Details for New Drug Application (NDA): 022567

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NDA 022567 describes VIIBRYD, which is a drug marketed by Allergan and is included in one NDA. It is available from four suppliers. There are four 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. Eleven suppliers are listed for this compound. Additional details are available on the vilazodone hydrochloride profile page.

Summary for 022567

Tradename:	VIIBRYD
Applicant:	Allergan
Ingredient:	vilazodone hydrochloride
Patents:	4
Formulation / Manufacturing:	see details

Medical Subject Heading (MeSH) Categories for 022567

Antidepressive Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Uptake Inhibitors

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:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Jan 21, 2011	TE:	AB	RLD:	Yes
Regulatory Exclusivity Expiration:	Jan 31, 2023
Regulatory Exclusivity Use:	INFORMATION ADDED TO THE LABELING REGARDING PEDIATRIC PATIENTS AGES 7 TO 17 YEARS OF AGE WITH MAJOR DEPRESSIVE DISORDER
Regulatory Exclusivity Expiration:	Jul 31, 2023
Regulatory Exclusivity Use:	PEDIATRIC EXCLUSIVITY
Patent:	⤷ Sign Up	Patent Expiration:	Dec 5, 2022	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 022567

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	VIIBRYD	vilazodone hydrochloride	TABLET;ORAL	022567-001	Jan 21, 2011	⤷ Sign Up	⤷ Sign Up
Allergan	VIIBRYD	vilazodone hydrochloride	TABLET;ORAL	022567-003	Jan 21, 2011	⤷ Sign Up	⤷ Sign Up
Allergan	VIIBRYD	vilazodone hydrochloride	TABLET;ORAL	022567-002	Jan 21, 2011	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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