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Last Updated: January 28, 2023

TRINTELLIX Drug Patent 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 eleven patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and fifteen 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.

DrugPatentWatch® Generic Entry Outlook for Trintellix

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

Annual sales in 2019 were $545mm 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.

There is one tentative approval for the generic drug (vortioxetine hydrobromide), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for TRINTELLIX
Drug Prices for TRINTELLIX

See drug prices for TRINTELLIX

Drug Sales Revenue Trends for TRINTELLIX

See drug sales revenues for TRINTELLIX

Recent Clinical Trials for TRINTELLIX

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

SponsorPhase
Seasons Biotechnology (Taizhou) Co., Ltd.Phase 1
H. Lundbeck A/SPhase 3
Todd DoylePhase 4

See all TRINTELLIX clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for TRINTELLIX
Paragraph IV (Patent) Challenges for TRINTELLIX
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 TRINTELLIX

TRINTELLIX is protected by ten US patents and two FDA Regulatory Exclusivities.

Patents protecting TRINTELLIX

Phenyl-piperazine derivatives as serotonin reuptake inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING AN AFFECTIVE DISORDER SUCH AS DEPRESSION

Phenyl-piperazine derivatives as serotonin reuptake inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING AN AFFECTIVE DISORDER SUCH AS DEPRESSION

1-[2-(2,4-dimethylphenylsulfanyl)-phenyl] piperazine as a compound with combined serotonin reuptake, 5-HT3 and 5-HT1A activity for the treatment of cognitive impairment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

1-[2-(2,4 dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HT3 and 5-HT1a activity for the treatment of cognitive impairment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING DEPRESSION OR MAJOR DEPRESSIVE DISORDER

1-[2-(2,4-dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HT.sub.3 and 5-HT.sub.1A activity for the treatment of cognitive impairment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE IN THE TREATMENT OF MAJOR DEPRESSIVE DISORDER TO IMPROVE PROCESSING SPEED, AN ASPECT OF COGNITIVE FUNCTION

1-[2-(2,4 dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HT.sub.3 and 5-HT.sub.1A activity for the treatment of cognitive impairment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE IN THE TREATMENT OF MAJOR DEPRESSIVE DISORDER TO IMPROVE PROCESSING SPEED, AN ASPECT OF COGNITIVE FUNCTION

1-[2-(2,4 dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HT.sub.3 and 5-HT.sub.1A activity for the treatment of cognitive impairment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE IN THE TREATMENT OF MAJOR DEPRESSIVE DISORDER TO IMPROVE PROCESSING SPEED, AN ASPECT OF COGNITIVE FUNCTION

1-[2-(2,4 dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HT3 and 5-HT1a activity for the treatment of cognitive impairment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING DEPRESSION OR MAJOR DEPRESSIVE DISORDER

Therapeutic uses of compounds having combined SERT, 5-HT.sub.3 and 5-HT.sub.1A activity
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE IN THE TREATMENT OF MAJOR DEPRESSIVE DISORDER TO IMPROVE TREATMENT EMERGENT SEXUAL DYSFUNCTION (TESD) INDUCED BY PRIOR SEROTONIN REUPTAKE INHIBITOR TREATMENT

1-[2-(2,4-dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HT.sub.3 and 5-HT.sub.1A activity for the treatment of cognitive impairment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING DEPRESSION OR MAJOR DEPRESSIVE DISORDER

FDA Regulatory Exclusivity protecting TRINTELLIX

INFORMATION ADDED TO THE LABELING REGARDING THE RESULT OF STUDY LUAA21004-402
Exclusivity Expiration: See Plans and Pricing

ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING
Exclusivity Expiration: 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
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 204447-003 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 204447-004 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 204447-004 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 204447-004 Sep 30, 2013 RX Yes Yes 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 TRINTELLIX

International Patents for TRINTELLIX

When does loss-of-exclusivity occur for TRINTELLIX?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 1481
Estimated Expiration: See Plans and Pricing

Patent: 5797
Estimated Expiration: See Plans and Pricing

Australia

Patent: 07260355
Estimated Expiration: See Plans and Pricing

Patent: 08228638
Estimated Expiration: See Plans and Pricing

Austria

Patent: 5745
Estimated Expiration: See Plans and Pricing

Patent: 0941
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0713425
Estimated Expiration: See Plans and Pricing

Patent: 0808941
Estimated Expiration: See Plans and Pricing

Patent: 2020011899
Estimated Expiration: See Plans and Pricing

Canada

Patent: 55212
Estimated Expiration: See Plans and Pricing

Patent: 84571
Estimated Expiration: See Plans and Pricing

Chile

Patent: 08000795
Estimated Expiration: See Plans and Pricing

Patent: 11001610
Estimated Expiration: See Plans and Pricing

China

Patent: 1472906
Estimated Expiration: See Plans and Pricing

Patent: 1636161
Estimated Expiration: See Plans and Pricing

Patent: 2614179
Estimated Expiration: See Plans and Pricing

Patent: 2617513
Estimated Expiration: See Plans and Pricing

Patent: 3948597
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 20962
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0110058
Estimated Expiration: See Plans and Pricing

Patent: 0120173
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 11183
Estimated Expiration: See Plans and Pricing

Patent: 12635
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 44043
Estimated Expiration: See Plans and Pricing

