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Last Updated: November 23, 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-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® Litigation and Generic Entry Outlook for Xtandi

A generic version of XTANDI was approved as enzalutamide by ZYDUS PHARMS on September 26th, 2024.

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Drug patent expirations by year for XTANDI
Drug Prices for XTANDI

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Recent Clinical Trials for XTANDI

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

SponsorPhase
Merck Sharp & Dohme LLCPhase 3
Orion Corporation, Orion PharmaPhase 3
Prostate Cancer FoundationPhase 1/Phase 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 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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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 AB 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
Astellas XTANDI enzalutamide TABLET;ORAL 213674-001 Aug 4, 2020 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Astellas XTANDI enzalutamide TABLET;ORAL 213674-001 Aug 4, 2020 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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
Patent: Diarylhydantoin compounds
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Patent: 07245022
Patent: Diarylthiohydantoin compounds
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Austria

Patent: 41571
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Brazil

Patent: 0610359
Patent: composto de diaril-hidantoìna, método de sintetização de compostos e método in vitro
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Patent: 0709682
Patent: compostos de diariltioidantoÍna
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Canada

Patent: 08436
Patent: COMPOSES DIARYLHYDANTOINES (DIARYLHYDANTOIN COMPOUNDS)
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Patent: 48139
Patent: COMPOSES DE DIARYLTHIOHYDANTOINE ET LEUR UTILISATION DANS LE TRAITEMENT DE TROUBLES D'HYPERPROLIFERATION (DIARYL THIOHYDANTOIN COMPOUNDS AND THEIR USE IN THE TREATMENT OF HYPERPROLIFERATIVE DISORDERS)
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China

Patent: 1222922
Patent: Diarylhydantoin compounds
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Patent: 1460467
Patent: Diarylthiohydantoin compounds
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Patent: 2584712
Patent: Diarylhydantoin compounds
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Patent: 2755318
Patent: Hyperproliferative disorders with diarylhydantoin compounds
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Patent: 5037273
Patent: Diaryl hydantoin compound
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Patent: 0003114
Patent: 二芳基乙内酰脲化合物 (Diaryl hydantoin compound)
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Patent: 6003328
Patent: 二芳基乙内酰脲化合物 (Diaryl hydantoin compound)
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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
Patent: COMPOSE DIARYLHYDANTOINE (DIARYLHYDANTOIN COMPOUND)
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Patent: 13187
Patent: COMPOSÉS DE DIARYLTHIOHYDANTOÏNE (DIARYLTHIOHYDANTOIN COMPOUNDS)
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Patent: 39196
Patent: Composés de diarylthiohydantoïne destinés à être utilisés dans une méthode de traitement d'une maladie hyperproliférative (Diarylthiohydantoin compounds for use in a method for the treatment of a hyperproliferative disorder)
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Patent: 44085
Patent: Composés de diarylhydantoïne en tant qu'antagoniste du recepteur androgén pour le traitement du cancer (Diarylhydantoin compounds as androgen receptor antagonists for treatment of cancer)
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Patent: 61871
Patent: Composés diarylhydantoines en tant qu'antagonistes du récepteur d'androgène pour le traitement du cancer (Diarylhydantoin compounds as androgen receptor antagonists for treatment of cancer)
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Patent: 20706
Patent: DÉRIVÉS DE DIARYLTHIOHYDANTOÏNE UTILES POUR LE TRAITEMENT DE MALADIES HYPERPROLIFÉRATIVES (DIARYLTHIOHYDANTOIN COMPOUNDS USEFUL FOR THE TREATMENT OF A HYPERPROLIFERATIVE DISORDER)
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Patent: 06162
Patent: COMPOSES DIARYLHYDANTOINES EN TANT QU'ANTAGONISTES DU RECEPTEUR D'ANDROGENE POUR LE TRAITEMENT DU CANCER (DIARYLHYDANTOIN COMPOUNDS AS ANDROGEN RECEPTOR ANTAGONISTS FOR TREATMENT OF CANCER)
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Patent: 70721
Patent: COMPOSÉS DIARYLHYDANTOINES EN TANT QU'ANTAGONISTES DU RÉCEPTEUR D'ANDROGÈNE POUR LE TRAITEMENT DU CANCER (DIARYLHYDANTOIN COMPOUNDS AS ANDROGEN RECEPTOR ANTAGONISTS FOR TREATMENT OF CANCER)
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Hong Kong

