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Last Updated: November 18, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204370

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NDA 204370 describes VRAYLAR, which is a drug marketed by Allergan Sales Llc and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the VRAYLAR profile page.

The generic ingredient in VRAYLAR is cariprazine hydrochloride. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cariprazine hydrochloride profile page.
Summary for 204370
Tradename:VRAYLAR
Applicant:Allergan Sales Llc
Ingredient:cariprazine hydrochloride
Patents:3
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 204370
Generic Entry Date for 204370*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;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.

Pharmacology for NDA: 204370
Suppliers and Packaging for NDA: 204370
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VRAYLAR cariprazine hydrochloride CAPSULE;ORAL 204370 NDA Allergan, Inc. 61874-115 61874-115-07 7 CAPSULE, GELATIN COATED in 1 BLISTER PACK (61874-115-07)
VRAYLAR cariprazine hydrochloride CAPSULE;ORAL 204370 NDA Allergan, Inc. 61874-115 61874-115-17 1 BLISTER PACK in 1 CARTON (61874-115-17) > 7 CAPSULE, GELATIN COATED in 1 BLISTER PACK
Paragraph IV (Patent) Challenges for 204370
Tradename Dosage Ingredient NDA Submissiondate
VRAYLAR CAPSULE;ORAL cariprazine hydrochloride 204370

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 1.5MG BASE
Approval Date:Sep 17, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Nov 9, 2020
Regulatory Exclusivity Use:INFORMATION ADDED TO THE LABELING TO INCLUDE THE EFFICACY AND SAFETY OF CARIPRAZINE RELATIVE TO PLACEBO IN THE PREVENTION OF RELAPSE OF SYMPTOMS IN PATIENTS WITH SCHIZOPHRENIA
Regulatory Exclusivity Expiration:Sep 17, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:May 24, 2022
Regulatory Exclusivity Use:TREATMENT OF DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER (BIPOLAR DEPRESSION)

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