Patent: 42193
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 5287
Estimated Expiration: See Plans and Pricing

Patent: 7058
Estimated Expiration: See Plans and Pricing

Patent: 0970018
Estimated Expiration: See Plans and Pricing

Patent: 0970870
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 44043
Estimated Expiration: See Plans and Pricing

Patent: 42193
Estimated Expiration: See Plans and Pricing

Patent: 39201
Estimated Expiration: See Plans and Pricing

Germany

Patent: 2008004643
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 34483
Estimated Expiration: See Plans and Pricing

Patent: 71951
Estimated Expiration: See Plans and Pricing

Patent: 72014
Estimated Expiration: See Plans and Pricing

Israel

Patent: 5511
Estimated Expiration: See Plans and Pricing

Patent: 0956
Estimated Expiration: See Plans and Pricing

Patent: 8068
Estimated Expiration: See Plans and Pricing

Japan

Patent: 90013
Estimated Expiration: See Plans and Pricing

Patent: 71790
Estimated Expiration: See Plans and Pricing

Patent: 02929
Estimated Expiration: See Plans and Pricing

Patent: 63609
Estimated Expiration: See Plans and Pricing

Patent: 01742
Estimated Expiration: See Plans and Pricing

Patent: 24082
Estimated Expiration: See Plans and Pricing

Patent: 09541216
Estimated Expiration: See Plans and Pricing

Patent: 10090165
Estimated Expiration: See Plans and Pricing

Patent: 10521501
Estimated Expiration: See Plans and Pricing

Patent: 13056933
Estimated Expiration: See Plans and Pricing

Patent: 15157872
Estimated Expiration: See Plans and Pricing

Patent: 17008086
Estimated Expiration: See Plans and Pricing

Patent: 18199689
Estimated Expiration: See Plans and Pricing

Patent: 20152732
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 0448
Estimated Expiration: See Plans and Pricing

Patent: 0647
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 08016141
Estimated Expiration: See Plans and Pricing

Patent: 09009672
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 575
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 2986
Estimated Expiration: See Plans and Pricing

Patent: 9721
Estimated Expiration: See Plans and Pricing

Norway

Patent: 3929
Estimated Expiration: See Plans and Pricing

Patent: 090229
Estimated Expiration: See Plans and Pricing

Poland

Patent: 44043
Estimated Expiration: See Plans and Pricing

Patent: 42193
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 44043
Estimated Expiration: See Plans and Pricing

Patent: 42193
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 560
Estimated Expiration: See Plans and Pricing

Patent: 205
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 44043
Estimated Expiration: See Plans and Pricing

Patent: 42193
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0810017
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1445514
Estimated Expiration: See Plans and Pricing

Patent: 1459168
Estimated Expiration: See Plans and Pricing

Patent: 1627901
Estimated Expiration: See Plans and Pricing

Patent: 090028712
Estimated Expiration: See Plans and Pricing

Patent: 090125251
Estimated Expiration: See Plans and Pricing

Patent: 130079619
Estimated Expiration: See Plans and Pricing

Patent: 130133078
Estimated Expiration: See Plans and Pricing

Spain

Patent: 55434
Estimated Expiration: See Plans and Pricing

Patent: 79200
Estimated Expiration: See Plans and Pricing

Patent: 32102
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 43091
Estimated Expiration: See Plans and Pricing

Patent: 0817340
Estimated Expiration: See Plans and Pricing

Patent: 0848411
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 08460
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 250
Estimated Expiration: See Plans and Pricing

Patent: 392
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TRINTELLIX around the world.

Country Patent Number Title Estimated Expiration
Brazil 0212733 COMPOSIÇÃO FARMACÊUTICA COMPREENDENDO COMPOSTO INIBIDOR DA RECAPTAÇÃO DE SEROTONINA, E, USO DO MESMO See Plans and Pricing
Argentina 066460 COMPUESTOS DERIVADOS DE FENIL-PIPERAZINA, FENIL-PIPERIDINA Y FENIL-TETRAHIDROPIRIDINA COMO INHIBIDORES DE LA REABSORCION DE LA SEROTONINA, UNA COMPOSICION FARMACEUTICA Y UTILIZACION DE LOS MISMOS PARA LA PREPARACION DE MEDICAMENTOS See Plans and Pricing
World Intellectual Property Organization (WIPO) 2009062517 See Plans and Pricing
Brazil 122012023120 composto inibidor da recaptação de serotonina See Plans and Pricing
Cyprus 1112646 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TRINTELLIX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1436271 CR 2014 00030 Denmark See Plans and Pricing PRODUCT NAME: VORTIOXETIN ELLER FARMACEUTISK ACCEPTABLE SYREADDITIONSSALTE DERAF, HERUNDER VORTIOXETINHYDROBROMID; REG. NO/DATE: EU/1/13/891 20131218
1436271 PA2014013 Lithuania See Plans and Pricing PRODUCT NAME: VORTIOXETINUM; REGISTRATION NO/DATE: EU/1/13/891 20131218
1436271 C01436271/01 Switzerland See Plans and Pricing PRODUCT NAME: VORTIOXETINE; REGISTRATION NO/DATE: SWISSMEDIC 65937 09.06.2016
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Dow
McKesson
Colorcon
Medtronic
Merck

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.