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Last Updated: January 17, 2022

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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 ten patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and thirteen 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® Litigation and Generic Entry Outlook for Trintellix

A generic version of TRINTELLIX was approved as vortioxetine hydrobromide by ZYDUS PHARMS on September 17th, 2021.

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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
H. Lundbeck A/SPhase 3
Todd DoylePhase 4
Noam SoreniPhase 3

See all TRINTELLIX clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for TRINTELLIX
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

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

Patents protecting TRINTELLIX

Phenyl-piperazine derivatives as serotonin reuptake inhibitors
Patent Number: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free
Patented Use: METHOD OF TREATING AN AFFECTIVE DISORDER SUCH AS DEPRESSION

Phenyl-piperazine derivatives as serotonin reuptake inhibitors
Patent Number: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free
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: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free

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: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free
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: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free
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: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free
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: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free
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: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free
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: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free
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: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free
Patented Use: METHOD OF TREATING DEPRESSION OR MAJOR DEPRESSIVE DISORDER

FDA Regulatory Exclusivity protecting TRINTELLIX

ADDITION TO THE CLINICAL STUDIES SECTION OF THE LABELING WITH THE SUBSECTION ENTITLED DIGIT SYMBOL SUBSTITUTION TEST IN MAJOR DEPRESSIVE DISORDER
Exclusivity Expiration: ⤷  Try it Free

UPDATE TO THE PRESCRIBING INFORMATION FOR VORTIOXETINE ON TREATMENT-EMERGENT SEXUAL DYSFUNCTION COMPARING VORTIOXETINE AND SSRIS
Exclusivity Expiration: ⤷  Try it Free

INFORMATION ADDED TO THE LABELING REGARDING THE RESULT OF STUDY LUAA21004-402
Exclusivity Expiration: ⤷  Try it Free

ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING
Exclusivity Expiration: ⤷  Try it Free

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 ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Takeda Pharms Usa TRINTELLIX vortioxetine hydrobromide TABLET;ORAL 204447-003 Sep 30, 2013 DISCN Yes No ⤷  Try it Free ⤷  Try it Free Y Y ⤷  Try it Free
Takeda Pharms Usa TRINTELLIX vortioxetine hydrobromide TABLET;ORAL 204447-004 Sep 30, 2013 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y Y ⤷  Try it Free
Takeda Pharms Usa TRINTELLIX vortioxetine hydrobromide TABLET;ORAL 204447-004 Sep 30, 2013 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Takeda Pharms Usa TRINTELLIX vortioxetine hydrobromide TABLET;ORAL 204447-004 Sep 30, 2013 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 302 50003-2014 Slovakia ⤷  Try it Free OWNER(S): H. LUNDBECK A/S, VALBY, DK
1436271 300652 Netherlands ⤷  Try it Free PRODUCT NAME: VORTIOXETINE OF EEN FARMACEUTISCH AANVAARDBAAR ZUURADDITIEZOUT ERVAN; REGISTRATION NO/DATE: EU/1/13/891/001-036 20131218
1436271 2014C/036 Belgium ⤷  Try it Free PRODUCT NAME: VORTIOXETINE; AUTHORISATION NUMBER AND DATE: EU/1/13/891 20131220
1436271 C01436271/01 Switzerland ⤷  Try it Free PRODUCT NAME: VORTIOXETINE; REGISTRATION NO/DATE: SWISSMEDIC 65937 09.06.2016
1436271 2014/022 Ireland ⤷  Try it Free 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

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Dow
McKesson
Colorcon
Medtronic
Merck

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