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Last Updated: January 24, 2021

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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

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Drug patent expirations by year for VRAYLAR
Drug Prices for VRAYLAR

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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

Pharmacology for VRAYLAR
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
Allergan VRAYLAR cariprazine hydrochloride CAPSULE;ORAL 204370-002 Sep 17, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
Allergan VRAYLAR cariprazine hydrochloride CAPSULE;ORAL 204370-003 Sep 17, 2015 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Allergan VRAYLAR cariprazine hydrochloride CAPSULE;ORAL 204370-001 Sep 17, 2015 RX Yes No   Start Trial   Start Trial   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 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
1663996 122017000083 Germany   Start Trial PRODUCT NAME: CARIPRAZIN, GEGEBENENFALLS IN FORM EINES SALZES, EINSCHLIESSLICH CARIPRAZINHYDROCHLORID; REGISTRATION NO/DATE: EU/1/17/1209 20170713
1663996 C201730042 Spain   Start Trial 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   Start Trial 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   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 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 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Mallinckrodt

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