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
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	3
Patent Applications:	4,642
Drug Prices:	Drug price information for ELOCON
What excipients (inactive ingredients) are in ELOCON?	ELOCON excipients list
DailyMed Link:	ELOCON at DailyMed

See drug prices for ELOCON

Recent Clinical Trials for ELOCON

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

Sponsor	Phase
LEO Pharma	Phase 1
University of Oulu	Phase 4
Schering-Plough	Phase 4

See all ELOCON clinical trials

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
Organon	ELOCON	mometasone furoate	LOTION;TOPICAL	019796-001	Mar 30, 1989		DISCN	Yes	No

Expired US Patents for ELOCON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	ELOCON	mometasone furoate	OINTMENT;TOPICAL	019543-001	Apr 30, 1987	4,472,393*PED
Organon	ELOCON	mometasone furoate	CREAM;TOPICAL	019625-001	May 6, 1987	4,472,393*PED
Organon	ELOCON	mometasone furoate	LOTION;TOPICAL	019796-001	Mar 30, 1989	4,775,529*PED
Organon	ELOCON	mometasone furoate	LOTION;TOPICAL	019796-001	Mar 30, 1989	4,472,393*PED
Organon	ELOCON	mometasone furoate	CREAM;TOPICAL	019625-001	May 6, 1987	4,808,610*PED

International Patents for ELOCON

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

Country	Patent Number	Title	Estimated Expiration
Mexico	9203395	COMPOSICION DE CREMA ANTIINFLAMATORIA DE FUROATO DE MOMETASONA USANDO HEXILENGLICOL.
Japan	H02500976
Finland	78111
Ireland	872633
Finland	820280
World Intellectual Property Organization (WIPO)	8802257
Kenya	3694	AROMATIC HETEROCYCLIC ESTERS OF STEROIDS,THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM

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
3043773	2022C/520	Belgium		PRODUCT NAME: MOMETASONE OF EEN ZOUT HIERVAN EN OLOPATADINE OF EEN ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: BE595626 20220203
0057401	94C0002	Belgium		PRODUCT NAME: MOMETASONI FUROAS; NAT. REG.: 304 S 131 F 7 19930813; FIRST REG.: GR 10681/89 19900622
3043773	2190041-0	Sweden		PRODUCT NAME: MOMETASONE OR A SALT THEREOF AND OLOPATADINE OR A SALT THEREOF; NAT. REG. NO/DATE: MT NR 60226 20210519; FIRST REG.: AT APPROVAL NR 140638 20210426
3043773	132021000000191	Italy		PRODUCT NAME: MOMETASONE O UN SUO SALE E OLOPATADINA O UN SUO SALE(RYALTRIS); AUTHORISATION NUMBER(S) AND DATE(S): 048499014, 048499026, 048499038, 20210726;140638, 20210426
0057401	94C0004	Belgium		PRODUCT NAME: MOMETASONI FUROAS; NAT REG.: 304 S 133 F 7 19930813; FIRST REG.: GR 10682/89 19900622
0112669	96C0002	Belgium		PRODUCT NAME: MOMETASONE FUROATE; NAT. REGISTRATION NO/DATE: NL 19601 19950919; FIRST REGISTRATION: GR - 10681/89 19900622

Market Dynamics and Financial Trajectory for ELOCON

Last updated: July 28, 2025

Introduction

ELOCON, an established topical corticosteroid branded medication, is widely used for dermatological conditions such as eczema, dermatitis, and psoriasis. Its active ingredient, mometasone furoate, is recognized for its potent anti-inflammatory and immunosuppressive properties, making it a preferred choice among clinicians globally. Understanding the market dynamics and financial trajectory of ELOCON involves analyzing its clinical efficacy, market penetration, competitive landscape, regulatory considerations, and evolving healthcare trends.

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Product Overview and Market Position

ELOCON's efficacy, combined with a relatively favorable safety profile, has cemented its position in the dermatological segment. As a mid-to-high potency corticosteroid, its applications extend across diverse patient populations, from pediatric to adult cases. The medication’s brand recognition, backed by robust R&D, regulatory approvals, and strong distribution channels, enhances its market presence.

Globally, ELOCON occupies a substantial share within the topical corticosteroid segment. Its primary markets include North America, Europe, and Asia-Pacific, where the incidence of dermatological conditions—impacted by rising pollution, urbanization, and increased awareness—continues to grow.

Market Dynamics Influencing ELOCON

1. Rising Prevalence of Dermatological Conditions

The global burden of skin diseases has escalated, driven by environmental factors, lifestyle changes, and an aging population. According to the Global Burden of Disease Study, skin conditions account for significant morbidity worldwide, prompting increased demand for effective topical therapies like ELOCON [1].

2. Regulatory Landscape and Patent Status

While the original formulation enjoys patent protection, patent expirations are approaching or have occurred in several jurisdictions, leading to the entry of generics. This introduces price competition but also broadens access and volume sales. Regulatory agencies such as the FDA and EMA reinforce stringent safety evaluations, impacting market strategies and formulations.

