DrugPatentWatch Database Preview
XTANDI Drug Profile
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-one patent family members in twenty-seven 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.
Summary for XTANDI
| International Patents: | 121 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 94 |
| Clinical Trials: | 108 |
| Patent Applications: | 147 |
| 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 |
|---|---|
| Astellas Pharma China, Inc. | Phase 3 |
| Oric Pharmaceuticals | Phase 1 |
| EMD Serono | 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 |
| Astellas Pharma Inc. v. Roxane Laboratories, Inc. | 2017-05-09 |
| Astellas Pharma Inc. v. Apotex Inc. | 2016-12-09 |
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 |
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 | See Pricing | See Pricing | See Pricing | ||||
| Astellas | XTANDI | enzalutamide | CAPSULE;ORAL | 203415-001 | Aug 31, 2012 | RX | Yes | Yes | See Pricing | See Pricing | See Pricing | ||||
| Astellas | XTANDI | enzalutamide | CAPSULE;ORAL | 203415-001 | Aug 31, 2012 | RX | Yes | Yes | See Pricing | See Pricing | See Pricing | ||||
| Astellas | XTANDI | enzalutamide | CAPSULE;ORAL | 203415-001 | Aug 31, 2012 | RX | Yes | Yes | See Pricing | See Pricing | Y | Y | See Pricing | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Paragraph IV (Patent) Challenges for XTANDI
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Capsules | 40 mg | ➤ Subscribe | See Pricing |
International Patents for XTANDI
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 20150086567 | See Pricing |
| Japan | 2012236843 | See Pricing |
| Portugal | 2444085 | See Pricing |
| Hong Kong | 1124612 | See Pricing |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for XTANDI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1893196 | PA2013029 | Lithuania | See Pricing | PRODUCT NAME: ENZALUTAMIDUM; REGISTRATION NO/DATE: EU/1/13/846 20130621 |
| 1893196 | 491 | Finland | See Pricing | |
| 1893196 | 2013C/074 | Belgium | See Pricing | PRODUCT NAME: ENZALUTAMIDE (ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/13/846 20130625 |
| 1893196 | SPC/GB13/079 | United Kingdom | See Pricing | PRODUCT NAME: ENZLUTAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/13/846 20130625 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
