Orange Book product · Brand (NDA)

NOCTIVA

DESMOPRESSIN ACETATE

Brand (NDA)NDA 201656DISCN ACERUS PHARMS

Mar 03, 2017

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Mar 03, 2017
9 yr 5 mo ago
Today
Patent 11419914 expires
Listed method-of-use patent (U-3431) expiration.
Jun 15, 2030
in 4 yr 1 mo
Patent 12090190 expires
Listed drug product patent expiration.
Jun 15, 2030
in 4 yr 1 mo
Patent 9539302 expires
Listed drug product patent expiration.
Jun 15, 2030
in 4 yr 1 mo

Active ingredient

DESMOPRESSIN ACETATE

Strength

0.00083MG/SPRAY

Dosage form

SPRAY, METERED

Route

NASAL

TE code

Not listed

Application

NDA 201656

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
11419914	Jun 15, 2030	in 4 yr 1 mo	U-3431
12090190	Jun 15, 2030	in 4 yr 1 mo	ProductU-4003
9539302	Jun 15, 2030	in 4 yr 1 mo	Product