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TRINTELLIX Drug Profile
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» See Plans and PricingWhich patents cover Trintellix, and when can generic versions of Trintellix launch?
Trintellix is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.
This drug has two hundred and eight patent family members in forty-one countries.
The generic ingredient in TRINTELLIX is vortioxetine hydrobromide. There are sixteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the vortioxetine hydrobromide profile page.
US ANDA Litigation and Generic Entry Outlook for Trintellix
Trintellix was eligible for patent challenges on September 30, 2017.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be June 30, 2031. This may change due to patent challenges or generic licensing.
Annual sales in 2017 were $427mm indicating the motivation for generic entry (peak sales were $441mm in 2016).
There have been twenty-two 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 TRINTELLIX
| International Patents: | 208 |
| US Patents: | 10 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 125 |
| Clinical Trials: | 8 |
| Patent Applications: | 74 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for TRINTELLIX |
| Drug Sales Revenues: | Drug sales revenues for TRINTELLIX |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TRINTELLIX |
| DailyMed Link: | TRINTELLIX at DailyMed |
See drug prices for TRINTELLIX
Generic Entry Opportunity Date for TRINTELLIX
Generic Entry Date for TRINTELLIX*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;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 TRINTELLIX
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Noam Soreni | Phase 3 |
| University of Catania | Phase 4 |
| Azienda Ospedaliera Universitaria Integrata Verona | Phase 4 |
Recent Litigation for TRINTELLIX
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| H. Lundbeck A/S v. Apicore US LLC | 2018-07-12 |
| H. Lundbeck A/S v. MSN Laboratories Private Limited | 2018-06-07 |
| H. Lundbeck A/S v. Lupin Limited | 2018-05-21 |
Synonyms for TRINTELLIX
| 1-(2-((2,4-Dimethylphenyl)sulfanyl)phenyl)piperazine monohydrobromide |
| 1-(2-((2,4-Dimethylphenyl)sulfanyl)phenyl}piperazine |
| 1-(2-((2,4-Dimethylphenyl)thio)phenyl)piperazine |
| 1-(2-((2,4-Dimethylphenyl)thio)phenyl)piperazine hydrobromide |
| 1-(2-((2,4-DIMETHYLPHENYL)THIO)PHENYL)PIPERAZINE HYDROCHLRIDE |
| 1-[2-(2,4-dimethyl-phenylsulfanyl)-phenyl]-piperazine |
| 1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine |
| 1-[2-(2,4-Dimethylphenylsulfanyl)-phenyl]piperazine |
| 1-[2-(2,4-dimethylphenylsulfanyl)phenyl]piperazine |
| 1-[2-(2,4-dimethylphenylsulfanyl)phenyl]piperazine-hbr |
| 1-[2-[(2,4-Dimethylphenyl)thio]phenyl]piperazine |
| 1-[2-[(2,4-dimethylphenyl)thio]phenyl]piperazine hydrobromide |
| 1-{2-[(2,4-dimethylphenyl)sulfanyl]phenyl}piperazine |
| 1-{2-[(2,4-dimethylphenyl)sulfanyl]phenyl}piperazine hydrobromide |
| 2796AH |
| 3O2K1S3WQV |
| 4-[2-(2,4-Dimethyl-phenylsulfanyl)-phenyl]-piperazine hydrobromide |
| 4-{2-[(2,4-dimethylphenyl)sulfanyl]phenyl}piperazin-1-ium bromide |
| 4CH-016292 |
| 508233-74-7 |
| 7034AB |
| 960203-27-4 |
| A12602 |
| A3926 |
| AB0165485 |
| AC-27648 |
| AC-28325 |
| AK110506 |
| AKOS016008748 |
| AKOS016340374 |
| API0019472 |
| AR-270/43507985 |
| AX8224799 |
| BCP05996 |
| BCP09588 |
| BDBM50400902 |
| Brintellix |
| Brintellix (TN) |
| C18H22N2S.BrH |
| CCG-229998 |
| CHEBI:76015 |
| CHEBI:76016 |
| CHEMBL2104993 |
| CHEMBL2107387 |
| CHEMBL2204360 |
| CS-1471 |
| CS-1472 |
| D10184 |
| D10185 |
| DA-42264 |
| DB09068 |
| DTXSID80965062 |
| EBD3080710 |
| EX-A2348 |
| FT-0686961 |
| FT-0696676 |
| GG-0052 |
| GTPL7351 |
| HG-0011 |
| HSDB 8250 |
| HY-15414 |
| HY-15414A |
| KS-0000062Y |
| Lu AA 21004 |
| Lu AA 21004 hydrobromide |
| Lu AA 21004 hydrobromide;Lu AA21004 hydrobromide |
| Lu AA 21004 pound>>LuAA21004 pound>> Lu-AA21004 pound>> Lu AA21004 pound>> AA21004 |
| Lu AA 21004|||1-[2-[(2,4-dimethylphenyl)thio]phenyl]-piperazine |
| Lu AA 21004|||1-[2-[(2,4-dimethylphenyl)thio]phenyl]-piperazine hydrobromide |
| Lu AA21004 |
| Lu AA21004 (HBr) |
| Lu AA21004 hydrobromide |
| Lu-AA-21004 |
