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Last Updated: April 22, 2024

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, and Abbvie, and is included in three NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cariprazine hydrochloride has one hundred and twenty-one 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
Abbvie VRAYLAR cariprazine hydrochloride CAPSULE;ORAL 204370-002 Sep 17, 2015 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Abbvie VRAYLAR cariprazine hydrochloride CAPSULE;ORAL 204370-001 Sep 17, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Abbvie VRAYLAR cariprazine hydrochloride CAPSULE;ORAL 204370-003 Sep 17, 2015 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Abbvie VRAYLAR cariprazine hydrochloride CAPSULE;ORAL 204370-004 Sep 17, 2015 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Abbvie VRAYLAR cariprazine hydrochloride CAPSULE;ORAL 204370-001 Sep 17, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Abbvie VRAYLAR cariprazine hydrochloride CAPSULE;ORAL 204370-004 Sep 17, 2015 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Sun Pharm CARIPRAZINE HYDROCHLORIDE cariprazine hydrochloride CAPSULE;ORAL 213932-001 Sep 30, 2022 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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
Hungary 0700339 ⤷  Try a Trial
South Korea 101612146 ⤷  Try a Trial
Serbia 53866 FARMACEUTSKE FORMULACIJE KOJE SADRŽE LIGANDE DOPAMINSKIH RECEPTORA (PHARMACEUTICAL FORMULATIONS CONTAINING DOPAMINE RECEPTOR LIGANDS) ⤷  Try a Trial
New Zealand 544999 (Thio) carbamoyl-cyclohexane derivatives as D3/D2 receptor antagonists ⤷  Try a Trial
South Korea 20060058096 (THIO)CARBAMOYL-CYCLOHEXANE DERIVATIVES AS D3/D2 RECEPTOR ANTAGONISTS ⤷  Try a Trial
Ukraine 102225 СОЛИ ПРОИЗВОДНЫХ ПИПЕРАЗИНА КАК ЯК D3/D2-АНТАГОНИСТЫ;СОЛІ ПОХІДНИХ ПІПЕРАЗИНУ ЯК D3/D2-АНТАГОНІСТИ (SALTS OF PIPERAZINE DERIVATIVES AS D3/D2 ANTAGONISTS) ⤷  Try a Trial
Croatia P20170918 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for cariprazine hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1663996 PA2017027,C1663996 Lithuania ⤷  Try a Trial PRODUCT NAME: KARIPRAZINAS, PASIRINKTINAI DRUSKOS FORMOS, ISKAITANT KARIPRAZINO HIDROCHLORIDA; REGISTRATION NO/DATE: EU/1/17/1209 20170713
1663996 132017000122667 Italy ⤷  Try a Trial PRODUCT NAME: CARIPRAZINA, OPZIONALMENTE NELLA FORMA DI UN SALE, INCLUSO CARIPRAZINA CLORIDRATO(REAGILA - CARIPRAZINA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1209, 20170717
1663996 PA2017027 Lithuania ⤷  Try a Trial PRODUCT NAME: KARIPRAZINAS, DRUSKOS FORMOS, KONKRECIAI JO HIDROCHLORIDO DRUSKOS FORMOS, T.Y. KARIPRAZINO HIDROCHLORIDAS; REGISTRATION NO/DATE: EU/1/17/1209 20170713
1663996 47/2017 Austria ⤷  Try a Trial PRODUCT NAME: CARIPRAZIN, GEGEBENENFALLS IN FORM EINES SALZES, EINSCHLIESSLICH CARIPRAZIN HYDROCHLORID; REGISTRATION NO/DATE: EU/1/17/1209 (MITTEILUNG) 20170717
1663996 17C0008 France ⤷  Try a Trial PRODUCT NAME: CARIPRAZINE,FACULTATIVEMENT SOUS FORME D'UN SEL,INCLUANT L'HYDROCHLORURE DE CARIPRAZINE.; REGISTRATION NO/DATE: EU/1/17/1209 20170717
1663996 C 2017 040 Romania ⤷  Try a Trial 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
1663996 1790042-4 Sweden ⤷  Try a Trial PRODUCT NAME: CARIPRAZINE, OPTIONALLY IN THE FORM OF A SALT, INCLUDING THE CARIPRAZINE HYDROCHLORIDE; REG. NO/DATE: EU/1/17/1209 20170717
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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