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Last Updated: December 10, 2019

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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 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 four patent family members in forty-one countries.

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

Recent Litigation for vortioxetine hydrobromide

Identify potential future generic entrants

District Court Litigation
Case NameDate
H. Lundbeck A/S v. Apicore US LLC2018-07-12
H. Lundbeck A/S v. MSN Laboratories Private Limited2018-06-07
H. Lundbeck A/S v. Lupin Limited2018-05-21

See all vortioxetine hydrobromide litigation

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
Paragraph IV (Patent) Challenges for VORTIOXETINE HYDROBROMIDE
Tradename Dosage Ingredient NDA Submissiondate
TRINTELLIX TABLET;ORAL vortioxetine hydrobromide 204447 2017-10-02

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 204447-002 Sep 30, 2013 RX Yes No   Start Trial   Start Trial   Start Trial
Takeda Pharms Usa TRINTELLIX vortioxetine hydrobromide TABLET;ORAL 204447-002 Sep 30, 2013 RX Yes No   Start Trial   Start Trial   Start Trial
Takeda Pharms Usa TRINTELLIX vortioxetine hydrobromide TABLET;ORAL 204447-001 Sep 30, 2013 RX Yes No   Start Trial   Start Trial   Start Trial
Takeda Pharms Usa TRINTELLIX vortioxetine hydrobromide TABLET;ORAL 204447-004 Sep 30, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
Takeda Pharms Usa TRINTELLIX vortioxetine hydrobromide TABLET;ORAL 204447-003 Sep 30, 2013 DISCN Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for vortioxetine hydrobromide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1436271 302 50003-2014 Slovakia   Start Trial OWNER(S): H. LUNDBECK A/S, VALBY, DK
1436271 1490023-7 Sweden   Start Trial PRODUCT NAME: VORTIOXETINE ELLER ETT FARMACEUTISKT GODTAGBART SYRAADDITIONSSALT DAERAV; REG. NO/DATE: EU/1/13/891 20131218
1436271 C20140012 00108 Estonia   Start Trial PRODUCT NAME: VORTIOKSETIIN;REG NO/DATE: K(2013)9715 LOPLIK 20.12.2013
1436271 92397 Luxembourg   Start Trial PRODUCT NAME: VORTIOXETINE OU UN SEL D ADDITION D ACIDE DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE
1436271 PA2014013 Lithuania   Start Trial PRODUCT NAME: VORTIOXETINUM; REGISTRATION NO/DATE: EU/1/13/891 20131218
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Boehringer Ingelheim
Merck
Johnson and Johnson
Medtronic
Dow

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