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-six 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 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
Summary for XTANDI
International Patents: | 136 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 121 |
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 |


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.
Patents protecting XTANDI
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 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
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
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 | CAPSULE;ORAL | 203415-001 | Aug 31, 2012 | 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 | TABLET;ORAL | 213674-002 | Aug 4, 2020 | 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: 1571
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
Estimated Expiration: ⤷ Try a Trial
Patent: 12236843
Estimated Expiration: ⤷ Try a Trial
Patent: 13136642
Estimated Expiration: ⤷ Try a Trial
Patent: 15098497
Estimated Expiration: ⤷ Try a Trial
Patent: 15117244
Estimated Expiration: ⤷ Try a Trial
Patent: 16183200
Estimated Expiration: ⤷ Try a Trial
Patent: 17031223
Estimated Expiration: ⤷ Try a Trial
Patent: 17031224
Estimated Expiration: ⤷ Try a Trial
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
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
Estimated Expiration: ⤷ Try a Trial
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
Estimated Expiration: ⤷ Try a Trial
Patent: 1456722
Estimated Expiration: ⤷ Try a Trial
Patent: 1515335
Estimated Expiration: ⤷ Try a Trial
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
Estimated Expiration: ⤷ Try a Trial
Patent: 120102147
Estimated Expiration: ⤷ Try a Trial
Patent: 130060369
Estimated Expiration: ⤷ Try a Trial
Patent: 140041831
Estimated Expiration: ⤷ Try a Trial
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 |
---|---|---|---|
Serbia | 53967 | DIARIL HIDANTOIN JEDINJENJA KAO ANTAGONISTI RECEPTORA ANDROGENA ZA LEČENJE RAKA (DIARYLHYDANTOIN COMPOUNDS AS ANDROGEN RECEPTOR ANTAGONISTS FOR TREATMENT OF CANCER) | ⤷ Try a Trial |
Japan | 2023075313 | ジアリールヒダントイン化合物 | ⤷ Try a Trial |
South Korea | 20150086567 | 디아릴히단토인 화합물 (DIARYLHYDANTOIN COMPOUNDS) | ⤷ Try a Trial |
European Patent Office | 3106162 | 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) | ⤷ Try a Trial |
Slovenia | 2444085 | ⤷ 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 | C01893196/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: ENZALUTAMID; REGISTRATION NO/DATE: SWISSMEDIC 63040 03.12.2013 |
1893196 | SPC/GB13/079 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: ENZLUTAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/13/846 20130625 |
1893196 | CR 2013 00065 | Denmark | ⤷ Try a Trial | PRODUCT NAME: ENZALUTAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/846 20130625 |
1893196 | CA 2013 00065 | Denmark | ⤷ Try a Trial | PRODUCT NAME: ENZALUTAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/846 20130625 |
1893196 | 2013/061 | Ireland | ⤷ Try a Trial | PRODUCT NAME: ENZALUTAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/846 20130625 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |