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Last Updated: January 28, 2021

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ABILIFY MAINTENA KIT Drug 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 ten patents protecting this drug.

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-one suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.

US ANDA 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

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Recent Clinical Trials for ABILIFY MAINTENA KIT

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

See all ABILIFY MAINTENA KIT clinical trials

US Patents and Regulatory Information for ABILIFY MAINTENA KIT

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 202971-002 Feb 28, 2013 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-003 Sep 29, 2014 RX Yes No   Start Trial   Start Trial Y   Start Trial
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-002 Feb 28, 2013 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-004 Sep 29, 2014 RX Yes No   Start Trial   Start Trial Y   Start 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   Start Trial   Start Trial
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-001 Feb 28, 2013   Start Trial   Start Trial
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-003 Sep 29, 2014   Start Trial   Start Trial
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-004 Sep 29, 2014   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ABILIFY MAINTENA KIT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0367141 300161 Netherlands   Start Trial 300161, 20091027, EXPIRES: 20141026
1675573 92427 Luxembourg   Start Trial PRODUCT NAME: ARIPIPRAZOLE
1675573 122014000057 Germany   Start Trial PRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: EU/1/13/882 20131115
0367141 SPC/GB04/039 United Kingdom   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Medtronic
Express Scripts
Moodys
Boehringer Ingelheim
Merck

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