AZELAIC ACID - Generic Drug Details

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 Sun Pharma Canada, and is included in eight NDAs. There are four 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:	4
Tradenames:	3
Applicants:	7
NDAs:	8
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	116
Clinical Trials:	40
Patent Applications:	6,664
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
Virginia Commonwealth University	PHASE1
Aswan University	NA
National Rosacea Society	NA

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

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

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
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015		RX	Yes	Yes			Y
Glenmark Speclt	AZELAIC ACID	azelaic acid	GEL;TOPICAL	204637-001	Nov 19, 2018	AB	RX	No	No
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015		RX	Yes	Yes
Teva Pharms Usa	AZELAIC ACID	azelaic acid	AEROSOL, FOAM;TOPICAL	210928-001	Oct 7, 2020		DISCN	No	No
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015		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	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015

International Patents for AZELAIC ACID

Country	Patent Number	Title	Estimated Expiration
Israel	173093
Australia	2004313285	Oleaginous pharmaceutical and cosmetic foam
Israel	188602
South Korea	20050083826	COSMETIC AND PHARMACEUTICAL FOAM
World Intellectual Property Organization (WIPO)	2007007198
Brazil	0314916	Espuma farmacêutica e cosmética

Market Dynamics and Financial Trajectory of Azelaic Acid in the Pharmaceutical Sector

Last updated: July 27, 2025

Introduction

Azelaic acid, a naturally occurring dicarboxylic acid, has gained considerable interest within the pharmaceutical and dermatological markets for its multifaceted therapeutic applications. Primarily used to treat conditions like acne vulgaris and rosacea, azelaic acid’s unique mechanism of action and safety profile position it as a valuable asset in topical formulations. As the global skin health market expands, understanding the evolving market dynamics and financial prospects of azelaic acid provides vital insights for stakeholders—including manufacturers, investors, and healthcare policymakers.

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1. Market Overview of Azelaic Acid

Azelaic acid’s origins trace back to its natural sources like grains such as wheat, barley, and rye, but commercial production predominantly involves chemical synthesis from oleic acid. The compound’s dermatological benefits—antibacterial, anti-inflammatory, and keratolytic—favor its inclusion in prescribed and over-the-counter (OTC) products. Globally, the dermatology segment accounts for the majority of azelaic acid utilization, with significant penetration in North America, Europe, and Asia-Pacific regions.

While the compound itself is often marketed as a generic entity, several branded formulations—such as Finacea (by Dermik/Evonik) and AzAcline—have established critical footholds. The pharmaceutical-grade azelaic acid market encompasses both raw material supplies and finished therapeutic products, with the latter primarily delivered through topical formulations.

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2. Market Drivers and Restraints

Drivers

• Increasing Incidence of Skin Disorders: Rising prevalence rates of acne (especially among adolescents) and rosacea globally fuel demand. The World Health Organization reports that acne affects up to 85% of adolescents worldwide, underpinning an expanding market for azelaic acid-based treatments.

• Growing Preference for Topical Therapies: Minimal systemic side effects associated with topical applications make azelaic acid attractive over other systemic agents like antibiotics or isotretinoin, aligning with the trend toward safer dermatological solutions.

• Regulatory Approvals and Reimbursement Policies: Enhanced regulatory pathways, especially in developed countries, facilitate faster market entry. For example, the FDA’s approval of formulations like Finacea provides a robust platform for commercial growth.

• Rising Awareness and Self-Medication: The shift toward OTC products and increased consumer awareness support market expansion, especially in emerging economies.

Restraints

• Limited Patent Protection: The availability of generic azelaic acid formulations constrains pricing power and associated revenues, limiting profit margins for branded products.

• High Manufacturing Costs: The complexity of synthesis and purification processes elevate production costs, impacting overall profitability, especially in pricing-sensitive markets.

• Competition from Alternative Therapies: Emergence of newer agents with better tolerability profiles (e.g., brimonidine for rosacea) heightens competition, thereby challenging azelaic acid’s market share.

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3. Competitive Landscape

While azelaic acid’s patent landscape is relatively sparse—most formulations are off-patent—the market sees competition primarily among generic manufacturers and a handful of branded product developers. Key players include:

• BASF and Evonik: Major raw material suppliers, leveraging economies of scale to meet demand.

• Private and Public Pharmaceutical Companies: Focused on formulation development, including OTC variants and prescription formulations (e.g., Finacea).

Market consolidation and innovation efforts aim to improve the stability, delivery, and ease of application of azelaic acid formulations, thereby influencing pricing strategy and consumer acceptance.

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4. Regulatory and Geographical Dynamics

Regulatory pathways shape market access. Europe and North America exhibit mature regulatory frameworks that streamline approval processes, while Asian markets like China, India, and Japan offer high growth potential owing to increasing dermatological care awareness and expanding healthcare infrastructures.

Recent regulatory decisions, such as the European Medicines Agency’s (EMA) approvals of azelaic acid for rosacea, have opened new therapeutic indications, further expanding the market horizon. Conversely, regulatory obstacles or delays remain potential hurdles, particularly regarding formulations’ safety and efficacy data in new indications.

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5. Market Forecast and Financial Trajectory

Historical Growth and Current Trends

The azelaic acid market has experienced steady growth, driven by dermatological applications. CAGRs (compound annual growth rates) for the global dermatology segment hover around 4–6%, with azelaic acid contributing a significant share due to expanding indications.

Future Outlook

Projection models suggest the global market for azelaic acid (including raw materials and formulations) will reach approximately USD 300–400 million by 2030, with a CAGR of 5–7% over the next decade. Key factors influencing this trajectory include:

• Product Innovation: Development of microemulsion and nanoformulations enhancing skin penetration could boost efficacy and patient adherence.

• Expanding Indications: Emerging uses in conditions like melasma and post-inflammatory hyperpigmentation may add new revenue streams.

• Market Penetration in Emerging Economies: Infrastructure development and increased healthcare access in Asia and Latin America will propel demand.

• Strategic Partnerships and Licensing: Collaborations among pharmaceutical entities, especially those focusing on formulation innovations or biosimilars, will influence market growth and competitiveness.

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6. Financial Considerations and Investment Opportunities

Investment in azelaic acid requires balancing high-volume manufacturing economics against pricing constraints. Margins are limited in highly competitive, generic-dominated markets, emphasizing the need for value-added formulations or novel delivery mechanisms.

Companies that successfully innovate or secure regulatory advantages can capture premium pricing, leading to higher profit margins. For instance, specialized formulations targeting difficult-to-treat melanotic hyperpigmentation can unlock niche markets with higher willingness-to-pay.

Additionally, raw material suppliers stand to benefit from economies of scale and supply chain efficiencies, strategically positioning themselves as key enablers in the market’s financial ecosystem.

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7. Challenges and Risks

Market growth faces challenges including regulatory variability, intellectual property expirations, and potential adverse event reports influencing safety perceptions. Fluctuations in raw material costs, especially due to environmental policies affecting oleic acid derivatives, further complicate the financial landscape. Moreover, market saturation in mature regions may constrain revenue growth, shifting focus toward emerging markets.

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8. Strategic Outlook

Commercial success hinges on innovation, regulatory agility, and market diversification strategies. Investing in formulation research to improve bioavailability and cosmetically elegant options could distinguish products. Geographic expansion, especially into underserved markets, remains vital.

Stakeholders should also monitor evolving safety profiles and regulatory standards to preempt potential barriers, while leveraging data to demonstrate long-term safety and efficacy.

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Key Takeaways

• The azelaic acid market is characterized by steady growth driven by dermatological applications, especially acne and rosacea.

• Patent expirations and the prevalence of generics limit pricing power; therefore, innovation and new indications hold significant revenue potential.

• Asia-Pacific and Latin American markets represent promising avenues for expansion, supported by increasing healthcare infrastructure and awareness.

• Formulation advancements and strategic alliances can yield competitive advantages and higher profit margins.

• Stakeholders should remain vigilant regarding regulatory developments, raw material costs, and emerging therapeutic uses to optimize financial trajectories.

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FAQs

1. What are the main therapeutic applications driving azelaic acid demand?
Azelaic acid is primarily used to treat acne vulgaris, rosacea, and hyperpigmentation disorders such as melasma. Its anti-inflammatory and antimicrobial properties also support emerging uses in various skin conditions.

2. How does patent protection influence azelaic acid market dynamics?
Most azelaic acid formulations are off-patent, leading to generic competition that suppresses prices and profit margins. Innovation in formulations and new indications are crucial to maintain market exclusivity and profitability.

3. Are there any burgeoning markets for azelaic acid?
Yes, emerging economies in Asia and Latin America offer high growth potential due to increasing dermatology awareness, expanding healthcare access, and favorable regulatory environments.

4. What challenges could hinder the future growth of azelaic acid?
Regulatory restrictions, high manufacturing costs, market saturation in mature regions, and competition from newer therapies can impede growth prospects.

5. What strategies can companies adopt to capitalize on azelaic acid’s market potential?
Investing in formulation innovation, expanding into new therapeutic indications, exploring geographic expansion, and forming strategic partnerships will enhance competitiveness and financial returns.

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References

1. [1] Global Skin Care Market Data. MarketResearch.com.
2. [2] World Health Organization. Acne prevalence statistics.
3. [3] European Medicines Agency. Approval information for azelaic acid formulations.
4. [4] Industry reports on pharmaceutical raw material markets.
5. [5] Regulatory filings and patent databases relevant to azelaic acid formulations.