Details for New Drug Application (NDA): 022517

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NDA 022517 describes NOCDURNA, which is a drug marketed by Ferring Pharms Inc and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the NOCDURNA profile page.

The generic ingredient in NOCDURNA is desmopressin acetate. There are twenty drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the desmopressin acetate profile page.

Summary for 022517

Tradename:	NOCDURNA
Applicant:	Ferring Pharms Inc
Ingredient:	desmopressin acetate
Patents:	5

Pharmacology for NDA: 022517

Physiological Effect	Increased Coagulation Factor VIII Activity Increased Coagulation Factor VIII Concentration

Suppliers and Packaging for NDA: 022517

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NOCDURNA	desmopressin acetate	TABLET;SUBLINGUAL	022517	NDA	Antares Pharma, Inc.	54436-325	54436-325-30	3 BLISTER PACK in 1 CARTON (54436-325-30) / 10 TABLET in 1 BLISTER PACK (54436-325-10)
NOCDURNA	desmopressin acetate	TABLET;SUBLINGUAL	022517	NDA	Antares Pharma, Inc.	54436-350	54436-350-30	3 BLISTER PACK in 1 CARTON (54436-350-30) / 10 TABLET in 1 BLISTER PACK (54436-350-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;SUBLINGUAL			Strength	0.0277MG
Approval Date:	Jun 21, 2018	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	May 21, 2029	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF NOCTURIA DUE TO NOCTURNAL POLYURIA IN ADULTS, COMPRISING MONITORING A PATIENT'S SERUM SODIUM CONCENTRATION
Patent:	⤷ Sign Up	Patent Expiration:	May 21, 2029	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF NOCTURIA DUE TO NOCTURNAL POLYURIA IN ADULTS, COMPRISING MONITORING A PATIENT'S SERUM SODIUM CONCENTRATION
Patent:	⤷ Sign Up	Patent Expiration:	Feb 2, 2024	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF NOCTURIA DUE TO NOCTURNAL POLYURIA IN ADULTS

Expired US Patents for NDA 022517

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ferring Pharms Inc	NOCDURNA	desmopressin acetate	TABLET;SUBLINGUAL	022517-001	Jun 21, 2018	⤷ Sign Up	⤷ Sign Up
Ferring Pharms Inc	NOCDURNA	desmopressin acetate	TABLET;SUBLINGUAL	022517-002	Jun 21, 2018	⤷ Sign Up	⤷ Sign Up
Ferring Pharms Inc	NOCDURNA	desmopressin acetate	TABLET;SUBLINGUAL	022517-001	Jun 21, 2018	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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