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Vortioxetine hydrobromide - Generic Drug Details

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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.

This ingredient has one hundred and thirty-seven patent family members in thirty-seven countries.

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

Summary for Generic Name: vortioxetine hydrobromide

Tradenames:1
Patents:5
Applicants:1
NDAs:1
Drug Master File Entries: see list2
Suppliers / Packaging: see list2
Formulation / Manufacturing:see details
Drug Prices:see low prices
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Takeda Pharms Usa
TRINTELLIX
vortioxetine hydrobromide
TABLET;ORAL204447-003Sep 30, 2013RXNo8,969,355► subscribe ► subscribe
Takeda Pharms Usa
TRINTELLIX
vortioxetine hydrobromide
TABLET;ORAL204447-004Sep 30, 2013RXYes8,969,355► subscribe ► subscribe
Takeda Pharms Usa
TRINTELLIX
vortioxetine hydrobromide
TABLET;ORAL204447-002Sep 30, 2013RXNo8,476,279► subscribeY ► subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
9,125,9081-[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
8,664,2251-[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
7,138,407Phenyl-piperazine derivatives as serotonin reuptake inhibitors► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: vortioxetine hydrobromide

Country Document Number Estimated Expiration
Iceland2732► subscribe
Slovenia2142193► subscribe
South Korea101459168► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: VORTIOXETINE HYDROBROMIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
14/022Ireland► subscribePRODUCT NAME: VORTIOXETINE OR A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/891 20131220
90023-7Sweden► subscribePRODUCT NAME: VORTIOXETINE ELLER ETT FARMACEUTISKT GODTAGBART SYRAADDITIONSSALT DAERAV; REG. NO/DATE: EU/1/13/891 20131218
2014 00030Denmark► subscribePRODUCT NAME: VORTIOXETIN ELLER FARMACEUTISK ACCEPTABLE SYREADDITIONSSALTE DERAF, HERUNDER VORTIOXETINHYDROBROMID; REG. NO/DATE: EU/1/13/891 20131218
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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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