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Last Updated: September 18, 2020

DrugPatentWatch Database Preview

Vortioxetine hydrobromide - Generic Drug Details

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What are the generic sources for vortioxetine hydrobromide and what is the scope of patent protection?

Vortioxetine hydrobromide is the generic ingredient in one branded drug marketed by Takeda Pharms Usa and is included in one NDA. 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 nine patent family members in forty-one countries.

There are sixteen drug master file entries for vortioxetine hydrobromide. Three suppliers are listed for this compound.

Paragraph IV (Patent) Challenges for VORTIOXETINE HYDROBROMIDE
Tradename Dosage Ingredient NDA Submissiondate
TRINTELLIX TABLET;ORAL vortioxetine hydrobromide 204447 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 204447-003 Sep 30, 2013 DISCN Yes No   Start Trial   Start Trial   Start Trial
Takeda Pharms Usa TRINTELLIX vortioxetine hydrobromide TABLET;ORAL 204447-001 Sep 30, 2013 RX 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 204447-002 Sep 30, 2013 RX Yes No   Start Trial   Start Trial 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

Supplementary Protection Certificates for vortioxetine hydrobromide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1436271 122014000049 Germany   Start Trial PRODUCT NAME: VORTIOXETIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SAEUREADDITIONSSALZ DAVON; REGISTRATION NO/DATE: EU/1/13/891 20131218
1436271 C300652 Netherlands   Start Trial PRODUCT NAME: VORTIOXETINE OF EEN; REGISTRATION NO/DATE: EU/1/13/891/001-036 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 2014C/036 Belgium   Start Trial PRODUCT NAME: VORTIOXETINE; AUTHORISATION NUMBER AND DATE: EU/1/13/891 20131220
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
AstraZeneca
Baxter
Mallinckrodt
Harvard Business School
Express Scripts

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