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Generated: January 23, 2019

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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
Generic Entry Opportunity Date for 204447
Generic Entry Date for 204447*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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 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 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:May 2, 2021
Regulatory Exclusivity Use:ADDITION TO THE CLINICAL STUDIES SECTION OF THE LABELING WITH THE SUBSECTION ENTITLED DIGIT SYMBOL SUBSTITUTION TEST IN MAJOR DEPRESSIVE DISORDER
Regulatory Exclusivity Expiration:Sep 30, 2018
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Oct 19, 2021
Regulatory Exclusivity Use:UPDATE TO THE PRESCRIBING INFORMATION FOR VORTIOXETINE ON TREATMENT-EMERGENT SEXUAL DYSFUNCTION COMPARING VORTIOXETINE AND SSRIS

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