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. One supplier is listed for this compound.

Summary for cariprazine hydrochloride

International Patents:	121
US Patents:	5
Tradenames:	2
Applicants:	3
NDAs:	3
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	46
Clinical Trials:	41
Patent Applications:	92
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for cariprazine hydrochloride
DailyMed Link:	cariprazine hydrochloride at DailyMed

Recent Clinical Trials for cariprazine hydrochloride

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

Sponsor	Phase
AbbVie	Phase 4
The Medical Research Network	Phase 4
AbbVie	Phase 3

See all cariprazine hydrochloride clinical trials

Pharmacology for cariprazine hydrochloride

Drug Class	Atypical Antipsychotic

Anatomical Therapeutic Chemical (ATC) Classes for cariprazine hydrochloride

N05AX	Other antipsychotics
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Zydus	CARIPRAZINE HYDROCHLORIDE	cariprazine hydrochloride	CAPSULE;ORAL	213984-002	Sep 9, 2022		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie	VRAYLAR	cariprazine hydrochloride	CAPSULE;ORAL	204370-003	Sep 17, 2015		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm	CARIPRAZINE HYDROCHLORIDE	cariprazine hydrochloride	CAPSULE;ORAL	213932-002	Sep 30, 2022		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie	VRAYLAR	cariprazine hydrochloride	CAPSULE;ORAL	204370-003	Sep 17, 2015		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Abbvie	VRAYLAR	cariprazine hydrochloride	CAPSULE;ORAL	204370-001	Sep 17, 2015		RX	Yes	Yes	⤷ 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

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Country	Patent Number	Title	Estimated Expiration
Tunisia	2011000018	PHARMACEUTICAL FORMULATIONS CONTAINING DOPAMINE RECEPTOR LIGANDS	⤷ Sign Up
Taiwan	I327141		⤷ Sign Up
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)	⤷ Sign Up
Slovenia	2317852		⤷ Sign Up
China	1829703	(Thio)carbamoyl-cyclohexane derivatives as D3/D2 receptor antagonists	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for cariprazine hydrochloride

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1663996	LUC00039	Luxembourg	⤷ Sign Up	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	⤷ Sign Up	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	⤷ Sign Up	PRODUCT NAME: KARIPRAZINAS, PASIRINKTINAI DRUSKOS FORMOS, ISKAITANT KARIPRAZINO HIDROCHLORIDA; REGISTRATION NO/DATE: EU/1/17/1209 20170713
1663996	122017000083	Germany	⤷ Sign Up	PRODUCT NAME: CARIPRAZIN, GEGEBENENFALLS IN FORM EINES SALZES, EINSCHLIESSLICH CARIPRAZINHYDROCHLORID; REGISTRATION NO/DATE: EU/1/17/1209 20170713
1663996	C 2017 040	Romania	⤷ Sign Up	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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