Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: October 15, 2019

DrugPatentWatch Database Preview

VRAYLAR Drug Profile

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When do Vraylar patents expire, and what generic alternatives are available?

Vraylar is a drug marketed by Allergan Sales Llc and is included in one NDA. There are three patents protecting this drug.

This drug has one hundred and sixteen patent family members in forty-one countries.

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.

Drug patent expirations by year for VRAYLAR
Drug Prices for VRAYLAR

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Generic Entry Opportunity Date for VRAYLAR
Generic Entry Date for VRAYLAR*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Recent Clinical Trials for VRAYLAR

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Forest LaboratoriesPhase 3
Forest Laboratories, LLC, an Allergan AffiliatePhase 3

See all VRAYLAR clinical trials

Pharmacology for VRAYLAR
Synonyms for VRAYLAR
1083076-69-0
3-((1R,4r)-4-(2-(4-(2,3-dichlorophenyl)piperazin-1-yl)ethyl)cyclohexyl)-1,1-dimethylurea hydrochloride
AKOS027338713
BCP24194
Cariprazine (hydrochloride)
Cariprazine HCl
CARIPRAZINE HYDROCHLORIDE
Cariprazine hydrochloride (JAN/USAN)
Cariprazine hydrochloride [USAN]
cariprazine monohydrochloride
cariprazine.HCl
CHEBI:90932
CHEMBL2024517
CS-1570
D09876
EX-A1644
FT-0701196
HY-14763A
KQD7C255YG
KS-00000640
MolPort-044-723-876
N'-(Trans-4-(2-(4-(2,3-dichlorophenyl)piperazin-1-yl)ethyl)cyclohexyl)-N,N-dimthylurea monohydrochloride
N'-(trans-4-{2-[4-(2,3-dichlorophenyl)piperazin-1-yl]ethyl}cyclohexyl)-N,N-dimethylurea hydrochloride
RGH-188 HCL
RGH-188 hydrochloride
SB16840
SCHEMBL183803
SCHEMBL183804
UNII-KQD7C255YG
Urea, N'-(trans-4-(2-(4-(2,3-dichlorophenyl)-1-piperazinyl)ethyl)cyclohexyl)-N,N- dimethyl-, hydrochloride (1:1)
Vraylar (TN)

US Patents and Regulatory Information for VRAYLAR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan Sales Llc VRAYLAR cariprazine hydrochloride CAPSULE;ORAL 204370-004 Sep 17, 2015 RX Yes Yes   See Pricing   See Pricing   See Pricing
Allergan Sales Llc VRAYLAR cariprazine hydrochloride CAPSULE;ORAL 204370-004 Sep 17, 2015 RX Yes Yes   See Pricing   See Pricing Y Y   See Pricing
Allergan Sales Llc VRAYLAR cariprazine hydrochloride CAPSULE;ORAL 204370-004 Sep 17, 2015 RX Yes Yes   See Pricing   See Pricing   See Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for VRAYLAR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1663996 122017000083 Germany   See Pricing PRODUCT NAME: CARIPRAZIN, GEGEBENENFALLS IN FORM EINES SALZES, EINSCHLIESSLICH CARIPRAZINHYDROCHLORID; REGISTRATION NO/DATE: EU/1/17/1209 20170713
1663996 PA2017027,C1663996 Lithuania   See Pricing PRODUCT NAME: KARIPRAZINAS, PASIRINKTINAI DRUSKOS FORMOS, ISKAITANT KARIPRAZINO HIDROCHLORIDA; REGISTRATION NO/DATE: EU/1/17/1209 20170713
1663996 C 2017 040 Romania   See Pricing PRODUCT NAME: CARIPRAZINA, OPTIONAL SUB FORMA UNEI SARI A ACESTEIA, INCLUZAND CARIPRAZINA CLORHIDRAT; NATIONAL AUTHORISATION NUMBER: EU/1/17/1209; DATE OF NATIONAL AUTHORISATION: 20170713; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1209; DATE OF FIRST AUTHORISATION IN EEA: 20170713
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Merck

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