Patent: 12856
Patent: DIARYLHYDANTOIN COMPOUND
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Patent: 24612
Patent: 二芳基乙內酰硫脲化合物 (DIARYLTHIOHYDANTOIN COMPOUNDS)
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Patent: 69321
Patent: 用於腫瘤治療作為雄激素受體拮抗劑的二芳基乙內酰脲化合物 (DIARYLHYDANTOIN COMPOUNDS AS ANDROGEN RECEPTOR ANTAGONISTS FOR TREATMENT OF CANCER)
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Patent: 77691
Patent: 二芳基硫代乙內酰脲化合物 (DIARYLTHIOHYDANTOIN COMPOUNDS)
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Patent: 17103
Patent: 二芳基乙內酰脲化合物 (DIARYLHYDANTOIN COMPOUNDS)
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Hungary

Patent: 300076
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Israel

Patent: 7328
Patent: N-מתיל-2-פלואורו-{4-[3-(4-ציאנו-3-טריפלואורומתילפניל)-5,5-דימתיל-4-אוקסו-2-תיאוקסו-אימידאזולידינ-1-איל]}בנזאמיד, תכשירים רוקחים המכילים אותו ושימוש בו להכנת תרופות (N-methyl-2-fluoro-{4-[3-(4-cyano-3-trifluoromethylphenyl)-5,5-dimethyl-4-oxo-2-thioxo-imidazolidin-1-yl]}benzamide, pharmaceutical compositions comprising the same and uses thereof in the manufacture of medicaments)
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Patent: 4438
Patent: תרכובות דיארילתיוהידנטואין, תכשירים רוקחיים המכילים אותן, שיטות לסינתוזן ושיטות אין-ויטרו להבאתן במגע עם תאי יונקים (Diarylthiohydantoin compounds, pharmaceutical compositions comprising them, methods for their synthesis and in vitro methods for contacting them with mammalian cells)
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Patent: 8880
Patent: תרכובות של דיארילהידנתוין (Diarylhydantoin compounds)
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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
Estimated Expiration: ⤷  Sign Up

Patent: 11068653
Patent: DIARYLHYDANTOIN COMPOUND
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Patent: 12211190
Patent: DIARYLHYDANTOIN COMPOUND
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Patent: 12236843
Patent: DIARYLHYDANTOIN COMPOUND
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Patent: 13136642
Patent: DIARYLTHIOHYDANTOIN COMPOUNDS
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Patent: 15098497
Patent: ジアリールヒダントイン化合物 (DIARYLHYDANTOIN COMPOUNDS)
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Patent: 15117244
Patent: ジアリールチオヒダントイン化合物 (DIARYLTHIOHYDANTOIN COMPOUNDS)
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Patent: 16183200
Patent: ジアリールヒダントイン化合物 (DIARYLHYDANTOIN COMPOUNDS)
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Patent: 17031223
Patent: ジアリールチオヒダントイン化合物 (DIARYLTHIOHYDANTOIN COMPOUNDS)
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Patent: 17031224
Patent: ジアリールチオヒダントイン化合物 (DIARYLTHIOHYDANTOIN COMPOUNDS)
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Patent: 18100292
Patent: ジアリールヒダントイン化合物 (DIARYLHYDANTOIN COMPOUNDS)
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Patent: 19218352
Patent: ジアリールヒダントイン化合物 (DIARYLHYDANTOIN COMPOUNDS)
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Patent: 21035970
Patent: ジアリールヒダントイン化合物 (DIARYLHYDANTOIN COMPOUNDS)
Estimated Expiration: ⤷  Sign Up

Patent: 22101657
Patent: ジアリールヒダントイン化合物
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Patent: 23075313
Patent: ジアリールヒダントイン化合物
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Luxembourg

Patent: 338
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 6924
Patent: COMPUESTOS DE DIARILHIDANTOINA. (DIARYLHYDANTOIN COMPOUNDS.)
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Patent: 07014132
Patent: COMPUESTOS DE DIARILHIDANTOINA. (DIARYLHYDANTOIN COMPOUNDS.)
Estimated Expiration: ⤷  Sign Up

