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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Cerilliant
AstraZeneca
Cantor Fitzgerald
Healthtrust
Johnson and Johnson
Colorcon
Covington
Teva

Generated: July 20, 2018

DrugPatentWatch Database Preview

Otsuka America Company Profile

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Summary for Otsuka America
International Patents:64
US Patents:2
Tradenames:3
Ingredients:2
NDAs:2

Drugs and US Patents for Otsuka America

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;ORAL 022275-001 May 19, 2009 RX Yes No 8,501,730 ➤ Try a Free Trial Y ➤ Try a Free Trial
Otsuka America Pharm SAMSCA tolvaptan TABLET;ORAL 022275-002 May 19, 2009 RX Yes Yes 8,501,730 ➤ Try a Free Trial Y ➤ Try a Free Trial
Otsuka America Pharm SAMSCA tolvaptan TABLET;ORAL 022275-003 May 19, 2009 DISCN Yes No 5,753,677 ➤ Try a Free Trial ➤ Try a Free Trial
Otsuka America BREATHTEK UBT FOR H-PYLORI urea c-13 FOR SOLUTION;ORAL 020586-002 May 10, 2001 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for Otsuka America

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka America Pharm SAMSCA tolvaptan TABLET;ORAL 022275-001 May 19, 2009 5,258,510 ➤ Try a Free Trial
Otsuka America BREATHTEK UBT FOR H-PYLORI urea c-13 FOR SOLUTION;ORAL 020586-002 May 10, 2001 4,830,010 ➤ Try a Free Trial
Otsuka America Pharm SAMSCA tolvaptan TABLET;ORAL 022275-002 May 19, 2009 5,258,510 ➤ Try a Free Trial
Otsuka America MERETEK UBT KIT (W/ PRANACTIN) urea c-13 FOR SOLUTION;ORAL 020586-001 Sep 17, 1996 4,830,010 ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for OTSUKA AMERICA drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Tablets 15 mg and 30 mg ➤ Subscribe 2013-09-23
➤ Subscribe Tablets 60 mg ➤ Subscribe 2018-03-26

Non-Orange Book US 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 ➤ Try a Free Trial
5,985,869 Benzoheterocyclic compounds ➤ Try a Free Trial
8,273,735 Process for preparing benzazepine compounds or salts thereof ➤ Try a Free Trial
5,559,230 Benzoheterocyclic compounds ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for Otsuka America Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0049 France ➤ Try a Free Trial PRODUCT NAME: TOLVAPTAN, EVENTUELLEMENT SOUS FORME DE SEL; REGISTRATION NO/DATE: EU/1/09/539/001 20090803
2009 00031 Denmark ➤ Try a Free Trial
00408 Netherlands ➤ Try a Free Trial PRODUCT NAME: TOLVAPTAN, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION NO/DATE: EU/1/09/539/001-004 20090803
0408 Netherlands ➤ Try a Free Trial 300408, 20101018, EXPIRES: 20151017
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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

Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Johnson and Johnson
Healthtrust
US Department of Justice
Medtronic
Cerilliant
Colorcon
Express Scripts
Daiichi Sankyo

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.