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Serving hundreds of leading biopharmaceutical companies globally:

UBS
Johnson and Johnson
Moodys
Mallinckrodt
Argus Health
Cipla
Express Scripts
Cantor Fitzgerald
Queensland Health

Generated: July 23, 2018

DrugPatentWatch Database Preview

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 nine 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. One supplier is listed for this compound.
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 ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Takeda Pharms Usa TRINTELLIX vortioxetine hydrobromide TABLET;ORAL 204447-002 Sep 30, 2013 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Takeda Pharms Usa TRINTELLIX vortioxetine hydrobromide TABLET;ORAL 204447-004 Sep 30, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Takeda Pharms Usa TRINTELLIX vortioxetine hydrobromide TABLET;ORAL 204447-003 Sep 30, 2013 DISCN Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
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
7,138,407 Phenyl-piperazine derivatives as serotonin reuptake inhibitors ➤ Sign Up
7,148,238 Phenyl-piperazine derivatives as serotonin reuptake inhibitors ➤ Sign Up
7,683,053 Phenyl-piperazine derivatives as serotonin reuptake inhibitors ➤ Sign Up
8,110,567 Phenyl-piperazine derivatives as serotonin reuptake inhibitors ➤ Sign Up
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
0140012 00108 Estonia ➤ Sign Up PRODUCT NAME: VORTIOKSETIIN;REG NO/DATE: K(2013)9715 LOPLIK 20.12.2013
2014 00030 Denmark ➤ Sign Up PRODUCT NAME: VORTIOXETIN ELLER FARMACEUTISK ACCEPTABLE SYREADDITIONSSALTE DERAF, HERUNDER VORTIOXETINHYDROBROMID; REG. NO/DATE: EU/1/13/891 20131218
397 Luxembourg ➤ Sign Up PRODUCT NAME: VORTIOXETINE OU UN SEL D ADDITION D ACIDE DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE
00652 Netherlands ➤ Sign Up PRODUCT NAME: VORTIOXETINE OF EEN; REGISTRATION NO/DATE: EU/1/13/891/001-036 20131218
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Julphar
Baxter
Argus Health
Farmers Insurance
Citi
Medtronic
US Department of Justice
Fuji

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