VRAYLAR Drug Patent Profile
✉ Email this page to a colleague
When do Vraylar patents expire, and what generic alternatives are available?
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
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: | 67 |
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 |
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 |
Pharmacology for VRAYLAR
Drug Class | Atypical Antipsychotic |
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 nineteen US patents and one FDA Regulatory Exclusivity.
Patents protecting VRAYLAR
(Thio) carbamoyl-cyclohexane derivatives as D3/D2 receptor antagonists
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF SCHIZOPHRENIA WITH CARIPRAZINE
(Thio) carbamoyl-cyclohexane derivatives as D3/D2 receptor antagonists
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Pharmaceutical formulations containing dopamine receptor ligands
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF SCHIZOPHRENIA WITH CARIPRAZINE
Pharmaceutical formulations containing dopamine receptor ligands
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: ADJUNCTIVE THERAPY TO ANTIDEPRESSANTS FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER
Pharmaceutical formulations containing dopamine receptor ligands
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH CARIPRAZINE
Pharmaceutical formulations containing dopamine receptor ligands
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER (BIPOLAR DEPRESSION) WITH CARIPRAZINE
Pharmaceutical formulations containing dopamine receptor ligands
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER (BIPOLAR DEPRESSION) WITH CARIPRAZINE
Pharmaceutical formulations containing dopamine receptor ligands
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH CARIPRAZINE
Pharmaceutical formulations containing dopamine receptor ligands
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF SCHIZOPHRENIA WITH CARIPRAZINE
Pharmaceutical formulations containing dopamine receptor ligands
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: ADJUNCTIVE THERAPY TO ANTIDEPRESSANTS FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF SCHIZOPHRENIA WITH CARIPRAZINE
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: ADJUNCTIVE THERAPY TO ANTIDEPRESSANTS FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH CARIPRAZINE
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Abbvie | VRAYLAR | cariprazine hydrochloride | CAPSULE;ORAL | 204370-001 | Sep 17, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Abbvie | VRAYLAR | cariprazine hydrochloride | CAPSULE;ORAL | 204370-004 | Sep 17, 2015 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Abbvie | VRAYLAR | cariprazine hydrochloride | CAPSULE;ORAL | 204370-002 | Sep 17, 2015 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Abbvie | VRAYLAR | cariprazine hydrochloride | CAPSULE;ORAL | 204370-003 | Sep 17, 2015 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>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.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Taiwan | 200505874 | New compounds with therapeutic effect | ⤷ Try a Trial |
Singapore | 192507 | PHARMACEUTICAL FORMULATIONS CONTAINING DOPAMINE RECEPTOR LIGANDS | ⤷ Try a Trial |
South Korea | 101668973 | ⤷ Try a Trial | |
Luxembourg | C00039 | ⤷ Try a Trial | |
Tunisia | 2011000018 | PHARMACEUTICAL FORMULATIONS CONTAINING DOPAMINE RECEPTOR LIGANDS | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VRAYLAR
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1663996 | 2017C/045 | Belgium | ⤷ Try a 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 | C 2017 040 | Romania | ⤷ Try a Trial | 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 | 17C0008 | France | ⤷ Try a Trial | PRODUCT NAME: CARIPRAZINE,FACULTATIVEMENT SOUS FORME D'UN SEL,INCLUANT L'HYDROCHLORURE DE CARIPRAZINE.; REGISTRATION NO/DATE: EU/1/17/1209 20170717 |
1663996 | 2017/050 | Ireland | ⤷ Try a Trial | PRODUCT NAME: CARIPRAZINE, OPTIONALLY IN THE FORM OF A SALT, INCLUDING THE CARIPRAZINE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/17/1209 20170713 |
1663996 | PA2017027 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: KARIPRAZINAS, DRUSKOS FORMOS, KONKRECIAI JO HIDROCHLORIDO DRUSKOS FORMOS, T.Y. KARIPRAZINO HIDROCHLORIDAS; REGISTRATION NO/DATE: EU/1/17/1209 20170713 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |