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TRINTELLIX Drug Profile

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Which patents cover Trintellix, and what generic alternatives are available?

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

This drug has one hundred and fifty-five patent family members in forty countries.

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

Summary for TRINTELLIX

International Patents:	155
US Patents:	9
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	100
Clinical Trials:	4
Patent Applications:	52
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TRINTELLIX
DailyMed Link:	TRINTELLIX at DailyMed

Synonyms for TRINTELLIX

1-(2-((2,4-Dimethylphenyl)sulfanyl)phenyl)piperazine monohydrobromide

1-(2-((2,4-Dimethylphenyl)thio)phenyl)piperazine hydrobromide

1-[2-(2,4-dimethylphenylsulfanyl)phenyl]piperazine-hbr

1-[2-[(2,4-dimethylphenyl)thio]phenyl]piperazine hydrobromide

1-{2-[(2,4-dimethylphenyl)sulfanyl]phenyl}piperazine hydrobromide

2796AH

4-[2-(2,4-Dimethyl-phenylsulfanyl)-phenyl]-piperazine hydrobromide

4-{2-[(2,4-dimethylphenyl)sulfanyl]phenyl}piperazin-1-ium bromide

960203-27-4

AB0165485

AC-28325

AKOS016340374

Brintellix

Brintellix (TN)

C18H22N2S.BrH

CHEBI:76015

CHEMBL2107387

CS-1472

D10185

EBD3080710

FT-0696676

HG-0011

HY-15414A

KB-81459

Lu AA 21004 hydrobromide;Lu AA21004 hydrobromide

Lu AA 21004|||1-[2-[(2,4-dimethylphenyl)thio]phenyl]-piperazine hydrobromide

Lu AA21004 (HBr)

Lu-AA-21004

Lu-AA21004-(HBr)

MFCD22383961

MolPort-023-298-793

Piperazine, 1-(2-((2,4-dimethylphenyl)thio)phenyl)-, hydrobromide (1:1)

s8021

SC-95551

SCHEMBL237653

TKS641KOAY

UNII-TKS641KOAY

VNGRUFUIHGGOOM-UHFFFAOYSA-N

Vortioxetine (hydrobromide)

Vortioxetine (Lu AA21004) HBr

Vortioxetine (Lu AA21004) hydrobromide

Vortioxetine HBr

Vortioxetine hydrobromide

Vortioxetine hydrobromide (JAN/USAN)

Vortioxetine hydrobromide [USAN]

vortioxetine monohydrobromide

W-5911

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

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Paragraph IV (Patent) Challenges for TRINTELLIX

Drugname	Dosage	Strength	RLD	Submissiondate
	Tablets	5 mg, 10 mg, 15 mgand 20 mg		2017-10-02

Non-Orange Book US Patents for TRINTELLIX

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
8,110,567	Phenyl-piperazine derivatives as serotonin reuptake inhibitors
9,101,626	Process for preparing 1-[2-(2,4-dimethylphenylsulfanyl)-phenyl]piperazine or pharmaceutically acceptable salt thereof
9,708,280	Phenyl-piperazine derivatives as serotonin reuptake inhibitors
7,138,407	Phenyl-piperazine derivatives as serotonin reuptake inhibitors

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International Patents for TRINTELLIX

Country	Document Number	Estimated Expiration
Luxembourg	92397
Japan	2007031447
Australia	2002333220
Eurasian Patent Organization	200970018

Supplementary Protection Certificates for TRINTELLIX

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2014 00030	Denmark		PRODUCT NAME: VORTIOXETIN ELLER FARMACEUTISK ACCEPTABLE SYREADDITIONSSALTE DERAF, HERUNDER VORTIOXETINHYDROBROMID; REG. NO/DATE: EU/1/13/891 20131218
14/022	Ireland		PRODUCT NAME: VORTIOXETINE OR A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/891 20131220
397	Luxembourg		PRODUCT NAME: VORTIOXETINE OU UN SEL D ADDITION D ACIDE DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE
2014013	Lithuania		PRODUCT NAME: VORTIOXETINUM; REGISTRATION NO/DATE: EU/1/13/891 20131218