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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Colorcon
Cipla
Mallinckrodt
Baxter
Fish and Richardson
Medtronic
Fuji
Cerilliant
Boehringer Ingelheim

Generated: November 24, 2017

DrugPatentWatch Database Preview

Otsuka America Company Profile

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

OTSUKA AMERICA has two approved drugs.

There are two US patents protecting OTSUKA AMERICA drugs.

There are sixty-four patent family members on OTSUKA AMERICA drugs in nineteen countries and five supplementary protection certificates in four countries.

Summary for Otsuka America

International Patents:64
US Patents:2
Tradenames:3
Ingredients:2
NDAs:2
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Otsuka America Pharm
SAMSCA
tolvaptan
TABLET;ORAL022275-003May 19, 2009DISCNYesNo► Subscribe► Subscribe ► Subscribe
Otsuka America Pharm
SAMSCA
tolvaptan
TABLET;ORAL022275-001May 19, 2009RXYesNo► Subscribe► Subscribe ► Subscribe
Otsuka America Pharm
SAMSCA
tolvaptan
TABLET;ORAL022275-002May 19, 2009RXYesYes► Subscribe► Subscribe ► Subscribe
Otsuka America Pharm
SAMSCA
tolvaptan
TABLET;ORAL022275-002May 19, 2009RXYesYes► Subscribe► SubscribeY ► Subscribe
Otsuka America
MERETEK UBT KIT (W/ PRANACTIN)
urea c-13
FOR SOLUTION;ORAL020586-001Sep 17, 1996DISCNNoNo► Subscribe► Subscribe► Subscribe
Otsuka America Pharm
SAMSCA
tolvaptan
TABLET;ORAL022275-003May 19, 2009DISCNYesNo► Subscribe► SubscribeY ► Subscribe
Otsuka America Pharm
SAMSCA
tolvaptan
TABLET;ORAL022275-001May 19, 2009RXYesNo► Subscribe► SubscribeY ► Subscribe
Otsuka America
BREATHTEK UBT FOR H-PYLORI
urea c-13
FOR SOLUTION;ORAL020586-002May 10, 2001DISCNNoNo► Subscribe► Subscribe► Subscribe
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Expired Patents for Otsuka America

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka America
BREATHTEK UBT FOR H-PYLORI
urea c-13
FOR SOLUTION;ORAL020586-002May 10, 2001► Subscribe► Subscribe
Otsuka America
MERETEK UBT KIT (W/ PRANACTIN)
urea c-13
FOR SOLUTION;ORAL020586-001Sep 17, 1996► Subscribe► Subscribe
Otsuka America Pharm
SAMSCA
tolvaptan
TABLET;ORAL022275-001May 19, 2009► Subscribe► Subscribe
Otsuka America Pharm
SAMSCA
tolvaptan
TABLET;ORAL022275-002May 19, 2009► Subscribe► Subscribe
Otsuka America Pharm
SAMSCA
tolvaptan
TABLET;ORAL022275-003May 19, 2009► 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
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Paragraph IV activity for OTSUKA AMERICA drugs

Drugname Dosage Strength Tradename Submissiondate
tolvaptan
Tablets15 mg and 30 mg
SAMSCA
9/23/2013

Non-Orange Book Patents for Otsuka America

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
5,258,510 United States Patent: 5258510   ( 1► Subscribe
8,273,735Process for preparing benzazepine compounds or salts thereof► Subscribe
5,985,869 Benzoheterocyclic compounds► Subscribe
5,559,230 Benzoheterocyclic compounds► 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 America Drugs

Country Document Number Estimated Expiration
Portugal1919874► Subscribe
South Korea20100133028► Subscribe
Cyprus1112496► Subscribe
European Patent Office1919874► Subscribe
Israel217445► Subscribe
South Korea101077329► Subscribe
China101273017► Subscribe
Germany122009000062► Subscribe
Germany602006019882► Subscribe
European Patent Office0450097► 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 America Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0408Netherlands► Subscribe300408, 20101018, EXPIRES: 20151017
00408Netherlands► SubscribePRODUCT NAME: TOLVAPTAN, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION NO/DATE: EU/1/09/539/001-004 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
C0049France► SubscribePRODUCT NAME: TOLVAPTAN, EVENTUELLEMENT SOUS FORME DE SEL; REGISTRATION NO/DATE: EU/1/09/539/001 20090803
2009 00031Denmark► Subscribe
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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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Serving leading biopharmaceutical companies globally:

McKesson
US Army
Cipla
Medtronic
Chinese Patent Office
Deloitte
McKinsey
Johnson and Johnson
Cerilliant
Baxter

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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