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Last Updated: April 28, 2024

CARIPRAZINE HYDROCHLORIDE - Generic Drug Details


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What are the generic 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
Sun Pharm CARIPRAZINE HYDROCHLORIDE cariprazine hydrochloride CAPSULE;ORAL 213932-003 Sep 30, 2022 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zydus CARIPRAZINE HYDROCHLORIDE cariprazine hydrochloride CAPSULE;ORAL 213984-001 Sep 9, 2022 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  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
>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
Brazil PI0413283 derivados de (tio)carbamoil-ciclohexano como antagonistas de receptor d3/d2 ⤷  Try a Trial
Taiwan 200505874 New compounds with therapeutic effect ⤷  Try a Trial
Georgia, Republic of P20146052 PHARMACEUTICAL FORMULATIONS CONTAINING DOPAMINE RECEPTOR LIGANDS ⤷  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 122017000083 Germany ⤷  Try a Trial PRODUCT NAME: CARIPRAZIN, GEGEBENENFALLS IN FORM EINES SALZES, EINSCHLIESSLICH CARIPRAZINHYDROCHLORID; 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 345 50018-2017 Slovakia ⤷  Try a Trial PRODUCT NAME: KARIPRAZIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/17/1209 20170717
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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