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 eleven 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 fifteen patent family members in forty-one countries.

There are fifteen drug master file entries for vortioxetine hydrobromide. Three suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for vortioxetine hydrobromide

International Patents:	215
US Patents:	11
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	74
Patent Applications:	196
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
See Plans and Pricing	See Plans and Pricing	20MG	TABLET;ORAL
See Plans and Pricing	See Plans and Pricing	10MG	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	204447-003	Sep 30, 2013		DISCN	Yes	No	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-004	Sep 30, 2013		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-003	Sep 30, 2013		DISCN	Yes	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-001	Sep 30, 2013		RX	Yes	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-004	Sep 30, 2013		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-002	Sep 30, 2013		RX	Yes	No	See Plans and Pricing	See Plans and Pricing	Y	Y		See Plans and Pricing
>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	See Plans and Pricing	See Plans and Pricing
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-003	Sep 30, 2013	See Plans and Pricing	See Plans and Pricing
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-004	Sep 30, 2013	See Plans and Pricing	See Plans and Pricing
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-002	Sep 30, 2013	See Plans and Pricing	See Plans and Pricing
>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
Lithuania	C1436271		See Plans and Pricing
Cyprus	1111183		See Plans and Pricing
Japan	2014193891	THERAPEUTIC USE OF COMPOUND HAVING ACTIVITY IN COMBINATION OF SERT, 5-HT3, AND 5-HT1A	See Plans and Pricing
Eurasian Patent Organization	007537	АЗОТСОДЕРЖАЩИЕ ГЕТЕРОЦИКЛИЧЕСКИЕ ПРОИЗВОДНЫЕ, СОДЕРЖАЩАЯ ИХ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, ИХ ПРИМЕНЕНИЕ И СПОСОБ ЛЕЧЕНИЯ (NITROGEN-CONTAINING HETEROCYCLIC DERIVATIVES, PHARMACEUTICAL COMPOSITION CONTAINING THEM, USE THEREOF AND METHOD FOR THE TREATMENT)	See Plans and Pricing
Israel	238068		See Plans and Pricing
Japan	7179035		See Plans and Pricing
>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	508	Finland	See Plans and Pricing
1436271	14C0033	France	See Plans and Pricing	PRODUCT NAME: VORTIOXETINE OU L'UN DE SES SELS D'ADDITION D'ACIDE PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/891 20131218
1436271	C300652	Netherlands	See Plans and Pricing	PRODUCT NAME: VORTIOXETINE OF EEN; REGISTRATION NO/DATE: EU/1/13/891/001-036 20131218
1436271	302 50003-2014	Slovakia	See Plans and Pricing	OWNER(S): H. LUNDBECK A/S, VALBY, DK
1436271	92397	Luxembourg	See Plans and Pricing	PRODUCT NAME: VORTIOXETINE OU UN SEL D ADDITION D ACIDE DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE
1436271	C01436271/01	Switzerland	See Plans and Pricing	PRODUCT NAME: VORTIOXETINE; REGISTRATION NO/DATE: SWISSMEDIC 65937 09.06.2016
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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