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Tolvaptan - Generic Drug Details

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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.

This ingredient has sixty-three patent family members in nineteen countries.

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

Summary for Generic Name: tolvaptan

Tradenames:1
Patents:2
Applicants:1
NDAs:1
Drug Master File Entries: see list6
Suppliers / Packaging: see list1
Formulation / Manufacturing:see details
Drug Prices:see low prices

Clinical Trials for: tolvaptan

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Otsuka America Pharm
SAMSCA
tolvaptan
TABLET;ORAL022275-001May 19, 2009RXNo8,501,730Sep 1, 2026Y
Otsuka America Pharm
SAMSCA
tolvaptan
TABLET;ORAL022275-002May 19, 2009RXYes8,501,730Sep 1, 2026Y
Otsuka America Pharm
SAMSCA
tolvaptan
TABLET;ORAL022275-002May 19, 2009RXYes5,753,677May 19, 2020
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Expired Orange Book Patents for Generic Ingredient: tolvaptan

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka America Pharm
SAMSCA
tolvaptan
TABLET;ORAL022275-001May 19, 20095,258,510<disabled>
Otsuka America Pharm
SAMSCA
tolvaptan
TABLET;ORAL022275-003May 19, 20095,258,510<disabled>
Otsuka America Pharm
SAMSCA
tolvaptan
TABLET;ORAL022275-002May 19, 20095,753,677<disabled>
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Non-Orange Book Patents for Generic Ingredient: 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
8,273,735Process for preparing benzazepine compounds or salts thereof<disabled in preview>
5,258,510 United States Patent: 5258510   ( 1<disabled in preview>
5,559,230 Benzoheterocyclic compounds<disabled in preview>
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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 Ingredient: tolvaptan

Country Document Number Estimated Expiration
Hong Kong1145835<disabled in preview>
Israel217444<disabled in preview>
China102219741<disabled in preview>
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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 Tradename: TOLVAPTAN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB09/037United Kingdom<disabled>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
C0049France<disabled>PRODUCT NAME: TOLVAPTAN, EVENTUELLEMENT SOUS FORME DE SEL; REGISTRATION NO/DATE: EU/1/09/539/001 20090803
0408Netherlands<disabled>300408, 20101018, EXPIRES: 20151017
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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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