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
Summary for XTANDI
International Patents: | 133 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 111 |
Clinical Trials: | 140 |
Patent Applications: | 2,437 |
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 |


Recent Clinical Trials for XTANDI
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Nuvation Bio Inc. | Phase 1/Phase 2 |
Fudan University | Phase 2 |
Clarus Therapeutics | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for XTANDI
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 |