VRAYLAR Drug Patent Profile
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Which patents cover Vraylar, 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. One supplier is 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: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 45 |
| Clinical Trials: | 9 |
| Patent Applications: | 57 |
| 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 |
|---|---|
| AbbVie | Phase 4 |
| The Medical Research Network | Phase 4 |
| AbbVie | Phase 3 |
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
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Pharmaceutical formulations containing dopamine receptor ligands
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
Pharmaceutical formulations containing dopamine receptor ligands
Patent Number: ⤷ Sign Up
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 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 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 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
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
| 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 | ||
| >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 |
|---|---|---|---|
| South Africa | 200601026 | (Thio) carbamoyl-cyclohexane derivatives as D3/D2 receptor antagonists | ⤷ Sign Up |
| Taiwan | 201002323 | Novel piperazine salts as D3/D2 antagonists | ⤷ Sign Up |
| South Korea | 20060058096 | (THIO)CARBAMOYL-CYCLOHEXANE DERIVATIVES AS D3/D2 RECEPTOR ANTAGONISTS | ⤷ Sign Up |
| >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 | ⤷ Sign Up | 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 | 674 | Finland | ⤷ Sign Up | |
| 1663996 | 122017000083 | Germany | ⤷ Sign Up | PRODUCT NAME: CARIPRAZIN, GEGEBENENFALLS IN FORM EINES SALZES, EINSCHLIESSLICH CARIPRAZINHYDROCHLORID; REGISTRATION NO/DATE: EU/1/17/1209 20170713 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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.
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