Time limited offer for new users ▶ Get up to 3 months free

Serving leading biopharmaceutical companies globally:

Medtronic
Baxter
Mallinckrodt
Merck
McKinsey
Colorcon

Last Updated: January 27, 2023

Vortioxetine hydrobromide - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


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 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 fifteen 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.

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 204447-003 Sep 30, 2013 DISCN Yes No See Plans and Pricing See Plans and Pricing Y 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 Y See Plans and Pricing
Takeda Pharms Usa TRINTELLIX vortioxetine hydrobromide TABLET;ORAL 204447-003 Sep 30, 2013 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa TRINTELLIX vortioxetine hydrobromide TABLET;ORAL 204447-001 Sep 30, 2013 RX Yes 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
Takeda Pharms Usa TRINTELLIX vortioxetine hydrobromide TABLET;ORAL 204447-002 Sep 30, 2013 RX Yes No See Plans and Pricing See Plans and Pricing Y Y 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 204447-001 Sep 30, 2013 See Plans and Pricing See Plans and Pricing
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 204447-004 Sep 30, 2013 See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa TRINTELLIX vortioxetine hydrobromide TABLET;ORAL 204447-002 Sep 30, 2013 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for vortioxetine hydrobromide

Country Patent Number Title Estimated Expiration
Lithuania C1436271 See Plans and Pricing
Cyprus 1111183 See Plans and Pricing
Japan 2014193891 THERAPEUTIC USE OF COMPOUND HAVING ACTIVITY IN COMBINATION OF SERT, 5-HT3, AND 5-HT1A See Plans and Pricing
Eurasian Patent Organization 007537 АЗОТСОДЕРЖАЩИЕ ГЕТЕРОЦИКЛИЧЕСКИЕ ПРОИЗВОДНЫЕ, СОДЕРЖАЩАЯ ИХ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, ИХ ПРИМЕНЕНИЕ И СПОСОБ ЛЕЧЕНИЯ (NITROGEN-CONTAINING HETEROCYCLIC DERIVATIVES, PHARMACEUTICAL COMPOSITION CONTAINING THEM, USE THEREOF AND METHOD FOR THE TREATMENT) See Plans and Pricing
Israel 238068 See Plans and Pricing
Japan 7179035 See Plans and Pricing
>Country >Patent Number >Title >Estimated 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 14C0033 France See Plans and Pricing PRODUCT NAME: VORTIOXETINE OU L'UN DE SES SELS D'ADDITION D'ACIDE PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/891 20131218
1436271 C300652 Netherlands See Plans and Pricing PRODUCT NAME: VORTIOXETINE OF EEN; REGISTRATION NO/DATE: EU/1/13/891/001-036 20131218
1436271 302 50003-2014 Slovakia See Plans and Pricing OWNER(S): H. LUNDBECK A/S, VALBY, DK
1436271 92397 Luxembourg See Plans and Pricing PRODUCT NAME: VORTIOXETINE OU UN SEL D ADDITION D ACIDE DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE
1436271 C01436271/01 Switzerland See Plans and Pricing PRODUCT NAME: VORTIOXETINE; REGISTRATION NO/DATE: SWISSMEDIC 65937 09.06.2016
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Dow
McKinsey
Mallinckrodt
Moodys
Harvard Business School

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.