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Last Updated: November 22, 2024

VORTIOXETINE HYDROBROMIDE - Generic Drug Details


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What are the generic sources for vortioxetine hydrobromide and what is the scope of freedom to operate?

Vortioxetine hydrobromide is the generic ingredient in two branded drugs marketed by Takeda Pharms Usa and Zydus Pharms, and is included in two NDAs. There are ten patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Vortioxetine hydrobromide has two hundred and sixteen patent family members in forty-two countries.

There are fifteen drug master file entries for vortioxetine hydrobromide. Two suppliers are listed for this compound. There are two tentative approvals for this compound.

Generic filers with tentative approvals for VORTIOXETINE HYDROBROMIDE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up20MGTABLET;ORAL
⤷  Sign Up⤷  Sign Up10MGTABLET;ORAL
⤷  Sign Up⤷  Sign UpEQ 20MG BASETABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Anatomical Therapeutic Chemical (ATC) Classes for VORTIOXETINE HYDROBROMIDE
Paragraph IV (Patent) Challenges for VORTIOXETINE HYDROBROMIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TRINTELLIX Tablets vortioxetine hydrobromide 5 mg, 10 mg, 15 mg and 20 mg 204447 15 2017-10-02

US Patents and Regulatory Information for VORTIOXETINE HYDROBROMIDE

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 204447-001 Sep 30, 2013 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Takeda Pharms Usa TRINTELLIX vortioxetine hydrobromide TABLET;ORAL 204447-004 Sep 30, 2013 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Takeda Pharms Usa TRINTELLIX vortioxetine hydrobromide TABLET;ORAL 204447-003 Sep 30, 2013 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Takeda Pharms Usa TRINTELLIX vortioxetine hydrobromide TABLET;ORAL 204447-004 Sep 30, 2013 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Takeda Pharms Usa TRINTELLIX vortioxetine hydrobromide TABLET;ORAL 204447-003 Sep 30, 2013 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for VORTIOXETINE HYDROBROMIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms Usa TRINTELLIX vortioxetine hydrobromide TABLET;ORAL 204447-001 Sep 30, 2013 ⤷  Sign Up ⤷  Sign Up
Takeda Pharms Usa TRINTELLIX vortioxetine hydrobromide TABLET;ORAL 204447-003 Sep 30, 2013 ⤷  Sign Up ⤷  Sign Up
Takeda Pharms Usa TRINTELLIX vortioxetine hydrobromide TABLET;ORAL 204447-004 Sep 30, 2013 ⤷  Sign Up ⤷  Sign Up
Takeda Pharms Usa TRINTELLIX vortioxetine hydrobromide TABLET;ORAL 204447-002 Sep 30, 2013 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for VORTIOXETINE HYDROBROMIDE

Country Patent Number Title Estimated Expiration
Mexico 2009009672 COMPUESTO 1-[2-(2,4-DIMETILFENILSULFANIL)-FENIL]PIPERAZINA EN COMBINACION CON SEROTONINA PARA LA ACTIVIDAD DE RECAPTACION, 5-HT3 Y 5-HT1 PARA EL TRATAIENTO DEL DOLOR O LOS SINTOMAS RESIDUALES EN LA DEPRESION RELACIONADOS CON EL SUEÑO Y LA COGNICION. (1- [2-(2,4-DIMETHYLPHENYLSULFANYL)-PHENYL] PIPERAZINE AS A COMPOUND WITH COMBINED SEROTONIN REUPTAKE, 5-HT3 AND 5-HT1A ACTIVITY FOR THE TREATMENT OF PAIN OR RESIDUAL SYMPTOMS IN DEPRESSION RELATING TO SLEEP AND COGNITION.) ⤷  Sign Up
Norway 343929 ⤷  Sign Up
South Korea 101627901 ⤷  Sign Up
Taiwan 200848411 Novel therapeutic uses of 1-[2-(2, 4-dimethylphenylsulfanyl)phenyl]-piperazine ⤷  Sign Up
Denmark 2431039 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VORTIOXETINE HYDROBROMIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1436271 122014000049 Germany ⤷  Sign Up PRODUCT NAME: VORTIOXETIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SAEUREADDITIONSSALZ DAVON; REGISTRATION NO/DATE: EU/1/13/891 20131218
1436271 132014902248131 Italy ⤷  Sign Up PRODUCT NAME: VORTIOXETINA O UN SUO SALE DI ADDIZIONE CON UN ACIDO FARMACEUTICAMENTE ACCETTABILE(BRINTELLIX); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/891/001-2-3-4-5-6-7, 20131218
1436271 92397 Luxembourg ⤷  Sign Up PRODUCT NAME: VORTIOXETINE OU UN SEL D ADDITION D ACIDE DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE
1436271 C 2014 023 Romania ⤷  Sign Up 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 C01436271/01 Switzerland ⤷  Sign Up PRODUCT NAME: VORTIOXETINE; REGISTRATION NO/DATE: SWISSMEDIC 65937 09.06.2016
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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