AZELAIC ACID - Generic Drug Details

✉ Email this page to a colleague

What are the generic drug sources for azelaic acid and what is the scope of freedom to operate?

Azelaic acid is the generic ingredient in three branded drugs marketed by Teva Pharms Usa, Leo Pharma As, Almirall, Actavis Labs Ut Inc, Encube, Glenmark Speclt, and Taro, and is included in eight NDAs. There are five patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Azelaic acid has one hundred and thirty-seven patent family members in twenty countries.

There are eight drug master file entries for azelaic acid. Nine suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for AZELAIC ACID

International Patents:	137
US Patents:	5
Tradenames:	3
Applicants:	7
NDAs:	8
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	148
Clinical Trials:	37
Patent Applications:	6,553
Drug Prices:	Drug price trends for AZELAIC ACID
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AZELAIC ACID
What excipients (inactive ingredients) are in AZELAIC ACID?	AZELAIC ACID excipients list
DailyMed Link:	AZELAIC ACID at DailyMed

See drug prices for AZELAIC ACID

Recent Clinical Trials for AZELAIC ACID

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Insel Gruppe AG, University Hospital Bern	Phase 2
Chang Gung Memorial Hospital	Phase 1/Phase 2
South Valley University	N/A

See all AZELAIC ACID clinical trials

Generic filers with tentative approvals for AZELAIC ACID

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	15%	AEROSOL, FOAM;TOPICAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for AZELAIC ACID

Physiological Effect	Decreased Protein Synthesis Decreased Sebaceous Gland Activity

Anatomical Therapeutic Chemical (ATC) Classes for AZELAIC ACID

D10AX	Other anti-acne preparations for topical use
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

Paragraph IV (Patent) Challenges for AZELAIC ACID

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FINACEA	Topical Foam	azelaic acid	15%	207071	1	2017-09-14
FINACEA	Gel	azelaic acid	15%	021470	1	2012-07-27

US Patents and Regulatory Information for AZELAIC ACID

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Almirall	AZELEX	azelaic acid	CREAM;TOPICAL	020428-001	Sep 13, 1995		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms Usa	AZELAIC ACID	azelaic acid	AEROSOL, FOAM;TOPICAL	210928-001	Oct 7, 2020		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Taro	AZELAIC ACID	azelaic acid	GEL;TOPICAL	210549-001	Aug 23, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Leo Pharma As	FINACEA	azelaic acid	GEL;TOPICAL	021470-001	Dec 24, 2002	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for AZELAIC ACID

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Almirall	AZELEX	azelaic acid	CREAM;TOPICAL	020428-001	Sep 13, 1995	⤷ Sign Up	⤷ Sign Up
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015	⤷ Sign Up	⤷ Sign Up
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015	⤷ Sign Up	⤷ Sign Up
Leo Pharma As	FINACEA	azelaic acid	GEL;TOPICAL	021470-001	Dec 24, 2002	⤷ Sign Up	⤷ Sign Up
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for AZELAIC ACID

Subscribe to access the full database, or Sign Up
Country	Patent Number	Title	Estimated Expiration
Israel	198688	תרכובות עם רכיבים מווסתים (Composition with modulating agents)	⤷ Sign Up
Canada	2565754	MOUSSES A CAVITES CORPORELLES (BODY CAVITY FOAMS)	⤷ Sign Up
European Patent Office	1919448	TROUSSE ET COMPOSITION VASOACTIVE ET LEURS UTILISATIONS (VASOACTIVE KIT AND COMPOSITION AND USES THEREOF)	⤷ Sign Up
European Patent Office	2494959	Véhicule moussant à base d'acide dicarboxylique et ses compositions pharmaceutiques (Dicarboxylic acid foamable vehicle and pharmaceutical compositions thereof)	⤷ Sign Up
South Africa	200507019	Body cavity foams	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.