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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 and is included in one NDA. There are three patents protecting this drug.

This drug has one hundred and seventeen patent family members in forty-one 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.

US ANDA Litigation and Generic Entry Outlook for Vraylar

Vraylar was eligible for patent challenges on September 17, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 16, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VRAYLAR

International Patents:	117
US Patents:	3
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	26
Clinical Trials:	2
Patent Applications:	18
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for VRAYLAR
DailyMed Link:	VRAYLAR at DailyMed

See drug prices for VRAYLAR

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.

Recent Clinical Trials for VRAYLAR

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

Sponsor	Phase
Forest Laboratories	Phase 3
Forest Laboratories, LLC, an Allergan Affiliate	Phase 3

See all VRAYLAR clinical trials

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

AKOS027338713

BCP24194

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

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

RGH-188 hydrochloride

SB16840

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)

Paragraph IV (Patent) Challenges for VRAYLAR

Tradename	Dosage	Ingredient	NDA	Submissiondate
VRAYLAR	CAPSULE;ORAL	cariprazine hydrochloride	204370

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	VRAYLAR	cariprazine hydrochloride	CAPSULE;ORAL	204370-004	Sep 17, 2015		RX	Yes	Yes
Allergan	VRAYLAR	cariprazine hydrochloride	CAPSULE;ORAL	204370-004	Sep 17, 2015		RX	Yes	Yes			Y	Y
Allergan	VRAYLAR	cariprazine hydrochloride	CAPSULE;ORAL	204370-004	Sep 17, 2015		RX	Yes	Yes
Allergan	VRAYLAR	cariprazine hydrochloride	CAPSULE;ORAL	204370-001	Sep 17, 2015		RX	Yes	No			Y	Y
Allergan	VRAYLAR	cariprazine hydrochloride	CAPSULE;ORAL	204370-002	Sep 17, 2015		RX	Yes	No
Allergan	VRAYLAR	cariprazine hydrochloride	CAPSULE;ORAL	204370-003	Sep 17, 2015		RX	Yes	No			Y	Y

International Patents for VRAYLAR

Country	Patent Number	Estimated Expiration
Israel	210615
Cyprus	1115994
South Korea	20110033852
Hungary	227534
Croatia	P20170918
Serbia	52771

Supplementary Protection Certificates for VRAYLAR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	122017000083	Germany		PRODUCT NAME: CARIPRAZIN, GEGEBENENFALLS IN FORM EINES SALZES, EINSCHLIESSLICH CARIPRAZINHYDROCHLORID; REGISTRATION NO/DATE: EU/1/17/1209 20170713
1663996	C 2017 040	Romania		PRODUCT NAME: CARIPRAZINA, OPTIONAL SUB FORMA UNEI SARI A ACESTEIA, INCLUZAND CARIPRAZINA CLORHIDRAT; NATIONAL AUTHORISATION NUMBER: EU/1/17/1209; DATE OF NATIONAL AUTHORISATION: 20170713; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1209; DATE OF FIRST AUTHORISATION IN EEA: 20170713
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	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
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