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Generated: September 24, 2017

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SAMSCA Drug Profile

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What is the patent landscape for Samsca, and what generic Samsca alternatives are available?

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

This drug has sixty-four 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
Bulk Api Vendors: see list55
Clinical Trials: see list34
Patent Applications: see list408
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:SAMSCA at DailyMed

Pharmacology for Tradename: SAMSCA

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;ORAL022275-001May 19, 2009RXYesNo► Subscribe► SubscribeY ► Subscribe
Otsuka America Pharm
SAMSCA
tolvaptan
TABLET;ORAL022275-002May 19, 2009RXYesYes► 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► SubscribeY ► Subscribe
Otsuka America Pharm
SAMSCA
tolvaptan
TABLET;ORAL022275-003May 19, 2009DISCNYesNo► Subscribe► Subscribe ► Subscribe
Otsuka America Pharm
SAMSCA
tolvaptan
TABLET;ORAL022275-003May 19, 2009DISCNYesNo► Subscribe► SubscribeY ► Subscribe
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Expired Patents for Tradename: SAMSCA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka America Pharm
SAMSCA
tolvaptan
TABLET;ORAL022275-001May 19, 2009► Subscribe► Subscribe
Otsuka America Pharm
SAMSCA
tolvaptan
TABLET;ORAL022275-003May 19, 2009► Subscribe► Subscribe
Otsuka America Pharm
SAMSCA
tolvaptan
TABLET;ORAL022275-002May 19, 2009► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges 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
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 Tradename: SAMSCA

Country Document Number Estimated Expiration
Japan2014205699► Subscribe
Cyprus1111788► Subscribe
Germany69026708► Subscribe
Israel217444► Subscribe
Hong Kong1144932► Subscribe
European Patent Office1919874► Subscribe
Israel189481► Subscribe
China102746229► Subscribe
Germany122009000062► Subscribe
Spain2379153► 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 Tradename: SAMSCA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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
2009 00031Denmark► Subscribe
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Cerilliant
Chinese Patent Office
US Department of Justice
Medtronic
Argus Health
McKinsey
Citi
Fuji
Accenture
Julphar

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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