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FINACEA

NDA

AZELAIC ACID | N207071 | LEO PHARMA AS

1 strength4 unique patents0 unique exclusivities

Patent Timeline

4 unique patents by expiration date

Active (4)Today

2027

2028

2029

Today

Sep. 18, 2027

Feb. 28, 2029

Dec. 8, 2027

Oct. 18, 2027

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
LEO Pharma A/S et al. v. Teva Pharmaceuticals USA, Inc. 1:2018cv00013 6 patentsANDA 210928azelaic acid	D. Del.	2018-01-03	Terminated 2019-10-17	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain5 active DMFs1 inactive

4 active API suppliers hold Drug Master Files for this ingredient.

BAYER AGAZELAIC ACID

DMF 92891991

BAYER AGAZELAIC ACID (A)

DMF 281902014

ALIVUS LIFE SCIENCES LTDAZELAIC ACID

DMF 299242016

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDAZELAIC ACID

DMF 334852019

FLAMMA SPAAZELAIC ACID

DMF 380422023

CU CHEMIE UETIKON GMBHInactiveAZELAIC ACID

DMF 108571994

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Dec 2, 2020	SUPPL -2	View Letter (PDF)
Dec 2, 2020	SUPPL -4	View Letter (PDF)
Jul 31, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 15%

RLD

4 patents0 exclusivities▴

AEROSOL, FOAM;TOPICAL | Approved: Jul 29, 2015

Patents (4)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7700076	Sep 18, 2027	—	—	Yes	—	—
9211259	Feb 28, 2029	—	—	—		—
9265725	Dec 8, 2027	—	—	Yes	—	—
10117812	Oct 18, 2027	—	—	Yes		—