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VRAYLAR Drug Profile

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When do Vraylar patents expire, and what generic alternatives are available?

Vraylar is a drug marketed by Allergan Sales Llc and is included in one NDA. There are two patents protecting this drug.

This drug has seventy-nine patent family members in thirty-six countries.

The generic ingredient in VRAYLAR is cariprazine hydrochloride. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cariprazine hydrochloride profile page.

Summary for VRAYLAR

International Patents:	79
US Patents:	2
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	20
Clinical Trials:	2
Patent Applications:	18
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for VRAYLAR
DailyMed Link:	VRAYLAR at DailyMed

Generic Entry Opportunity Date for VRAYLAR

NDA:

204370

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for VRAYLAR

Drug Class

Atypical Antipsychotic

Synonyms for VRAYLAR

1083076-69-0

3-((1R,4r)-4-(2-(4-(2,3-dichlorophenyl)piperazin-1-yl)ethyl)cyclohexyl)-1,1-dimethylurea hydrochloride

AK341028

AKOS027338713

Cariprazine (hydrochloride)

Cariprazine HCl

CARIPRAZINE HYDROCHLORIDE

Cariprazine hydrochloride (JAN/USAN)

Cariprazine hydrochloride [USAN]

cariprazine monohydrochloride

cariprazine.HCl

CHEBI:90932

CHEMBL2024517

CS-1570

D09876

EX-A1644

FT-0701196

HY-14763A

KQD7C255YG

KS-00000640

MFCD26142670

MolPort-044-723-876

N'-(Trans-4-(2-(4-(2,3-dichlorophenyl)piperazin-1-yl)ethyl)cyclohexyl)-N,N-dimthylurea monohydrochloride

N'-(trans-4-{2-[4-(2,3-dichlorophenyl)piperazin-1-yl]ethyl}cyclohexyl)-N,N-dimethylurea hydrochloride

RGH-188 HCL

SCHEMBL183803

SCHEMBL183804

UNII-KQD7C255YG

Urea, N'-(trans-4-(2-(4-(2,3-dichlorophenyl)-1-piperazinyl)ethyl)cyclohexyl)-N,N- dimethyl-, hydrochloride (1:1)

Vraylar (TN)

US Patents and Regulatory Information for VRAYLAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Allergan Sales Llc	VRAYLAR	cariprazine hydrochloride	CAPSULE;ORAL	204370-001	Sep 17, 2015		RX	Yes	No			Y	Y
Allergan Sales Llc	VRAYLAR	cariprazine hydrochloride	CAPSULE;ORAL	204370-002	Sep 17, 2015		RX	Yes	No
Allergan Sales Llc	VRAYLAR	cariprazine hydrochloride	CAPSULE;ORAL	204370-001	Sep 17, 2015		RX	Yes	No
Allergan Sales Llc	VRAYLAR	cariprazine hydrochloride	CAPSULE;ORAL	204370-003	Sep 17, 2015		RX	Yes	No
Allergan Sales Llc	VRAYLAR	cariprazine hydrochloride	CAPSULE;ORAL	204370-002	Sep 17, 2015		RX	Yes	No
Allergan Sales Llc	VRAYLAR	cariprazine hydrochloride	CAPSULE;ORAL	204370-004	Sep 17, 2015		RX	Yes	Yes

International Patents for VRAYLAR

Country	Document Number	Estimated Expiration
Hong Kong	1140473
Hong Kong	1093494
New Zealand	580642
Taiwan	I327141
World Intellectual Property Organization (WIPO)	2008139235
Japan	2010526861

Supplementary Protection Certificates for VRAYLAR

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0913	Netherlands		PRODUCT NAME: CARIPRAZINE, OPTIONEEL IN DE VORM VAN EEN ZOUT, WAARONDER CARIPRAZINE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/17/1209 20170717
2017027	Lithuania		PRODUCT NAME: KARIPRAZINAS, DRUSKOS FORMOS, KONKRECIAI JO HIDROCHLORIDO DRUSKOS FORMOS, T.Y. KARIPRAZINO HIDROCHLORIDAS; REGISTRATION NO/DATE: EU/1/17/1209 20170713
2017000083	Germany		PRODUCT NAME: CARIPRAZIN, GEGEBENENFALLS IN FORM EINES SALZES, EINSCHLIESSLICH CARIPRAZINHYDROCHLORID; REGISTRATION NO/DATE: EU/1/17/1209 20170713
/2017	Austria		PRODUCT NAME: CARIPRAZIN, GEGEBENENFALLS IN FORM EINES SALZES, EINSCHLIESSLICH CARIPRAZIN HYDROCHLORID; REGISTRATION NO/DATE: EU/1/17/1209 (MITTEILUNG) 20170717