Viewing data from:

FINACEA

NDA

AZELAIC ACID | N021470 | LEO PHARMA AS

1 strength0 unique patents0 unique exclusivities

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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Intendis, Inc. (Foley & Lardner LLP) - Citizen Petition FDA-2011-P-0227 · 4 docket documents Intendis, Inc. filed this citizen petition under sections 505(b), 505(j), and 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA issue a timely response to Intendis' August 2010 comments on the May 2010 Draft Guidance on Azelaic Acid, stay the review and approval of any pendi	505(q) Stay Request	2011-04-11	Partially Denied	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

30 trials from ClinicalTrials.gov, 27 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Safety and Efficacy of Azelaic Acid Foam, 15 % in Papulopustular Rosacea NCT01555463	Phase 3	Completed	LEO Pharma	961	2012-09 → 2014-01
A Study to Evaluate the Safety and Clinical Study of Azelaic Acid Gel 15% in Patients With Moderate Facial Rosacea NCT02120924	Phase 3	Completed	Actavis Inc.	1,009	2013-07 → 2014-09
Exploration of Safety and Efficacy of AzA 15% Foam Twice a Day in Rosacea NCT00617903	Phase 2	Completed	LEO Pharma	83	2008-01 → 2008-06
A Study of Azelaic Acid (AzA) 15% Gel in the Treatment of Seborrheic Dermatitis of the Face NCT00408330	Phase 2	Completed	LEO Pharma	48	2006-12 → 2007-03
Azelaic Acid Foam 15% in the Treatment of Papulopustular Rosacea NCT03418610	Phase 4	Completed	Clinical Research Center of the Carolinas	5	2017-12-06 → 2019-01-09
Split-face Tolerability Comparison Between MetroGel® 1% vs Finacea® 15% in Subjects With Healthy Skin NCT01139047	Phase 4	Completed	Galderma R&D	77	2010-06 → 2010-06
A Study of Azelaic Acid (AzA) 15% in Topical Treatment of Mild to Moderate Perioral Dermatitis NCT00403949	Phase 2	Completed	LEO Pharma	48	2006-11 → 2007-03
21 Day Irritancy Test of Azelaic Acid Pre-foam Formulation NCT01430312	Phase 1	Completed	LEO Pharma	40	2011-09 → 2011-12
Phase 3 Papulopustular Rosacea Study NCT01493687	Phase 3	Completed	Galderma R&D	683	2011-12 → 2013-08
To Evaluate the Therapeutic Equivalence and Safety in Treatment of Moderate Facial Rosacea NCT03689010	Phase 1	Completed	Sun Pharmaceutical Industries, Inc.	1,116	2017-12-12 → 2018-09-28

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$0.4519

per gm

Lowest NADAC/Unit

$0.4519

per gm

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00781717250AZELAIC ACID 15% GEL	$0.4519	GM	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$4.05

Highest Price

$4.05

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00781-7172-50AZELAIC ACID 15% GEL,TOP	$4.05	FSS	Sandoz, Inc.	08/14/2028

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Finacea (2024)

Total Spending

$2.8M

Total Claims

6,032

Beneficiaries

3,256

Avg Cost/Unit

$8.49

Spending Trend

$1.6M(2019)→$1.6M(2020)→$2.2M(2021)→$2.3M(2022)→$2.5M(2023)→$2.8M(2024)

YoY Change:-1.7%

5yr CAGR:+3.9%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain6 active DMFs1 inactive

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

BAYER AGAZELAIC ACID

DMF 92891991

BAYER AGAZELAIC ACID (A)

DMF 281902014

TARO PHARMACEUTICAL INDUSTRIES LTDAZELAIC ACID, MICRONIZED

DMF 294842015

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

10 letters from Drugs@FDA

Date	Submission	Document
Nov 2, 2021	SUPPL -17	View Letter (PDF)
Dec 1, 2020	SUPPL -16	View Letter (PDF)
Dec 1, 2020	SUPPL -15	View Letter (PDF)
Aug 5, 2016	SUPPL -13	View Letter (PDF)
Jan 11, 2016	SUPPL -12	View Letter (PDF)
Apr 6, 2015	SUPPL -10	View Letter (PDF)
Dec 21, 2012	SUPPL -7	View Letter (PDF)
Nov 3, 2010	SUPPL -5	View Letter (PDF)
May 17, 2005	SUPPL -3	View Letter (PDF)
Jun 4, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 15%

RLDAB

0 patents0 exclusivities▴

GEL;TOPICAL | Approved: Dec 24, 2002

No patent or exclusivity listings for this strength.