Details for New Drug Application (NDA): 204441

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NDA 204441 describes JYNARQUE, which is a drug marketed by Otsuka 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. Six suppliers are listed for this compound. Additional details are available on the tolvaptan profile page.

Summary for 204441

Tradename:	JYNARQUE
Applicant:	Otsuka
Ingredient:	tolvaptan
Patents:	2

Pharmacology for NDA: 204441

Mechanism of Action	Vasopressin V2 Receptor Antagonists

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	59148-079-28	4 BLISTER PACK in 1 CARTON (59148-079-28) / 1 KIT in 1 BLISTER PACK (59148-079-07)
JYNARQUE	tolvaptan	TABLET;ORAL	204441	NDA	Otsuka America Pharmaceutical, Inc.	59148-080	59148-080-28	4 BLISTER PACK in 1 CARTON (59148-080-28) / 1 KIT in 1 BLISTER PACK (59148-080-07)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	15MG
Approval Date:	Apr 23, 2018	TE:		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)
Patent:	⤷ Sign Up	Patent Expiration:	Apr 7, 2030	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Sep 1, 2026	Product Flag?		Substance Flag?	Y	Delist Request?

Expired US Patents for NDA 204441

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-002	Apr 23, 2018	⤷ Sign Up	⤷ Sign Up
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-005	Apr 23, 2018	⤷ Sign Up	⤷ Sign Up
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-004	Apr 23, 2018	⤷ Sign Up	⤷ Sign Up
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-001	Apr 23, 2018	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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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.