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Last Updated: June 13, 2024

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
Formulation / Manufacturing:see details
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 107, LLC 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 107, LLC 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:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Sep 30, 2013TE: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

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 204447-002 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 204447-003 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.