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Profile for Tradename: SAMSCA

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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 fifty-six patent family members in eighteen 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: see list1

Clinical Trials for: SAMSCA

Post-Authorisation Safety Study of Samsca (Tolvaptan) Used in Routine Medical Practice
Status: Active, not recruiting Condition: SIADH; Non-SIADH Hyponatremia; Non-Hyponatremia

Effects of Tolvaptan in Healthy Adults
Status: Recruiting Condition: Healthy

A PK Study of 3 Dosages of Tolvaptan in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)
Status: Recruiting Condition: Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)

Effects of Tolvaptan vs Fluid Restriction in Hospitalized Subjects With Dilutional Hyponatremia
Status: Terminated Condition: Hyponatremia; Dilutional Hyponatremia; Inappropriate ADH Syndrome

Effect of the Aquaretic Tolvaptan on Nitric Oxide System. A Dose-response Study (DOVA)
Status: Active, not recruiting Condition: Nephropathy

Phase III Study of Tolvaptan Tablet to Treat Cirrhosis Ascites
Status: Completed Condition: Ascites; Hepatic Cirrhosis

Study of the Safety and Effectiveness of SAMSCA® (Tolvaptan) in Children and Adolescents With Euvolemic or Hypervolemic Hyponatremia
Status: Recruiting Condition: Hyponatremia

A Trial of Tolvaptan in Children and Adolescent Subjects With Euvolemic and Hypervolemic Hyponatremia
Status: Not yet recruiting Condition: Euvolemic Hyponatremia; Hypervolemic Hyponatremia

Tolvaptan for Ascites in Cirrhotic Patients
Status: Completed Condition: Ascites; Cirrhosis

Bioavailability Study Comparing Tolvaptan Administered Via Nasogastric Tube to Tolvaptan Tablets Swallowed Intact
Status: Completed Condition: Healthy

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
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>
Otsuka America Pharm
SAMSCA
tolvaptan
TABLET;ORAL022275-002May 19, 2009RXYes5,753,677<disabled><disabled>
Otsuka America Pharm
SAMSCA
tolvaptan
TABLET;ORAL022275-003May 19, 2009DISCNNo8,501,730<disabled>Y<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
5,985,869 Benzoheterocyclic compounds<disabled in preview>
5,258,510 United States Patent: 5258510   ( 1<disabled in preview>
8,273,735Process for preparing benzazepine compounds or salts thereof<disabled in preview>
5,559,230 Benzoheterocyclic compounds<disabled in preview>
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International Patent Family for Tradename: SAMSCA

Country Document Number Publication Date
Portugal1919874Mar 14, 2011
Denmark2261215Feb 02, 2015
Hong Kong1124318Dec 02, 2011
Germany602006019882Mar 10, 2011
South Korea20110029184Mar 22, 2011
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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