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, 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
		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
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015		RX	Yes	Yes	9,211,259
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015		RX	Yes	Yes	9,265,725		Y
Teva Pharms Usa	AZELAIC ACID	azelaic acid	AEROSOL, FOAM;TOPICAL	210928-001	Oct 7, 2020		DISCN	No	No
Almirall	AZELEX	azelaic acid	CREAM;TOPICAL	020428-001	Sep 13, 1995		RX	Yes	Yes

Expired US Patents for azelaic acid

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	8,900,554
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015	10,322,085
Leo Pharma As	FINACEA	azelaic acid	GEL;TOPICAL	021470-001	Dec 24, 2002	4,713,394
Almirall	AZELEX	azelaic acid	CREAM;TOPICAL	020428-001	Sep 13, 1995	4,386,104

International Patents for azelaic acid

Country	Patent Number	Title	Estimated Expiration
Mexico	PA05004278	ESPUMA COSMETICA Y FARMACEUTICA. (COSMETIC AND PHARMACEUTICAL FOAM.)
World Intellectual Property Organization (WIPO)	2008152444
Australia	2006313443	Foamable vehicle and pharmaceutical compositions thereof
World Intellectual Property Organization (WIPO)	2006003481

Azelaic acid Market Analysis and Financial Projection Experimental

Azelaic Acid Market Dynamics and Financial Trajectory

Market Size and Growth Projections

The azelaic acid market is poised for significant growth over the next decade. As of 2023, the global azelaic acid market was valued at $208.7 million and is projected to reach $415.3 million by 2033, growing at a Compound Annual Growth Rate (CAGR) of 7.2% from 2024 to 2033[1].

Drivers of Market Growth

Increasing Demand for Biodegradable Polymers

One of the key drivers of the azelaic acid market is the growing demand for biodegradable polymers. Azelaic acid is a crucial component in the production of these polymers, which are sought after for their eco-friendly properties. As industries and consumers increasingly prioritize sustainability, the use of azelaic acid in biodegradable polymers is expected to continue driving market growth[1].

Preference for Natural Ingredients in Cosmetics

The cosmetic industry's shift towards natural and organic ingredients is another significant driver. Azelaic acid, being a naturally-derived compound, aligns perfectly with this trend. Consumers are increasingly seeking skincare and hair care products that are free from harmful chemicals, which has led to a surge in demand for azelaic acid-based products[4].

Pharmaceutical and Cosmetic Industry Expansion

The robust growth of the pharmaceutical and cosmetic industries, particularly in regions like Asia-Pacific and Europe, is also driving the demand for azelaic acid. In Asia-Pacific, the rising middle class and growing economies are boosting demand for skincare and cosmetic products. In Europe, the focus on advanced pharmaceutical formulations and innovative biodegradable polymers is creating substantial demand[1].

Regional Market Dynamics

Asia-Pacific

In the Asia-Pacific region, the azelaic acid market is driven by the rapid expansion of the middle class and the increasing demand for skincare and cosmetic products. Countries in this region are seeing a significant rise in the use of azelaic acid due to its anti-inflammatory and antimicrobial properties[1].

Europe

Europe is another key region for the azelaic acid market, with countries like Germany, France, Italy, and the UK leading in cosmetic sales. The European cosmetic industry's emphasis on innovation and sustainability has made azelaic acid a favored ingredient due to its natural origin and eco-friendly properties[1].

Market Restraints

Availability of Alternatives

Despite the positive growth trends, the azelaic acid market faces challenges from the availability of alternatives and substitutes. Various industries are seeking other organic acids or synthetic compounds with comparable properties, which could affect the demand for azelaic acid. Additionally, the emergence of novel ingredients and technological advancements in formulation may further diminish the market share of azelaic acid[1].

Market Opportunities

Sustainable and Eco-Friendly Solutions

The increasing emphasis on sustainable and eco-friendly solutions presents a significant opportunity for the azelaic acid market. Derived from renewable sources, azelaic acid offers a sustainable alternative in various applications. Its biodegradability and low environmental impact make it attractive for companies seeking greener alternatives, aligning with consumer preferences and regulatory trends[1].

Key Market Players

The azelaic acid market is dominated by several key players, including Molekula Group, Spectrum Chemical, BASF SE, Croda International Plc, Cargill, Incorporated, Emery Oleochemicals, Anant Pharmaceuticals Pvt. Ltd., Nantong Hengxing Electronic Materials Co., Ltd., Krishana Enterprises, and Matrica S.p.A. These companies are driving innovation and growth through their focus on sustainable and high-performance materials[1].

Financial Performance and Projections

• Market Size by 2033: The market is expected to reach $415.3 million by 2033[1].
• Growth Rate: A CAGR of 7.2% from 2024 to 2033[1].
• Forecast Period: 2024 to 2033[1].

Other reports also highlight similar growth trajectories, with the market expected to reach $353.0 million by 2031 at a CAGR of 7.7% from 2023[4], and $348.2 million by 2029 at a CAGR of 7.0% from 2022[2].

Industry Trends

Regulatory Emphasis on Eco-Friendly Solutions

Regulatory bodies are increasingly emphasizing the need for eco-friendly solutions, which is driving the demand for azelaic acid. As industries comply with these regulations, the use of azelaic acid in various applications is expected to rise[1].

Consumer Awareness and Preferences

Growing consumer awareness about the benefits of natural and sustainable products is another trend influencing the market. Consumers are more likely to choose products formulated with eco-friendly ingredients like azelaic acid, driving further market expansion[1].

"Consumer awareness grows, the demand for products formulated with eco-friendly ingredients like azelaic acid is expected to rise, driving further market expansion."[1]

Key Takeaways

• The azelaic acid market is projected to grow significantly, driven by demand for biodegradable polymers and natural ingredients in cosmetics.
• The Asia-Pacific and European regions are key drivers of market growth due to their robust pharmaceutical and cosmetic industries.
• Despite growth, the market faces challenges from the availability of alternatives and substitutes.
• The emphasis on sustainable and eco-friendly solutions presents significant opportunities for the azelaic acid market.
• Key market players are driving innovation and growth through their focus on sustainable materials.

FAQs

Q: What is the projected market size of azelaic acid by 2033? A: The global azelaic acid market is projected to reach $415.3 million by 2033[1].

Q: What is the CAGR of the azelaic acid market from 2024 to 2033? A: The azelaic acid market is expected to grow at a CAGR of 7.2% from 2024 to 2033[1].

Q: Which regions are driving the growth of the azelaic acid market? A: The Asia-Pacific and European regions are significantly driving the growth of the azelaic acid market[1].

Q: What are the main drivers of the azelaic acid market? A: The main drivers include the increasing demand for biodegradable polymers and the preference for natural ingredients in cosmetics[1][4].

Q: Who are the key players in the azelaic acid market? A: Key players include Molekula Group, Spectrum Chemical, BASF SE, Croda International Plc, and others[1].

Sources

1. Allied Market Research - Azelaic Acid Market Size and Share Growth Report 2033
2. Business Research Insights - Azelaic Acid Suspension Market Size, Share, Trend Report, 2032
3. DataIntelo - Technical Grade Azelaic Acid Sales Market Research Report 2032
4. Coherent Market Insights - Azelaic Acid Market Size and Trends
5. EIN Presswire - Azelaic Acid Market is estimated to surpass US$ 393.35 million by 2028