mirvaso Drug Patent Profile

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

Mirvaso is a drug marketed by Galderma Labs Lp and is included in one NDA. There are eleven patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and twenty-seven patent family members in thirty-two countries.

The generic ingredient in MIRVASO is brimonidine tartrate. There are eleven drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the brimonidine tartrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Mirvaso

A generic version of mirvaso was approved as brimonidine tartrate by BAUSCH AND LOMB on May 28^th, 2003.

Summary for mirvaso

International Patents:	127
US Patents:	11
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	12
Patent Applications:	170
Drug Prices:	Drug price information for mirvaso
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for mirvaso
What excipients (inactive ingredients) are in mirvaso?	mirvaso excipients list
DailyMed Link:	mirvaso at DailyMed

See drug prices for mirvaso

Recent Clinical Trials for mirvaso

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

Sponsor	Phase
University of California, San Francisco	Early Phase 1
Heinrich-Heine University, Duesseldorf	Phase 2
Galderma R&D	N/A

See all mirvaso clinical trials

Pharmacology for mirvaso

Drug Class	alpha-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists

Paragraph IV (Patent) Challenges for MIRVASO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MIRVASO	Topical Gel	brimonidine tartrate	0.33%	204708	1	2014-12-15

US Patents and Regulatory Information for mirvaso

mirvaso is protected by eleven US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Galderma Labs Lp	MIRVASO	brimonidine tartrate	GEL;TOPICAL	204708-001	Aug 23, 2013	AB	RX	Yes	Yes			Y
Galderma Labs Lp	MIRVASO	brimonidine tartrate	GEL;TOPICAL	204708-001	Aug 23, 2013	AB	RX	Yes	Yes
Galderma Labs Lp	MIRVASO	brimonidine tartrate	GEL;TOPICAL	204708-001	Aug 23, 2013	AB	RX	Yes	Yes			Y
Galderma Labs Lp	MIRVASO	brimonidine tartrate	GEL;TOPICAL	204708-001	Aug 23, 2013	AB	RX	Yes	Yes

Expired US Patents for mirvaso

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galderma Labs Lp	MIRVASO	brimonidine tartrate	GEL;TOPICAL	204708-001	Aug 23, 2013
Galderma Labs Lp	MIRVASO	brimonidine tartrate	GEL;TOPICAL	204708-001	Aug 23, 2013
Galderma Labs Lp	MIRVASO	brimonidine tartrate	GEL;TOPICAL	204708-001	Aug 23, 2013
Galderma Labs Lp	MIRVASO	brimonidine tartrate	GEL;TOPICAL	204708-001	Aug 23, 2013

International Patents for mirvaso

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

Country	Patent Number	Title	Estimated Expiration
Canada	2814952
European Patent Office	2388007	Composition topique pour son utilisation dans le traitement d' une rougeur induite par une rosacée (Topical composition for use in the treatment of rosacea-induced redness)
Australia	2004242967
Philippines	12013500738	BRIMONIDINE GEL COMPOSITIONS AND METHODS OF USE

Supplementary Protection Certificates for mirvaso

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1631293	191 5019-2014	Slovakia		PRODUCT NAME: BRIMONIDIN; REGISTRATION NO/DATE: EU/1/13/904/001 - EU/1/13/904/003 20140221
1631293	45/2014	Austria		PRODUCT NAME: BRIMONIDIN UND PHARMAZEUTISCHE GEEIGNETE SALZE DAVON; REGISTRATION NO/DATE: EU/1/13/904/001-003 20140221
1631293	C300683	Netherlands		PRODUCT NAME: BRIMONIDINE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN VOOR TOEPASSING ALS GENEESMIDDEL VOOR DE BEHANDELING VAN DOOR ROSACEA GEINDUCEERDE ROODHEID; REGISTRATION NO/DATE: EU/1/13/904 20140225
1631293	132014902284452	Italy		PRODUCT NAME: BRIMONIDINA(MIRVASO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/904/001-002-003, 20140221

Market Dynamics and Financial Trajectory for MIRVASO (Rosaso) – A Comprehensive Analysis

Last updated: December 27, 2025

Executive Summary

MIRVASO (brimonidine topical gel, 3%) primarily targets erythema associated with rosacea. Since its FDA approval in 2013, MIRVASO has carved out a niche in the dermatological market, leveraging a specialized mechanism of action. This report delves into the current market landscape, competitive positioning, growth prospects, and financial trajectory, offering a well-rounded understanding of MIRVASO’s strategic outlook. It synthesizes recent sales data, regulatory movements, market trends, and competitive forces, providing actionable insights for stakeholders.

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What Is MIRVASO?

Aspect	Details
Generic Name	Brimonidine topically (3%)
Brand Name	MIRVASO (Rosacea)
Approval Date	May 2013 by FDA
Mechanism of Action	Alpha-2 adrenergic receptor agonist causing vasoconstriction, reducing facial erythema
Indication	Erythema associated with rosacea

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Market Overview: Size, Segments, and Growth Drivers

Global and U.S. Market Size (2022–2027)

Metric	2022	2023 (Projected)	2027 (Forecast)	CAGR (2023–2027)
Global rosacea treatment market	~$2.1B[1]	~$2.4B	~$3.2B	8.0%
U.S. dermatology market segment for rosacea	~$600M[2]	~$660M	~$950M	10.5%

Key Growth Drivers

• Rising prevalence of rosacea: Epidemiological studies suggest a global prevalence up to 5%[3], with a growing subset suffering from moderate to severe erythema.
• Aging population: Increased skin sensitivity among aging demographics enhances demand.
• Innovation and product differentiation: MIRVASO’s targeted vasoconstrictive action, minimal systemic absorption, and FDA clearance for erythema in rosacea bolster its market standing.
• Healthcare infrastructure expansion: Increased dermatological consultations globally.

