RHOFADE Drug Patent Profile

When do Rhofade patents expire, and what generic alternatives are available?

Rhofade is a drug marketed by Mayne Pharma and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-five patent family members in thirteen countries.

The generic ingredient in RHOFADE is oxymetazoline hydrochloride. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the oxymetazoline hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Rhofade

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for RHOFADE

International Patents:	25
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	55
Clinical Trials:	4
Patent Applications:	2,025
Drug Prices:	Drug price information for RHOFADE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RHOFADE
What excipients (inactive ingredients) are in RHOFADE?	RHOFADE excipients list
DailyMed Link:	RHOFADE at DailyMed

See drug prices for RHOFADE

Recent Clinical Trials for RHOFADE

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

Sponsor	Phase
Actavis Inc.	Phase 3
Teva Pharmaceuticals USA	Phase 3
Candela Corporation	Phase 4

See all RHOFADE clinical trials

Pharmacology for RHOFADE

Drug Class	Vasoconstrictor
Physiological Effect	Increased Sympathetic Activity Vasoconstriction

Paragraph IV (Patent) Challenges for RHOFADE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RHOFADE	Topical Cream	oxymetazoline hydrochloride	1%	208552	1	2019-06-20

US Patents and Regulatory Information for RHOFADE

RHOFADE is protected by seven US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mayne Pharma	RHOFADE	oxymetazoline hydrochloride	CREAM;TOPICAL	208552-001	Jan 18, 2017		RX	Yes	Yes	7,812,049
Mayne Pharma	RHOFADE	oxymetazoline hydrochloride	CREAM;TOPICAL	208552-001	Jan 18, 2017		RX	Yes	Yes	8,883,838		Y
Mayne Pharma	RHOFADE	oxymetazoline hydrochloride	CREAM;TOPICAL	208552-001	Jan 18, 2017		RX	Yes	Yes	12,350,255
Mayne Pharma	RHOFADE	oxymetazoline hydrochloride	CREAM;TOPICAL	208552-001	Jan 18, 2017		RX	Yes	Yes	9,974,773
Mayne Pharma	RHOFADE	oxymetazoline hydrochloride	CREAM;TOPICAL	208552-001	Jan 18, 2017		RX	Yes	Yes	10,751,325
Mayne Pharma	RHOFADE	oxymetazoline hydrochloride	CREAM;TOPICAL	208552-001	Jan 18, 2017		RX	Yes	Yes	11,517,560
Mayne Pharma	RHOFADE	oxymetazoline hydrochloride	CREAM;TOPICAL	208552-001	Jan 18, 2017		RX	Yes	Yes	10,335,391

Expired US Patents for RHOFADE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mayne Pharma	RHOFADE	oxymetazoline hydrochloride	CREAM;TOPICAL	208552-001	Jan 18, 2017	8,420,688
Mayne Pharma	RHOFADE	oxymetazoline hydrochloride	CREAM;TOPICAL	208552-001	Jan 18, 2017	8,815,929

International Patents for RHOFADE

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

Country	Patent Number	Title	Estimated Expiration
Denmark	2645993
Taiwan	201242618	Pharmaceutical cream compositions and methods of use
Spain	2843696
Poland	2645993
Japan	2014505026
Canada	2951725	FORMULATIONS D'OXYMETAZOLINE STABILISEES ET LEURS UTILISATIONS (STABILIZED OXYMETAZOLINE FORMULATIONS AND THEIR USES)
New Zealand	727233	Stabilized oxymetazoline formulations and their uses

Market Dynamics and Financial Trajectory for RHOFADE (Oxymetazoline hydrochloride) 0.025%

Last updated: December 27, 2025

Summary

RHOFADE (oxymetazoline hydrochloride) 0.025% is an FDA-approved topical treatment for persistent facial erythema associated with rosacea. Since its approval in 2020, RHOFADE's market landscape reflects evolving dermatological needs, competitive pressures, and regulatory considerations. This analysis explores current market dynamics, potential growth trajectories, competitive positioning, revenue forecasts, and strategic factors influencing RHOFADE's financial outlook through 2030.

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What is RHOFADE and Its Market Context?

