Viewing data from:

AZELAIC ACID

ANDA

AZELAIC ACID | A204637 | GLENMARK SPECIALTY SA

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: FINACEA(TE code: AB)

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Intendis, Inc. (Foley & Lardner LLP) - Citizen Petition FDA-2011-P-0227 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and Cosmetic Act requesting that the FDA issue a timely response to Intendis' August 2010 comments on the May 2010 Draft Guidance on Azelaic Acid, stay the review and approval of any pendi	505(q) Stay Request	2011-04-11	Denied	—

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

Medicare Part D Spending

CMS annual spending data for Azelaic Acid (2023)

Total Spending

$9.8M

Total Claims

66,353

Beneficiaries

37,203

Avg Cost/Unit

$2.69

Spending Trend

$7.8M(2019)→$8.1M(2020)→$8.9M(2021)→$9.3M(2022)→$9.8M(2023)

YoY Change:-12.9%

5yr CAGR:-9.9%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

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

1 letter from Drugs@FDA

Date	Submission	Document
Feb 19, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 15%

0 patents0 exclusivities▴

GEL;TOPICAL | Approved: Nov 19, 2018

No patent or exclusivity listings for this strength.