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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 six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Vortioxetine hydrobromide has one hundred and fifty-five patent family members in forty countries.

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

Summary for vortioxetine hydrobromide

International Patents:	155
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	16
Suppliers / Packagers:	2
Bulk Api Vendors:	32
Clinical Trials:	120
Patent Applications:	48
Formulation / Manufacturing:	see details
Drug Prices:	see low prices
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

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

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	204447-004	Sep 30, 2013		RX	Yes	Yes			Y	Y
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

Non-Orange Book US Patents for vortioxetine hydrobromide

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
9,101,626	Process for preparing 1-[2-(2,4-dimethylphenylsulfanyl)-phenyl]piperazine or pharmaceutically acceptable salt thereof
8,664,225	1-[2-(2,4-dimethylphenylsulfanyl)-phenyl] piperazine as a compound with combined serotonin reuptake, 5-HT3 and 5-HT1A activity for the treatment of pain or residual symptoms in depression relating to sleep and cognition
7,683,053	Phenyl-piperazine derivatives as serotonin reuptake inhibitors
8,110,567	Phenyl-piperazine derivatives as serotonin reuptake inhibitors

International Patents for vortioxetine hydrobromide

Country	Document Number	Estimated Expiration
Cyprus	1111183
Japan	2009541216
Hungary	0402313
Ukraine	97392

Supplementary Protection Certificates for vortioxetine hydrobromide

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
14/022	Ireland		PRODUCT NAME: VORTIOXETINE OR A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/891 20131220
0652	Netherlands		PRODUCT NAME: VORTIOXETINE OF EEN FARMACEUTISCH AANVAARDBAAR ZUURADDITIEZOUT ERVAN; REGISTRATION NO/DATE: EU/1/13/891/001-036 20131218
2014 00030	Denmark		PRODUCT NAME: VORTIOXETIN ELLER FARMACEUTISK ACCEPTABLE SYREADDITIONSSALTE DERAF, HERUNDER VORTIOXETINHYDROBROMID; REG. NO/DATE: EU/1/13/891 20131218
2014000049	Germany		PRODUCT NAME: VORTIOXETIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SAEUREADDITIONSSALZ DAVON; REGISTRATION NO/DATE: EU/1/13/891 20131218