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Serving leading biopharmaceutical companies globally:

Julphar
Fish and Richardson
AstraZeneca
UBS
McKesson
Express Scripts
US Department of Justice
Queensland Health
Healthtrust
Teva

Generated: February 21, 2018

DrugPatentWatch Database Preview

Tolvaptan - Generic Drug Details

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What are the generic drug sources for tolvaptan and what is the scope of tolvaptan freedom to operate?

Tolvaptan
is the generic ingredient in one branded drug marketed by Otsuka America Pharm and is included in one NDA. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Tolvaptan has seventy-five patent family members in nineteen countries.

There are seven drug master file entries for tolvaptan. One supplier is listed for this compound.
Pharmacology for tolvaptan

US Patents and Regulatory Information for tolvaptan

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 022275-002 May 19, 2009 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Otsuka America Pharm SAMSCA tolvaptan TABLET;ORAL 022275-002 May 19, 2009 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Otsuka America Pharm SAMSCA tolvaptan TABLET;ORAL 022275-003 May 19, 2009 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Otsuka America Pharm SAMSCA tolvaptan TABLET;ORAL 022275-001 May 19, 2009 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Otsuka America Pharm SAMSCA tolvaptan TABLET;ORAL 022275-003 May 19, 2009 DISCN Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Otsuka America Pharm SAMSCA tolvaptan TABLET;ORAL 022275-001 May 19, 2009 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
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 tolvaptan

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka America Pharm SAMSCA tolvaptan TABLET;ORAL 022275-001 May 19, 2009 ➤ Sign Up ➤ Sign Up
Otsuka America Pharm SAMSCA tolvaptan TABLET;ORAL 022275-003 May 19, 2009 ➤ Sign Up ➤ Sign Up
Otsuka America Pharm SAMSCA tolvaptan TABLET;ORAL 022275-002 May 19, 2009 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for tolvaptan

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 ➤ Sign Up
8,273,735 Process for preparing benzazepine compounds or salts thereof ➤ Sign Up
5,559,230 Benzoheterocyclic compounds ➤ Sign Up
5,985,869 Benzoheterocyclic compounds ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for tolvaptan

Country Document Number Estimated Expiration
Israel 217446 ➤ Sign Up
Denmark 2261215 ➤ Sign Up
Japan 2007091738 ➤ Sign Up
Slovenia 2251319 ➤ Sign Up
Japan 2905909 ➤ Sign Up
Japan 2014205699 ➤ Sign Up
Portugal 2261215 ➤ Sign Up
South Korea 20100133028 ➤ Sign Up
Hong Kong 1144932 ➤ Sign Up
China 101273017 ➤ Sign Up
Country Document Number Estimated Expiration

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Supplementary Protection Certificates for tolvaptan

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0049 France ➤ Sign Up PRODUCT NAME: TOLVAPTAN, EVENTUELLEMENT SOUS FORME DE SEL; REGISTRATION NO/DATE: EU/1/09/539/001 20090803
0408 Netherlands ➤ Sign Up 300408, 20101018, EXPIRES: 20151017
C/GB09/037 United Kingdom ➤ Sign Up PRODUCT 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
00408 Netherlands ➤ Sign Up PRODUCT NAME: TOLVAPTAN, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION NO/DATE: EU/1/09/539/001-004 20090803
2009 00031 Denmark ➤ Sign Up
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Medtronic
US Army
QuintilesIMS
McKesson
Chinese Patent Office
Chubb
AstraZeneca
Fuji

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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