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Last Updated: July 6, 2020

DrugPatentWatch Database Preview

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 two 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. Two 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
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)
Paragraph IV (Patent) Challenges for 022567
Tradename Dosage Ingredient NDA Submissiondate
VIIBRYD TABLET;ORAL vilazodone hydrochloride 022567 2015-01-21

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jan 21, 2011TE:ABRLD: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:  Start TrialPatent Expiration:Dec 5, 2022Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 022567

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

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