3. Competitive Environment

ELOCON’s main competitors include other topical corticosteroids such as hydrocortisone, clobetasol, betamethasone, and generic equivalents. The market also witnesses competition from non-steroidal anti-inflammatory agents and biologics in more severe cases. Price sensitivity and physician prescribing habits heavily influence market share dynamics.

4. Regional Variance in Adoption

Resource-rich markets like North America and Western Europe favor brand continuity and physician preference, underpinning higher margins for ELOCON. Conversely, emerging markets such as India and Southeast Asia, characterized by cost-conscious consumers and expanding healthcare infrastructure, see increased penetration of generic formulations.

5. Healthcare Trends and Consumer Preferences

Growing consumer awareness and preference for efficacious, minimal-side-effect medications foster increased adoption of ELOCON. Additionally, the shift toward outpatient dermatology clinics and online medicine sales channels accelerates accessibility and market reach.

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Financial Trajectory and Revenue Drivers

1. Revenue Trends and Market Share

ELOCON’s revenues are driven by volume sales in established markets and incremental market penetration in emerging economies. Despite patent challenges, revenue stability is maintained through brand loyalty and clinical efficacy. Significant revenue contributions originate from chronic conditions requiring long-term therapy, such as eczema.

2. Impact of Patent Expirations and Generics

Patent expiry typically results in revenue erosion owing to generic competition. However, pharmaceutical companies often counteract this through the launch of new formulations—such as combination products or variants with improved delivery—and marketing strategies emphasizing brand loyalty.

3. Pricing Strategies and Reimbursement Landscape

Pricing remains a critical determinant of financial performance. Direct-to-consumer advertising, insurance reimbursement policies, and healthcare provider prescribing behaviors influence pricing strategies. Countries with universal healthcare systems may impose price caps, limiting revenue growth but maintaining volume.

4. Strategic Collaborations and Market Expansion

Partnerships with local distributors and direct market entries foster growth. Volumes escalate in emerging markets via targeted awareness campaigns and affordability initiatives. Investment in digital marketing and teledermatology services further expands the reach.

5. R&D Pipeline and Product Innovation

Continued investment in R&D aims to develop novel formulations, including low-potency corticosteroids, combination therapies, and non-steroidal alternatives, which could diversify revenue streams and sustain market relevance.

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Future Outlook and Key Market Drivers

The market for ELOCON and similar dermatological therapies is projected to grow at a compounded annual growth rate (CAGR) of approximately 4-6% over the next five years, driven by:

• Increased prevalence and diagnosis of skin conditions
• Geographic expansion into underserved markets
• Innovation in drug formulations to enhance safety and compliance
• Rising dermatological awareness and patient advocacy

Regulatory shifts emphasizing safety and side-effect profiles may influence formulation development, impacting future sales. Additionally, the integration of digital health solutions for monitoring and managing dermatological conditions is poised to improve patient adherence and outcomes, indirectly benefiting topically administered drugs like ELOCON.

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Strategic Implications for Stakeholders

Pharmaceutical companies should focus on maintaining brand relevance through innovation and global expansion, especially in emerging markets.

Healthcare providers benefit from understanding the positioning of ELOCON within its therapeutic class to optimize treatment pathways.

Investors need to monitor patent status timelines, regulatory developments, and competitive dynamics to assess long-term revenue stability.

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Key Takeaways

• ELOCON maintains a strong market position driven by clinical efficacy, especially in dermatological conditions with high prevalence.
• Patent expiration and the proliferation of generics pose challenges but are counterbalanced by ongoing innovation and brand loyalty efforts.
• Emerging markets represent significant growth opportunities, supported by increasing healthcare infrastructure and rising dermatological disease burden.
• Regulatory standards emphasizing safety foster innovation in formulation, which can influence the drug's financial trajectory.
• Digital health initiatives and strategic collaborations are critical to expanding ELOCON’s market reach and sustaining revenue growth.

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FAQs

Q1: How does patent expiration impact ELOCON's market performance?
Patent expiration typically leads to increased generic competition, reducing prices and margins. However, brand loyalty and formulation innovations can mitigate revenue declines.

Q2: What factors are driving growth in ELOCON’s emerging markets?
Increased prevalence of dermatological conditions, expanding healthcare access, affordability initiatives, and strategic marketing efforts foster growth.

Q3: How does regulatory scrutiny influence ELOCON’s market dynamics?
Regulatory agencies enforce safety standards, impacting formulation development and approval processes. Stringent regulations may delay new formulations but also enhance brand credibility.

Q4: Are there new formulations or combinations of ELOCON being developed?
Yes, ongoing R&D efforts aim to improve safety profiles and efficacy through combination products, lower potency versions, and non-steroidal therapies.

Q5: What are the main challenges facing ELOCON’s market outlook?
Key challenges include patent cliff effects, aggressive pricing pressures from generics, and competitive innovations from alternative therapies.

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References

[1] Global Burden of Disease Study, 2021. "Prevalence and Impact of Skin Diseases."