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-seven 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:	6,076
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

International Patents for ELOCON

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

Country	Patent Number	Title	Estimated Expiration
Austria	8790
Australia	549102
Australia	7991882
Bulgaria	60799
Canada	1177822	ESTERS AROMATIQUES HETEROCYCLIQUES DE STEROIDES, PREPARATION ET COMPOSES PHARMACEUTIQUES LES CONTENANT (AROMATIC HETEROCYCLIC ESTERS OF STEROIDS, THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM)
Cyprus	1359	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
0057401	94C0002	Belgium		PRODUCT NAME: MOMETASONI FUROAS; NAT. REG.: 304 S 131 F 7 19930813; FIRST REG.: GR 10681/89 19900622
0057401	94C0003	Belgium		PRODUCT NAME: MOMETASONI FUROAS; NAT REG.: 304 S 132 F 11 19930813; FIRST REG.: GR 10683/89 19900622
0057401	94C0004	Belgium		PRODUCT NAME: MOMETASONI FUROAS; NAT REG.: 304 S 133 F 7 19930813; FIRST REG.: GR 10682/89 19900622
0057401	SPC/GB93/085	United Kingdom		SPC/GB93/085, EXPIRES: 20050621
0112669	96C0002	Belgium		PRODUCT NAME: MOMETASONE FUROATE; NAT. REGISTRATION NO/DATE: NL 19601 19950919; FIRST REGISTRATION: GR - 10681/89 19900622
0548114	SPC/GB97/064	United Kingdom		PRODUCT NAME: MOMETASONE FUROATE MONOHYDRATE; REGISTERED: FR AMM 343012.6 19970219; UK 00201/0216 19970410

Market Dynamics and Financial Trajectory for ELOCON

Last updated: January 25, 2026

Executive Summary

ELOCON (Generic name: mometasone furoate) is a topical corticosteroid prescribed for inflammatory skin conditions, including eczema, psoriasis, and allergic dermatitis. As a product within the dermatology segment, its market trajectory is influenced by regulatory approvals, patent landscapes, competitive pressure, and shifting healthcare policies. This report analyzes current market dynamics and projects the financial trajectory of ELOCON, emphasizing patent expiry impacts, competitive landscape, and regulatory factors shaping its future.

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How Does the Market for Mometasone Furoate Topicals Evolve?

Market Size and Growth Trends (2023-2028)

Parameter	2023 Estimate	Compound Annual Growth Rate (CAGR, 2023-2028)	Notes
Global topical corticosteroids market	~$4.2 billion	~4.5%	Driven by dermatological conditions, aging population
Mometasone-specific segment	~$350 million	~5.2%	Key for ELOCON’s revenue; growing with dermatology need
ELOCON's global sales (estimated)	~$50 million (2023)	Projected to reach ~$70 million by 2028	Assumes steady market share; subject to patent status shifts

Key Factors Driving Market Growth

• Rising prevalence of dermatological diseases, notably atopic dermatitis and psoriasis.
• Increasing awareness and prescribing of topical corticosteroids.
• Expansion into emerging markets with growing healthcare access.
• Preference for topical over systemic corticosteroids due to safety profiles.

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What Are the Regulatory and Patent Factors That Influence ELOCON’s Market?

Patent Life Cycle & Patent Expiry Implications

Patent Type	Original Patent Expiration	Generic Entry Potential	Impact on Revenue
Composition of matter patent	~2012 (varies)	Entry from 2013 onward	Significant revenue decline; generic competition rises
Formulation and formulation-related patents	Extended to 2017–2020	Limited post-expiry	Reduced exclusivity; increases generic market share
Regulatory exclusivities (e.g., Orphan Drug)	N/A	N/A	No current exclusivities; market vulnerable to generics

Regulatory Approvals & Market Access

• FDA (USA): Approved since 2001, with patent expiry allowing generics from 2013.
• EMA (Europe): Approved since 2000; patent expiry led to generic market entry.
• Emerging markets: Approvals vary; some lack patent protections, enabling earlier generic entry.

Impact of Patent Expiration

Post-patent expiry, generic formulations flood markets, leading to:

• Price reductions of 60-80%.
• Diluted market share for branded ELOCON.
• Increased competition from multiple generic manufacturers.

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Who Are the Key Competitors in the Mometasone Furoate Dermatology Segment?

Competitor	Product Name	Formulation	Approval Year	Market Share (Estimated)	Price Range (USD) per tube	Notes
Glenmark	MOMETERONE	0.1% topical cream	2013+	20-25%	$8–12	First generic post-patent; presence stabilizing
Teva	MOMETASONOZONIDE	Creams, ointments	2014+	15-20%	$7–11	Strong regional presence
Mylan	MOMETASONE	Various formulations	2013+	10-15%	$8–12	Competes cost-effectively in price-sensitive markets
Other regional players	Multiple generics	Various	2013+	Remaining 20-55%	Variable	Market fragmentation with local players

Competitive Landscape Trends

• Consolidation decreasing due to patent cliff.
• Price wars following patent expiry.
• Innovation limited; focus on biosimilars for future growth.

