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Generated: November 16, 2018

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Details for New Drug Application (NDA): 022567

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NDA 022567 describes VIIBRYD, which is a drug marketed by Allergan Sales Llc and is included in one NDA. It is available from two suppliers. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the VIIBRYD profile page.

The generic ingredient in VIIBRYD is vilazodone hydrochloride. There are fourteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the vilazodone hydrochloride profile page.
Summary for 022567
Tradename:VIIBRYD
Applicant:Allergan Sales Llc
Ingredient:vilazodone hydrochloride
Patents:5
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 022567
Generic Entry Date for 022567*:
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.

Medical Subject Heading (MeSH) Categories for 022567
Suppliers and Packaging for NDA: 022567
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VIIBRYD vilazodone hydrochloride TABLET;ORAL 022567 NDA Allergan, Inc. 0456-1100 0456-1100-31 1 KIT in 1 BLISTER PACK (0456-1100-31)
VIIBRYD vilazodone hydrochloride TABLET;ORAL 022567 NDA Allergan, Inc. 0456-1101 0456-1101-30 1 KIT in 1 BLISTER PACK (0456-1101-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jan 21, 2011TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 16, 2018
Regulatory Exclusivity Use:CHANGE IN TARGET DOSING TO 20MG TO 40MG ORALLY ONCE DAILY
Patent:➤ Sign UpPatent Expiration:Sep 29, 2019Product Flag?YSubstance Flag?YDelist Request?
Patent:➤ Sign UpPatent Expiration:Jun 5, 2022Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)

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