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Last Updated: April 25, 2024

Vortioxetine hydrobromide - Generic Drug Details

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What are the generic sources for vortioxetine hydrobromide and what is the scope of freedom to operate?

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:	147
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
⤷ Try a Trial	⤷ Try a Trial	20MG	TABLET;ORAL
⤷ Try a Trial	⤷ Try a Trial	10MG	TABLET;ORAL
⤷ Try a Trial	⤷ Try a Trial	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.

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	204447-004	Sep 30, 2013		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-002	Sep 30, 2013		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-002	Sep 30, 2013		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-001	Sep 30, 2013		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Zydus Pharms	VORTIOXETINE HYDROBROMIDE	vortioxetine hydrobromide	TABLET;ORAL	211146-003	Sep 17, 2021		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-003	Sep 30, 2013		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-001	Sep 30, 2013		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
>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	204447-003	Sep 30, 2013	⤷ Try a Trial	⤷ Try a Trial
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-001	Sep 30, 2013	⤷ Try a Trial	⤷ Try a Trial
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-004	Sep 30, 2013	⤷ Try a Trial	⤷ Try a Trial
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-002	Sep 30, 2013	⤷ Try a Trial	⤷ Try a Trial
>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
Japan	2014193891	THERAPEUTIC USE OF COMPOUND HAVING ACTIVITY IN COMBINATION OF SERT, 5-HT3, AND 5-HT1A	⤷ Try a Trial
Spain	2355434		⤷ Try a Trial
Norway	2014011		⤷ Try a Trial
Serbia	20120158		⤷ Try a Trial
China	102614179	1- [2- (2,4-dimethylphenylsulfanyl)-phenyl] piperazine as a compound with combined serotonin reuptake, 5-ht3 and 5-ht1a activity for the treatment of cognitive impairment	⤷ Try a Trial
Poland	210551		⤷ Try a Trial
Chile	2011001610	Proceso de preparacion de 1-[2-(2,4-dimetilfenilsulfanil)-fenil]piperazina (div. sol. 1758-07).	⤷ Try a Trial
>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	C01436271/01	Switzerland	⤷ Try a Trial	PRODUCT NAME: VORTIOXETINE; REGISTRATION NO/DATE: SWISSMEDIC 65937 09.06.2016
1436271	CR 2014 00030	Denmark	⤷ Try a Trial	PRODUCT NAME: VORTIOXETIN ELLER FARMACEUTISK ACCEPTABLE SYREADDITIONSSALTE DERAF, HERUNDER VORTIOXETINHYDROBROMID; REG. NO/DATE: EU/1/13/891 20131218
1436271	92397	Luxembourg	⤷ Try a Trial	PRODUCT NAME: VORTIOXETINE OU UN SEL D ADDITION D ACIDE DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE
1436271	PA2014013,C1436271	Lithuania	⤷ Try a Trial	PRODUCT NAME: VORTIOKSETINAS ARBA JO FARMACINIU POZIURIU PRIIMTINA RUGSTIES PRISIJUNGIMO DRUSKA; REGISTRATION NO/DATE: EU/1/13/891 20131218
1436271	14C0033	France	⤷ Try a Trial	PRODUCT NAME: VORTIOXETINE OU L'UN DE SES SELS D'ADDITION D'ACIDE PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/891 20131218
1436271	2014C/036	Belgium	⤷ Try a Trial	PRODUCT NAME: VORTIOXETINE; AUTHORISATION NUMBER AND DATE: EU/1/13/891 20131220
1436271	508	Finland	⤷ Try a Trial
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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