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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 three patents protecting this drug and one Paragraph IV challenge.

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

Suppliers: see list1

Clinical Trials for: SAMSCA

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)

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

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

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

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

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

Tolvaptan in Hyponatremic Cancer Patients
Status: Completed Condition: Advanced Cancers

Courtesy of
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
TABLET;ORAL022275May 19, 2009RXYes5,753,677<disabled><disabled>
Otsuka America Pharm
TABLET;ORAL022275May 19, 2009RXNo5,753,677<disabled><disabled>
Otsuka America Pharm
TABLET;ORAL022275May 19, 2009DISCNNo5,753,677<disabled><disabled>
Otsuka America Pharm
TABLET;ORAL022275May 19, 2009DISCNNo8,501,730<disabled>Y<disabled>
Otsuka America Pharm
TABLET;ORAL022275May 19, 2009RXYes<disabled><disabled>
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Paragraph IV activity for: SAMSCA

Drugname Dosage Strength RLD Submissiondate
tolvaptanTablets15 mg and 30 mgSamsca9/23/2013
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Preferred citation:
Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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