).

Treatment of hyperproliferative disorders with diarylhydantoin compounds
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Patented Use: THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER

Treatment of hyperproliferative disorders with diarylhydantoin compounds
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Patented Use: TREATMENT OF PATIENTS WITH CASTRATION-RESISTANT PROSTATE CANCER (CRPC)

Treatment of hyperproliferative disorders with diarylhydantoin compounds
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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
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Patented Use: TREATMENT OF PATIENTS WITH CASTRATION-RESISTANT PROSTATE CANCER (CRPC)

Treatment of hyperproliferative disorders with diarylhydantoin compounds
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Patented Use: THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (CRPC).

Treatment of hyperproliferative disorders with diarylhydantoin compounds
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Patented Use: THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER

Treatment of hyperproliferative disorders with diarylhydantoin compounds
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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
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Glossary
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 ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Astellas XTANDI enzalutamide TABLET;ORAL 213674-002 Aug 4, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Astellas XTANDI enzalutamide CAPSULE;ORAL 203415-001 Aug 31, 2012 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Astellas XTANDI enzalutamide TABLET;ORAL 213674-001 Aug 4, 2020 RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Astellas XTANDI enzalutamide TABLET;ORAL 213674-001 Aug 4, 2020 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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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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

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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
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Patent: 07245022
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Austria

Patent: 41571
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Brazil

Patent: 0610359
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Patent: 0709682
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Canada

Patent: 08436
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Patent: 48139
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China

Patent: 1222922
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Patent: 1460467
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Patent: 2584712
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Patent: 2755318
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Patent: 5037273
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Patent: 0003114
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Patent: 6003328
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Croatia

Patent: 0120323
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Patent: 0150437
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Cyprus

Patent: 12798
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Patent: 16426
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Denmark

Patent: 93196
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Patent: 44085
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European Patent Office

Patent: 93196
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Patent: 13187
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Patent: 39196
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Patent: 44085
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Patent: 61871
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Patent: 20706
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Patent: 06162
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Patent: 70721
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Hong Kong

Patent: 12856
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Patent: 24612
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Patent: 69321
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Patent: 77691
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Patent: 17103
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Hungary

Patent: 300076
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Israel

Patent: 7328
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Patent: 4438
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Patent: 8880
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Japan

Patent: 44737
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Patent: 38753
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Patent: 50780
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Patent: 50217
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Patent: 34670
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Patent: 13535
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Patent: 08540523
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Patent: 09531449
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Patent: 11068653
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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
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Patent: 17031223
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Patent: 17031224
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Patent: 18100292
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Patent: 19218352
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Patent: 21035970
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Patent: 22101657
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Patent: 23075313
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Luxembourg

Patent: 338
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Mexico

Patent: 6924
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Patent: 07014132
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Patent: 08012492
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Patent: 19015200
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Patent: 22009759
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Montenegro

Patent: 992
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New Zealand

Patent: 4223
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Patent: 2374
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Patent: 1119
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Patent: 6260
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Patent: 0368
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Patent: 0355
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Patent: 1414
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Norway

Patent: 9997
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Patent: 1071
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Patent: 2490
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Patent: 17019
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Patent: 076401
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Patent: 084480
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Patent: 161996
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Patent: 170919
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Patent: 180225
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Poland

Patent: 93196
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Patent: 44085
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Portugal

Patent: 93196
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Patent: 44085
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Russian Federation

Patent: 48096
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Patent: 49993
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Patent: 38833
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Patent: 68972
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Patent: 07146462
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Patent: 08142728
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Patent: 12101095
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Patent: 17142159
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Patent: 18135606
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Serbia

Patent: 274
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Patent: 967
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Singapore

Patent: 0809
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Patent: 201408699T
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Patent: 201703816S
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Slovenia

Patent: 93196
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Patent: 44085
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South Africa

Patent: 0710870
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Patent: 0809098
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Patent: 1201793
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South Korea

Patent: 1169832
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Patent: 1332889
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Patent: 1332924
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Patent: 1431407
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Patent: 1456722
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Patent: 1515335
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Patent: 1519705
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Patent: 1579701
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Patent: 1600230
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Patent: 1782236
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Patent: 2020721
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Patent: 2324567
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Patent: 2481886
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Patent: 080014039
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Patent: 090009215
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Patent: 110041580
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Patent: 120102140
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Patent: 120102147
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Patent: 130060369
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Patent: 140041831
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Patent: 140141676
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Patent: 150008506
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Patent: 150086567
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Patent: 160027254
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Patent: 170107585
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Patent: 190104244
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Patent: 210136161
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Patent: 230003445
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Spain

Patent: 78778
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Patent: 35179
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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
Mexico 363974 FORMULACIONES DE ENZALUTAMIDA. (FORMULATIONS OF ENZALUTAMIDE.) ⤷  Sign Up
Norway 20076401 ⤷  Sign Up
Japan 2016204392 エンザルタミドの製剤 (FORMULATIONS OF ENZALUTAMIDE) ⤷  Sign Up
Cyprus 1116426 ⤷  Sign Up
Japan 2011068653 DIARYLHYDANTOIN COMPOUND ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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Supplementary Protection Certificates for xtandi

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1893196 92338 Luxembourg ⤷  Sign Up PRODUCT NAME: ENZALUTAMIDE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES (XTANDI); FIRST REGISTRATION DATE: 20130625
1893196 PA2013029 Lithuania ⤷  Sign Up PRODUCT NAME: ENZALUTAMIDUM; REGISTRATION NO/DATE: EU/1/13/846 20130621
1893196 C300632 Netherlands ⤷  Sign Up PRODUCT NAME: ENZALUTAMIDE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/13/846 20130621
1893196 2013/061 Ireland ⤷  Sign Up PRODUCT NAME: ENZALUTAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/846 20130625
1893196 C01893196/01 Switzerland ⤷  Sign Up PRODUCT NAME: ENZALUTAMID; REGISTRATION NO/DATE: SWISSMEDIC 63040 03.12.2013
>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.

 
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