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Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204370

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NDA 204370 describes VRAYLAR, which is a drug marketed by Forest Res Inst Inc and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the VRAYLAR profile page.

The generic ingredient in VRAYLAR is cariprazine hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the cariprazine hydrochloride profile page.

Summary for 204370

Tradename:1
Applicant:1
Ingredient:1
Patents:2
Formulation / Manufacturing:see details

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 USA, 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 USA, Inc. 61874-115 61874-115-90 90 CAPSULE, GELATIN COATED in 1 BOTTLE (61874-115-90)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 1.5MG BASE
Approval Date:Sep 17, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 17, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:► SubscribePatent Expiration:Mar 27, 2027Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF SCHIZOPHRENIA AND/OR ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH CARIPRAZINE
Patent:► SubscribePatent Expiration:Dec 16, 2028Product Flag?YSubstance Flag?YDelist Request?


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Serving leading biopharmaceutical companies globally:

Healthtrust
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Deloitte
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Queensland Health
Medtronic

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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