Azelaic Acid Patent Expiration

Azelaic Acid is Used for treating inflammatory papules and pustules of mild to moderate rosacea. It was first introduced by Almirall Llc in its drug Azelex on Sep 13, 1995. Another drug containing Azelaic Acid is Finacea. 7 different companies have introduced drugs containing Azelaic Acid.


Azelaic Acid Patents

Given below is the list of patents protecting Azelaic Acid, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Finacea US10117812 Foamable composition combining a polar solvent and a hydrophobic carrier Oct 18, 2027 Leo Pharma As
Finacea US10322085 Dicarboxylic acid foamable vehicle and pharmaceutical compositions thereof Oct 24, 2023

(Expired)

Leo Pharma As
Finacea US6534070 Composition with azelaic acid Nov 18, 2018

(Expired)

Leo Pharma As
Finacea US6730288 Mousse composition Sep 08, 2019

(Expired)

Leo Pharma As
Finacea US7700076 Penetrating pharmaceutical foam Sep 18, 2027 Leo Pharma As
Finacea US8435498 Penetrating pharmaceutical foam Mar 01, 2024

(Expired)

Leo Pharma As
Finacea US8722021 Foamable carriers Oct 24, 2023

(Expired)

Leo Pharma As
Finacea US8900554 Foamable composition and uses thereof Oct 24, 2023

(Expired)

Leo Pharma As
Finacea US9211259 Antibiotic kit and composition and uses thereof Feb 28, 2029 Leo Pharma As
Finacea US9265725 Dicarboxylic acid foamable vehicle and pharmaceutical compositions thereof Dec 08, 2027 Leo Pharma As


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Azelaic Acid Generics

Several generic applications have been filed for Azelaic Acid. The first generic version for Azelaic Acid was by Actavis Laboratories Ut Inc and was approved on Nov 19, 2018. And the latest generic version is by Teva Pharmaceuticals Usa Inc and was approved on Oct 7, 2020.

Given below is the list of companies who have filed for Azelaic Acid generic.


1. GLENMARK SPECLT

Glenmark Specialty Sa has filed for 1 generic for Azelaic Acid. Given below are the details of the strengths of this generic introduced by Glenmark Speclt.

Strength Dosage Form Availability Application Pathway TE code Launch Date
15% gel Prescription TOPICAL AB Nov 19, 2018


2. TARO

Taro Pharmaceuticals Inc has filed for 1 generic for Azelaic Acid. Given below are the details of the strengths of this generic introduced by Taro.

Strength Dosage Form Availability Application Pathway TE code Launch Date
15% gel Prescription TOPICAL AB Aug 23, 2019


3. ACTAVIS LABS UT INC

Actavis Laboratories Ut Inc has filed for 1 generic for Azelaic Acid. Given below are the details of the strengths of this generic introduced by Actavis Labs Ut Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
15% gel Prescription TOPICAL AB Nov 19, 2018


4. ENCUBE

Encube Ethicals Private Ltd has filed for 1 generic for Azelaic Acid. Given below are the details of the strengths of this generic introduced by Encube.

Strength Dosage Form Availability Application Pathway TE code Launch Date
15% gel Prescription TOPICAL AB Nov 19, 2018


5. TEVA PHARMS USA

Teva Pharmaceuticals Usa Inc has filed for 1 generic for Azelaic Acid. Given below are the details of the strengths of this generic introduced by Teva Pharms Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
15% aerosol, foam Discontinued TOPICAL N/A Oct 7, 2020