Time limited offer for new users ▶ Get up to 3 months free

Serving leading biopharmaceutical companies globally:

AstraZeneca
Moodys
Medtronic
Harvard Business School
Merck
Johnson and Johnson

Last Updated: January 28, 2023

VRAYLAR Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


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.

Drug patent expirations by year for VRAYLAR
Drug Prices for VRAYLAR

See drug prices for VRAYLAR

Recent Clinical Trials for VRAYLAR

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

SponsorPhase
The Medical Research NetworkPhase 4
AbbViePhase 4
AbbViePhase 3

See all VRAYLAR clinical trials

Pharmacology for VRAYLAR
Anatomical Therapeutic Chemical (ATC) Classes for VRAYLAR
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

(Thio) carbamoyl-cyclohexane derivatives as D3/D2 receptor antagonists
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH CARIPRAZINE

(Thio) carbamoyl-cyclohexane derivatives as D3/D2 receptor antagonists
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER (BIPOLAR DEPRESSION) WITH CARIPRAZINE

(Thio) carbamoyl-cyclohexane derivatives as D3/D2 receptor antagonists
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA WITH CARIPRAZINE

(Thio) carbamoyl-cyclohexane derivatives as D3/D2 receptor antagonists
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA AND/OR ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH CARIPRAZINE

Salts of piperazine compounds as D.sub.3/D.sub.2 antagonists
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical formulations containing dopamine receptor ligands
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA AND/OR ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH CARIPRAZINE

Pharmaceutical formulations containing dopamine receptor ligands
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA WITH CARIPRAZINE

Pharmaceutical formulations containing dopamine receptor ligands
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH CARIPRAZINE

Pharmaceutical formulations containing dopamine receptor ligands
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER (BIPOLAR DEPRESSION) WITH CARIPRAZINE

Pharmaceutical formulations containing dopamine receptor ligands
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER (BIPOLAR DEPRESSION) WITH CARIPRAZINE

Pharmaceutical formulations containing dopamine receptor ligands
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH CARIPRAZINE

Pharmaceutical formulations containing dopamine receptor ligands
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA WITH CARIPRAZINE

FDA Regulatory Exclusivity protecting VRAYLAR

TREATMENT OF DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER (BIPOLAR DEPRESSION)
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Allergan VRAYLAR cariprazine hydrochloride CAPSULE;ORAL 204370-001 Sep 17, 2015 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Allergan VRAYLAR cariprazine hydrochloride CAPSULE;ORAL 204370-001 Sep 17, 2015 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Allergan VRAYLAR cariprazine hydrochloride CAPSULE;ORAL 204370-001 Sep 17, 2015 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Allergan VRAYLAR cariprazine hydrochloride CAPSULE;ORAL 204370-003 Sep 17, 2015 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

Patent: 04261490
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0413283
Estimated Expiration: See Plans and Pricing

Canada

Patent: 32818
Estimated Expiration: See Plans and Pricing

China

Patent: 29703
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0120715
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 13099
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 63996
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 9022
Estimated Expiration: See Plans and Pricing

Patent: 0600364
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 63996
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 93494
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 700044
Estimated Expiration: See Plans and Pricing

Patent: 7534
Estimated Expiration: See Plans and Pricing

Patent: 02451
Estimated Expiration: See Plans and Pricing

Iceland

Patent: 05
Estimated Expiration: See Plans and Pricing

Patent: 99
Estimated Expiration: See Plans and Pricing

Israel

Patent: 2746
Estimated Expiration: See Plans and Pricing

Japan

Patent: 99806
Estimated Expiration: See Plans and Pricing

Patent: 07501215
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 663996
Estimated Expiration: See Plans and Pricing

Patent: 2017027
Estimated Expiration: See Plans and Pricing

Luxembourg

Patent: 0039
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 2760
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 06001033
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 564
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 024
Estimated Expiration: See Plans and Pricing

Netherlands

Patent: 0913
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 4999
Estimated Expiration: See Plans and Pricing

Norway

Patent: 4973
Estimated Expiration: See Plans and Pricing

Patent: 17051
Estimated Expiration: See Plans and Pricing

Patent: 061076
Estimated Expiration: See Plans and Pricing

Poland

Patent: 63996
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 63996
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 771
Estimated Expiration: See Plans and Pricing

Patent: 060041
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 63996
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0601026
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 0870284
Estimated Expiration: See Plans and Pricing

Patent: 060058096
Estimated Expiration: See Plans and Pricing

Spain

Patent: 89840
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 27141
Estimated Expiration: See Plans and Pricing

Patent: 0505874
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 05328
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 022
Estimated Expiration: See Plans and Pricing

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) See Plans and Pricing
Denmark 2317852 See Plans and Pricing
South Korea 20110033852 PHARMACEUTICAL FORMULATIONS CONTAINING DOPAMINE RECEPTOR LIGANDS See Plans and Pricing
Hungary 227534 (THIO)CARBAMOYL-CYCLOHEXANE DERIVATIVES, PROCESS FOR PRODUCING THEM AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM See Plans and Pricing
Hungary 230748 New piperazine salt and process for its preparation See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VRAYLAR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1663996 47/2017 Austria See Plans and Pricing PRODUCT NAME: CARIPRAZIN, GEGEBENENFALLS IN FORM EINES SALZES, EINSCHLIESSLICH CARIPRAZIN HYDROCHLORID; REGISTRATION NO/DATE: EU/1/17/1209 (MITTEILUNG) 20170717
1663996 122017000083 Germany See Plans and Pricing PRODUCT NAME: CARIPRAZIN, GEGEBENENFALLS IN FORM EINES SALZES, EINSCHLIESSLICH CARIPRAZINHYDROCHLORID; REGISTRATION NO/DATE: EU/1/17/1209 20170713
1663996 C 2017 040 Romania See Plans and Pricing 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 See Plans and Pricing 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 See Plans and Pricing PRODUCT NAME: CARIPRAZINE, OPTIONALLY IN THE FORM OF A SALT, INCLUDING THE CARIPRAZINE HYDROCHLORIDE; REG. NO/DATE: EU/1/17/1209 20170717
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKesson
Moodys
Dow
Medtronic
Boehringer Ingelheim
Mallinckrodt

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.