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Last Updated: January 26, 2021

DrugPatentWatch Database Preview

TRINTELLIX Drug Profile

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Which patents cover Trintellix, and when can generic versions of Trintellix launch?

Trintellix is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and ten patent family members in forty-one countries.

The generic ingredient in TRINTELLIX is vortioxetine hydrobromide. There are sixteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the vortioxetine hydrobromide profile page.

US ANDA Litigation and Generic Entry Outlook for Trintellix

Trintellix was eligible for patent challenges on September 30, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 30, 2031. This may change due to patent challenges or generic licensing.

Annual sales in 2018 were $526mm indicating the motivation for generic entry.

There have been twenty-three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for TRINTELLIX
Drug Prices for TRINTELLIX

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Drug Sales Revenue Trends for TRINTELLIX

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Generic Entry Opportunity Date for TRINTELLIX
Generic Entry Date for TRINTELLIX*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for TRINTELLIX

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Noam SoreniPhase 3
University of CataniaPhase 4
Azienda Ospedaliera Universitaria Integrata VeronaPhase 4

See all TRINTELLIX clinical trials

Paragraph IV (Patent) Challenges for TRINTELLIX
Tradename Dosage Ingredient NDA Submissiondate
TRINTELLIX TABLET;ORAL vortioxetine hydrobromide 204447 2017-10-02

US Patents and Regulatory Information for TRINTELLIX

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   Start Trial   Start Trial   Start Trial
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 204447-004 Sep 30, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
Takeda Pharms Usa TRINTELLIX vortioxetine hydrobromide TABLET;ORAL 204447-003 Sep 30, 2013 DISCN Yes No   Start Trial   Start Trial   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 TRINTELLIX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1436271 1490023-7 Sweden   Start Trial PRODUCT NAME: VORTIOXETINE ELLER ETT FARMACEUTISKT GODTAGBART SYRAADDITIONSSALT DAERAV; REG. NO/DATE: EU/1/13/891 20131218
1436271 2014/022 Ireland   Start Trial PRODUCT NAME: VORTIOXETINE OR A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/891 20131220
1436271 C20140012 00108 Estonia   Start Trial PRODUCT NAME: VORTIOKSETIIN;REG NO/DATE: K(2013)9715 LOPLIK 20.12.2013
1436271 PA2014013 Lithuania   Start Trial PRODUCT NAME: VORTIOXETINUM; 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.