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VRAYLAR Drug Profile

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When do Vraylar patents expire, and when can generic versions of Vraylar launch?

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 twenty patent family members in forty-two 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 September 17, 2029. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for VRAYLAR

International Patents:	120
US Patents:	3
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	36
Clinical Trials:	2
Patent Applications:	18
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for VRAYLAR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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, LLC, an Allergan Affiliate	Phase 3
Forest Laboratories	Phase 3

See all VRAYLAR clinical trials

Pharmacology for VRAYLAR

Drug Class

Atypical Antipsychotic

Paragraph IV (Patent) Challenges for VRAYLAR

Tradename	Dosage	Ingredient	NDA	Submissiondate
VRAYLAR	CAPSULE;ORAL	cariprazine hydrochloride	204370	2019-09-17

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

International Patents for VRAYLAR

Country	Patent Number	Estimated Expiration
Japan	2007501215
Israel	201533
Eurasian Patent Organization	025636
Taiwan	I424846
Israel	172746
Australia	2009270823
Eurasian Patent Organization	200600364

Supplementary Protection Certificates for VRAYLAR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1663996	17C0008	France		PRODUCT NAME: CARIPRAZINE,FACULTATIVEMENT SOUS FORME D'UN SEL,INCLUANT L'HYDROCHLORURE DE CARIPRAZINE.; REGISTRATION NO/DATE: EU/1/17/1209 20170717
1663996	122017000083	Germany		PRODUCT NAME: CARIPRAZIN, GEGEBENENFALLS IN FORM EINES SALZES, EINSCHLIESSLICH CARIPRAZINHYDROCHLORID; REGISTRATION NO/DATE: EU/1/17/1209 20170713
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	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	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	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	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