Tolvaptan

Sold as Samsca, Jynarque. Every FDA application for this active ingredient: 2 branded and 9 generic.

As of Nov 14, 2026, FDA lists 11 applications for Tolvaptan (sold as Samsca, Jynarque), first approved May 19, 2009, with 0 new uses approved and 0 published complete response letters.

First approved: May 19, 2009
Applications: 11
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $182M
First approved in the EU: Aug 2, 2009
First approved in Japan: Oct 27, 2010
Safety program: REMS

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Jynarque	Part D	$101M	-3%	722
Tolvaptan	Part D	$75.6M	+171%	2,148
Samsca	Part D	$6.1M	-31%	73

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

TOLVAPTAN 15 MG TABLET: $11.78 per unitGeneric · -68% in a year

Orphan Designations (FDA)

One designation, 1 approved for the designated use; see all orphan designations

Treatment of autosomal dominant polycystic kidney diseaseOtsuka Pharmaceutical Company, Ltd. · designated Apr 6, 2012 · approved Apr 23, 2018

Approvals in the EU (EMA)

First approved in the EU 2 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

JinarcOtsuka Pharmaceutical Netherlands B.V. · May 27, 2015
Samsca, new substanceOtsuka Pharmaceutical Netherlands B.V. · Aug 2, 2009

Approvals in Japan (PMDA)

First approved in Japan 17 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

Samtasu, new ingredientDrugs with a new active ingredient indicated for the treatment of fluid retention in heart failure patients who have not responded sufficiently to other… · Otsuka Pharmaceutical Co., Ltd. · Mar 28, 2022 · Review report
SamscaDrugs with a new indication and a new dosage for the improvement of hyponatraemia in patients with syndrome of inappropriate secretion of antidiuretic… · Otsuka Pharmaceutical Co., Ltd. · Jun 29, 2020
SamscaDrugs with a new additional indication and a new dosage, and a drug with a newly-added dosage form indicated for inhibiting the progression of autosomal… · Otsuka Pharmaceutical Co., Ltd. · Mar 24, 2014 · Review report
SamscaA drug with a new additional indication and a new dosage for the treatment of fluid retention in patients with hepatic cirrhosis who have not responded… · Otsuka Pharmaceutical Co., Ltd. · Sep 13, 2013
Samsca, new ingredientA drug with a new active ingredient indicated for the treatment of fluid retention in heart failure patients who have not responded sufficiently to other… · Otsuka Pharmaceutical Co., Ltd. · Oct 27, 2010

Safety Programs (REMS)

FDA requires these when a drug's risks need more than a label: training, enrollment or extra checks before it is prescribed or dispensed

Program	Updated
Tolvaptan for ADPKD Shared System REMSRestricted: prescribers, pharmacies or patients must be certified or enrolled	May 29, 2025

Clinical Trials

7 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Bempedoic Acid Therapy for Polycystic Kidney DiseaseADPKD (Autosomal Dominant Polycystic Kidney Disease) · Kenneth Hallows	Phase 2	Recruiting	Dec 15, 2025
Shared Decision Making for Choosing Autosomal DOminant Polycystic Kidney Disease TreatmentADPKD (autosomal Dominant Polycystic Kidney Disease) · Seoul National University Hospital	Not applicable	Recruiting	Oct 1, 2024
Samtasu Post-marketing General Drug Use-results Survey in Patients With Volume Overload in Heart Failure.Heart Failure · Otsuka Pharmaceutical Co., Ltd.	—	Active, not recruiting	Feb 3, 2023
HYDROchlorothiazide to PROTECT Polycystic Kidney Disease Patients and Improve Their Quality of LifeADPKD · University Medical Center Groningen	Phase 3	Recruiting	May 13, 2022
Samsca Post-marketing General Drug Use-results Survey in Patients With Hyponatremia in SIADHAntidiuretic Hormone, Inappropriate Secretion · Otsuka Pharmaceutical Co., Ltd.	—	Active, not recruiting	Mar 10, 2021
A Study to See if Tolvaptan is Safe in Infants and Children Who at Enrollment Are 28 Days to Less Than 18 Years Old With Autosomal Recessive Polycystic Kidney Disease (ARPKD)Autosomal Recessive Polycystic Kidney (ARPKD) · Otsuka Pharmaceutical Development & Commercialization, Inc.	Phase 3	Recruiting	Mar 4, 2021
The German ADPKD Tolvaptan Treatment RegistryADPKD (Autosomal Dominant Polycystic Kidney Disease) · University of Cologne	—	Recruiting	Jul 14, 2015

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


May 19, 2009	SamscaNDA 22275 · New molecular entity	Otsuka	11	Marketed
Apr 23, 2018	JynarqueNDA 204441 · New indication	Otsuka	9	Marketed
Feb 15, 2022	TolvaptanANDA 206119	Ph Health	0	Marketed
Sep 6, 2022	TolvaptanANDA 205646	Hetero Labs Ltd V	0	Marketed
Sep 6, 2022	TolvaptanANDA 207605	Apotex	1	Marketed
Sep 6, 2022	TolvaptanANDA 211891	Alkem Labs Ltd	1	Marketed
Jun 21, 2023	TolvaptanANDA 216949	Msn	0	Marketed
Apr 23, 2025	TolvaptanANDA 216063	Lupin	0	Marketed
Nov 10, 2025	TolvaptanANDA 218381	Apotex	0	Marketed
Apr 21, 2026	TolvaptanANDA 220147	Alkem Labs Ltd	0	Marketed
Jul 21, 2026	TolvaptanANDA 216933	Teva Pharms Inc	0	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA