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:	10,905,694	Patent Expiration:	Apr 7, 2030	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	8,501,730	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	204441-005	Apr 23, 2018	5,753,677	⤷ Subscribe
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-003	Apr 23, 2018	5,972,882	⤷ Subscribe
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-001	Apr 23, 2018	5,753,677	⤷ Subscribe
Otsuka	JYNARQUE	tolvaptan	TABLET;ORAL	204441-004	Apr 23, 2018	5,753,677	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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