VRAYLAR Drug Patent Profile

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 four patents protecting this drug and one Paragraph IV challenge.

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. Two suppliers are listed for this compound. Additional details are available on the cariprazine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Vraylar

A generic version of VRAYLAR was approved as cariprazine hydrochloride by ZYDUS PHARMS on September 9^th, 2022.

Summary for VRAYLAR

International Patents:	120
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	41
Clinical Trials:	9
Patent Applications:	66
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for VRAYLAR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VRAYLAR
What excipients (inactive ingredients) are in VRAYLAR?	VRAYLAR excipients list
DailyMed Link:	VRAYLAR at DailyMed

See drug prices for VRAYLAR

Recent Clinical Trials for VRAYLAR

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

Sponsor	Phase
The Medical Research Network	Phase 4
AbbVie	Phase 4
AbbVie	Phase 3

See all VRAYLAR clinical trials

Pharmacology for VRAYLAR

Drug Class

Atypical Antipsychotic

Anatomical Therapeutic Chemical (ATC) Classes for VRAYLAR

N05AX	Other antipsychotics
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for VRAYLAR

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 VRAYLAR

VRAYLAR is protected by twelve US patents and one FDA Regulatory Exclusivity.

Patents protecting VRAYLAR

FDA Regulatory Exclusivity protecting 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	204370-003	Sep 17, 2015	AB	RX	Yes	No			Y	Y
Allergan	VRAYLAR	cariprazine hydrochloride	CAPSULE;ORAL	204370-001	Sep 17, 2015	AB	RX	Yes	Yes			Y	Y
Allergan	VRAYLAR	cariprazine hydrochloride	CAPSULE;ORAL	204370-001	Sep 17, 2015	AB	RX	Yes	Yes
Allergan	VRAYLAR	cariprazine hydrochloride	CAPSULE;ORAL	204370-001	Sep 17, 2015	AB	RX	Yes	Yes			Y	Y
Allergan	VRAYLAR	cariprazine hydrochloride	CAPSULE;ORAL	204370-003	Sep 17, 2015	AB	RX	Yes	No

International Patents for VRAYLAR

When does loss-of-exclusivity occur for VRAYLAR?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Iceland

Israel

Japan

Lithuania

Luxembourg

Malaysia

Mexico

Montenegro

Morocco

Netherlands

New Zealand

Norway

Poland

Portugal

Serbia

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering VRAYLAR around the world.

Country	Patent Number	Title	Estimated Expiration
Israel	210615	תכשיר רוקחי המכיל טרנס-1-{4-[2-[4-(3,2דיכלורופניל)-פיפרזין-1-יל]-אתיל]-ציקלוהקסיל}-3,3-דימתיל-אוראה ושימושים שלו לטיפול בסכיזופרניה, הפרעה דו-קוטבית או מאניה אקוטית (Pharmaceutical formulation comprising trans-1{4-[2-[4-(2,3 dichlorophenyl)-piperazin-1-yl]-ethyl]-cyclohexyl}-3,3-dimethyl-urea and uses thereof for treating schizophrenia, bipolar disorder or acute mania)
Denmark	2317852
South Korea	20110033852	PHARMACEUTICAL FORMULATIONS CONTAINING DOPAMINE RECEPTOR LIGANDS
Hungary	227534	(THIO)CARBAMOYL-CYCLOHEXANE DERIVATIVES, PROCESS FOR PRODUCING THEM AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM
Hungary	230748	New piperazine salt and process for its preparation

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 CLORHIDRATIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1209; DATE OF FIRST AUTHORISATION IN EEA: 20170713 ; NATIONAL AUTHORISATION NUMBER: EU/1/17/1209; DATE OF NATIONAL AUTHORISATION: 20170713; NUMBER OF F
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