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SAMSCA Drug Profile

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Samsca is a drug marketed by Otsuka America Pharm and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in SAMSCA is tolvaptan. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the tolvaptan profile page.

Summary for Tradename: SAMSCA

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list1

Clinical Trials for: SAMSCA

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, 2009RXNo5,753,677<disabled> <disabled>
Otsuka America Pharm
SAMSCA
tolvaptan
TABLET;ORAL022275-002May 19, 2009RXYes8,501,730<disabled>Y <disabled>
Otsuka America Pharm
SAMSCA
tolvaptan
TABLET;ORAL022275-001May 19, 2009RXNo8,501,730<disabled>Y <disabled>
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Expired Patents for Tradename: SAMSCA

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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;ORAL022275-002May 19, 20095,753,677<disabled>
Otsuka America Pharm
SAMSCA
tolvaptan
TABLET;ORAL022275-001May 19, 20095,753,677<disabled>
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Paragraph IV activity for: SAMSCA

Drugname Dosage Strength RLD Submissiondate
tolvaptanTablets15 mg and 30 mgSamsca9/23/2013

Non-Orange Book Patents for Tradename: SAMSCA

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>
5,985,869 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 Tradename: SAMSCA

Country Document Number Estimated Expiration
Germany69026708<disabled in preview>
China102219741<disabled in preview>
Japan2905909<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: SAMSCA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0049France<disabled>PRODUCT NAME: TOLVAPTAN, EVENTUELLEMENT SOUS FORME DE SEL; REGISTRATION NO/DATE: EU/1/09/539/001 20090803
00408Netherlands<disabled>PRODUCT NAME: TOLVAPTAN, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION NO/DATE: EU/1/09/539/001-004 20090803
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
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