➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

McKesson
Medtronic
Merck
Johnson and Johnson
Boehringer Ingelheim
AstraZeneca

Last Updated: July 7, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204441


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

NDA 204441 describes JYNARQUE, which is a drug marketed by Otsuka Pharm Co Ltd and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the JYNARQUE profile page.

The generic ingredient in JYNARQUE is tolvaptan. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the tolvaptan profile page.
Summary for 204441
Tradename:JYNARQUE
Applicant:Otsuka Pharm Co Ltd
Ingredient:tolvaptan
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 204441
Suppliers and Packaging for NDA: 204441
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
JYNARQUE tolvaptan TABLET;ORAL 204441 NDA Otsuka America Pharmaceutical, Inc. 59148-079 59148-079-07 1 BLISTER PACK in 1 CARTON (59148-079-07) > 1 KIT in 1 BLISTER PACK
JYNARQUE tolvaptan TABLET;ORAL 204441 NDA Otsuka America Pharmaceutical, Inc. 59148-079 59148-079-28 4 BLISTER PACK in 1 CARTON (59148-079-28) > 1 KIT in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG
Approval Date:Apr 23, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 23, 2025
Regulatory Exclusivity Use:INDICATED TO SLOW KIDNEY FUNCTION DECLINE IN ADULTS AT RISK OF RAPIDLY PROGRESSING AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD)
Regulatory Exclusivity Expiration:Apr 23, 2021
Regulatory Exclusivity Use:USE OF TOLVAPTAN TO SLOW KIDNEY FUNCTION DECLINE IN ADULTS AT RISK OF RAPIDLY PROGRESSING AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD)
Patent:  Start TrialPatent Expiration:May 19, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE

Expired US Patents for NDA 204441

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka Pharm Co Ltd JYNARQUE tolvaptan TABLET;ORAL 204441-003 Apr 23, 2018   Start Trial   Start Trial
Otsuka Pharm Co Ltd JYNARQUE tolvaptan TABLET;ORAL 204441-001 Apr 23, 2018   Start Trial   Start Trial
Otsuka Pharm Co Ltd JYNARQUE tolvaptan TABLET;ORAL 204441-002 Apr 23, 2018   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

AstraZeneca
McKinsey
Express Scripts
Merck
McKesson
Harvard Business School

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 data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. 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.