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Serving leading biopharmaceutical companies globally:

Fuji
Covington
Argus Health
Chubb
McKesson
Mallinckrodt
Deloitte
Colorcon
Healthtrust
Cerilliant

Generated: October 21, 2017

DrugPatentWatch Database Preview

Otsuka Pharm Company Profile

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What is the competitive landscape for OTSUKA PHARM, and what generic alternatives to OTSUKA PHARM drugs are available?

OTSUKA PHARM has four approved drugs.

There are twelve US patents protecting OTSUKA PHARM drugs.

There are two hundred and thirty-seven patent family members on OTSUKA PHARM drugs in thirty-seven countries and nine supplementary protection certificates in eight countries.

Summary for Applicant: Otsuka Pharm

International Patents:237
US Patents:12
Tradenames:4
Ingredients:4
NDAs:4
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;INTRAMUSCULAR202971-004Sep 29, 2014RXYesNo► Subscribe► SubscribeY ► Subscribe
Otsuka Pharm Co Ltd
ABILIFY MAINTENA KIT
aripiprazole
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-004Sep 29, 2014RXYesNo► Subscribe► SubscribeY ► Subscribe
Otsuka Pharm Co Ltd
DACOGEN
decitabine
INJECTABLE;INTRAVENOUS021790-001May 2, 2006APRXYesYes► Subscribe► Subscribe► Subscribe
Otsuka Pharm Co Ltd
ABILIFY MAINTENA KIT
aripiprazole
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-004Sep 29, 2014RXYesNo► Subscribe► SubscribeY ► Subscribe
Otsuka Pharm Co Ltd
REXULTI
brexpiprazole
TABLET;ORAL205422-001Jul 10, 2015RXYesNo► Subscribe► SubscribeY ► Subscribe
Otsuka Pharm Co Ltd
ABILIFY MAINTENA KIT
aripiprazole
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-001Feb 28, 2013RXYesNo► Subscribe► Subscribe► Subscribe
Otsuka Pharm Co Ltd
REXULTI
brexpiprazole
TABLET;ORAL205422-001Jul 10, 2015RXYesNo► Subscribe► Subscribe ► Subscribe
Otsuka Pharm Co Ltd
ABILIFY MAINTENA KIT
aripiprazole
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-002Feb 28, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
Otsuka Pharm Co Ltd
ABILIFY MAINTENA KIT
aripiprazole
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-003Sep 29, 2014RXYesNo► Subscribe► Subscribe► Subscribe
Otsuka Pharm Co Ltd
REXULTI
brexpiprazole
TABLET;ORAL205422-005Jul 10, 2015RXYesNo► Subscribe► Subscribe► Subscribe
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Expired Patents for Otsuka Pharm

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka Pharm
BUSULFEX
busulfan
INJECTABLE;INJECTION020954-001Feb 4, 1999► Subscribe► Subscribe
Otsuka Pharm Co Ltd
ABILIFY MAINTENA KIT
aripiprazole
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-003Sep 29, 2014► Subscribe► Subscribe
Otsuka Pharm Co Ltd
ABILIFY MAINTENA KIT
aripiprazole
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-001Feb 28, 2013► Subscribe► Subscribe
Otsuka Pharm Co Ltd
ABILIFY MAINTENA KIT
aripiprazole
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-002Feb 28, 2013► Subscribe► Subscribe
Otsuka Pharm
BUSULFEX
busulfan
INJECTABLE;INJECTION020954-001Feb 4, 1999► Subscribe► Subscribe
Otsuka Pharm Co Ltd
ABILIFY MAINTENA KIT
aripiprazole
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-004Sep 29, 2014► Subscribe► Subscribe
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Paragraph IV activity for OTSUKA PHARM drugs

Drugname Dosage Strength Tradename Submissiondate
busulfan
Injection6 mg/mL
BUSULFEX
12/26/2012

Non-Orange Book Patents for Otsuka Pharm

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
8,426,423Method of treating Attention Deficit Hyper-Activity Disorder► Subscribe
8,901,303Low hygroscopic aripiprazole drug substance and processes for the preparation thereof► Subscribe
8,703,773Low hygroscopic aripiprazole drug substance and processes for the preparation thereof► Subscribe
8,952,013Controlled release sterile injectable aripiprazole formulation and method► Subscribe
9,387,2075-HT1A receptor subtype agonist► Subscribe
7,910,589Low hygroscopic aripiprazole drug substance and processes for the preparation thereof► Subscribe
8,901,130Low hygroscopic aripiprazole drug substance and processes for the preparation► Subscribe
8,680,105Method of treating down's syndrome► Subscribe
8,017,615Low hygroscopic aripiprazole drug substance and processes for the preparation thereof► Subscribe
7,053,0925-HT1a receptor subtype agonist► 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 Otsuka Pharm Drugs

Country Document Number Estimated Expiration
Japan3750023► Subscribe
Ukraine84923► Subscribe
EcuadorSP034434► Subscribe
Canada2688915► Subscribe
China103191118► Subscribe
Poland393607► Subscribe
South Korea20080002817► Subscribe
Canada2689052► Subscribe
Malaysia142746► Subscribe
Cyprus1110244► 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 Otsuka Pharm Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
427Luxembourg► SubscribePRODUCT NAME: ARIPIPRAZOLE
00669Netherlands► SubscribePRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
1675573/01Switzerland► SubscribePRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: SWISSMEDIC 63177 28.04.2014
0669Netherlands► SubscribePRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
2014 00026Denmark► SubscribePRODUCT NAME: ARIPIPRAZOL; REG. NO/DATE: EU/1/13/882/001-004 20131115
9 5013-2014Slovakia► SubscribePRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: EU/1/13/882/001 - EU/1/13/882/004 20131119
/2014Austria► SubscribePRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: EU/1/13/882 (MITTEILUNG) 20131119
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
2014020Lithuania► SubscribePRODUCT NAME: ARIPIPRAZOLUM; REGISTRATION NO/DATE: EU/1/13/882 20131115
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Similar Applicant Names

Individual applicants are sometimes listed under multiple names.
Here is a list of applicants with similar names.

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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Medtronic
Fish and Richardson
Daiichi Sankyo
US Department of Justice
McKinsey
UBS
Merck
Chubb
Farmers Insurance

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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