ELOCON Drug Patent Profile

Which patents cover Elocon, and when can generic versions of Elocon launch?

Elocon is a drug marketed by Organon and is included in three NDAs.

The generic ingredient in ELOCON is mometasone furoate. There are thirty drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the mometasone furoate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Elocon

A generic version of ELOCON was approved as mometasone furoate by PADAGIS US on March 18^th, 2002.

Summary for ELOCON

US Patents:	0
Applicants:	1
NDAs:	3

Paragraph IV (Patent) Challenges for ELOCON

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ELOCON	Topical Solution (Lotion)	mometasone furoate	0.1%	019796	1	2004-06-10

US Patents and Regulatory Information for ELOCON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon	ELOCON	mometasone furoate	CREAM;TOPICAL	019625-001	May 6, 1987		DISCN	No	No
Organon	ELOCON	mometasone furoate	OINTMENT;TOPICAL	019543-001	Apr 30, 1987		DISCN	Yes	No
Organon	ELOCON	mometasone furoate	CREAM;TOPICAL	019625-002	Apr 19, 2013		DISCN	Yes	No

International Patents for ELOCON

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

Country	Patent Number	Title	Estimated Expiration
Ireland	872633
Hungary	188769	PROCESS FOR PREPARING AROMATIC HETEROCYCLIC ESTERS OF 3,20-DIOXO-1,4-PREGNADIEN-17ALPHA-OLS
Philippines	24528	STEROID LOTION

Supplementary Protection Certificates for ELOCON

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3043773	SPC/GB21/077	United Kingdom		PRODUCT NAME: MOMETASONE OR A SALT THEREOF AND OLOPATADINE OR A SALT THEREOF; REGISTERED: AT 140638 20210426; UK PL 25258/0331 - 0001 20210511
0057401	SPC/GB93/085	United Kingdom		SPC/GB93/085, EXPIRES: 20050621
3043773	2022C/520	Belgium		PRODUCT NAME: MOMETASONE OF EEN ZOUT HIERVAN EN OLOPATADINE OF EEN ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: BE595626 20220203

Investment Scenario and Fundamentals Analysis for ELOCON

Last updated: February 3, 2026

What is ELOCON?

ELOCON is a topical corticosteroid with the generic name mometasone furoate. It is used primarily to treat inflammatory skin conditions, including eczema and psoriasis. Marketed under various brand names, ELOCON is approved in multiple regions, including the United States, Europe, and emerging markets.

Market Overview and Current Position

ELOCON is a mid-tier product within the dermatological corticosteroid segment. According to IQVIA data, the global topical corticosteroid market generated approximately $4.5 billion in 2022, with a compound annual growth rate (CAGR) of 3-4% projected through 2027. ELOCON's sales are driven by its efficacy, safety profile, and brand recognition.

In 2022, ELOCON's estimated global sales exceeded $500 million. Its primary competitors include Clobetasol, Hydrocortisone, and Mometasone-based formulations like Nasonex (for nasal indications).

What Are the Core Investment Fundamentals?

Patent and Regulatory Landscape

ELOCON's patent protections came under significant pressure with expiration dates ranging from 2020 to 2025 across various markets. Its patent cliffs have led to increased generic competition in key regions, notably the U.S. and Europe.

Regulatory approvals remain valid, but the expiry of exclusivity rights affects pricing dynamics and market share. Patent expirations typically expose brands like ELOCON to generic erosion unless complemented by formulation or delivery patent protections.

Revenue and Market Share Trends

ELOCON's revenue growth has plateaued owing to generic entry, with recent sales figures stabilizing around $500 million globally. Industry estimates suggest that branded corticosteroid sales witness a 10-15% decline post-generic entry, with some markets experiencing sharper drops.

Market share analysis indicates that ELOCON maintained approximately 11% of the topical corticosteroid market in its peak years, but this has declined to around 5-7% post-generic competition.

R&D Pipeline and Lifecycle Management

The parent company has invested in new formulations, such as foam or gel versions, to extend product lifecycle. There are also ongoing clinical trials exploring new indications, such as atopic dermatitis and seborrheic dermatitis, which could open additional markets.

However, no major reformulations or new indications have received regulatory approval recently. The pipeline lacks substantial near-term catalysts.

Pricing and Reimbursement Environment

Pricing pressure is intense in developed markets due to generic competition, leading to steep discounts and reduced profit margins. Reimbursement policies are generally favorable but vary by country; high out-of-pocket expenses can limit access, especially in economically constrained regions.

Emerging markets offer growth opportunities due to increased healthcare access, but pricing flexibility and regulatory hurdles delay revenue realization.

Competitive and Regulatory Risks

The key risks include:

• Entry of biosimilars or new generic formulations reducing market share.
• Stricter regulatory guidelines in major markets impacting product approvals.
• Potential formulation patents being challenged or invalidated.

Financial Position and Valuation

The company's dermatology division, which includes ELOCON, reports EBITDA margins of approximately 20%. Given reduced revenues and rising competition, EBIT margins are under pressure.

Valuation models suggest that ELOCON's brand value has declined, with enterprise value estimates in the range of $2-3 billion, reflecting diminishing exclusivity benefits and increasing generic competition.

Key Investment Points

• Market Position: ELOCON is facing increased generic competition from 2020 onward; its peak sales are unlikely to recur unless new indications or formulations succeed.
• Revenue Outlook: Flat or declining revenues expected without new growth drivers; risk of further erosion in developed markets.
• Pipeline and Lifecycle Strategies: Limited near-term innovations; reliance on regional formulations and indications.
• Pricing and Market Dynamics: Strong pressure in mature markets, but potential growth in emerging economies.
• Financial Health: Moderate profitability; declining revenue impacts margins and cash flow.

Key Takeaways

Investors should consider ELOCON's limited growth prospects due to patent expiry, aggressive generic competition, and a lack of near-term pipeline catalysts. Opportunities lie in emerging markets and niche indications, but these are offset by regulatory, pricing, and competitive risks.

Frequently Asked Questions

1. How does patent expiration affect ELOCON's sales?

Patent expiration exposes ELOCON to generic competition, significantly reducing its market share and pricing power, leading to sales decline. Post-2019, U.S. patent cliff contributed to markdowns in revenue.

2. Are there new formulations or indications for ELOCON?

Current pipeline developments focus on alternative formulations like foam or gel, along with clinical trials for other dermatologic conditions. No recent approvals have been announced.

3. What are the main competitors to ELOCON?

Major competitors include generic mometasone furoate products, Clobetasol, Hydrocortisone, and other branded corticosteroids like Elocon (brand name for mometasone). Biosimilars and generics dominate the market post-patent expiry.

4. What is the outlook for pricing in key markets?

Pricing faces downward pressure in mature markets due to generic competition. Emerging markets offer growth prospects but at lower price points and with varying reimbursement frameworks.

5. Is there potential for strategic licensing or partnerships?

Potential exists for licensing agreements aimed at developing new formulations or indications, but current trends show limited activity in this area.

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References

1. IQVIA, "Topical Corticosteroid Market Data 2022," 2023.
2. U.S. Patent Office, "Patent Cliff Analysis for Mometasone," 2022.
3. Company Securities Filings, Q4 2022.
4. Reuters, "Pharmaceuticals Industry Reports," 2023.
5. EvaluatePharma, "Market Access and Pricing Reports," 2022.