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Last Updated: November 2, 2024

ABILIFY MAINTENA KIT Drug Patent Profile


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When do Abilify Maintena Kit patents expire, and when can generic versions of Abilify Maintena Kit launch?

Abilify Maintena Kit is a drug marketed by Otsuka Pharm Co Ltd and is included in one NDA. There are eleven patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and eighty-six patent family members in forty-one countries.

The generic ingredient in ABILIFY MAINTENA KIT is aripiprazole. There are forty-nine drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Abilify Maintena Kit

A generic version of ABILIFY MAINTENA KIT was approved as aripiprazole by ALEMBIC on April 28th, 2015.

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Drug patent expirations by year for ABILIFY MAINTENA KIT
Drug Prices for ABILIFY MAINTENA KIT

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Recent Clinical Trials for ABILIFY MAINTENA KIT

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Otsuka Beijing Research InstitutePhase 1
Otsuka Pharmaceutical Co., Ltd.Phase 4
Chonbuk National University HospitalPhase 4

See all ABILIFY MAINTENA KIT clinical trials

Paragraph IV (Patent) Challenges for ABILIFY MAINTENA KIT
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ABILIFY MAINTENA KIT Extended-release Injectable Suspension aripiprazole 300 mg/vial and 400 mg/vial 202971 1 2021-12-20

US Patents and Regulatory Information for ABILIFY MAINTENA KIT

ABILIFY MAINTENA KIT is protected by twenty-two US patents.

Patents protecting ABILIFY MAINTENA KIT

Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA

Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
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Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA, WITH EFFICACY IN TREATING ACUTE EPISODES OF SCHIZOPHRENIA

Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: MAINTENANCE MONOTHERAPY TREATMENT OF BIPOLAR 1 DISORDER

Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
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Patented Use: TREATMENT OF SCHIZOPHRENIA

Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA, WITH EFFICACY IN TREATING ACUTE EPISODES OF SCHIZOPHRENIA

Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
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Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA, WITH EFFICACY IN TREATING ACUTE EPISODES OF SCHIZOPHRENIA

Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA

Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
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Patent Expiration: ⤷  Sign Up
Patented Use: MAINTENANCE MONOTHERAPY TREATMENT OF BIPOLAR I DISORDER

Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA, WITH EFFICACY IN TREATING ACUTE EPISODES OF SCHIZOPHRENIA

Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: MAINTENANCE MONOTHERAPY TREATMENT OF BIPOLAR I DISORDER

Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA

Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: MAINTENANCE MONOTHERAPY TREATMENT OF BIPOLAR I DISORDER

Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA

Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF SCHIZOPHRENIA, WITH EFFICACY IN TREATING ACUTE EPISODES OF SCHIZOPHRENIA


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Controlled release sterile injectable aripiprazole formulation and method
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Controlled release sterile injectable aripiprazole formulation and method
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Patented Use: TREATMENT OF SCHIZOPHRENIA

Controlled release sterile injectable aripiprazole formulation and method
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Patented Use: TREATMENT OF SCHIZOPHRENIA, WITH EFFICACY IN TREATING ACUTE EPISODES OF SCHIZOPHRENIA

Methods for administering aripiprazole
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Patented Use: TREATMENT OF SCHIZOPHRENIA

Methods for administering aripiprazole
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Patented Use: USE OF ARIPIPRAZOLE IN EXTENDED RELEASE INJECTABLE SUSPENSION IN TREATING ACUTE EPISODES OF SCHIZOPHRENIA

Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
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Controlled release sterile injectable aripiprazole formulation and method
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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
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-004 Sep 29, 2014 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-003 Sep 29, 2014 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-004 Sep 29, 2014 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-002 Feb 28, 2013 RX Yes Yes ⤷  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

Expired US Patents for ABILIFY MAINTENA KIT

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-001 Feb 28, 2013 ⤷  Sign Up ⤷  Sign Up
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-002 Feb 28, 2013 ⤷  Sign Up ⤷  Sign Up
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-004 Sep 29, 2014 ⤷  Sign Up ⤷  Sign Up
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-002 Feb 28, 2013 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for ABILIFY MAINTENA KIT

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Mylan Pharmaceuticals Limited Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen) aripiprazole EMEA/H/C/003803
Aripiprazole Mylan Pharma is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.Aripiprazole Mylan Pharma is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.Aripiprazole Mylan Pharma is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older.
Authorised yes no no 2015-06-30
Otsuka Pharmaceutical Netherlands B.V. Abilify aripiprazole EMEA/H/C/000471
Abilify is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.Abilify is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.Abilify is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older.
Authorised no no no 2004-06-04
Otsuka Pharmaceutical Netherlands B.V. Abilify Maintena aripiprazole EMEA/H/C/002755
Maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole.
Authorised no no no 2013-11-14
Accord Healthcare S.L.U. Aripiprazole Accord aripiprazole EMEA/H/C/004021
Aripiprazole Accord is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older., , Aripiprazole Accord is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment., , Aripiprazole Accord is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older.,
Authorised yes no no 2015-11-15
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for ABILIFY MAINTENA KIT

See the table below for patents covering ABILIFY MAINTENA KIT around the world.

Country Patent Number Title Estimated Expiration
Slovenia 1419776 ⤷  Sign Up
Austria 522200 ⤷  Sign Up
China 106420627 ⤷  Sign Up
European Patent Office 2340810 Suspension injectable d'aripiprazole (Aripiprazole injectable suspension) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ABILIFY MAINTENA KIT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1675573 2014C/029 Belgium ⤷  Sign Up PRODUCT NAME: ARIPIPRAZOLE; AUTHORISATION NUMBER AND DATE: EU/1/13/882 20131119
1675573 C01675573/01 Switzerland ⤷  Sign Up PRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: SWISSMEDIC 63177 28.04.2014
1675573 32/2014 Austria ⤷  Sign Up PRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: EU/1/13/882 (MITTEILUNG) 20131119
1675573 122014000057 Germany ⤷  Sign Up PRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: EU/1/13/882 20131115
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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