Azelaic acid - Generic Drug Details

What are the generic sources for azelaic acid and what is the scope of patent protection?

Azelaic acid is the generic ingredient in three branded drugs marketed by Teva Pharms Usa, Leo Pharma As, Almirall, Actavis Labs Ut Inc, Glenmark Pharms, Taro, and Tolmar, and is included in eight NDAs. There are eight 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. Eight suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for azelaic acid

International Patents:	137
US Patents:	8
Tradenames:	3
Applicants:	7
NDAs:	8
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	136
Clinical Trials:	32
Patent Applications:	6,021
Formulation / Manufacturing:	see details
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
Wake Forest University Health Sciences	Early Phase 1
Assiut University	Phase 4
Clinical Research Center of the Carolinas	Phase 4

See all azelaic acid clinical trials

Generic filers with tentative approvals for AZELAIC ACID

Applicant	Application No.	Strength	Dosage Form
		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

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015	AB	RX	Yes	Yes			Y
Taro	AZELAIC ACID	azelaic acid	GEL;TOPICAL	210549-001	Aug 23, 2019	AB	RX	No	No
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015	AB	RX	Yes	Yes			Y
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015	AB	RX	Yes	Yes			Y

Expired US Patents for azelaic acid

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Almirall	AZELEX	azelaic acid	CREAM;TOPICAL	020428-001	Sep 13, 1995
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015
Leo Pharma As	FINACEA	azelaic acid	GEL;TOPICAL	021470-001	Dec 24, 2002
Leo Pharma As	FINACEA	azelaic acid	GEL;TOPICAL	021470-001	Dec 24, 2002

International Patents for azelaic acid

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1556009	MOUSSE COSMETIQUE ET PHARMACEUTIQUE (COSMETIC AND PHARMACEUTICAL FOAM)
Japan	2007508243
Australia	2007355106	Foamable waterless compositions with modulating agents
Australia	2007356328	Stable non-alcoholic foamable pharmaceutical emulsion compositions with an unctuous emollient and their uses