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Last Updated: January 27, 2023

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 two branded drugs marketed by Sun Pharm, Zydus Pharms, and Allergan, and is included in three NDAs. There are four 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
The Medical Research NetworkPhase 4
AbbViePhase 4
AbbViePhase 3

See all cariprazine hydrochloride clinical trials

Pharmacology for cariprazine hydrochloride
Paragraph IV (Patent) Challenges for CARIPRAZINE HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
VRAYLAR Capsules cariprazine hydrochloride 1.5 mg, 3 mg, 4.5 mg and 6 mg 204370 3 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 204370-004 Sep 17, 2015 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Zydus Pharms CARIPRAZINE HYDROCHLORIDE cariprazine hydrochloride CAPSULE;ORAL 213984-002 Sep 9, 2022 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sun Pharm CARIPRAZINE HYDROCHLORIDE cariprazine hydrochloride CAPSULE;ORAL 213932-002 Sep 30, 2022 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Allergan VRAYLAR cariprazine hydrochloride CAPSULE;ORAL 204370-001 Sep 17, 2015 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sun Pharm CARIPRAZINE HYDROCHLORIDE cariprazine hydrochloride CAPSULE;ORAL 213932-004 Sep 30, 2022 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Allergan VRAYLAR cariprazine hydrochloride CAPSULE;ORAL 204370-002 Sep 17, 2015 AB RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for cariprazine hydrochloride

Country Patent Number Title Estimated Expiration
South Korea 20060058096 (THIO)CARBAMOYL-CYCLOHEXANE DERIVATIVES AS D3/D2 RECEPTOR ANTAGONISTS See Plans and Pricing
South Africa 201101134 PHARMACEUTICAL FORMULATIONS CONTAINING DOPAMINE RECEPTOR LIGANDS See Plans and Pricing
Canada 2684404 NOUVEAUX SELS DE PIPERAZINE COMME ANTAGONISTES DES RECEPTEURS DOPAMINERGIQUES D3/D2 (NOVEL PIPERAZINE SALTS AS D3/D2 ANTAGONISTS) See Plans and Pricing
South Africa 200907511 Novel piperazine salts as D3/D2 antagonists See Plans and Pricing
Chile 2011000091 Formulacion farmaceutica que comprende trans-1{4-[2-[4-(2,3-diclorofenil)-piperazin-1-il]etil]-ciclohexil}-3,3-dimetil-urea, en la cual la formulacion comprende menos del 1% de trans 4-[2-[4-(2,3-diclorofenil)-piperazin-1-il]etil]-ciclohexil-amina o una sal; uso en esquizofrenia, trastorno bipolar y mania aguda. See Plans and Pricing
Tunisia SN05328 (THIO) CARBAMOYL-CYCLOHEXANE DERIVATIVES AS D3/D2 RECEPTOR ANTAGONISTS See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for cariprazine hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1663996 2017/050 Ireland See Plans and Pricing PRODUCT NAME: CARIPRAZINE, OPTIONALLY IN THE FORM OF A SALT, INCLUDING THE CARIPRAZINE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/17/1209 20170713
1663996 LUC00039 Luxembourg See Plans and Pricing PRODUCT NAME: CARIPRAZINE, OPTIONALLY IN THE FORM OF A SALT, INCLUDING THE CARIPRAZINE HYDROCHLORIDE; AUTHORISATION NUMBER AND DATE: EU/1/17/1209 20170717
1663996 CR 2017 00042 Denmark See Plans and Pricing PRODUCT NAME: CARIPRAZINE, OPTIONALLY IN THE FORM OF A SALT, INCLUDING THE CARIPRAZINE HYDROCHLORIDE; REG. NO/DATE: EU/1/17/1209 20170717
1663996 345 50018-2017 Slovakia See Plans and Pricing PRODUCT NAME: KARIPRAZIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/17/1209 20170717
1663996 300913 Netherlands See Plans and Pricing PRODUCT NAME: CARIPRAZINE, OPTIONEEL IN DE VORM VAN EEN ZOUT, WAARONDER CARIPRAZINE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/17/1209 20170717
1663996 C 2017 040 Romania See Plans and Pricing PRODUCT NAME: CARIPRAZINA, OPTIONAL SUB FORMA UNEI SARI A ACESTEIA, INCLUZAND CARIPRAZINA CLORHIDRATIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1209; DATE OF FIRST AUTHORISATION IN EEA: 20170713 ; NATIONAL AUTHORISATION NUMBER: EU/1/17/1209; DATE OF NATIONAL AUTHORISATION: 20170713; NUMBER OF F
>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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