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Vortioxetine hydrobromide - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for vortioxetine hydrobromide?

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. Additional information is available in the individual branded drug profile pages.

Vortioxetine hydrobromide has one hundred and thirty-nine patent family members in thirty-eight countries.

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

Summary for Generic Name: vortioxetine hydrobromide

Tradenames:1
Patents:6
Applicants:1
NDAs:1
Drug Master File Entries: see list3
Suppliers / Packagers: see list2
Bulk Api Vendors: see list31
Clinical Trials: see list66
Patent Applications: see list39
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:vortioxetine hydrobromide at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Takeda Pharms Usa
TRINTELLIX
vortioxetine hydrobromide
TABLET;ORAL204447-004Sep 30, 2013RXYesYes7,144,884► SubscribeYY ► Subscribe
Takeda Pharms Usa
TRINTELLIX
vortioxetine hydrobromide
TABLET;ORAL204447-004Sep 30, 2013RXYesYes8,722,684► SubscribeYY ► Subscribe
Takeda Pharms Usa
TRINTELLIX
vortioxetine hydrobromide
TABLET;ORAL204447-001Sep 30, 2013RXYesNo► Subscribe► Subscribe
Takeda Pharms Usa
TRINTELLIX
vortioxetine hydrobromide
TABLET;ORAL204447-004Sep 30, 2013RXYesYes8,969,355► Subscribe ► Subscribe
Takeda Pharms Usa
TRINTELLIX
vortioxetine hydrobromide
TABLET;ORAL204447-001Sep 30, 2013RXYesNo8,969,355► Subscribe ► 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
9,125,9101-[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
9,095,588Process for preparing 1-[2-(2,4-dimethylphenysulfanyl)-pheny]piperazine or pharmaceutically acceptable salt thereof► Subscribe
7,138,407Phenyl-piperazine derivatives as serotonin reuptake inhibitors► Subscribe
9,101,626Process for preparing 1-[2-(2,4-dimethylphenylsulfanyl)-phenyl]piperazine or pharmaceutically acceptable salt thereof► 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
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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
Israel195511► Subscribe
Eurasian Patent Organization200601269► Subscribe
Serbia27704► Subscribe
Hong Kong1171951► Subscribe
Japan2017008086► 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
C0033France► SubscribePRODUCT NAME: VORTIOXETINE OU L'UN DE SES SELS D'ADDITION D'ACIDE PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/891 20131218
2014013Lithuania► SubscribePRODUCT NAME: VORTIOXETINUM; REGISTRATION NO/DATE: EU/1/13/891 20131218
00652Netherlands► SubscribePRODUCT NAME: VORTIOXETINE OF EEN; REGISTRATION NO/DATE: EU/1/13/891/001-036 20131218
2014 00030Denmark► SubscribePRODUCT NAME: VORTIOXETIN ELLER FARMACEUTISK ACCEPTABLE SYREADDITIONSSALTE DERAF, HERUNDER VORTIOXETINHYDROBROMID; REG. NO/DATE: EU/1/13/891 20131218
90023-7Sweden► SubscribePRODUCT NAME: VORTIOXETINE ELLER ETT FARMACEUTISKT GODTAGBART SYRAADDITIONSSALT DAERAV; 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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