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. Two suppliers are 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:	2
Raw Ingredient (Bulk) Api Vendors:	46
Clinical Trials:	41
Patent Applications:	101
Formulation / Manufacturing:	see details
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
The Medical Research Network	Phase 4
AbbVie	Phase 4
AbbVie	Phase 3

See all cariprazine hydrochloride clinical trials

Pharmacology for cariprazine hydrochloride

Drug Class

Atypical Antipsychotic

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

International Patents for cariprazine hydrochloride

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	017270	НОВЫЕ СОЛИ ПИПЕРАЗИНА В КАЧЕСТВЕ D/D-АНТАГОНИСТОВ (NOVEL PIPERAZINE SALTS AS D/DANTAGONISTS)
Tunisia	SN05328	(THIO) CARBAMOYL-CYCLOHEXANE DERIVATIVES AS D3/D2 RECEPTOR ANTAGONISTS
Georgia, Republic of	P20125522	NOVEL PIPERAZINE SALTS AS D3/D2 ANTAGONISTS
Lithuania	C1663996
Taiwan	201002323	Novel piperazine salts as D3/D2 antagonists
Ukraine	104869	ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, КОТОРЫЕ СОДЕРЖАТ ЛИГАНДЫ РЕЦЕПТОРА ДОФАМИНА;ФАРМАЦЕВТИЧНІ КОМПОЗИЦІЇ, ЩО МІСТЯТЬ ЛІГАНДИ РЕЦЕПТОРА ДОФАМІНУ (Normal;heading 1;heading 2;heading 3;PHARMACEUTICAL FORMULATIONS CONTAINING DOPAMINE RECEPTOR LIGANDS)
Serbia	53866	FARMACEUTSKE FORMULACIJE KOJE SADRŽE LIGANDE DOPAMINSKIH RECEPTORA (PHARMACEUTICAL FORMULATIONS CONTAINING DOPAMINE RECEPTOR LIGANDS)

Supplementary Protection Certificates for cariprazine hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1663996	PA2017027	Lithuania		PRODUCT NAME: KARIPRAZINAS, DRUSKOS FORMOS, KONKRECIAI JO HIDROCHLORIDO DRUSKOS FORMOS, T.Y. KARIPRAZINO HIDROCHLORIDAS; REGISTRATION NO/DATE: EU/1/17/1209 20170713
1663996	2017/050	Ireland		PRODUCT NAME: CARIPRAZINE, OPTIONALLY IN THE FORM OF A SALT, INCLUDING THE CARIPRAZINE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/17/1209 20170713
1663996	132017000122667	Italy		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	345 50018-2017	Slovakia		PRODUCT NAME: KARIPRAZIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/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	47/2017	Austria		PRODUCT NAME: CARIPRAZIN, GEGEBENENFALLS IN FORM EINES SALZES, EINSCHLIESSLICH CARIPRAZIN HYDROCHLORID; REGISTRATION NO/DATE: EU/1/17/1209 (MITTEILUNG) 20170717
1663996	SPC/GB17/059	United Kingdom		PRODUCT NAME: CARIPRAZINE, OPTIONALLY IN THE FORM OF A SALT, INCLUDING CARIPRAZINE HYDROCHLORIDE; REGISTERED: UK EU/1/17/1209/001-040 20170717; UK PLGB 04854/0173 20170717; UK PLGB 04854/0174 20170717; UK PLGB 04854/0175 20170717; UK PLGB 04854/0176 20170717