AZELEX Drug Patent Profile

When do Azelex patents expire, and when can generic versions of Azelex launch?

Azelex is a drug marketed by Almirall and is included in one NDA.

The generic ingredient in AZELEX is azelaic acid. There are eight drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the azelaic acid profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Azelex

A generic version of AZELEX was approved as azelaic acid by ACTAVIS LABS UT INC on November 19^th, 2018.

Summary for AZELEX

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	148
Patent Applications:	4,642
Drug Prices:	Drug price information for AZELEX
What excipients (inactive ingredients) are in AZELEX?	AZELEX excipients list
DailyMed Link:	AZELEX at DailyMed

See drug prices for AZELEX

Pharmacology for AZELEX

Physiological Effect

Decreased Protein Synthesis Decreased Sebaceous Gland Activity

US Patents and Regulatory Information for AZELEX

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

Expired US Patents for AZELEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Almirall	AZELEX	azelaic acid	CREAM;TOPICAL	020428-001	Sep 13, 1995	4,386,104

International Patents for AZELEX

See the table below for patents covering AZELEX around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	1137873	COMPOSE POUR LE TRAITEMENT DES DERMATOSES PROVOQUANT UNE HYPERPIGMENTATION ET AUTRES AFFECTIONS DU GENRE (COMPOSITION OF TREATMENT OF HYPERPIGMENTARY DERMATOSES AND THE LIKE)
South Africa	7802125
Switzerland	638099	Composition for the treatment of dermatoses characterised by hyperpigmentation
Australia	3502778
Italy	1075741	COMPOSIZIONE PER IL TRATTAMENTO DI DERMATOSI IPERPIGMENTARIE
Japan	S631287
Belgium	866151

AZELEX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of AZELEX (Azelaic Acid)

Introduction to AZELEX

AZELEX, a topical cream containing azelaic acid, is widely used for the treatment of mild-to-moderate inflammatory acne vulgaris. Its efficacy in addressing skin conditions such as acne, hyperpigmentation, and rosacea has made it a significant player in the pharmaceutical and cosmetic industries.

Market Size and Growth

The azelaic acid market, which includes products like AZELEX, is projected to experience substantial growth. By 2031, the market size is expected to reach $353 million, up from $210 million in 2023, with a compound annual growth rate (CAGR) of 7.7% during the forecast period[1][4].

Key Drivers of Market Growth

Increasing Demand for Skin Care Products

The rising demand for skin lightening and the treatment of hyperpigmentation and acne are major drivers of the azelaic acid market. Consumers are increasingly seeking effective and natural ingredients for their skincare routines, which has boosted the demand for azelaic acid-based products[1][4].

Expanding Pharmaceutical and Cosmetic Industries

Azelaic acid's wide application in both pharmaceutical and cosmetic industries is a significant factor contributing to market growth. Its antimicrobial properties and ability to normalize keratinization make it a valuable ingredient in various skincare products[1][3].

Regional Market Dynamics

• North America and Europe: These regions are expected to contribute significantly to the global market due to the increased adoption of premium skin care products. The U.S. and Canada in North America, and Germany, France, and the UK in Europe, are key markets[1][4].
• Asia-Pacific: This region is anticipated to grow at the fastest CAGR from 2023 to 2032, driven by expanding cosmetic enterprises, rising demand for skincare products, and growing awareness of azelaic acid's benefits. China and India are notable markets in this region[4].

Market Challenges

Regulatory Hurdles

Stringent regulations regarding the use of azelaic acid can pose challenges to smooth market growth. Compliance with these regulations is crucial for manufacturers to ensure the continued availability of their products[1].

Alternative Products

The availability of alternative products for acne treatment and skin lightening can also restrict market revenue. Manufacturers must differentiate their products and highlight the unique benefits of azelaic acid to maintain market share[1].

