Azelaic acid - Generic Drug Details

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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, 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:	5,390
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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glenmark Speclt	AZELAIC ACID	azelaic acid	GEL;TOPICAL	204637-001	Nov 19, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Encube	AZELAIC ACID	azelaic acid	GEL;TOPICAL	208724-001	Nov 19, 2018	AB	RX	No	No	⤷ 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
Actavis Labs Ut Inc	AZELAIC ACID	azelaic acid	GEL;TOPICAL	208011-001	Nov 19, 2018	AB	RX	No	No	⤷ 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
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015		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				⤷ 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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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	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
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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for azelaic acid

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Country	Patent Number	Title	Estimated Expiration
Mexico	PA06006923	ESPUMA OLEAGINOSA FARMACEUTICA Y COSMETICA. (OLEAGINOUS PHARMACEUTICAL AND COSMETIC FOAM.)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2007072216		⤷ Sign Up
South Africa	200502171	Foam carrier containing amphiphilic copolymeric gelling agent	⤷ Sign Up
Australia	2005204347	Kit and composition of imidazole with enhanced biovailability	⤷ Sign Up
European Patent Office	2097065	COMPOSITIONS COMPORTANT DES AGENTS DE MODULATION (FOAMABLE WATERLESS COMPOSITIONS WITH MODULATING AGENTS)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2007054818		⤷ Sign Up
Slovenia	2494959		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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