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Last Updated: September 16, 2021

DrugPatentWatch Database Preview

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 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. 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:10
Formulation / Manufacturing:see details
DrugPatentWatch® Estimated 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)
Paragraph IV (Patent) Challenges for 204447
Tradename Dosage Ingredient NDA Submissiondate
TRINTELLIX TABLET;ORAL vortioxetine hydrobromide 204447 2017-10-02

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: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:Nov 13, 2023
Regulatory Exclusivity Use:INFORMATION ADDED TO THE LABELING REGARDING THE RESULT OF STUDY LUAA21004-402

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Serving leading biopharmaceutical companies globally:

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Colorcon
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Medtronic

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.