| Lu-AA21004 |
| Lu-AA21004-(HBr) |
| LuAA21004 |
| MFCD22380814 |
| MFCD22383961 |
| PIP107 |
| Piperazine, 1-(2-((2,4-dimethylphenyl)thio)phenyl)- |
| Piperazine, 1-(2-((2,4-dimethylphenyl)thio)phenyl)-, hydrobromide (1:1) |
| Piperazine, 1-[2-[(2,4-dimethylphenyl)thio]phenyl]- |
| Piperazine, 1-[2-[(2,4-dimethylphenyl)thio]phenyl]-, hydrobromide (1:1) |
| Q27145682 |
| Q3563148 |
| s5506 |
| s8021 |
| SB16506 |
| SB16507 |
| SC-53652 |
| SC-95551 |
| SCHEMBL236115 |
| SCHEMBL237653 |
| ST2408515 |
| STL483777 |
| SW219360-1 |
| TKS641KOAY |
| Trintellix (TN) |
| UNII-3O2K1S3WQV |
| UNII-TKS641KOAY |
| VNGRUFUIHGGOOM-UHFFFAOYSA-N |
| vortioxetina |
| VORTIOXETINE |
| Vortioxetine (hydrobromide) |
| Vortioxetine (Lu AA21004) |
| Vortioxetine (Lu AA21004) HBr |
| Vortioxetine (Lu AA21004) hydrobromide |
| Vortioxetine (USAN) |
| Vortioxetine [USAN:INN] |
| Vortioxetine HBr |
| Vortioxetine hydrobromide |
| Vortioxetine hydrobromide (JAN/USAN) |
| Vortioxetine hydrobromide [USAN] |
| vortioxetine monohydrobromide |
| vortioxetine-lu-aa21004-hydrobromide |
| Vortioxetine, Lu AA21004 |
| vortioxetinum |
| W-5909 |
| W-5911 |
| YQNWZWMKLDQSAC-UHFFFAOYSA-N |
| ZINC34051848 |
Paragraph IV (Patent) Challenges for TRINTELLIX
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| TRINTELLIX | TABLET;ORAL | vortioxetine hydrobromide | 204447 | 2017-10-02 |
US Patents and Regulatory Information for TRINTELLIX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Takeda Pharms Usa | TRINTELLIX | vortioxetine hydrobromide | TABLET;ORAL | 204447-004 | Sep 30, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Takeda Pharms Usa | TRINTELLIX | vortioxetine hydrobromide | TABLET;ORAL | 204447-003 | Sep 30, 2013 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Takeda Pharms Usa | TRINTELLIX | vortioxetine hydrobromide | TABLET;ORAL | 204447-004 | Sep 30, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Takeda Pharms Usa | TRINTELLIX | vortioxetine hydrobromide | TABLET;ORAL | 204447-003 | Sep 30, 2013 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Takeda Pharms Usa | TRINTELLIX | vortioxetine hydrobromide | TABLET;ORAL | 204447-003 | Sep 30, 2013 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Takeda Pharms Usa | TRINTELLIX | vortioxetine hydrobromide | TABLET;ORAL | 204447-003 | Sep 30, 2013 | DISCN | Yes | No | Start Trial | Start Trial | 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 TRINTELLIX
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Cyprus | 1111183 | Start Trial |
| South Korea | 20130133078 | Start Trial |
| Japan | 2010521501 | Start Trial |
| Eurasian Patent Organization | 007537 | Start Trial |
| Iceland | 7164 | Start Trial |
| Mexico | PA04002959 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for TRINTELLIX
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1436271 | PA2014013,C1436271 | Lithuania | Start Trial | PRODUCT NAME: VORTIOKSETINAS ARBA JO FARMACINIU POZIURIU PRIIMTINA RUGSTIES PRISIJUNGIMO DRUSKA; REGISTRATION NO/DATE: EU/1/13/891 20131218 |
| 1436271 | C 2014 023 | Romania | Start Trial | PRODUCT NAME: VORTIOXETINA SAU O SARE DE ADITIE ACIDA A ACESTEIAACCEPTABILA FARMACEUTIC1-[2-(2,4-DIMETILFENILSULFANIL)FENIL]PIPERAZINA; NATIONAL AUTHORISATION NUMBER: EU/1/13/891; DATE OF NATIONAL AUTHORISATION: 20131218; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/891; DATE OF FIRST AUTHORISATION IN EEA: 20131218 |
| 1436271 | 122014000049 | Germany | Start Trial | PRODUCT NAME: VORTIOXETIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SAEUREADDITIONSSALZ DAVON; REGISTRATION NO/DATE: EU/1/13/891 20131218 |
| 1436271 | 300652 | Netherlands | Start Trial | PRODUCT NAME: VORTIOXETINE OF EEN FARMACEUTISCH AANVAARDBAAR ZUURADDITIEZOUT ERVAN; REGISTRATION NO/DATE: EU/1/13/891/001-036 20131218 |
| 1436271 | 1490023-7 | Sweden | Start Trial | PRODUCT NAME: VORTIOXETINE ELLER ETT FARMACEUTISKT GODTAGBART SYRAADDITIONSSALT DAERAV; REG. NO/DATE: EU/1/13/891 20131218 |
| 1436271 | 14C0033 | France | Start Trial | PRODUCT NAME: VORTIOXETINE OU L'UN DE SES SELS D'ADDITION D'ACIDE PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/891 20131218 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
