Orange Book product · Brand (NDA)

NOCDURNA

DESMOPRESSIN ACETATE

Brand (NDA)NDA 022517DISCN FERRING PHARMS INC

Jun 21, 2018

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jun 21, 2018
8 yr 1 mo ago
Today
Patent 11020448 expires
Listed method-of-use patent (U-2327) expiration.
May 21, 2029
in 3 yr
Patent 11963995 expires
Listed method-of-use patent (U-2327) expiration.
May 21, 2029
in 3 yr
Patent 9974826 expires
Listed method-of-use patent (U-2326) expiration.
Apr 13, 2030
in 3 yr 10 mo

Active ingredient

DESMOPRESSIN ACETATE

Strength

0.0277MG

Dosage form

TABLET

Route

SUBLINGUAL

TE code

Not listed

Application

NDA 022517

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
11020448	May 21, 2029	in 3 yr	U-2327
11963995	May 21, 2029	in 3 yr	U-2327
9974826	Apr 13, 2030	in 3 yr 10 mo	U-2326