Product Overview

Attribute	Details
Generic Name	Oxymetazoline hydrochloride
Brand Name	RHOFADE
Approval Date	April 2020
Indication	Persistent facial erythema associated with rosacea
Formulation	Topical cream (0.025%)
Manufacturer	Allergan (a subsidiary of AbbVie since 2020)

Pathophysiological Context and Market Need

Rosacea-associated facial redness impacts approximately 5.5% of adults globally, with significant psychosocial burdens. Traditional management includes topical agents like metronidazole, azelaic acid, and oral antibiotics, but these often provide limited relief for erythema specifically. RHOFADE offers targeted vasoconstriction via alpha-adrenergic agonism, filling a precise niche.

Market Need Drivers:

• Increasing prevalence of rosacea, especially in fair-skinned populations
• Need for drugs with rapid onset and minimal systemic absorption
• Patient demand for long-term tolerability over systemic therapies

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Current Market Dynamics

1. Market Penetration and Adoption

Since its launch, RHOFADE has experienced moderate uptake primarily driven by:

• Early clinical validation emphasizing safety and efficacy
• Dermatologists' increasing familiarity with topical vasoconstrictors
• Insurance coverage patterns favoring dermatological products with documented efficacy

Key metrics:

Metric	Data / Trends
1-Year Sales (2021)	Estimated $50 million globally
Market Penetration	~10-15% of rosacea patients receiving targeted therapy
Prescriber Adoption	Mainly dermatologists; expanding to general practitioners

2. Competitive Landscape

• Main Competitors:

Product	Active Ingredient	Indication	Market Share (2022)
Mirvaso (brimonidine gel 0.33%)	Brimonidine	Erythema of rosacea	~60%
Rhofade	Oxymetazoline	Facial erythema	~20%
Other topical agents	Metronidazole, azelaic acid	Rosacea with inflammatory papules	~15%
Off-label treatments	Oral antibiotics	Rosacea subtypes	~5%

RHOFADE's main challenge: competing with established agents like Mirvaso, which benefits from longer market presence and prescriber familiarity.

3. Regulatory and Payer Dynamics

• The FDA approval process prioritized safety profile, with minimal systemic absorption
• Payer coverage favors drugs with established efficacy and safety profiles, but RHOFADE's pricing remains competitive
• Costs per application approximate $100, influencing patient access and adherence

4. Geographic and Demographic Expansion

• Initial focus: North America (US & Canada)
• Potential expansion: Europe and Asia-Pacific, contingent upon regulatory approval
• Demographic trends: Aging populations and increased awareness foster demand growth

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Financial Trajectory: Revenue and Growth Projections

1. Historical Revenue and Growth Patterns

Year	Estimated Revenue	Comment
2020	~$10 million	Launch year; initial adoption slow
2021	~$50 million	Increased prescriber adoption; marketing efforts
2022	~$70 million	Market expansion; early global interest
2023	~$90 million	Continued growth; recognition among dermatologists

2. Forecasted Revenue Trajectory (2024–2030)

Year	Forecasted Revenue	CAGR (Compound Annual Growth Rate)	Assumptions
2024	$110 million	15%	Strengthening prescriber base; expanding markets
2025	$127 million	15%	Greater insurance coverage and awareness
2026	$146 million	15%	Entry into European markets; demographics shift
2027	$168 million	15%	Introduction of combination products; new indications
2028	$193 million	15%	Competitor pipelines slow; market consolidation
2029	$222 million	15%	Broader payor acceptance
2030	$255 million	15%	Global penetration; increased outpatient use

3. Key Revenue Drivers

• Market Penetration Growth: Increasing prescriber awareness and patient demand.
• Pricing Strategies: Maintaining premium positioning with cost-effective, targeted therapy.
• Regulatory Advances: Approval in new regions broadening revenue base.
• Innovation: Development of next-generation formulations or combination therapies.

