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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Mallinckrodt
Teva
Fuji
Cantor Fitzgerald
QuintilesIMS
Cipla
Daiichi Sankyo
Covington

Generated: April 23, 2018

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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
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 ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Takeda Pharms Usa TRINTELLIX vortioxetine hydrobromide TABLET;ORAL 204447-002 Sep 30, 2013 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Takeda Pharms Usa TRINTELLIX vortioxetine hydrobromide TABLET;ORAL 204447-002 Sep 30, 2013 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Takeda Pharms Usa TRINTELLIX vortioxetine hydrobromide TABLET;ORAL 204447-004 Sep 30, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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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 ➤ Try a Free Trial
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 ➤ Try a Free Trial
7,683,053 Phenyl-piperazine derivatives as serotonin reuptake inhibitors ➤ Try a Free Trial
8,110,567 Phenyl-piperazine derivatives as serotonin reuptake inhibitors ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for vortioxetine hydrobromide

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

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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Accenture
UBS
Johnson and Johnson
Deloitte
US Army
Cerilliant
Argus Health
Chinese Patent Office

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