Pharmacokinetics and Safety Profile

Azelaic acid, when applied topically, penetrates into the stratum corneum and other viable skin layers with negligible cutaneous metabolism. Approximately 4% of the topically applied azelaic acid is systemically absorbed, and it is mainly excreted unchanged in the urine. This profile indicates a favorable safety profile for topical use[2][3].

Seasonal and Cyclical Trends

The demand for azelaic acid-based products can vary seasonally, with higher demand during summer months when skincare concerns like acne and hyperpigmentation are more prevalent. Economic factors, global crises, and shifts in consumer behavior also influence market dynamics and pricing structures[4].

Competitive Landscape

Leading market players are investing heavily in research and development to expand their product lines. Strategic activities such as new product launches, contractual agreements, mergers and acquisitions, and collaborations are common among market participants. To remain competitive, the industry must offer cost-effective products while maintaining quality and efficacy[4].

Financial Assistance and Affordability

For patients who may struggle with the cost of AZELEX, various financial assistance programs are available. For instance, AstraZeneca's AZ&Me program helps qualifying individuals without insurance or those on Medicare to afford their medications, including potentially those containing azelaic acid[5].

Market Segmentation

The azelaic acid market is segmented based on application, with the Pharmaceuticals and Cosmetics category generating the most revenue. This is due to the increased demand for skincare products and dermatological procedures, driven by the rising prevalence of skin conditions like rosacea and acne[4].

Consumer Behavior and Preferences

Consumers are increasingly preferring natural and organic skincare products, which has driven up the demand for azelaic acid. Formulation advances and the effectiveness of azelaic acid in reducing hyperpigmentation further support its market growth[4].

Future Outlook

The azelaic acid market is poised for significant growth, driven by rising consumer health consciousness, advancements in medicine, and the increasing demand for biolubricants. As the awareness of azelaic acid's benefits continues to grow, especially in emerging economies, the market is expected to expand further.

"The azelaic acid market is expected to experience stable growth over the forecast period, driven by the increasing demand for skin lightening and the treatment of hyperpigmentation and acne."[1]

Key Takeaways

• The azelaic acid market is projected to grow significantly, reaching $353 million by 2031.
• Key drivers include increasing demand for skin care products, expanding pharmaceutical and cosmetic industries, and regional market dynamics.
• Challenges include regulatory hurdles and the availability of alternative products.
• Azelaic acid has a favorable pharmacokinetics and safety profile.
• Seasonal and cyclical trends, as well as economic factors, influence market dynamics.
• Leading market players are investing in research and development and strategic activities.
• Financial assistance programs are available to help patients afford azelaic acid-based products.

FAQs

What is AZELEX used for?

AZELEX is used for the topical treatment of mild-to-moderate inflammatory acne vulgaris.

What are the key drivers of the azelaic acid market?

The key drivers include increasing demand for skin lightening and the treatment of hyperpigmentation and acne, as well as the expanding pharmaceutical and cosmetic industries.

Which regions are expected to contribute significantly to the global azelaic acid market?

North America and Europe are expected to contribute significantly, with the Asia-Pacific region showing the fastest growth.

What are the challenges facing the azelaic acid market?

Stringent regulations and the availability of alternative products are significant challenges.

How does azelaic acid penetrate the skin?

Azelaic acid penetrates into the stratum corneum and other viable skin layers with negligible cutaneous metabolism, and approximately 4% is systemically absorbed.

Are there financial assistance programs available for AZELEX?

Yes, programs like AstraZeneca's AZ&Me help qualifying individuals afford their medications, including those containing azelaic acid.

Sources

1. Coherent Market Insights: Azelaic Acid Market - Share, Size and Industry Analysis.
2. Drugs.com: Azelex: Package Insert / Prescribing Information.
3. FDA: AZELEX® (azelaic acid cream) 20% For Dermatologic Use Only.
4. Market Research Future: Azelaic Acid Market Analysis.
5. AstraZeneca US: Affordability.