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ABILIFY MAINTENA KIT Drug Profile

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Which patents cover Abilify Maintena Kit, and what substitute generic drugs are available?

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

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

The generic ingredient in ABILIFY MAINTENA KIT is aripiprazole. There are forty-three drug master file entries for this compound. Forty 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
Bulk Api Vendors: see list95
Clinical Trials: see list187
Patent Applications: see list3,053
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:ABILIFY MAINTENA KIT at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date 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;INTRAMUSCULAR202971-002Feb 28, 2013RXYesYes8,399,469► SubscribeY ► Subscribe
Otsuka Pharm Co Ltd
ABILIFY MAINTENA KIT
aripiprazole
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-002Feb 28, 2013RXYesYes8,338,427► SubscribeY ► Subscribe
Otsuka Pharm Co Ltd
ABILIFY MAINTENA KIT
aripiprazole
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-004Sep 29, 2014RXYesNo8,759,351► SubscribeY ► Subscribe
Otsuka Pharm Co Ltd
ABILIFY MAINTENA KIT
aripiprazole
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-004Sep 29, 2014RXYesNo8,399,469► SubscribeY ► Subscribe
Otsuka Pharm Co Ltd
ABILIFY MAINTENA KIT
aripiprazole
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-003Sep 29, 2014RXYesNo► Subscribe► 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;INTRAMUSCULAR202971-001Feb 28, 20135,006,528*PED► Subscribe
Otsuka Pharm Co Ltd
ABILIFY MAINTENA KIT
aripiprazole
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-002Feb 28, 20135,006,528*PED► Subscribe
Otsuka Pharm Co Ltd
ABILIFY MAINTENA KIT
aripiprazole
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-003Sep 29, 20145,006,528*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
8,703,773Low hygroscopic aripiprazole drug substance and processes for the preparation thereof► Subscribe
8,426,423Method of treating Attention Deficit Hyper-Activity Disorder► Subscribe
8,680,105Method of treating down's syndrome► Subscribe
8,952,013Controlled release sterile injectable aripiprazole formulation and method► Subscribe
8,580,796Low hygroscopic aripiprazole drug substance and processes for the preparation thereof► 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
Norway2014027► Subscribe
CroatiaP20110646► Subscribe
European Patent Office1419776► Subscribe
Hong Kong1136961► Subscribe
China104306374► 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
0669Netherlands► SubscribePRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
00669Netherlands► SubscribePRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
/2014Austria► SubscribePRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: EU/1/13/882 (MITTEILUNG) 20131119
2014 00026Denmark► SubscribePRODUCT NAME: ARIPIPRAZOL; REG. NO/DATE: EU/1/13/882/001-004 20131115
427Luxembourg► SubscribePRODUCT NAME: ARIPIPRAZOLE
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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 verifification 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.

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