Patent: 08012492
Patent: COMPUESTOS DE DIARILTIOHIDANTOINA. (DIARYLTHIOHYDANTOIN COMPOUNDS.)
Estimated Expiration: ⤷  Sign Up

Patent: 19015200
Patent: COMPUESTOS DE DIARILHIDANTOINA. (DIARYLHYDANTOIN COMPOUNDS.)
Estimated Expiration: ⤷  Sign Up

Patent: 22009759
Patent: EL USO DE 1-(4-CIANO-3-TRIFLUOROMETIL-FENIL)-3-[7-(4-CIANO-3-TRIFL UOROMETIL-FENIL)-6-TIOXO-5-P-TOLILO-5,7-DIAZAESPIRO[3.4]OCT-8-ILI DENO]-TIOUREA. (DIARYLHYDANTOIN COMPOUNDS.)
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Montenegro

Patent: 992
Patent: JEDINJENJE DIARILHIDANTOINA (DIARYLHYDANTOIN COMPOUNDS)
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New Zealand

Patent: 4223
Patent: Diarylhydantoin compounds for treating hormone refractory prostate cancer
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Patent: 2374
Patent: DIARYLTHIOHYDANTOIN COMPOUNDS
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Patent: 1119
Patent: Use of diarylhydantoin compounds for treating specific cancers
Estimated Expiration: ⤷  Sign Up

Patent: 6260
Patent: DIARYLTHIOHYDANTOIN COMPOUNDS
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Patent: 0368
Patent: Diarylhydantoin compounds
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Patent: 0355
Patent: Diarylhydantoin compounds
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Patent: 1414
Patent: Diarylhydantoin compounds
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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
Estimated Expiration: ⤷  Sign Up

Patent: 161996
Patent: Diarylhydantoinforbindelse og anvendelse derav
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Patent: 170919
Patent: Diaryltiohydantoinforbindelser
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Patent: 180225
Patent: Diarylhydantoinforbindelser
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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
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 48096
Patent: ДИАРИЛГИДАНТОИНЫ (DIARYLHYDANTOINS)
Estimated Expiration: ⤷  Sign Up

Patent: 49993
Patent: ДИАРИЛТИОГИДАНТОИНОВЫЕ СОЕДИНЕНИЯ (DIARYLTHIOHYDATOIC COMPOUNDS)
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Patent: 38833
Patent: ДИАРИЛГИДАНТОИНЫ (DIARYL HYDANTOINS)
Estimated Expiration: ⤷  Sign Up

Patent: 68972
Patent: ДИАРИЛ-СПИРОГИДАНТОИНОВЫЕ СОЕДИНЕНИЯ, ПОЛЕЗНЫЕ ПРИ ЛЕЧЕНИИ ГИПЕРПРОЛИФЕРАТИВНОГО НАРУШЕНИЯ (DIARYL-SPIROHYDANTOIC COMPOUNDS USEFUL IN HYPERPOLIFERATIVE DISORDER TREATMENT)
Estimated Expiration: ⤷  Sign Up

Patent: 07146462
Patent: ДИАРИЛГИДАНТОИНЫ
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Patent: 08142728
Patent: ДИАРИЛТИОГИДАНТОИНОВЫЕ СОЕДИНЕНИЯ
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Patent: 12101095
Patent: ДИАРИЛ-СПИРОГИДАНТОИНОВЫЕ СОЕДИНЕНИЯ, ПОЛЕЗНЫЕ ПРИ ЛЕЧЕНИИ ГИПЕРПРОЛИФЕРАТИВНОГО НАРУШЕНИЯ (DIARYL-SPIROHYDANTOIC COMPOUNDS USEFUL IN HYPERPOLIFERATIVE DISORDER TREATMENT)
Estimated Expiration: ⤷  Sign Up

Patent: 17142159
Patent: ДИАРИЛГИДАНТОИНЫ
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Patent: 18135606
Patent: ДИАРИЛТИОГИДАНТОИНОВЫЕ СОЕДИНЕНИЯ
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Serbia

Patent: 274
Patent: JEDINJENJE DIARILHIDANTOINA (DIARZLHZDANTOIN COMPOUND)
Estimated Expiration: ⤷  Sign Up

