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Serving leading biopharmaceutical companies globally:

Argus Health
Colorcon
Harvard Business School
Deloitte
Julphar
AstraZeneca
Johnson and Johnson
Dow
Boehringer Ingelheim
Federal Trade Commission

Generated: November 19, 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 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 Pharm Co Ltd
ABILIFY MAINTENA KIT
aripiprazole
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-003Sep 29, 2014RXYesNo► Subscribe► Subscribe ► Subscribe
Otsuka
ABILIFY
aripiprazole
TABLET, ORALLY DISINTEGRATING;ORAL021729-005Jun 7, 2006DISCNYesNo► Subscribe► Subscribe ► Subscribe
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-001Nov 15, 2002ABRXYesYes► Subscribe► Subscribe► Subscribe
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-001Nov 15, 2002ABRXYesYes► Subscribe► Subscribe ► Subscribe
Otsuka
ABILIFY
aripiprazole
TABLET, ORALLY DISINTEGRATING;ORAL021729-002Jun 7, 2006DISCNNoNo► Subscribe► Subscribe► Subscribe
Otsuka Pharm Co Ltd
DACOGEN
decitabine
INJECTABLE;INTRAVENOUS021790-001May 2, 2006APRXYesYes► Subscribe► Subscribe► Subscribe
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-002Nov 15, 2002ABRXYesNo► Subscribe► Subscribe ► Subscribe
Otsuka Pharm Co Ltd
ABILIFY MAINTENA KIT
aripiprazole
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-002Feb 28, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-004Nov 15, 2002ABRXYesNo► Subscribe► Subscribe ► Subscribe
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-002Nov 15, 2002ABRXYesNo► Subscribe► Subscribe ► Subscribe
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Expired Patents for Otsuka

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka America Pharm
SAMSCA
tolvaptan
TABLET;ORAL022275-001May 19, 2009► Subscribe► Subscribe
Otsuka America
MERETEK UBT KIT (W/ PRANACTIN)
urea c-13
FOR SOLUTION;ORAL020586-001Sep 17, 1996► Subscribe► Subscribe
Otsuka
ABILIFY
aripiprazole
TABLET, ORALLY DISINTEGRATING;ORAL021729-003Jun 7, 2006► Subscribe► Subscribe
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-005Nov 15, 2002► Subscribe► Subscribe
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-003Nov 15, 2002► Subscribe► Subscribe
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-004Nov 15, 2002► Subscribe► Subscribe
Otsuka America
MERETEK UBT KIT (W/ PRANACTIN)
urea c-13
FOR SOLUTION;ORAL020586-001Sep 17, 1996► Subscribe► Subscribe
Otsuka America
BREATHTEK UBT FOR H-PYLORI
urea c-13
FOR SOLUTION;ORAL020586-002May 10, 2001► Subscribe► Subscribe
Otsuka Pharm Co Ltd
ABILIFY MAINTENA KIT
aripiprazole
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-004Sep 29, 2014► Subscribe► Subscribe
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-006Nov 15, 2002► 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
8,623,874Method of treating neurodegenerative diseases► Subscribe
8,901,130Low hygroscopic aripiprazole drug substance and processes for the preparation► Subscribe
8,273,735Process for preparing benzazepine compounds or salts thereof► Subscribe
5,258,510 United States Patent: 5258510   ( 1► Subscribe
8,703,773Low hygroscopic aripiprazole drug substance and processes for the preparation thereof► Subscribe
8,030,3125-HT1A receptor subtype agonist► Subscribe
9,480,686Piperazine-substituted benzothiophenes for treatment of mental disorders► Subscribe
9,006,2485-HT.sub.1A receptor subtype agonist► Subscribe
8,901,303Low hygroscopic aripiprazole drug substance and processes for the preparation thereof► Subscribe
7,910,589Low 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 Otsuka Drugs

Country Document Number Estimated Expiration
Hong Kong1187048► Subscribe
Latvia12731► Subscribe
Norway20052359► Subscribe
Argentina073111► Subscribe
Hong Kong1129891► Subscribe
Hong Kong1168792► Subscribe
Portugal1419776► Subscribe
Hong Kong1172329► Subscribe
Japan2007503460► Subscribe
Bulgaria65007► 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 Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
427Luxembourg► SubscribePRODUCT NAME: ARIPIPRAZOLE
/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
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
C0049France► SubscribePRODUCT NAME: TOLVAPTAN, EVENTUELLEMENT SOUS FORME DE SEL; REGISTRATION NO/DATE: EU/1/09/539/001 20090803
0408Netherlands► Subscribe300408, 20101018, EXPIRES: 20151017
2009 00031Denmark► Subscribe
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
80011Netherlands► SubscribePRODUCT NAME: GREPAFLOXACINUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AA NVAARDBAAR ZOUT OF IN DE VORM VAN EEN ESTER MET EEN ALKANOL MET 1-6 KOOLSTOFATOMEN, IN HET BIJZONDER GREPAFLOXACINI HYDROCHLOR IDUM SESQUIHYDRATUM; NAT. REGISTRATION NO/DATE: RVG 21894, RVG 21895 19971113; FIRST REGISTRATION: DE 40682.00.00, 40682.01.00, 40682.02.00 19970731
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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:

Mallinckrodt
Chubb
Daiichi Sankyo
Argus Health
Cipla
Harvard Business School
Express Scripts
Deloitte
Colorcon
Julphar

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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