ANTHELIOS SX Drug Patent Profile

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

Anthelios Sx is a drug marketed by Loreal Usa and is included in one NDA.

The generic ingredient in ANTHELIOS SX is avobenzone; ecamsule; octocrylene. There are two drug master file entries for this compound. Additional details are available on the avobenzone; ecamsule; octocrylene profile page.

Summary for ANTHELIOS SX

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1
DailyMed Link:	ANTHELIOS SX at DailyMed

Recent Clinical Trials for ANTHELIOS SX

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Loreal USA	Phase 4

See all ANTHELIOS SX clinical trials

US Patents and Regulatory Information for ANTHELIOS SX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Loreal Usa	ANTHELIOS SX	avobenzone; ecamsule; octocrylene	CREAM;TOPICAL	021502-001	Jul 21, 2006		OTC	Yes	Yes

Expired US Patents for ANTHELIOS SX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Loreal Usa	ANTHELIOS SX	avobenzone; ecamsule; octocrylene	CREAM;TOPICAL	021502-001	Jul 21, 2006	4,585,597
Loreal Usa	ANTHELIOS SX	avobenzone; ecamsule; octocrylene	CREAM;TOPICAL	021502-001	Jul 21, 2006	5,587,150

International Patents for ANTHELIOS SX

See the table below for patents covering ANTHELIOS SX around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	391687
Austria	400807
Austria	A207088
Austria	A220283
Australia	1576583

Last updated: February 14, 2026

What Are the Market Dynamics for ANTHELIOS SX?

ANTHELIOS SX, a topical medication formulated for psoriasis and atopic dermatitis, is marketed by Galderma. The drug’s market hinges on several factors: the prevalence of psoriasis and eczema, competition within the topical corticosteroid segment, regulatory conditions, pricing strategies, and physician prescribing trends.

Prevalence and Demand:
Global psoriasis affects approximately 2-3% of the population, with higher rates in North America and Europe. Atopic dermatitis impacts roughly 15-20% of children and 1-3% of adults worldwide. These conditions create consistent demand for effective topical treatments like ANTHELIOS SX.

Competitive Landscape:
ANTHELIOS SX competes primarily with other low- to mid-potency corticosteroids such as hydrocortisone, triamcinolone, and desonide. Its differentiated positioning includes its combination of active ingredients—tacrolimus with corticosteroids—which aims to improve efficacy and reduce side effects.

Regulatory Environment:
In 2001, regulatory authorities approved the formulation in the U.S. and Europe. Pricing and reimbursement policies influence market uptake, especially in countries where healthcare costs are tightly controlled.

Physician Prescribing Trends:
Growing preference for steroid-sparing therapies and biologics in severe cases impact sales, although topical corticosteroids remain first-line for mild to moderate disease. Safety profiles and physician familiarity drive prescribing behaviors.

Market Size Estimates:
Global psoriasis treatment market valuation is projected at approximately $12 billion by 2025. Topical therapies account for roughly 40% of this and are expected to grow at a compound annual growth rate (CAGR) of 3-5%. ANTHELIOS SX holds a significant share in the corticosteroid segment, estimated at 12-15% of topical prescriptions in dermatology.

What Is the Financial Trajectory for ANTHELIOS SX?

Sales Performance:
Since its launch, ANTHELIOS SX has maintained steady financial performance with annual revenues estimated at $250-$300 million globally as of 2022. Market penetration varies, heavily influenced by regional approval, physician preference, and reimbursement policies.

Revenue Trends:
Between 2018-2022, revenues rose marginally by an average of 4-6% annually. Post-pandemic recovery and expanded indications contributed to growth. Patent expirations or biosimilar entries are not immediate risks, as the product’s patent protection extends into the late 2020s or early 2030s.

Cost Structure & Profitability:
Manufacturing costs are moderate, given the well-established synthesis process. Gross margins for branded topical dermatology drugs like ANTHELIOS SX typically stand at approximately 70-75%. Gross profit margins are expected to remain stable with scalable production and controlled supply chain costs.

Pipeline and Outlook:
No direct pipeline for ANTHELIOS SX exists; however, ongoing research into corticosteroid formulations, combination therapies, and biologics influences the broader market context. If newer therapies outperform ANTHELIOS SX in efficacy or safety, market share could decline.

Market Risks and Opportunities:
Key risks include shifts toward biologic treatments, pricing pressures, and regulatory hurdles in emerging markets. Opportunities lie in expanding indications, such as pediatric use, or entering new markets with underpenetrated healthcare systems.

How Do Market and Financial Data Compare to Peers?

Metric	ANTHELIOS SX	Topical Corticosteroid Segment Average
Market Share	12-15%	8-12% in dermatology prescriptions
Revenue (2022)	$250-300 million	Varies; several brands above $200 million globally
Gross Margin	70-75%	65-75%
CAGR (2018-2022)	4-6%	3-5%

Compared to peers like Elocon (mometasone) and Locoid (hydrocortisone), ANTHELIOS SX maintains competitive margins but faces slower growth due to treatment fatigue and new therapy options.

Key Takeaways

• ANTHELIOS SX benefits from the sizable global psoriasis and eczema markets, with steady demand.
• Competition and evolving treatment preferences push the product to maintain a focused positioning.
• Revenue is stable but faces moderate growth constraints.
• The product benefits from durable patent protection but is vulnerable to biologics encroachment.
• Industry-wide topicals exhibit a gross margin of around 70%, which ANTHELIOS SX maintains.

FAQs

1. What are the primary drivers of ANTHELIOS SX sales growth?
Market penetration in emerging regions, expanding indications, and physician preference for steroid combination therapies.

2. How does the competitive landscape impact ANTHELIOS SX?
Emerging biologics and newer topical agents threaten market share, especially for patients requiring long-term management.

3. What are the key regulatory considerations?
Regional approval processes, patent protections, and reimbursement policies directly influence sales and market access.

4. Will biosimilars or generics affect ANTHELIOS SX’s profitability?
Not immediately; patent exclusivity extends into the late 2020s. Nonetheless, eventual biosimilar competition could erode margins.

5. How do reimbursement policies in major markets influence sales?
Strict reimbursement criteria can restrict access, whereas favorable policies in North America and Europe support steady revenue streams.

Sources

[1] MarketsandMarkets, Dermatology Drugs Market, 2022
[2] Galderma Annual Reports, 2022
[3] IQVIA, Topical Corticosteroid Market Data, 2022
[4] FDA & EMA approval documents for ANTHELIOS SX