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Serving leading biopharmaceutical companies globally:

Deloitte
Mallinckrodt
Covington
Queensland Health
US Army
QuintilesIMS
Boehringer Ingelheim
Chubb
Farmers Insurance
McKesson

Generated: February 19, 2018

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 two suppliers. There are six 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:6
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 Takeda Pharmaceuticals America, Inc. 64764-550 E 64764-550-30
TRINTELLIX vortioxetine hydrobromide TABLET;ORAL 204447 NDA Takeda Pharmaceuticals America, Inc. 64764-550 E 64764-550-07

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Sep 30, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 30, 2018
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Sign UpPatent Expiration:Oct 2, 2022Product Flag?YSubstance Flag?YDelist Request?
Patented Use:METHOD OF TREATING AN AFFECTIVE DISORDER SUCH AS DEPRESSION
Patent:➤ Sign UpPatent Expiration:Oct 2, 2022Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING AN AFFECTIVE DISORDER SUCH AS DEPRESSION

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Argus Health
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Covington
UBS
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Chinese Patent Office
Fuji
QuintilesIMS

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