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Serving leading biopharmaceutical companies globally:

Julphar
QuintilesIMS
Express Scripts
Fish and Richardson
Deloitte
McKinsey
Citi
Johnson and Johnson
Medtronic
Accenture

Generated: October 18, 2017

DrugPatentWatch Database Preview

Otsuka Company Profile

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What is the competitive landscape for OTSUKA, and when can generic versions of OTSUKA drugs launch?

OTSUKA has thirteen approved drugs.

There are twenty-eight US patents protecting OTSUKA drugs.

There are five hundred and forty-five patent family members on OTSUKA drugs in fifty-two countries and seventeen supplementary protection certificates in ten countries.

Summary for Applicant: Otsuka

International Patents:545
US Patents:28
Tradenames:11
Ingredients:9
NDAs:13
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-003Nov 15, 2002ABRXYesNo► Subscribe► Subscribe► Subscribe
Otsuka Pharm Co Ltd
REXULTI
brexpiprazole
TABLET;ORAL205422-002Jul 10, 2015RXYesNo► Subscribe► Subscribe► Subscribe
Otsuka
ABILIFY
aripiprazole
TABLET, ORALLY DISINTEGRATING;ORAL021729-005Jun 7, 2006DISCNYesNo► Subscribe► SubscribeY► Subscribe
Otsuka Pharm Co Ltd
ABILIFY MAINTENA KIT
aripiprazole
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-001Feb 28, 2013RXYesNo► Subscribe► SubscribeY ► Subscribe
Otsuka America
BREATHTEK UBT FOR H-PYLORI
urea c-13
FOR SOLUTION;ORAL020586-002May 10, 2001DISCNNoNo► Subscribe► Subscribe► Subscribe
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-004Nov 15, 2002ABRXYesNo► Subscribe► Subscribe ► Subscribe
Otsuka Pharm Co Ltd
REXULTI
brexpiprazole
TABLET;ORAL205422-003Jul 10, 2015RXYesNo► Subscribe► Subscribe► Subscribe
Otsuka
ABILIFY
aripiprazole
TABLET, ORALLY DISINTEGRATING;ORAL021729-003Jun 7, 2006DISCNNoNo► Subscribe► Subscribe► Subscribe
Otsuka Pharm Co Ltd
REXULTI
brexpiprazole
TABLET;ORAL205422-004Jul 10, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
Otsuka Pharm Co Ltd
ABILIFY MAINTENA KIT
aripiprazole
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-003Sep 29, 2014RXYesNo► Subscribe► Subscribe► Subscribe
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Expired Patents for Otsuka

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-001Nov 15, 2002► Subscribe► Subscribe
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-002Nov 15, 2002► Subscribe► Subscribe
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-003Nov 15, 2002► Subscribe► Subscribe
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-003Nov 15, 2002► Subscribe► Subscribe
Otsuka Pharm
BUSULFEX
busulfan
INJECTABLE;INJECTION020954-001Feb 4, 1999► Subscribe► Subscribe
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-004Nov 15, 2002► Subscribe► Subscribe
Otsuka
ABILIFY
aripiprazole
SOLUTION;ORAL021713-001Dec 10, 2004► Subscribe► Subscribe
Otsuka
RAXAR
grepafloxacin hydrochloride
TABLET;ORAL020695-001Nov 6, 1997► Subscribe► Subscribe
Otsuka
ABILIFY
aripiprazole
TABLET, ORALLY DISINTEGRATING;ORAL021729-005Jun 7, 2006► Subscribe► Subscribe
Otsuka Pharm Co Ltd
ABILIFY MAINTENA KIT
aripiprazole
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-002Feb 28, 2013► Subscribe► Subscribe
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Paragraph IV activity for OTSUKA drugs

Drugname Dosage Strength Tradename Submissiondate
tolvaptan
Tablets15 mg and 30 mg
SAMSCA
9/23/2013
busulfan
Injection6 mg/mL
BUSULFEX
12/26/2012
aripiprazole
Oral Solution1 mg/mL
ABILIFY
12/20/2007
aripiprazole
Tablets2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg
ABILIFY
11/15/2006
aripiprazole
Orally Disintegrating Tablets10 mg, 15 mg, 20 mg and 30 mg
ABILIFY
11/15/2006

Non-Orange Book Patents for Otsuka

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
9,694,009Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders► Subscribe
8,426,423Method of treating Attention Deficit Hyper-Activity Disorder► Subscribe
9,480,686Piperazine-substituted benzothiophenes for treatment of mental disorders► Subscribe
8,952,013Controlled release sterile injectable aripiprazole formulation and method► Subscribe
7,910,589Low hygroscopic aripiprazole drug substance and processes for the preparation thereof► Subscribe
5,258,510 United States Patent: 5258510   ( 1► Subscribe
8,680,105Method of treating down's syndrome► Subscribe
8,901,303Low hygroscopic aripiprazole drug substance and processes for the preparation thereof► Subscribe
8,703,772Low hygroscopic aripiprazole drug substance and processes for the preparation thereof► Subscribe
9,206,167Piperazine-substituted benzothiophenes for treatment of mental disorders► 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 Drugs

Country Document Number Estimated Expiration
Russian Federation2342931► Subscribe
Norway20062319► Subscribe
Ukraine84924► Subscribe
Australia2002334413► Subscribe
Israel158202► Subscribe
European Patent Office1869025► Subscribe
Ukraine63993► Subscribe
Lithuania4896► Subscribe
Slovenia1919874► Subscribe
China1845721► 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.

Export unavailable in trial.
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Supplementary Protection Certificates for Otsuka Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0049France► SubscribePRODUCT NAME: TOLVAPTAN, EVENTUELLEMENT SOUS FORME DE SEL; REGISTRATION NO/DATE: EU/1/09/539/001 20090803
C/GB09/037United Kingdom► SubscribePRODUCT NAME: TOLVAPTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/09/539/001 20090803; UK EU/1/09/539/002 20090803; UK EU/1/09/539/003 20090803; UK EU/1/09/539/004 20090803
0669Netherlands► SubscribePRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
9 5013-2014Slovakia► SubscribePRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: EU/1/13/882/001 - EU/1/13/882/004 20131119
2014 00026Denmark► SubscribePRODUCT NAME: ARIPIPRAZOL; REG. NO/DATE: EU/1/13/882/001-004 20131115
1675573/01Switzerland► SubscribePRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: SWISSMEDIC 63177 28.04.2014
C/GB98/016United Kingdom► SubscribePRODUCT NAME: GREPAFLOXACIN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT INCLUDING GREPAFLOXACIN HYDROCHLORIDE SESQUIHYDRATE; REGISTERED: DE 40682.00.00 19970731; DE 40682.01.00 19970731; DE 40682.02.00 19970731; UK 10949/0299 19971209; UK 10949/0300 19971209
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
2009 00031Denmark► Subscribe
00669Netherlands► SubscribePRODUCT NAME: ARIPIPRAZOLE; 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:

Novartis
Teva
Healthtrust
Accenture
Cantor Fitzgerald
Johnson and Johnson
Baxter
Queensland Health
Argus Health
Merck

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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