You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: May 18, 2024

ABILIFY MAINTENA KIT Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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-eight 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.

  Try a Trial

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

See drug prices for ABILIFY MAINTENA KIT

Recent Clinical Trials for ABILIFY MAINTENA KIT

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

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

See all ABILIFY MAINTENA KIT clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for ABILIFY MAINTENA KIT
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF SCHIZOPHRENIA

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

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

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

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

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

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

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

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

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


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Controlled release sterile injectable aripiprazole formulation and method
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Controlled release sterile injectable aripiprazole formulation and method
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF SCHIZOPHRENIA

Controlled release sterile injectable aripiprazole formulation and method
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF SCHIZOPHRENIA, WITH EFFICACY IN TREATING ACUTE EPISODES OF SCHIZOPHRENIA

Methods for administering aripiprazole
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF SCHIZOPHRENIA

Methods for administering aripiprazole
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Controlled release sterile injectable aripiprazole formulation and method
Patent Number: ⤷  Try a Trial
Patent 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
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-004 Sep 29, 2014 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-003 Sep 29, 2014 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-004 Sep 29, 2014 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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

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 202971-002 Feb 28, 2013 ⤷  Try a Trial ⤷  Try a Trial
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-001 Feb 28, 2013 ⤷  Try a Trial ⤷  Try a Trial
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-001 Feb 28, 2013 ⤷  Try a Trial ⤷  Try a Trial
>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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Supplementary Protection Certificates for ABILIFY MAINTENA KIT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1675573 2014C/029 Belgium ⤷  Try a Trial PRODUCT NAME: ARIPIPRAZOLE; AUTHORISATION NUMBER AND DATE: EU/1/13/882 20131119
1675573 92427 Luxembourg ⤷  Try a Trial PRODUCT NAME: ARIPIPRAZOLE
0367141 300161 Netherlands ⤷  Try a Trial 300161, 20091027, EXPIRES: 20141026
>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.