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Vortioxetine hydrobromide - Generic Drug Details

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What are the generic sources for vortioxetine hydrobromide and what is the scope of vortioxetine hydrobromide freedom to operate?

Vortioxetine hydrobromide is the generic ingredient in one branded drug marketed by Takeda Pharms Usa and is included in one NDA. There are ten patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Vortioxetine hydrobromide has two hundred and three patent family members in forty-one countries.

There are sixteen drug master file entries for vortioxetine hydrobromide. Two suppliers are listed for this compound.

Summary for vortioxetine hydrobromide

International Patents:	203
US Patents:	10
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	16
Suppliers / Packagers:	2
Bulk Api Vendors:	50
Patent Applications:	50
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for vortioxetine hydrobromide
DailyMed Link:	vortioxetine hydrobromide at DailyMed

Synonyms for vortioxetine hydrobromide

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

BCP09588

Brintellix

Brintellix (TN)

C18H22N2S.BrH

CHEBI:76015

CHEMBL2107387

CS-1472

D10185

EBD3080710

EX-A2348

FT-0696676

HG-0011

HY-15414A

KB-81459

Lu AA 21004 hydrobromide

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)

MolPort-023-298-793

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

s8021

SB16507

SC-95551

SCHEMBL237653

SW219360-1

TKS641KOAY

Trintellix

UNII-TKS641KOAY

VNGRUFUIHGGOOM-UHFFFAOYSA-N

Vortioxetine (hydrobromide)

Vortioxetine (Lu AA21004) HBr

Vortioxetine (Lu AA21004) hydrobromide

Vortioxetine HBr

Vortioxetine hydrobromide (JAN/USAN)

Vortioxetine hydrobromide [USAN]

vortioxetine monohydrobromide

W-5911

US Patents and Regulatory Information for vortioxetine hydrobromide

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	204447-001	Sep 30, 2013		RX	Yes	No
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-002	Sep 30, 2013		RX	Yes	No
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-002	Sep 30, 2013		RX	Yes	No
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	204447-002	Sep 30, 2013		RX	Yes	No
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-003	Sep 30, 2013		DISCN	Yes	No

International Patents for vortioxetine hydrobromide

Country	Patent Number	Estimated Expiration
Australia	2002333220
Brazil	122012009534
Malaysia	150448
Japan	2007031447
Eurasian Patent Organization	200970870
New Zealand	579721
China	101636161

Supplementary Protection Certificates for vortioxetine hydrobromide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1436271	CR 2014 00030	Denmark		PRODUCT NAME: VORTIOXETIN ELLER FARMACEUTISK ACCEPTABLE SYREADDITIONSSALTE DERAF, HERUNDER VORTIOXETINHYDROBROMID; REG. NO/DATE: EU/1/13/891 20131218
1436271	2014C/036	Belgium		PRODUCT NAME: VORTIOXETINE; AUTHORISATION NUMBER AND DATE: EU/1/13/891 20131220
1436271	C20140012 00108	Estonia		PRODUCT NAME: VORTIOKSETIIN;REG NO/DATE: K(2013)9715 LOPLIK 20.12.2013
1436271	PA2014013,C1436271	Lithuania		PRODUCT NAME: VORTIOKSETINAS ARBA JO FARMACINIU POZIURIU PRIIMTINA RUGSTIES PRISIJUNGIMO DRUSKA; REGISTRATION NO/DATE: EU/1/13/891 20131218
1436271	C 2014 023	Romania		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	1490023-7	Sweden		PRODUCT NAME: VORTIOXETINE ELLER ETT FARMACEUTISKT GODTAGBART SYRAADDITIONSSALT DAERAV; REG. NO/DATE: EU/1/13/891 20131218
1436271	2014/022	Ireland		PRODUCT NAME: VORTIOXETINE OR A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/891 20131220