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Last Updated: May 20, 2022

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 twelve patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and forty-three patent family members in thirty-eight countries.

The generic ingredient in ABILIFY MAINTENA KIT is aripiprazole. There are forty-nine drug master file entries for this compound. Forty-six 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 PHARMS LTD on April 28th, 2015.

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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-one US patents.

Patents protecting ABILIFY MAINTENA KIT

Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA

Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MAINTENANCE MONOTHERAPY TREATMENT OF BIPOLAR 1 DISORDER

Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA

Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA

Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MAINTENANCE MONOTHERAPY TREATMENT OF BIPOLAR I DISORDER

Controlled release sterile injectable aripiprazole formulation and method
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Controlled release sterile injectable aripiprazole formulation and method
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA

Controlled release sterile injectable aripiprazole formulation and method
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA, WITH EFFICACY IN TREATING ACUTE EPISODES OF SCHIZOPHRENIA

Methods for administering aripiprazole
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA

Methods for administering aripiprazole
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF ARIPIPRAZOLE IN EXTENDED RELEASE INJECTABLE SUSPENSION IN TREATING ACUTE EPISODES OF SCHIZOPHRENIA

Methods for administering aripiprazole
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF ARIPIPRAZOLE IN EXTENDED RELEASE INJECTABLE SUSPENSION IN TREATING ACUTE EPISODES OF SCHIZOPHRENIA

Methods for administering aripiprazole
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA

Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Controlled release sterile injectable aripiprazole formulation and method
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods for administering aripiprazole
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF ARIPIPRAZOLE IN EXTENDED RELEASE INJECTABLE SUSPENSION

Methods for administering aripiprazole
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Method of treating cognitive impairments and schizophrenias
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SCHIZOPHRENIA

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 202971-003 Sep 29, 2014 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-002 Feb 28, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-002 Feb 28, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-002 Feb 28, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-004 Sep 29, 2014 See Plans and Pricing See Plans and Pricing
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-003 Sep 29, 2014 See Plans and Pricing See Plans and Pricing
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-003 Sep 29, 2014 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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
China 106420627 See Plans and Pricing
Hong Kong 1092808 See Plans and Pricing
Brazil PI0415531 método e formulação de aripiprazol injetável estável estéril de liberação controlada See Plans and Pricing
Ukraine 84923 КРИСТАЛЛИЧЕСКИЙ БЕЗВОДНЫЙ АРИПИПРАЗОЛ G, СПОСОБ ЕГО ПОЛУЧЕНИЯ, ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ АРИПИПРАЗОЛ G, И СПОСОБ ЕЕ ПОЛУЧЕНИЯ;КРИСТАЛІЧНИЙ БЕЗВОДНИЙ АРИПІПРАЗОЛ G, СПОСІБ ЙОГО ОДЕРЖАННЯ, ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ, ЩО МІСТИТЬ АРИПІПРАЗОЛ G, ТА СПОСІБ ЇЇ ОДЕРЖАННЯ (CRYSTAL ANHYDROUS ARYPIPRASOLE G, A METHOD FOR ITS OBTAINING, PHARMACEUTICAL COMPOSITIONS, CONTAINING ARYPIPRASOLE G, AND METHOD FOR ITS OBTAINING) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ABILIFY MAINTENA KIT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0367141 C00367141/01 Switzerland See Plans and Pricing FORMER REPRESENTATIVE: BOHEST AG, CH
1675573 2014C/029 Belgium See Plans and Pricing PRODUCT NAME: ARIPIPRAZOLE; AUTHORISATION NUMBER AND DATE: EU/1/13/882 20131119
0367141 SPC/GB04/039 United Kingdom See Plans and Pricing PRODUCT NAME: ARIPIPRAZOLE OR A SALT THEREOF; REGISTERED: UK EU/1/04/276/001 20040604; UK EU/1/04/276/002 20040604; UK EU/1/04/276/003 20040604; UK EU/1/04/276/004 20040604; UK EU/1/04/276/005 20040604; UK EU/1/04/276/006 20040604; UK EU/1/04/276/007 20040604; UK EU/1/04/276/008 20040604; UK EU/1/04/276/009 20040604; UK EU/1/04/276/010 20040604; UK EU/1/04/276/011 20040604; UK EU/1/04/276/012 20040604; UK EU/1/04/276/013 20040604; UK EU/1/04/276/014 20040604; UK EU/1/04/276/015 20040604; UK EU/1/04/276/016 20040604; UK EU/1/04/276/017 20040604; UK EU/1/04/276/018 20040604; UK EU/1/04/276/019 20040604; UK EU/1/04/276/020 20040604
1675573 300669 Netherlands See Plans and Pricing PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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