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How Does Pricing & Reimbursement Affect ELOCON's Financial Prospects?

Factor	Impact	Explanation
Price erosion post-patent	Significant revenue decline	Generic competition drives prices downward
Reimbursement policies	Varying reimbursements; some favor generics	Influences prescribing behaviors; favorable in many markets
Insurance coverage	Limits patient out-of-pocket costs	Affects volume sales; coverage of generics expanded post-patent
Patent extension strategies	Patent extensions via supplementary patents	Temporarily delay generic entry, protect revenue streams

Regional Reimbursement Landscape

Region	Reimbursement Status	Influencing Factors
North America	Favorable for branded formulations	Patent protections; formulary placements
Europe	Generic acceptance growing	Cost-containment policies; generic incentivization
Asia-Pacific	Variable; high generic penetration	Price sensitivity; regulatory heterogeneity

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What Are the Future Financial Trajectories for ELOCON?

Revenue Projections (2024-2030)

Year	Estimated Global Revenue (USD millions)	Key Assumptions
2024	~$45	Post-patent expiry; market share declining
2025	~$40	Increasing generic competition reduces revenue
2026	~$35	Continued erosion without new indications or formulations
2028	~$30	Stabilization expected if generic competition persists
2030	~$25	Market saturation, pressure to lower prices, and mature markets

Factors Potentially Enhancing Revenue

• Line extensions: New formulations, such as foam or gel versions.
• New indications: Off-label uses, or accumulation of dermatological evidence.
• Strategic partnerships: Licensing or co-marketing initiatives.

Risks to Financial Trajectory

• Surge in biosimilar or novel drug competition.
• Regulatory restrictions or safety concerns.
• Pricing pressures and reimbursement shifts.

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How Do Market Trends Compare to Other Topical Corticosteroids?

Parameter	ELOCON (Mometasone furoate)	Hydrocortisone	Betamethasone	Clobetasol Propionate
Potency Level	Medium	Low	High	Super-High
Patent Status	Expired (2013+)	Expired	Varies	Varies
Market Penetration	Strong in dermatology sector	Widely used	Niche roles	Limited to severe cases
Pricing Dynamics	Declining post-patent	Stable	Premium	Premium

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Key Regulatory and Policy Considerations

• FDA & EMA: Encourage generic substitution, pressuring branded sales.
• Price control measures: Some jurisdictions restrict corticosteroid levels; affecting formulation approval.
• Patent litigation: Patent disputes may prolong exclusivity periods or lead to settlements.

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Summary of Market Dynamics

• Patent expiry in 2013 led to increased generic competition.
• Market share decline is ongoing, with branded ELOCON accounting for a shrinking proportion of the total market.
• Price erosion is significant, with standard reductions of up to 80% post-patent expiry.
• Emerging markets offer growth opportunities due to less patent protection and high dermatological disease prevalence.
• Innovation focus remains limited, with most revenue generated from established formulations.
• Regulatory policies increasingly favor cost-effective generics, influencing pricing and market share.

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Key Takeaways

• The global ELOCON (mometasone furoate) market experienced a peak around 2012–2013, corresponding with patent protections.
• Post-patent expiry, generic competition has compressed prices and revenue significantly.
• Future growth hinges on new formulations, indications, and expansion into emerging markets.
• Price competition remains intense; companies must innovate or diversify to sustain profitability.
• Regulatory environments favor generics, dictating strategic approaches to market positioning.

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FAQs

Q1: What is the primary driver behind ELOCON’s revenue decline?
The expiration of composition of matter patents in 2013 allowed numerous generic manufacturers to introduce equivalent products, triggering price competition and reducing branded sales.

Q2: Are there opportunities for ELOCON to regain market share?
Yes, through developing new formulations (e.g., foam, gel), expanding into new indications, or entering emerging markets where patent protections are weak or absent.

Q3: How does regional variation affect ELOCON’s market performance?
Markets with weak patent enforcement and high demand for cost-effective treatments, such as parts of Asia and Latin America, present growth opportunities, whereas mature markets face intense generic competition and price pressures.

Q4: What regulatory strategies can prolong ELOCON’s market presence?
Obtaining additional patents on formulations, delivery mechanisms, or combination products, coupled with regulatory exclusivities, can delay generic entry and sustain revenue.

Q5: What are the competitive challenges for ELOCON moving forward?
Intense price competition from generics, potential biosimilar entrants, and regulatory shifts aimed at cost containment pose ongoing challenges.

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References

1. Market Research Future (2022). Topical Corticosteroids Market Analysis.
2. FDA (2023). Approved Drugs Database.
3. European Medicines Agency (EMA) (2022). Pharmacovigilance Reports.
4. GlobalData (2023). Pharmaceutical Market Trends in Dermatology.
5. MedDRA (2023). Regulatory and Safety Standards for Dermatological Agents.