You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

McKesson
Moodys
Dow
Medtronic
Boehringer Ingelheim
Mallinckrodt

Last Updated: June 4, 2020

DrugPatentWatch Database Preview

VRAYLAR Drug Profile


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

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 nineteen 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

< Available with Subscription >

  Start Trial

Drug patent expirations by year for VRAYLAR
Drug Prices for VRAYLAR

See drug prices for VRAYLAR

Generic Entry Opportunity Date for VRAYLAR
Generic Entry Date for VRAYLAR*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Forest Laboratories, LLC, an Allergan AffiliatePhase 3
Forest LaboratoriesPhase 3

See all VRAYLAR clinical trials

Recent Litigation for VRAYLAR

Identify potential future generic entrants

District Court Litigation
Case NameDate
Allergan USA, Inc. v. Sun Pharmaceutical Industries Limited2019-12-20

See all VRAYLAR litigation

Pharmacology for VRAYLAR
Synonyms for VRAYLAR
1083076-69-0
3-((1R,4r)-4-(2-(4-(2,3-dichlorophenyl)piperazin-1-yl)ethyl)cyclohexyl)-1,1-dimethylurea hydrochloride
3-[4-[2-[4-(2,3-dichlorophenyl)piperazin-1-yl]ethyl]cyclohexyl]-1,1-dimethylurea;hydrochloride
A15036
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
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
Q27162922
RGH-188 HCL
RGH-188 hydrochloride
RGH188 hydrochloride
s5849
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 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   Start Trial   Start Trial   Start Trial
Allergan VRAYLAR cariprazine hydrochloride CAPSULE;ORAL 204370-004 Sep 17, 2015 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Allergan VRAYLAR cariprazine hydrochloride CAPSULE;ORAL 204370-004 Sep 17, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Allergan VRAYLAR cariprazine hydrochloride CAPSULE;ORAL 204370-001 Sep 17, 2015 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for VRAYLAR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1663996 1790042-4 Sweden   Start Trial PRODUCT NAME: CARIPRAZINE, OPTIONALLY IN THE FORM OF A SALT, INCLUDING THE CARIPRAZINE HYDROCHLORIDE; REG. NO/DATE: EU/1/17/1209 20170717
1663996 2017C/045 Belgium   Start Trial PRODUCT NAME: CARIPRAZINE, EVENTUELLEMENT SOUS LA FORME D'UN SEL, Y COMPRIS L'HYDROCHLORURE DE CARIPRAZINE; AUTHORISATION NUMBER AND DATE: EU/1/17/1209 20170717
1663996 LUC00039 Luxembourg   Start Trial PRODUCT NAME: CARIPRAZINE, OPTIONALLY IN THE FORM OF A SALT, INCLUDING THE CARIPRAZINE HYDROCHLORIDE; AUTHORISATION NUMBER AND DATE: EU/1/17/1209 20170717
1663996 17C0008 France   Start Trial PRODUCT NAME: CARIPRAZINE,FACULTATIVEMENT SOUS FORME D'UN SEL,INCLUANT L'HYDROCHLORURE DE CARIPRAZINE.; REGISTRATION 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.