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Details for Generic Name: tolvaptan

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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-one 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

Drug Master File Entries: see list6
Suppliers / Packaging: see list2
Formulation / Manufacturing:see details

Clinical Trials for: tolvaptan

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

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

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

Efficacy and Safety of Tolvaptan in Cirrhotic Patients With Hyponatremia
Status: Completed Condition: Liver Cirrhosis; Hyponatremia

Tolvaptan For Worsening Outpatient Heart Failure: Role of Copeptin In Identifying Responders
Status: Not yet recruiting Condition: Congestive Heart Failure

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

Effect of the Aquaretic Tolvaptan on Nitric Oxide System
Status: Recruiting Condition: Autosomal Dominant Polycystic Kidney Disease

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

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

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

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;ORAL022275-003May 19, 2009DISCNNo8,501,730<disabled>Y <disabled>
Otsuka America Pharm
TABLET;ORAL022275-001May 19, 2009RXNo8,501,730<disabled>Y <disabled>
Otsuka America Pharm
TABLET;ORAL022275-002May 19, 2009RXYes5,753,677<disabled> <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
5,258,510 United States Patent: 5258510   ( 1<disabled in preview>
8,273,735Process for preparing benzazepine compounds or salts thereof<disabled in preview>
5,985,869 Benzoheterocyclic compounds<disabled in preview>
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International Patent Family for Ingredient: tolvaptan

Country Document Number Publication Date
China101967107Dec 12, 2012
Portugal2251319Mar 05, 2012
European Patent Office2251319Nov 17, 2010
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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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