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Last Updated: December 7, 2022

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 two branded drugs marketed by Takeda Pharms Usa and Zydus Pharms, and is included in two NDAs. There are eleven 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 fourteen patent family members in forty-one countries.

There are fifteen drug master file entries for vortioxetine hydrobromide. Three suppliers are listed for this compound. There is one tentative approval for this compound.

Generic filers with tentative approvals for VORTIOXETINE HYDROBROMIDE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing20MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing10MGTABLET;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 204447-004 Sep 30, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Zydus Pharms VORTIOXETINE HYDROBROMIDE vortioxetine hydrobromide TABLET;ORAL 211146-001 Sep 17, 2021 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa TRINTELLIX vortioxetine hydrobromide TABLET;ORAL 204447-004 Sep 30, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 204447-003 Sep 30, 2013 See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa TRINTELLIX vortioxetine hydrobromide TABLET;ORAL 204447-001 Sep 30, 2013 See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa TRINTELLIX vortioxetine hydrobromide TABLET;ORAL 204447-004 Sep 30, 2013 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for vortioxetine hydrobromide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1436271 508 Finland See Plans and Pricing
1436271 2014/022 Ireland See Plans and Pricing PRODUCT NAME: VORTIOXETINE OR A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/891 20131220
1436271 PA2014013,C1436271 Lithuania See Plans and Pricing PRODUCT NAME: VORTIOKSETINAS ARBA JO FARMACINIU POZIURIU PRIIMTINA RUGSTIES PRISIJUNGIMO DRUSKA; REGISTRATION NO/DATE: EU/1/13/891 20131218
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.