Cariprazine hydrochloride - Generic Drug Details

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. 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

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	213984-004	Sep 9, 2022		DISCN	No	No
Abbvie	VRAYLAR	cariprazine hydrochloride	CAPSULE;ORAL	204370-001	Sep 17, 2015		RX	Yes	Yes			Y	Y
Zydus	CARIPRAZINE HYDROCHLORIDE	cariprazine hydrochloride	CAPSULE;ORAL	213984-003	Sep 9, 2022		DISCN	No	No
Zydus	CARIPRAZINE HYDROCHLORIDE	cariprazine hydrochloride	CAPSULE;ORAL	213984-002	Sep 9, 2022		DISCN	No	No
Zydus	CARIPRAZINE HYDROCHLORIDE	cariprazine hydrochloride	CAPSULE;ORAL	213984-001	Sep 9, 2022		DISCN	No	No
Abbvie	VRAYLAR	cariprazine hydrochloride	CAPSULE;ORAL	204370-001	Sep 17, 2015		RX	Yes	Yes			Y	Y
Sun Pharm	CARIPRAZINE HYDROCHLORIDE	cariprazine hydrochloride	CAPSULE;ORAL	213932-002	Sep 30, 2022		DISCN	No	No

International Patents for cariprazine hydrochloride

Country	Patent Number	Title	Estimated Expiration
Malaysia	156288	PHARMACEUTICAL FORMULATIONS CONTAINING DOPAMINE RECEPTOR LIGANDS.
Cyprus	1113099
Australia	2009270823	Pharmaceutical formulations containing dopamine receptor ligands
Denmark	1663996
World Intellectual Property Organization (WIPO)	2005012266
China	1829703	(Thio)carbamoyl-cyclohexane derivatives as D3/D2 receptor antagonists
Eurasian Patent Organization	009022	ПРОИЗВОДНЫЕ (ТИО)КАРБАМОИЛЦИКЛОГЕКСАНА В КАЧЕСТВЕ АНТАГОНИСТОВ D/DРЕЦЕПТОРА ((THIO) CARBAMOYL-CYCLOHEXANE DERIVATIVES AS D3/D2 RECEPTOR ANTAGONISTS)

Supplementary Protection Certificates for cariprazine hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1663996	1790042-4	Sweden		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		PRODUCT NAME: KARIPRAZINAS, PASIRINKTINAI DRUSKOS FORMOS, ISKAITANT KARIPRAZINO HIDROCHLORIDA; REGISTRATION NO/DATE: EU/1/17/1209 20170713
1663996	2017C/045	Belgium		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	LUC00039	Luxembourg		PRODUCT NAME: CARIPRAZINE, OPTIONALLY IN THE FORM OF A SALT, INCLUDING THE CARIPRAZINE HYDROCHLORIDE; AUTHORISATION NUMBER AND DATE: EU/1/17/1209 20170717
1663996	C201730042	Spain		PRODUCT NAME: CARIPRAZINA, O SUS SALES, INCLUYENDO HIDROCLORURO DE CARIPRAZINA; NATIONAL AUTHORISATION NUMBER: EU/1/17/1209; DATE OF AUTHORISATION: 20170713; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1209; DATE OF FIRST AUTHORISATION IN EEA: 20170713
1663996	47/2017	Austria		PRODUCT NAME: CARIPRAZIN, GEGEBENENFALLS IN FORM EINES SALZES, EINSCHLIESSLICH CARIPRAZIN HYDROCHLORID; REGISTRATION NO/DATE: EU/1/17/1209 (MITTEILUNG) 20170717
1663996	CR 2017 00042	Denmark		PRODUCT NAME: CARIPRAZINE, OPTIONALLY IN THE FORM OF A SALT, INCLUDING THE CARIPRAZINE HYDROCHLORIDE; REG. NO/DATE: EU/1/17/1209 20170717