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ABILIFY MAINTENA KIT Drug Profile

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Abilify Maintena Kit is a drug marketed by Otsuka Pharm Co Ltd and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug.

This drug has one hundred and ninety-seven patent family members in thirty-four countries.

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

Summary for Tradename: ABILIFY MAINTENA KIT

Patents:9
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Drug Prices: :see details
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Otsuka Pharm Co Ltd
ABILIFY MAINTENA KIT
aripiprazole
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-002Feb 28, 2013RXYes7,807,680► subscribeY ► subscribe
Otsuka Pharm Co Ltd
ABILIFY MAINTENA KIT
aripiprazole
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-002Feb 28, 2013RXYes8,030,313► subscribe ► subscribe
Otsuka Pharm Co Ltd
ABILIFY MAINTENA KIT
aripiprazole
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-004Sep 29, 2014RXNo8,338,427► subscribeY ► subscribe
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Expired Patents for Tradename: 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;INTRAMUSCULAR202971-004Sep 29, 20145,006,528*PED► subscribe
Otsuka Pharm Co Ltd
ABILIFY MAINTENA KIT
aripiprazole
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-003Sep 29, 20145,006,528*PED► subscribe
Otsuka Pharm Co Ltd
ABILIFY MAINTENA KIT
aripiprazole
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-002Feb 28, 20135,006,528*PED► subscribe
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Non-Orange Book Patents for Tradename: ABILIFY MAINTENA KIT

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,722,680Method of treating neurodegenerative diseases► subscribe
7,053,0925-HT1a receptor subtype agonist► subscribe
8,642,600Method of treating autism► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: ABILIFY MAINTENA KIT

Country Document Number Estimated Expiration
MexicoPA03000440► subscribe
Denmark1330249► subscribe
China103751118► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: ABILIFY MAINTENA KIT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014 00026Denmark► subscribePRODUCT NAME: ARIPIPRAZOL; REG. NO/DATE: EU/1/13/882/001-004 20131115
0669Netherlands► subscribePRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
C/GB04/039United Kingdom► subscribePRODUCT 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
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