Details for New Drug Application (NDA): 201656

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NDA 201656 describes NOCTIVA, which is a drug marketed by Acerus Pharms and is included in one NDA. There are three patents protecting this drug. Additional details are available on the NOCTIVA profile page.

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

Summary for 201656

Tradename:	NOCTIVA
Applicant:	Acerus Pharms
Ingredient:	desmopressin acetate
Patents:	3

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SPRAY, METERED;NASAL			Strength	0.00083MG/SPRAY
Approval Date:	Mar 3, 2017	TE:		RLD:	Yes
Patent:	11,419,914	Patent Expiration:	Jun 15, 2030	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF NOCTURIA DUE TO NOCTURNAL POLYURIA IN ADULTS WHO AWAKEN AT LEAST 2 TIMES PER NIGHT TO VOID BY INDUCING AN ANTIDIURETIC EFFECT BY INTRANASALLY ADMINISTERING A PLUME OF DROPLETS COMPRISING A DOSE OF ABOUT 0.05-5 MCG DESMOPRESSIN
Patent:	12,090,190	Patent Expiration:	Jun 15, 2030	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF NOCTURIA DUE TO NOCTURNAL POLYURIA IN ADULTS WHO AWAKEN AT LEAST 2 TIMES PER NIGHT TO VOID BY INTRANASALLY ADMINISTERING A PLUME OF DROPLETS COMPRISING A DOSE OF 0.75 MCG OR 1.5 MCG DESMOPRESSIN
Patent:	9,539,302	Patent Expiration:	Jun 15, 2030	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 201656

Show entries

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

Acerus Pharms	NOCTIVA	desmopressin acetate	SPRAY, METERED;NASAL	201656-001	Mar 3, 2017	7,799,761	⤷ Try for Free
Acerus Pharms	NOCTIVA	desmopressin acetate	SPRAY, METERED;NASAL	201656-002	Mar 3, 2017	7,579,321	⤷ Try for Free
Acerus Pharms	NOCTIVA	desmopressin acetate	SPRAY, METERED;NASAL	201656-001	Mar 3, 2017	7,405,203	⤷ Try for Free
Acerus Pharms	NOCTIVA	desmopressin acetate	SPRAY, METERED;NASAL	201656-002	Mar 3, 2017	7,799,761	⤷ Try for Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Showing 1 to 4 of 4 entries

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