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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Chubb
AstraZeneca
Accenture
Deloitte
US Department of Justice
Express Scripts
Johnson and Johnson
US Army
Moodys

Generated: December 16, 2017

DrugPatentWatch Database Preview

TRINTELLIX Drug Profile

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Which patents cover Trintellix, and what generic alternatives are available?

Trintellix is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and fifty-five patent family members in forty countries and twelve supplementary protection certificates in ten countries.

The generic ingredient in TRINTELLIX is vortioxetine hydrobromide. There are sixteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the vortioxetine hydrobromide profile page.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Takeda Pharms UsaTRINTELLIXvortioxetine hydrobromideTABLET;ORAL204447-001Sep 30, 2013RXYesNo► Subscribe► SubscribeYY► Subscribe
Takeda Pharms UsaTRINTELLIXvortioxetine hydrobromideTABLET;ORAL204447-003Sep 30, 2013DISCNYesNo► Subscribe► Subscribe► Subscribe
Takeda Pharms UsaTRINTELLIXvortioxetine hydrobromideTABLET;ORAL204447-004Sep 30, 2013RXYesYes► Subscribe► Subscribe► Subscribe
Takeda Pharms UsaTRINTELLIXvortioxetine hydrobromideTABLET;ORAL204447-002Sep 30, 2013RXYesNo► Subscribe► SubscribeYY► Subscribe
Takeda Pharms UsaTRINTELLIXvortioxetine hydrobromideTABLET;ORAL204447-001Sep 30, 2013RXYesNo► Subscribe► Subscribe► Subscribe
Takeda Pharms UsaTRINTELLIXvortioxetine hydrobromideTABLET;ORAL204447-002Sep 30, 2013RXYesNo► Subscribe► Subscribe► Subscribe
Takeda Pharms UsaTRINTELLIXvortioxetine hydrobromideTABLET;ORAL204447-004Sep 30, 2013RXYesYes► Subscribe► SubscribeYY► Subscribe
Takeda Pharms UsaTRINTELLIXvortioxetine hydrobromideTABLET;ORAL204447-002Sep 30, 2013RXYesNo► Subscribe► SubscribeYY► Subscribe
Takeda Pharms UsaTRINTELLIXvortioxetine hydrobromideTABLET;ORAL204447-004Sep 30, 2013RXYesYes► Subscribe► SubscribeYY► Subscribe
Takeda Pharms UsaTRINTELLIXvortioxetine hydrobromideTABLET;ORAL204447-003Sep 30, 2013DISCNYesNo► Subscribe► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for TRINTELLIX

Drugname Dosage Strength RLD Submissiondate
vortioxetine newTablets5 mg, 10 mg, 15 mgand 20 mgTrintellix 20444710/2/2017

Non-Orange Book Patents for Tradename: TRINTELLIX

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
9,125,9091-[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
9,101,626Process for preparing 1-[2-(2,4-dimethylphenylsulfanyl)-phenyl]piperazine or pharmaceutically acceptable salt thereof► Subscribe
7,138,407Phenyl-piperazine derivatives as serotonin reuptake inhibitors► Subscribe
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
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
9,708,280Phenyl-piperazine derivatives as serotonin reuptake inhibitors► Subscribe
8,110,567Phenyl-piperazine derivatives as serotonin reuptake inhibitors► Subscribe
9,090,575Phenyl-piperazine derivatives as serotonin reuptake inhibitors► Subscribe
7,683,053Phenyl-piperazine derivatives as serotonin reuptake inhibitors► Subscribe
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
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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 Tradename: TRINTELLIX

Country Document Number Estimated Expiration
Taiwan200848411► Subscribe
BrazilPI0808941► Subscribe
Australia2006215994► Subscribe
Serbia52205► Subscribe
Japan2007031447► Subscribe
Colombia6220962► Subscribe
CroatiaP20120173► Subscribe
Serbia51560► Subscribe
Australia2002333220► Subscribe
LithuaniaC1436271► 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: TRINTELLIX

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90023-7Sweden► SubscribePRODUCT NAME: VORTIOXETINE ELLER ETT FARMACEUTISKT GODTAGBART SYRAADDITIONSSALT DAERAV; REG. NO/DATE: EU/1/13/891 20131218
14/022Ireland► SubscribePRODUCT NAME: VORTIOXETINE OR A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/891 20131220
0140012 00108Estonia► SubscribePRODUCT NAME: VORTIOKSETIIN;REG NO/DATE: K(2013)9715 LOPLIK 20.12.2013
C0033France► SubscribePRODUCT NAME: VORTIOXETINE OU L'UN DE SES SELS D'ADDITION D'ACIDE PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/891 20131218
2014013,C1436271Lithuania► SubscribePRODUCT NAME: VORTIOKSETINAS ARBA JO FARMACINIU POZIURIU PRIIMTINA RUGSTIES PRISIJUNGIMO DRUSKA; REGISTRATION 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
00652Netherlands► SubscribePRODUCT NAME: VORTIOXETINE OF EEN; REGISTRATION NO/DATE: EU/1/13/891/001-036 20131218
2014000049Germany► SubscribePRODUCT NAME: VORTIOXETIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SAEUREADDITIONSSALZ DAVON; REGISTRATION NO/DATE: EU/1/13/891 20131218
2014013Lithuania► SubscribePRODUCT NAME: VORTIOXETINUM; REGISTRATION NO/DATE: EU/1/13/891 20131218
0652Netherlands► SubscribePRODUCT NAME: VORTIOXETINE OF EEN FARMACEUTISCH AANVAARDBAAR ZUURADDITIEZOUT ERVAN; REGISTRATION NO/DATE: EU/1/13/891/001-036 20131218
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Serving leading biopharmaceutical companies globally:

Moodys
Chinese Patent Office
Argus Health
AstraZeneca
Chubb
Dow
Novartis
Daiichi Sankyo
Farmers Insurance
Cerilliant

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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