You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 7, 2024

VORTIOXETINE HYDROBROMIDE - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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
Zydus Pharms VORTIOXETINE HYDROBROMIDE vortioxetine hydrobromide TABLET;ORAL 211146-002 Sep 17, 2021 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  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
Takeda Pharms Usa TRINTELLIX vortioxetine hydrobromide TABLET;ORAL 204447-002 Sep 30, 2013 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  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
>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 204447-002 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 204447-001 Sep 30, 2013 ⤷  Sign Up ⤷  Sign Up
Takeda Pharms Usa TRINTELLIX vortioxetine hydrobromide TABLET;ORAL 204447-003 Sep 30, 2013 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for VORTIOXETINE HYDROBROMIDE

Country Patent Number Title Estimated Expiration
South Korea 101536023 ⤷  Sign Up
Ukraine 101341 ТЕРАПЕВТИЧЕСКИЕ ПРИМЕНЕНИЯ СОЕДИНЕНИЙ, КОТОРЫЕ ИМЕЮТ КОМБИНИРОВАННУЮ АКТИВНОСТЬ В ОТНОШЕНИИ SERT, 5-НТ3 И 5-НТ1A;ТЕРАПЕВТИЧНІ ЗАСТОСУВАННЯ СПОЛУК, ЩО МАЮТЬ КОМБІНОВАНУ АКТИВНІСТЬ СТОСОВНО SERT, 5-HT3 ТА 5-HT1A (Normal;heading 1;heading 2;heading 3;THERAPEUTIC USES OF COMPOUNDS HAVING COMBINED SERT, 5-HT3 AND 5-HT1A ACTIVITY) ⤷  Sign Up
Croatia P20110058 ⤷  Sign Up
Poland 2142193 ⤷  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 C20140012 00108 Estonia ⤷  Sign Up PRODUCT NAME: VORTIOKSETIIN;REG NO/DATE: K(2013)9715 LOPLIK 20.12.2013
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 PA2014013 Lithuania ⤷  Sign Up PRODUCT NAME: VORTIOXETINUM; REGISTRATION NO/DATE: EU/1/13/891 20131218
1436271 2014/022 Ireland ⤷  Sign Up PRODUCT NAME: VORTIOXETINE OR A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/891 20131220
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.