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Serving leading biopharmaceutical companies globally:

Harvard Business School
Fish and Richardson
Novartis
Chubb
Merck
McKinsey
Dow
Express Scripts
QuintilesIMS
Boehringer Ingelheim

Generated: January 18, 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 five patents protecting this compound. 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

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 ➤ Subscribe ➤ Subscribe ➤ Subscribe
Takeda Pharms Usa TRINTELLIX vortioxetine hydrobromide TABLET;ORAL 204447-003 Sep 30, 2013 DISCN Yes No ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Takeda Pharms Usa TRINTELLIX vortioxetine hydrobromide TABLET;ORAL 204447-004 Sep 30, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Takeda Pharms Usa TRINTELLIX vortioxetine hydrobromide TABLET;ORAL 204447-003 Sep 30, 2013 DISCN Yes No ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Takeda Pharms Usa TRINTELLIX vortioxetine hydrobromide TABLET;ORAL 204447-001 Sep 30, 2013 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Takeda Pharms Usa TRINTELLIX vortioxetine hydrobromide TABLET;ORAL 204447-003 Sep 30, 2013 DISCN Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Takeda Pharms Usa TRINTELLIX vortioxetine hydrobromide TABLET;ORAL 204447-004 Sep 30, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Takeda Pharms Usa TRINTELLIX vortioxetine hydrobromide TABLET;ORAL 204447-003 Sep 30, 2013 DISCN Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Takeda Pharms Usa TRINTELLIX vortioxetine hydrobromide TABLET;ORAL 204447-001 Sep 30, 2013 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Takeda Pharms Usa TRINTELLIX vortioxetine hydrobromide TABLET;ORAL 204447-001 Sep 30, 2013 RX Yes No ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
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
9,125,909 1-[2-(2,4 dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HT.sub.3 and 5-HT.sub.1A activity for the treatment of cognitive impairment ➤ Subscribe
9,090,575 Phenyl-piperazine derivatives as serotonin reuptake inhibitors ➤ Subscribe
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 ➤ Subscribe
7,148,238 Phenyl-piperazine derivatives as serotonin reuptake inhibitors ➤ Subscribe
9,708,280 Phenyl-piperazine derivatives as serotonin reuptake inhibitors ➤ Subscribe
9,095,588 Process for preparing 1-[2-(2,4-dimethylphenysulfanyl)-pheny]piperazine or pharmaceutically acceptable salt thereof ➤ Subscribe
9,125,910 1-[2-(2,4 dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HT.sub.3 and 5-HT.sub.1A activity for the treatment of cognitive impairment ➤ Subscribe
9,125,908 1-[2-(2,4-dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HT.sub.3 and 5-HT.sub.1A activity for the treatment of cognitive impairment ➤ Subscribe
9,101,626 Process for preparing 1-[2-(2,4-dimethylphenylsulfanyl)-phenyl]piperazine or pharmaceutically acceptable salt thereof ➤ Subscribe
8,110,567 Phenyl-piperazine derivatives as serotonin reuptake inhibitors ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for vortioxetine hydrobromide

Supplementary Protection Certificates for vortioxetine hydrobromide

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014013 Lithuania ➤ Subscribe PRODUCT NAME: VORTIOXETINUM; REGISTRATION NO/DATE: EU/1/13/891 20131218
397 Luxembourg ➤ Subscribe PRODUCT NAME: VORTIOXETINE OU UN SEL D ADDITION D ACIDE DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE
0652 Netherlands ➤ Subscribe PRODUCT NAME: VORTIOXETINE OF EEN FARMACEUTISCH AANVAARDBAAR ZUURADDITIEZOUT ERVAN; REGISTRATION NO/DATE: EU/1/13/891/001-036 20131218
90023-7 Sweden ➤ Subscribe PRODUCT NAME: VORTIOXETINE ELLER ETT FARMACEUTISKT GODTAGBART SYRAADDITIONSSALT DAERAV; REG. NO/DATE: EU/1/13/891 20131218
14/022 Ireland ➤ Subscribe PRODUCT NAME: VORTIOXETINE OR A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/891 20131220
2014000049 Germany ➤ Subscribe PRODUCT NAME: VORTIOXETIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SAEUREADDITIONSSALZ DAVON; REGISTRATION NO/DATE: EU/1/13/891 20131218
8 Finland ➤ Subscribe
0140012 00108 Estonia ➤ Subscribe PRODUCT NAME: VORTIOKSETIIN;REG NO/DATE: K(2013)9715 LOPLIK 20.12.2013
00652 Netherlands ➤ Subscribe PRODUCT NAME: VORTIOXETINE OF EEN; REGISTRATION NO/DATE: EU/1/13/891/001-036 20131218
C0033 France ➤ Subscribe PRODUCT NAME: VORTIOXETINE OU L'UN DE SES SELS D'ADDITION D'ACIDE PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/891 20131218
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Cantor Fitzgerald
Fuji
Cerilliant
Johnson and Johnson
Deloitte
Cipla
Express Scripts
Colorcon

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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