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Last Updated: December 7, 2022

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 three suppliers. There are eleven 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. Three 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:11
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:Nov 13, 2023
Regulatory Exclusivity Use:INFORMATION ADDED TO THE LABELING REGARDING THE RESULT OF STUDY LUAA21004-402
Patent:See Plans and PricingPatent Expiration:Jun 15, 2027Product Flag?YSubstance Flag?Delist Request?
Patented Use:USE OF TRINTELLIX FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD) IN ADULTS

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 204447-003 Sep 30, 2013 See Plans and Pricing See Plans and Pricing
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 204447-004 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

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