Vortioxetine hydrobromide - Generic Drug Details

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What are the generic sources for vortioxetine hydrobromide and what is the scope of patent protection?

Vortioxetine hydrobromide is the generic ingredient in two branded drugs marketed by Takeda Pharms Usa and Zydus Pharms, and is included in two NDAs. 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 sixteen patent family members in forty-two countries.

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

Summary for vortioxetine hydrobromide

International Patents:	216
US Patents:	10
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	83
Patent Applications:	137
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for vortioxetine hydrobromide
DailyMed Link:	vortioxetine hydrobromide at DailyMed

Generic filers with tentative approvals for VORTIOXETINE HYDROBROMIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	20MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	10MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	EQ 5MG BASE	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Anatomical Therapeutic Chemical (ATC) Classes for vortioxetine hydrobromide

N06AX	Other antidepressants
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for VORTIOXETINE HYDROBROMIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TRINTELLIX	Tablets	vortioxetine hydrobromide	5 mg, 10 mg, 15 mg and 20 mg	204447	15	2017-10-02

US Patents and Regulatory Information for vortioxetine hydrobromide

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Glossary

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

Expired US Patents for vortioxetine hydrobromide

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-001	Sep 30, 2013	⤷ Sign Up	⤷ Sign Up
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-003	Sep 30, 2013	⤷ Sign Up	⤷ Sign Up
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-004	Sep 30, 2013	⤷ Sign Up	⤷ Sign Up
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-002	Sep 30, 2013	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for vortioxetine hydrobromide

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Country	Patent Number	Title	Estimated Expiration
Mexico	2009009672	COMPUESTO 1-[2-(2,4-DIMETILFENILSULFANIL)-FENIL]PIPERAZINA EN COMBINACION CON SEROTONINA PARA LA ACTIVIDAD DE RECAPTACION, 5-HT3 Y 5-HT1 PARA EL TRATAIENTO DEL DOLOR O LOS SINTOMAS RESIDUALES EN LA DEPRESION RELACIONADOS CON EL SUEÑO Y LA COGNICION. (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.)	⤷ Sign Up
Norway	343929		⤷ Sign Up
South Korea	101627901		⤷ Sign Up
Taiwan	200848411	Novel therapeutic uses of 1-[2-(2, 4-dimethylphenylsulfanyl)phenyl]-piperazine	⤷ Sign Up
Denmark	2431039		⤷ Sign Up
Portugal	1436271		⤷ Sign Up
Spain	2298425		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for vortioxetine hydrobromide

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1436271	122014000049	Germany	⤷ Sign Up	PRODUCT NAME: VORTIOXETIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SAEUREADDITIONSSALZ DAVON; REGISTRATION NO/DATE: EU/1/13/891 20131218
1436271	132014902248131	Italy	⤷ Sign Up	PRODUCT NAME: VORTIOXETINA O UN SUO SALE DI ADDIZIONE CON UN ACIDO FARMACEUTICAMENTE ACCETTABILE(BRINTELLIX); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/891/001-2-3-4-5-6-7, 20131218
1436271	92397	Luxembourg	⤷ Sign Up	PRODUCT NAME: VORTIOXETINE OU UN SEL D ADDITION D ACIDE DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE
1436271	C 2014 023	Romania	⤷ Sign Up	PRODUCT NAME: VORTIOXETINA SAU O SARE DE ADITIE ACIDA A ACESTEIAACCEPTABILA FARMACEUTIC1-[2-(2,4-DIMETILFENILSULFANIL)FENIL]PIPERAZINA; NATIONAL AUTHORISATION NUMBER: EU/1/13/891; DATE OF NATIONAL AUTHORISATION: 20131218; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/891; DATE OF FIRST AUTHORISATION IN EEA: 20131218
1436271	C01436271/01	Switzerland	⤷ Sign Up	PRODUCT NAME: VORTIOXETINE; REGISTRATION NO/DATE: SWISSMEDIC 65937 09.06.2016
1436271	2014/022	Ireland	⤷ Sign Up	PRODUCT NAME: VORTIOXETINE OR A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/891 20131220
1436271	302 50003-2014	Slovakia	⤷ Sign Up	OWNER(S): H. LUNDBECK A/S, VALBY, DK
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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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 verification 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.