Competitive intelligence on 
 small-molecule drugs and 
 the 90,000 global patents 
 covering them 

Start your free trial now

Plans and Pricing

DrugPatentWatch Ultimate Plan Preview

Details for Generic Name: tolvaptan

« Back to Dashboard
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.

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: see list1
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: Recruiting Condition: Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)

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

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

Role of Midodrine and Tolvaptan in Patients With Cirrhosis With Refractory or Recurrent Ascites
Status: Recruiting Condition: Cirrhosis; Refractory/Recurrent Ascites

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

8-Week Study of Tolvaptan Dose Forms in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Status: Completed Condition: Autosomal Dominant Polycystic Kidney Disease

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;ORAL022275-001May 19, 2009RXNo8,501,730<disabled>Y<disabled>
Otsuka America Pharm
TABLET;ORAL022275-001May 19, 2009RXNo5,753,677<disabled><disabled>
Otsuka America Pharm
TABLET;ORAL022275-003May 19, 2009DISCNNo5,753,677<disabled><disabled>
Otsuka America Pharm
TABLET;ORAL022275-003May 19, 2009DISCNNo8,501,730<disabled>Y<disabled>
Otsuka America Pharm
TABLET;ORAL022275-002May 19, 2009RXYes8,501,730<disabled>Y<disabled>
This preview shows a limited data set
Subscribe for full access, or try a free trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

DrugPatentWatch Archives

You are viewing the current data set
Select a link below to view the archives:

 2000   2001   2002   2003   2004   2005   2006   2007   2008   2009   2010   2011   2012   2013   2014  

For more information try a free trial or see the plan comparison

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 information. There is no warranty that the information contained herein is error free. 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.

Copyright 2002-2015 thinkBiotech LLC
ISSN: 2162-2639

Preferred citation:

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

Connect with Social Media:

Follow DrugPatentWatch on Twitter
Connect with DrugPatentWatch on Linkedin
Drug Patents on LinkedIn