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Last Updated: April 10, 2020

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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 eight 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. Two 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 2017 were $427mm indicating the motivation for generic entry (peak sales were $441mm in 2016).

There have been twenty-two 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

See drug prices for TRINTELLIX

Drug Sales Revenue Trends for TRINTELLIX

See drug sales revenues for TRINTELLIX

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

Recent Litigation for TRINTELLIX

Identify potential future generic entrants

District Court Litigation
Case NameDate
H. Lundbeck A/S v. Apicore US LLC2018-07-12
H. Lundbeck A/S v. MSN Laboratories Private Limited2018-06-07
H. Lundbeck A/S v. Lupin Limited2018-05-21

See all TRINTELLIX litigation

Synonyms for TRINTELLIX
1-(2-((2,4-Dimethylphenyl)sulfanyl)phenyl)piperazine monohydrobromide
1-(2-((2,4-Dimethylphenyl)sulfanyl)phenyl}piperazine
1-(2-((2,4-Dimethylphenyl)thio)phenyl)piperazine
1-(2-((2,4-Dimethylphenyl)thio)phenyl)piperazine hydrobromide
1-(2-((2,4-DIMETHYLPHENYL)THIO)PHENYL)PIPERAZINE HYDROCHLRIDE
1-[2-(2,4-dimethyl-phenylsulfanyl)-phenyl]-piperazine
1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine
1-[2-(2,4-Dimethylphenylsulfanyl)-phenyl]piperazine
1-[2-(2,4-dimethylphenylsulfanyl)phenyl]piperazine
1-[2-(2,4-dimethylphenylsulfanyl)phenyl]piperazine-hbr
1-[2-[(2,4-Dimethylphenyl)thio]phenyl]piperazine
1-[2-[(2,4-dimethylphenyl)thio]phenyl]piperazine hydrobromide
1-{2-[(2,4-dimethylphenyl)sulfanyl]phenyl}piperazine
1-{2-[(2,4-dimethylphenyl)sulfanyl]phenyl}piperazine hydrobromide
2796AH
3O2K1S3WQV
4-[2-(2,4-Dimethyl-phenylsulfanyl)-phenyl]-piperazine hydrobromide
4-{2-[(2,4-dimethylphenyl)sulfanyl]phenyl}piperazin-1-ium bromide
4CH-016292
508233-74-7
7034AB
960203-27-4
A12602
A3926
AB0165485
AC-27648
AC-28325
AK110506
AKOS016008748
AKOS016340374
API0019472
AR-270/43507985
AX8224799
BCP05996
BCP09588
BDBM50400902
Brintellix
Brintellix (TN)
C18H22N2S.BrH
CCG-229998
CHEBI:76015
CHEBI:76016
CHEMBL2104993
CHEMBL2107387
CHEMBL2204360
CS-1471
CS-1472
D10184
D10185
DA-42264
DB09068
DTXSID80965062
EBD3080710
EX-A2348
FT-0686961
FT-0696676
GG-0052
GTPL7351
HG-0011
HSDB 8250
HY-15414
HY-15414A
KS-0000062Y
Lu AA 21004
Lu AA 21004 hydrobromide
Lu AA 21004 hydrobromide;Lu AA21004 hydrobromide
Lu AA 21004 pound>>LuAA21004 pound>> Lu-AA21004 pound>> Lu AA21004 pound>> AA21004
Lu AA 21004|||1-[2-[(2,4-dimethylphenyl)thio]phenyl]-piperazine
Lu AA 21004|||1-[2-[(2,4-dimethylphenyl)thio]phenyl]-piperazine hydrobromide
Lu AA21004
Lu AA21004 (HBr)
Lu AA21004 hydrobromide
Lu-AA-21004
Lu-AA21004
Lu-AA21004-(HBr)
LuAA21004
MFCD22380814
MFCD22383961
PIP107
Piperazine, 1-(2-((2,4-dimethylphenyl)thio)phenyl)-
Piperazine, 1-(2-((2,4-dimethylphenyl)thio)phenyl)-, hydrobromide (1:1)
Piperazine, 1-[2-[(2,4-dimethylphenyl)thio]phenyl]-
Piperazine, 1-[2-[(2,4-dimethylphenyl)thio]phenyl]-, hydrobromide (1:1)
Q27145682
Q3563148
s5506
s8021
SB16506
SB16507
SC-53652
SC-95551
SCHEMBL236115
SCHEMBL237653
ST2408515
STL483777
SW219360-1
TKS641KOAY
Trintellix (TN)
UNII-3O2K1S3WQV
UNII-TKS641KOAY
VNGRUFUIHGGOOM-UHFFFAOYSA-N
vortioxetina
VORTIOXETINE
Vortioxetine (hydrobromide)
Vortioxetine (Lu AA21004)
Vortioxetine (Lu AA21004) HBr
Vortioxetine (Lu AA21004) hydrobromide
Vortioxetine (USAN)
Vortioxetine [USAN:INN]
Vortioxetine HBr
Vortioxetine hydrobromide
Vortioxetine hydrobromide (JAN/USAN)
Vortioxetine hydrobromide [USAN]
vortioxetine monohydrobromide
vortioxetine-lu-aa21004-hydrobromide
Vortioxetine, Lu AA21004
vortioxetinum
W-5909
W-5911
YQNWZWMKLDQSAC-UHFFFAOYSA-N
ZINC34051848
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 Y   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
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 204447-003 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 PA2014013,C1436271 Lithuania   Start Trial PRODUCT NAME: VORTIOKSETINAS ARBA JO FARMACINIU POZIURIU PRIIMTINA RUGSTIES PRISIJUNGIMO DRUSKA; REGISTRATION NO/DATE: EU/1/13/891 20131218
1436271 C 2014 023 Romania   Start Trial PRODUCT NAME: VORTIOXETINA SAU O SARE DE ADITIE ACIDA A ACESTEIAACCEPTABILA FARMACEUTIC1-[2-(2,4-DIMETILFENILSULFANIL)FENIL]PIPERAZINA; NATIONAL AUTHORISATION NUMBER: EU/1/13/891; DATE OF NATIONAL AUTHORISATION: 20131218; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/891; DATE OF FIRST AUTHORISATION IN EEA: 20131218
1436271 122014000049 Germany   Start Trial PRODUCT NAME: VORTIOXETIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SAEUREADDITIONSSALZ DAVON; REGISTRATION NO/DATE: EU/1/13/891 20131218
1436271 300652 Netherlands   Start Trial PRODUCT NAME: VORTIOXETINE OF EEN FARMACEUTISCH AANVAARDBAAR ZUURADDITIEZOUT ERVAN; REGISTRATION NO/DATE: EU/1/13/891/001-036 20131218
1436271 1490023-7 Sweden   Start Trial PRODUCT NAME: VORTIOXETINE ELLER ETT FARMACEUTISKT GODTAGBART SYRAADDITIONSSALT DAERAV; REG. NO/DATE: EU/1/13/891 20131218
1436271 14C0033 France   Start Trial PRODUCT NAME: VORTIOXETINE OU L'UN DE SES SELS D'ADDITION D'ACIDE PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/891 20131218
>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
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.