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

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Last Updated: November 17, 2019

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Cariprazine hydrochloride - Generic Drug Details

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What are the generic sources for cariprazine hydrochloride and what is the scope of freedom to operate?

Cariprazine hydrochloride is the generic ingredient in one branded drug marketed by Allergan Sales Llc and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cariprazine hydrochloride has one hundred and sixteen patent family members in forty-one countries.

There are two drug master file entries for cariprazine hydrochloride. One supplier is listed for this compound.

Summary for cariprazine hydrochloride
Recent Clinical Trials for cariprazine hydrochloride

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

SponsorPhase
AllerganPhase 3
Anna Rose ChildressPhase 2
National Institute on Drug Abuse (NIDA)Phase 2

See all cariprazine hydrochloride clinical trials

Pharmacology for cariprazine hydrochloride
Synonyms for cariprazine hydrochloride
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 (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
Vraylar (TN)
Paragraph IV (Patent) Challenges for CARIPRAZINE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
VRAYLAR CAPSULE;ORAL cariprazine hydrochloride 204370

US Patents and Regulatory Information for cariprazine hydrochloride

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   Start Trial   Start Trial   Start Trial
Allergan Sales Llc VRAYLAR cariprazine hydrochloride CAPSULE;ORAL 204370-002 Sep 17, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
Allergan Sales Llc VRAYLAR cariprazine hydrochloride CAPSULE;ORAL 204370-004 Sep 17, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Allergan Sales Llc VRAYLAR cariprazine hydrochloride CAPSULE;ORAL 204370-001 Sep 17, 2015 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Allergan Sales Llc VRAYLAR cariprazine hydrochloride CAPSULE;ORAL 204370-001 Sep 17, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
>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 cariprazine hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1663996 PA2017027,C1663996 Lithuania   Start Trial PRODUCT NAME: KARIPRAZINAS, PASIRINKTINAI DRUSKOS FORMOS, ISKAITANT KARIPRAZINO HIDROCHLORIDA; REGISTRATION NO/DATE: EU/1/17/1209 20170713
1663996 47/2017 Austria   Start Trial PRODUCT NAME: CARIPRAZIN, GEGEBENENFALLS IN FORM EINES SALZES, EINSCHLIESSLICH CARIPRAZIN HYDROCHLORID; REGISTRATION NO/DATE: EU/1/17/1209 (MITTEILUNG) 20170717
1663996 PA2017027 Lithuania   Start Trial PRODUCT NAME: KARIPRAZINAS, DRUSKOS FORMOS, KONKRECIAI JO HIDROCHLORIDO DRUSKOS FORMOS, T.Y. KARIPRAZINO HIDROCHLORIDAS; REGISTRATION NO/DATE: EU/1/17/1209 20170713
1663996 C201730042 Spain   Start Trial PRODUCT NAME: CARIPRAZINA, O SUS SALES, INCLUYENDO HIDROCLORURO DE CARIPRAZINA; NATIONAL AUTHORISATION NUMBER: EU/1/17/1209; DATE OF AUTHORISATION: 20170713; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1209; DATE OF FIRST AUTHORISATION IN EEA: 20170713
1663996 2017/050 Ireland   Start Trial PRODUCT NAME: CARIPRAZINE, OPTIONALLY IN THE FORM OF A SALT, INCLUDING THE CARIPRAZINE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/17/1209 20170713
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.