Patent: 967
Patent: DIARIL HIDANTOIN JEDINJENJA KAO ANTAGONISTI RECEPTORA ANDROGENA ZA LEČENJE RAKA (DIARYLHYDANTOIN COMPOUNDS AS ANDROGEN RECEPTOR ANTAGONISTS FOR TREATMENT OF CANCER)
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Singapore

Patent: 0809
Patent: DIARYLTHIOHYDANTOIN COMPOUNDS
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Patent: 201408699T
Patent: DIARYLTHIOHYDANTOIN COMPOUNDS
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Patent: 201703816S
Patent: DIARYLHYDANTOIN COMPOUNDS
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Slovenia

Patent: 93196
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Patent: 44085
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South Africa

Patent: 0710870
Patent: DIARYLHYDANTOIN COMPOUNDS
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Patent: 0809098
Patent: DIARYLTHIOHYDANTOIN COMPOUNDS
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Patent: 1201793
Patent: DIARYLHYDANTOIN COMPOUNDS
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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
Estimated Expiration: ⤷  Sign Up

Patent: 080014039
Patent: DIARYLHYDANTOIN COMPOUNDS
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Patent: 090009215
Patent: DIARYLTHIOHYDANTOIN COMPOUNDS
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Patent: 110041580
Patent: DIARYLHYDANTOIN COMPOUNDS
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Patent: 120102140
Patent: DIARYLHYDANTOIN COMPOUNDS
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Patent: 120102147
Patent: DIARYLTHIOHYDANTOIN COMPOUNDS
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Patent: 130060369
Patent: DIARYLHYDANTOIN COMPOUNDS
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Patent: 140041831
Patent: DIARYLHYDANTOIN COMPOUNDS
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Patent: 140141676
Patent: DIARYLHYDANTOIN COMPOUNDS
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Patent: 150008506
Patent: DIARYLTHIOHYDANTOIN COMPOUNDS
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Patent: 150086567
Patent: 디아릴히단토인 화합물 (DIARYLHYDANTOIN COMPOUNDS)
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Patent: 160027254
Patent: 디아릴티오히단토인 화합물 (DIARYLTHIOHYDANTOIN COMPOUNDS)
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Patent: 170107585
Patent: 디아릴히단토인 화합물 (DIARYLHYDANTOIN COMPOUNDS)
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Patent: 190104244
Patent: 디아릴히단토인 화합물 (DIARYLHYDANTOIN COMPOUNDS)
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Patent: 210136161
Patent: 디아릴히단토인 화합물 (DIARYLHYDANTOIN COMPOUNDS)
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Patent: 230003445
Patent: 디아릴히단토인 화합물 (DIARYLHYDANTOIN COMPOUNDS)
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Spain

Patent: 78778
Estimated Expiration: ⤷  Sign Up

Patent: 35179
Estimated Expiration: ⤷  Sign Up

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
Philippines 12015500525 FORMULATIONS OF ENZALUTAMIDE ⤷  Sign Up
Luxembourg 92338 ⤷  Sign Up
Singapore 170809 DIARYLTHIOHYDANTOIN COMPOUNDS ⤷  Sign Up
Lithuania 3725778 ⤷  Sign Up
Cyprus 1112798 ⤷  Sign Up
South Korea 101519705 ⤷  Sign Up
South Korea 101169832 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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 2013/061 Ireland ⤷  Sign Up PRODUCT NAME: ENZALUTAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/846 20130625
1893196 CR 2013 00065 Denmark ⤷  Sign Up PRODUCT NAME: ENZALUTAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/846 20130625
1893196 122013000155 Germany ⤷  Sign Up PRODUCT NAME: ENZALUTAMID ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ HIERVON; REGISTRATION NO/DATE: EU/1/13/846 20130621
1893196 PA2013029 Lithuania ⤷  Sign Up PRODUCT NAME: ENZALUTAMIDUM; REGISTRATION NO/DATE: EU/1/13/846 20130621
1893196 2013C/074 Belgium ⤷  Sign Up PRODUCT NAME: ENZALUTAMIDE (ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/13/846 20130625
1893196 C20130036 00106 Estonia ⤷  Sign Up PRODUCT NAME: ENSALUTAMIID;REG NO/DATE: K(2013)4019 (LOPLIK) 25.06.2013
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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