Orange Book product · Brand (NDA)

FINACEA

AZELAIC ACID

Brand (NDA)NDA 207071RX LEO PHARMA AS

Jul 29, 2015

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jul 29, 2015
11 yr 1 mo ago
Today
Patent 7700076 expires
Listed drug product patent expiration.
Sep 18, 2027
in 1 yr 3 mo
Patent 10117812 expires
Listed drug product patent expiration.
Oct 18, 2027
in 1 yr 4 mo
Patent 9265725 expires
Listed drug product patent expiration.
Dec 08, 2027
in 1 yr 6 mo
Patent 9211259 expires
Listed method-of-use patent (U-1796) expiration.
Feb 28, 2029
in 2 yr 9 mo

Active ingredient

AZELAIC ACID

Strength

15%

Dosage form

AEROSOL, FOAM

Route

TOPICAL

TE code

Not listed

Application

NDA 207071

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

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
7700076	Sep 18, 2027	in 1 yr 3 mo	Product
10117812	Oct 18, 2027	in 1 yr 4 mo	ProductU-1796
9265725	Dec 08, 2027	in 1 yr 6 mo	Product
9211259	Feb 28, 2029	in 2 yr 9 mo	U-1796