VRAYLAR Drug Patent Profile

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

Vraylar is a drug marketed by Abbvie and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and twenty-one 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^® Generic Entry Outlook for Vraylar

Vraylar was eligible for patent challenges on September 17, 2019.

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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Summary for VRAYLAR

International Patents:	121
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	45
Clinical Trials:	9
Patent Applications:	57
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

Drug patent expirations by year 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

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 nineteen US patents and one FDA Regulatory Exclusivity.

Patents protecting VRAYLAR

(Thio) carbamoyl-cyclohexane derivatives as D3/D2 receptor antagonists
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA WITH CARIPRAZINE

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

(Thio) carbamoyl-cyclohexane derivatives as D3/D2 receptor antagonists
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: ADJUNCTIVE THERAPY TO ANTIDEPRESSANTS FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER

Salts of piperazine compounds as D.sub.3/D.sub.2 antagonists
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Patent Expiration: ⤷ Sign Up

Pharmaceutical formulations containing dopamine receptor ligands
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Patent Expiration: ⤷ Sign Up
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
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Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA WITH CARIPRAZINE

Pharmaceutical formulations containing dopamine receptor ligands
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: ADJUNCTIVE THERAPY TO ANTIDEPRESSANTS FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER

Pharmaceutical formulations containing dopamine receptor ligands
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH CARIPRAZINE

Pharmaceutical formulations containing dopamine receptor ligands
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER (BIPOLAR DEPRESSION) WITH CARIPRAZINE

Pharmaceutical formulations containing dopamine receptor ligands
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA WITH CARIPRAZINE

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA WITH CARIPRAZINE

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: ADJUNCTIVE THERAPY TO ANTIDEPRESSANTS FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH CARIPRAZINE

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER (BIPOLAR DEPRESSION) WITH CARIPRAZINE

FDA Regulatory Exclusivity protecting VRAYLAR

ADJUNCTIVE THERAPY TO ANTIDEPRESSANTS FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER IN ADULTS
Exclusivity Expiration: ⤷ Sign Up

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	VRAYLAR	cariprazine hydrochloride	CAPSULE;ORAL	204370-002	Sep 17, 2015		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie	VRAYLAR	cariprazine hydrochloride	CAPSULE;ORAL	204370-001	Sep 17, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Abbvie	VRAYLAR	cariprazine hydrochloride	CAPSULE;ORAL	204370-004	Sep 17, 2015		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Abbvie	VRAYLAR	cariprazine hydrochloride	CAPSULE;ORAL	204370-002	Sep 17, 2015		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie	VRAYLAR	cariprazine hydrochloride	CAPSULE;ORAL	204370-003	Sep 17, 2015		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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

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Country	Patent Number	Title	Estimated Expiration
Japan	2007501215		⤷ Sign Up
Eurasian Patent Organization	017270	НОВЫЕ СОЛИ ПИПЕРАЗИНА В КАЧЕСТВЕ D/D-АНТАГОНИСТОВ (NOVEL PIPERAZINE SALTS AS D/DANTAGONISTS)	⤷ Sign Up
Cyprus	1119076		⤷ Sign Up
Eurasian Patent Organization	200600364	ПРОИЗВОДНЫЕ (ТИО)КАРБАМОИЛЦИКЛОГЕКСАНА В КАЧЕСТВЕ АНТАГОНИСТОВ D/DРЕЦЕПТОРА	⤷ Sign Up
Cyprus	1113099		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for VRAYLAR

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1663996	47/2017	Austria	⤷ Sign Up	PRODUCT NAME: CARIPRAZIN, GEGEBENENFALLS IN FORM EINES SALZES, EINSCHLIESSLICH CARIPRAZIN HYDROCHLORID; REGISTRATION NO/DATE: EU/1/17/1209 (MITTEILUNG) 20170717
1663996	17C0008	France	⤷ Sign Up	PRODUCT NAME: CARIPRAZINE,FACULTATIVEMENT SOUS FORME D'UN SEL,INCLUANT L'HYDROCHLORURE DE CARIPRAZINE.; REGISTRATION NO/DATE: EU/1/17/1209 20170717
1663996	1790042-4	Sweden	⤷ Sign Up	PRODUCT NAME: CARIPRAZINE, OPTIONALLY IN THE FORM OF A SALT, INCLUDING THE CARIPRAZINE HYDROCHLORIDE; REG. NO/DATE: EU/1/17/1209 20170717
1663996	C201730042	Spain	⤷ Sign Up	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	674	Finland	⤷ Sign Up
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description