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XTANDI Drug Profile
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When do Xtandi patents expire, and when can generic versions of Xtandi launch?
Xtandi is a drug marketed by Astellas and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and twenty-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.
US ANDA Litigation and Generic Entry Outlook for Xtandi
Xtandi was eligible for patent challenges on August 31, 2016.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be August 13, 2027. This may change due to patent challenges or generic licensing.
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: | 123 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 96 |
| Clinical Trials: | 114 |
| Patent Applications: | 157 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for XTANDI |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for XTANDI |
| DailyMed Link: | XTANDI at DailyMed |
Generic Entry Opportunity Date for XTANDI
Generic Entry Date for XTANDI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for XTANDI
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Clovis Oncology, Inc. | Phase 1 |
| Bayer | Phase 2 |
| Zenith Epigenetics | Phase 1/Phase 2 |
Recent Litigation for XTANDI
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Astellas Pharma Inc. v. Eugia Pharma Specialities Ltd. | 2018-05-17 |
| Degui Chen v. Michael E. Jung | 2018-03-12 |
| Astellas Pharma Inc. v. Roxane Laboratories, Inc. | 2017-05-09 |
Pharmacology for XTANDI
Synonyms for XTANDI
| 4-(3-(4-Cyano-3-(trifluoromethyl)phenyl)-5,5-dimethyl-4-oxo-2-thioxoimidazolidin-1-yl)-2-fluoro-N-me |
| 4-(3-(4-cyano-3-(trifluoromethyl)phenyl)-5,5-dimethyl-4-oxo-2-thioxoimidazolidin-1-yl)-2-fluoro-N-methylbenzamide |
| 4-[3-[4-cyano-3-(trifluoromethyl)phenyl]-5,5-dimethyl-4-oxo-2-thioxo-imidazolidin-1-yl]-2-fluoro-N-methyl-benzamide |
| 4-{3-[4-cyano-3-(trifluoromethyl)phenyl]-5,5-dimethyl-4-oxo-2-sulfanylideneimidazolidin-1-yl}-2-fluoro-N-methylbenzamide |
| 4-{3-[4-cyano-3-(trifluoromethyl)phenyl]-5,5-dimethyl-4-oxo-2-thioxoimidazolidin-1-yl}-2-fluoro-N-methylbenzamide |
| 915087-33-1 |
| 93T0T9GKNU |
| A25302 |
| AB0008149 |
| AB01565849_02 |
| ABP000459 |
| AC-26924 |
| ACN-026804 |
| AK-72825 |
| AKOS015851022 |
| AMX10212 |
| AN-16279 |
| ANW-54164 |
| AOB87731 |
| API0007596 |
| AS-17047 |
| ASP-9785 |
| AX8165432 |
| BBL102957 |
| BC660065 |
| BCP9000901 |
| BCPP000169 |
| BDBM50425732 |
| Benzamide, 4-(3-(4-cyano-3-(trifluoromethyl)phenyl)-5,5-dimethyl-4-oxo-2-thioxo-1-imidazolidinyl)-2-fluoro-N-methyl- |
| Benzamide,4-[3-[4-cyano-3-(trifluoromethyl)phenyl]-5,5-dimethyl-4-oxo-2-thioxo-1-imidazolidinyl]-2-fluoro-N-methyl- |
| BR-72825 |
| BRD-K56851771-001-01-9 |
| C21H16F4N4O2S |
| CHEBI:68534 |
| CHEMBL1082407 |
| CJ-18592 |
| CS-0317 |
| CTK8B6725 |
| D10218 |
| DB08899 |
| Enzalutamide |
| Enzalutamide (JAN/USAN) |
| Enzalutamide (MDV3100) |
| Enzalutamide [USAN:INN] |
| EX-A046 |
| FT-0670957 |
| GTPL6812 |
| HMS3654L07 |
| HY-70002 |
| J-519668 |
| KB-53497 |
| KS-0000079W |
| MDV 3100 |
| MDV-3100 |
| MDV-3100, 915087-33-1 |
| MDV3100 |
| MDV3100 (Enzalutamide) |
| MDV3100 Enzalutamide |
| MDV3100, AldrichCPR |
| MDV3100/MDV-3100 |
| MLS006010067 |
| MolPort-009-679-470 |
| n-methyl-4-[3-(4-cyano-3-trifluoromethylphenyl)-5,5-dimethyl-4-oxo-2-thioxoimidazolidin-1-yl]-2-fluo |
| NC-54 |
| NCGC00263120-01 |
| PubChem19320 |
| QCR-130 |
| RL05765 |
| S-3847 |
| s1250 |
| SB20413 |
| SC-69109 |
| SCHEMBL189749 |
| SMR004701227 |
| SR-01000941580 |
| SR-01000941580-1 |
| ST24028748 |
| STL556766 |
| SW219288-1 |
| TC-142909 |
| Tube704 |
| UNII-93T0T9GKNU |
| W9480 |
| WXCXUHSOUPDCQV-UHFFFAOYSA-N |
| Xtandi (TN) |
| ZINC34806477 |
Paragraph IV (Patent) Challenges for XTANDI
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| XTANDI | CAPSULE;ORAL | enzalutamide | 203415 | 2016-08-31 |
US Patents and Regulatory Information for XTANDI
| 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 | Start Trial | Start Trial | Start Trial | ||||
| Astellas | XTANDI | enzalutamide | CAPSULE;ORAL | 203415-001 | Aug 31, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Astellas | XTANDI | enzalutamide | CAPSULE;ORAL | 203415-001 | Aug 31, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Astellas | XTANDI | enzalutamide | CAPSULE;ORAL | 203415-001 | Aug 31, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| >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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 1893196 | Start Trial |
| South Korea | 101600230 | Start Trial |
| New Zealand | 620368 | Start Trial |
| Montenegro | 01992 | Start Trial |
| Spain | 2535179 | Start Trial |
| Cyprus | 1116426 | Start Trial |
| Norway | 2017019 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for XTANDI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1893196 | CR 2013 00065 | Denmark | Start Trial | PRODUCT NAME: ENZALUTAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/846 20130625 |
| 1893196 | C 2013 041 | Romania | Start Trial | PRODUCT NAME: ENZALUTAMIDA SAU O SARE ACCEPTABILA FARMACEUTIC AACESTEIA; NATIONAL AUTHORISATION NUMBER: EU/1/13/846; DATE OF NATIONAL AUTHORISATION: 20130621; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/846; DATE OF FIRST AUTHORISATION IN EEA: 20130621 |
| 1893196 | PA2013029 | Lithuania | Start Trial | PRODUCT NAME: ENZALUTAMIDUM; REGISTRATION NO/DATE: EU/1/13/846 20130621 |
| 1893196 | 2013/061 | Ireland | Start Trial | PRODUCT NAME: ENZALUTAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/846 20130625 |
| 1893196 | 491 | Finland | Start Trial | |
| 1893196 | CA 2013 00065 | Denmark | Start Trial | PRODUCT NAME: ENZALUTAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/846 20130625 |
| 1893196 | 169 50005-2013 | Slovakia | Start Trial | PRODUCT NAME: ENZALUTAMID; REGISTRATION NO/DATE: EU/1/13/846 20130621 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