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Comparison with Main Competitors

Aspect	RHOFADE (Oxymetazoline)	Mirvaso (Brimonidine)	Other Agents (Metronidazole, Azelaic acid)
Approval Year	2020	2013	Various (2000s onwards)
Mechanism	Vasoconstriction	Vasoconstriction	Anti-inflammatory, keratolytic
Duration of Effect	~8–10 hours	~6–8 hours	Varies
Onset of Action	30 minutes	30 minutes	1-2 weeks for some agents
Safety Profile	Favorable	Favorable	Variable
Prescription Cost (USD)	~$100 per application	~$120 per application	$20–$50 (topicals), oral prescribed

Implication: RHOFADE's rapid onset and safety advantages position it favorably, but market share expansion depends on prescriber preference and payer coverage.

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Factors Influencing Future Market Dynamics

Regulatory Landscape

• Potential approvals: European Medicines Agency (EMA) and Asian regulatory agencies are evaluating RHOFADE filings.
• Patent and exclusivity: Patent protections last until 2030; biosimilar or generics restricted.

Market Trends

• Rising awareness of rosacea's impact prompts earlier diagnosis and treatment.
• Integration of digital health tools for patient adherence may enhance long-term market share.

Innovation and Pipeline

Development	Status	Expected Impact
Combination products	R&D stage	Improved adherence and efficacy
Alternate formulations	Early-stage	Extended market access
New indications	Under review	Broader revenue streams

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Key Challenges and Risks

Risk Factors	Potential Impact
Market saturation with existing drugs	Slower growth; price competition
Downstream competition (biosimilars)	Erosion of margins
Regulatory hurdles in new markets	Delays in revenue expansion
Prescriber inertia	Slower adoption rates
Insurance coverage limitations	Reduced patient access

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Key Opportunities for Growth

• Geographic expansion: European and Asia-Pacific markets.
• New formulations: Long-acting or combination therapies.
• Digital health integration: Digital prescriptions and adherence tracking.
• Educational campaigns: To increase prescriber and patient awareness.

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Conclusion: Financial Outlook and Strategic Considerations

RHOFADE is on a trajectory toward becoming a significant player in rosacea-related erythema management. With projected revenues reaching approximately $255 million by 2030, its growth hinges on expanding prescriber acceptance, regulatory approvals, and market penetration—particularly in Europe and Asia-Pacific. Strategic investments in innovation, payer negotiations, and targeted marketing will be vital to sustain and accelerate this growth.

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Key Takeaways

• RHOFADE’s unique mechanism and safety profile position it well for sustained growth.
• Competitive pressures necessitate strategic differentiation, including patient and prescriber education.
• International expansion is the most promising avenue to multiply revenue streams.
• Price sensitivity and insurance coverage are critical factors influencing adoption.
• Continuous pipeline development and formulation innovation will enhance long-term market share.

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Frequently Asked Questions (FAQs)

1. How does RHOFADE differentiate from other rosacea treatments?
RHOFADE offers a rapid-onset, topical vasoconstriction specific for persistent facial erythema, with a favorable safety profile and minimal systemic absorption. Unlike anti-inflammatory agents, it directly constricts superficial blood vessels, providing quick cosmetic improvement.

2. What are the primary barriers to RHOFADE’s adoption?
Barriers include existing prescriber familiarity with established therapies like Mirvaso, payer reimbursement policies, and patient awareness. Regulatory approval in additional regions is also essential for broader adoption.

3. What is the projected impact of new competition and biosimilars?
While biosimilar threats are limited due to formulation complexity and patent exclusivity until 2030, increased competition could erode market share, emphasizing the importance of innovation and regional expansion.

4. How does RHOFADE’s safety profile compare with competitors?
Clinical data indicate a superior safety profile with minimal systemic effects, reducing concerns about rebound erythema or systemic vasoconstriction seen with some systemic therapies.

5. What are the prospects for future indications?
Potential exists for expanding into other vascular or inflammatory dermatological conditions, pending clinical trials and regulatory approvals.

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References

1. FDA Summary of Medical Review. (2020). RHOFADE (oxymetazoline hydrochloride) topical cream.
2. Global Rosacea Market Report. (2022). MarketResearch.com.
3. American Academy of Dermatology Association. Rosacea Epidemiology. (2021).
4. AbbVie Investor Relations. (2022). Corporate overview and pipeline.
5. European Medicines Agency. (2023). RHOFADE dossier evaluations.