Details for New Drug Application (NDA): 204447

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NDA 204447 describes TRINTELLIX, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from two suppliers. There are ten patents protecting this drug and one Paragraph IV challenge. Additional details are available on the TRINTELLIX profile page.

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.

Summary for 204447

Tradename:	TRINTELLIX
Applicant:	Takeda Pharms Usa
Ingredient:	vortioxetine hydrobromide
Patents:	10

Suppliers and Packaging for NDA: 204447

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447	NDA	CARDINAL HEALTH 110, LLC. DBA LEADER	55154-0256	55154-0256-8	2520 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-0256-8)
TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447	NDA	CARDINAL HEALTH 110, LLC. DBA LEADER	55154-0257	55154-0257-8	2430 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-0257-8)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE
Approval Date:	Sep 30, 2013	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Jan 22, 2024
Regulatory Exclusivity Use:	ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING
Regulatory Exclusivity Expiration:	Aug 23, 2026
Regulatory Exclusivity Use:	INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES
Regulatory Exclusivity Expiration:	Feb 23, 2027
Regulatory Exclusivity Use:	PEDIATRIC EXCLUSIVITY

Expired US Patents for NDA 204447

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

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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.