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Last Updated: October 24, 2021

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Cariprazine hydrochloride - Generic Drug Details

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What are the generic drug sources for cariprazine hydrochloride and what is the scope of patent protection?

Cariprazine hydrochloride is the generic ingredient in one branded drug marketed by Allergan 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 twenty patent family members in forty-two countries.

There are two drug master file entries for cariprazine hydrochloride. Two suppliers are listed for this compound.

Recent Clinical Trials for cariprazine hydrochloride

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

SponsorPhase
AllerganPhase 2
Dr. Martin A. KatzmanPhase 4
Jayasree BasivireddyPhase 3

See all cariprazine hydrochloride clinical trials

Pharmacology for cariprazine hydrochloride
Paragraph IV (Patent) Challenges for CARIPRAZINE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
VRAYLAR CAPSULE;ORAL cariprazine hydrochloride 204370 2019-09-17

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 VRAYLAR cariprazine hydrochloride CAPSULE;ORAL 204370-001 Sep 17, 2015 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever Trial
Allergan VRAYLAR cariprazine hydrochloride CAPSULE;ORAL 204370-001 Sep 17, 2015 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever Trial
Allergan VRAYLAR cariprazine hydrochloride CAPSULE;ORAL 204370-002 Sep 17, 2015 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever Trial
Allergan VRAYLAR cariprazine hydrochloride CAPSULE;ORAL 204370-001 Sep 17, 2015 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Allergan VRAYLAR cariprazine hydrochloride CAPSULE;ORAL 204370-004 Sep 17, 2015 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever Trial
Allergan VRAYLAR cariprazine hydrochloride CAPSULE;ORAL 204370-004 Sep 17, 2015 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever 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 1790042-4 Sweden ⤷  Free Forever Trial PRODUCT NAME: CARIPRAZINE, OPTIONALLY IN THE FORM OF A SALT, INCLUDING THE CARIPRAZINE HYDROCHLORIDE; REG. NO/DATE: EU/1/17/1209 20170717
1663996 PA2017027,C1663996 Lithuania ⤷  Free Forever Trial PRODUCT NAME: KARIPRAZINAS, PASIRINKTINAI DRUSKOS FORMOS, ISKAITANT KARIPRAZINO HIDROCHLORIDA; REGISTRATION NO/DATE: EU/1/17/1209 20170713
1663996 PA2017027 Lithuania ⤷  Free Forever Trial PRODUCT NAME: KARIPRAZINAS, DRUSKOS FORMOS, KONKRECIAI JO HIDROCHLORIDO DRUSKOS FORMOS, T.Y. KARIPRAZINO HIDROCHLORIDAS; REGISTRATION NO/DATE: EU/1/17/1209 20170713
1663996 17C0008 France ⤷  Free Forever Trial PRODUCT NAME: CARIPRAZINE,FACULTATIVEMENT SOUS FORME D'UN SEL,INCLUANT L'HYDROCHLORURE DE CARIPRAZINE.; REGISTRATION NO/DATE: EU/1/17/1209 20170717
1663996 300913 Netherlands ⤷  Free Forever Trial PRODUCT NAME: CARIPRAZINE, OPTIONEEL IN DE VORM VAN EEN ZOUT, WAARONDER CARIPRAZINE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/17/1209 20170717
1663996 C201730042 Spain ⤷  Free Forever 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
Baxter
Boehringer Ingelheim
Johnson and Johnson
Medtronic
Dow

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