You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: June 17, 2024

Cariprazine hydrochloride - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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
Anatomical Therapeutic Chemical (ATC) Classes 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 204370-004 Sep 17, 2015 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Abbvie VRAYLAR cariprazine hydrochloride CAPSULE;ORAL 204370-004 Sep 17, 2015 RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Abbvie VRAYLAR cariprazine hydrochloride CAPSULE;ORAL 204370-003 Sep 17, 2015 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus CARIPRAZINE HYDROCHLORIDE cariprazine hydrochloride CAPSULE;ORAL 213984-003 Sep 9, 2022 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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
Colombia 6241112 SALES NOVEDOSAS DE PIPERAZINA COMO ANTAGONISTAS D3/D2 ⤷  Sign Up
Montenegro 00564 DERIVATI (TIO) KARBAMOIL-CIKLOHEKSANA KAO ANTAGONISTI D3/D2 RECEPTORA ((THIO) CARBAMOYL-CYCLOHEXANE DERIVATIVES AS D3/D2 RECEPTOR ANTAGONISTS) ⤷  Sign Up
Brazil PI0811199 NOVOS SAIS DE PIPERAZINA COMO ANTAGONISTAS DE D3/D2 ⤷  Sign Up
South Africa 200907511 Novel piperazine salts as D3/D2 antagonists ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for cariprazine hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1663996 2017C/045 Belgium ⤷  Sign Up PRODUCT NAME: CARIPRAZINE, EVENTUELLEMENT SOUS LA FORME D'UN SEL, Y COMPRIS L'HYDROCHLORURE DE CARIPRAZINE; AUTHORISATION NUMBER AND DATE: EU/1/17/1209 20170717
1663996 122017000083 Germany ⤷  Sign Up PRODUCT NAME: CARIPRAZIN, GEGEBENENFALLS IN FORM EINES SALZES, EINSCHLIESSLICH CARIPRAZINHYDROCHLORID; REGISTRATION NO/DATE: EU/1/17/1209 20170713
1663996 PA2017027 Lithuania ⤷  Sign Up PRODUCT NAME: KARIPRAZINAS, DRUSKOS FORMOS, KONKRECIAI JO HIDROCHLORIDO DRUSKOS FORMOS, T.Y. KARIPRAZINO HIDROCHLORIDAS; REGISTRATION NO/DATE: EU/1/17/1209 20170713
1663996 674 Finland ⤷  Sign Up
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.