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JYNARQUE

tolvaptan · Tablet

Prescription NDA TE AB2 RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
JYNARQUE
Generic name
tolvaptan
Dosage form
Tablet
Route
Oral
Marketing category
NDA · NDA
Labeler
Otsuka America Pharmaceutical, Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
2
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Tolvaptan 15 mg/1 2044355 View
Tolvaptan 30 mg/1 2044355 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet
Route of administration
Oral
Presentations
4

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Vasopressin V2 Receptor Antagonist [EPC] EPC 3 members — no class page
Vasopressin V2 Receptor Antagonists [MoA] MoA 3 members — no class page

Regulatory status

Source: Drugs@FDANDC Directory
Application number
204441
Application type
NDA · New Drug Application
Approval date
April 23, 2018
Sponsor
OTSUKA
Products on application
5
Submissions recorded
10
Products approved under application 204441.
Product Trade name Form Strength Ingredient Status TE Flags
204441-001 JYNARQUE TABLET TOLVAPTAN Prescription AB2 RLD
204441-002 JYNARQUE TABLET TOLVAPTAN Prescription AB2 RLD
204441-003 JYNARQUE TABLET TOLVAPTAN Prescription AB2 RLD RS
204441-004 JYNARQUE TABLET TOLVAPTAN Prescription AB2 RLD
204441-005 JYNARQUE TABLET TOLVAPTAN Prescription AB2 RLD

Therapeutic equivalence

Source: Orange Book
TE code
AB2
Reference Listed Drug
Yes
Reference Standard
Yes

What this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
8501730 September 1, 2026 001 Yes May 21, 2018
8501730 September 1, 2026 002 Yes May 21, 2018
8501730 September 1, 2026 003 Yes May 21, 2018
8501730 September 1, 2026 004 Yes May 21, 2018
8501730 September 1, 2026 005 Yes May 21, 2018
10905694 April 7, 2030 001 No February 26, 2021
10905694 April 7, 2030 002 No February 26, 2021
10905694 April 7, 2030 003 No February 26, 2021
10905694 April 7, 2030 004 No February 26, 2021
10905694 April 7, 2030 005 No February 26, 2021

Approval history

Source: Drugs@FDA
Most recent submissions on application 204441.
Type No. Action Status Date Review
Supplement 16 Labeling Approved September 15, 2026 Standard
Supplement 14 REMS Approved April 23, 2025 N/A
Supplement 12 Manufacturing (CMC) Approved December 16, 2024 N/A
Supplement 10 REMS Approved September 29, 2023 N/A
Supplement 9 REMS Approved November 25, 2020 N/A
Supplement 8 Labeling Approved October 19, 2020 Standard
Supplement 7 REMS Approved December 3, 2019 N/A
Supplement 2 REMS Approved December 1, 2018 N/A
Supplement 1 REMS Approved July 30, 2018 N/A
Original application 1 Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated Approved April 23, 2018 Priority

Review documents

  • 0 · Supplement · September 22, 2026
  • 0 · Supplement · September 16, 2026
  • 0 · Supplement · September 16, 2026
  • 0 · Supplement · May 1, 2025
  • 0 · Supplement · March 26, 2025
  • 0 · Original application · November 6, 2023
  • 0 · Supplement · October 3, 2023
  • 0 · Supplement · December 7, 2020
  • 0 · Supplement · November 27, 2020
  • 0 · Supplement · October 21, 2020
  • 0 · Supplement · December 4, 2019
  • 0 · Supplement · December 7, 2018
  • 0 · Supplement · December 4, 2018
  • 0 · Original application · September 5, 2018
  • 0 · Supplement · August 3, 2018
  • 0 · Original application · June 8, 2018
  • 0 · Original application · April 24, 2018

Adverse event reports

Source: openFDA FAERS
14,448
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: TOLVAPTAN. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
59148-082-13 59148-082 Otsuka America Pharmaceutical, Inc. 1 BOTTLE in 1 CARTON (59148-082-13) / 30 TABLET in 1 BOTTLE April 23, 2018
59148-083-13 59148-083 Otsuka America Pharmaceutical, Inc. 1 BOTTLE in 1 CARTON (59148-083-13) / 30 TABLET in 1 BOTTLE April 23, 2018
59148-082 59148-082 Otsuka America Pharmaceutical, Inc. — April 23, 2018
59148-083 59148-083 Otsuka America Pharmaceutical, Inc. — April 23, 2018

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 12 sections on this page.