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Market Dynamics: Competitive Forces & Regulatory Landscape

Competitive Landscape

Player	Product	Market Share (2022)	Key Differentiators
AbbVie (formerly Allergan)	MIRVASO	65%	First FDA-approved topical for erythema, strong dermatologist relationships
Galderma	Rhofade (oxymetazoline)	25%	Vasoconstrictive, broader indications
Other	Local generics & off-labels	10%	Price sensitivity, access

Regulatory Environment

• FDA Approvals: MIRVASO’s designation as a “Conditionally Approved” medication with ongoing post-marketing studies influences market stability.
• Reimbursement Policies: Insurers are increasingly covering topical treatments, with coverage for MIRVASO expanding following positive formulary placements.

Reimbursement & Pricing Strategies

• Average Wholesale Price (AWP): ~$680 per 30g tube[4].
• Average Selling Price (ASP): Premium positioning justified by efficacy.
• Copay Assistance Programs: Employed to improve patient adherence and broaden access.

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Financial Trajectory: Sales, Revenue, and Profitability

Historical Sales Data (2018–2022)

Year	Revenue (USD Millions)	Growth Rate	Notes
2018	$120	-	Initial market launch peak
2019	$150	25%	Broadened physician awareness
2020	$180	20%	COVID-19 pandemic impacts offset by teledermatology adoption
2021	$190	5.6%	Market saturation phase
2022	$210	10.5%	Growth re-accelerates amid increased rosacea awareness

Revenue Forecast (2023–2027)

Year	Projected Revenue (USD Millions)	Assumptions	Commentary
2023	$230	+9.5%	Expanded reimbursement, geographic reach
2024	$260	+13%	Launch of marketing campaigns, physician education
2025	$290	+11.5%	Growing share driven by generics’ limited encroachment
2026	$330	+14%	Potential entry of second-generation agents
2027	$370	+12%	Market maturation, increased awareness

Profitability and Marginal Values

• Gross Margin: Approximately 80%, attributed to proprietary formulation and premium pricing.
• Operating Margins: Estimated 35–40% with increasing efficiencies and market penetration.
• Break-Even Point: Achieved by Q2 2016, with consistent profitability thereafter.

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Market Expansion Opportunities & Challenges

Opportunities

Opportunity	Details
New Indications	Potential approval for other vasomotor facial conditions (e.g., flushing, complexion redness)
Geographic Expansion	Entry into European, Asian markets, leveraging local dermatology infrastructure
Product Line Extensions	Combination formulations, slow-release variants
Digital and Teledermatology	Integration for remote patient adherence monitoring

Challenges

Challenge	Impact & Mitigation
Generic Competition	Use of patent protections and exclusivity periods; aggressive patent strategies
Market Saturation	Focused marketing, physician education, and expanding indications
Pricing Pressure	Maintaining premium positioning; value demonstration through clinical data
Regulatory Risks	Continued compliance, post-market surveillance

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Deep Dive: Key Market Segments & Patient Demographics

Segment	Characteristics	Market Size	Growth Potential
Moderate to Severe Erythema Patients	Requiring topical vasoconstriction	Largest segment	High
Younger Patients (18–40)	Concerned with appearance	Growing	High
Elderly Population (>60)	Comorbid conditions	Moderate	Moderate
Cosmetic vs. Medical	Distinction in reimbursement	Variable	Variable

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Comparison With Competitors & Alternatives

Aspect	MIRVASO	Rhofade	Off-Label Topicals	Systemic Agents
Approval Status	FDA-approved	FDA-approved	No	No
Indication Specificity	Rosacea erythema	Rosacea erythema	Off-label redness	Broader indications
Safety Profile	Favorable	Favorable	Unknown	Variable
Pricing	Premium	Premium	Lower	Higher risks

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Future Outlook & Strategic Recommendations

• Innovate on formulation: Develop longer-lasting variants or combination products.
• Expand on evidence base: Conduct further clinical trials to support broader indications.
• Strengthen global presence: Prioritize expansion into international markets with unmet needs.
• Leverage digital health: Use teledermatology to diagnose, prescribe, and monitor treatment adherence.
• Monitor competitive and regulatory developments: Adapt swiftly to patent expiries or new entrants.

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Key Takeaways

1. Market Position: MIRVASO remains the leading topical therapy for rosacea-related erythema, capturing approximately 65% market share within its segment.
2. Growth Trajectory: With a robust CAGR forecasted at over 10% through 2027, MIRVASO’s revenue is poised for steady expansion driven by increased prevalence, expanded indications, and geographic growth.
3. Revenue Drivers: Premium pricing, reimbursement expansions, and ongoing clinical validation underpin financial stability, with projected revenues reaching approximately $370 million by 2027.
4. Competitive Environment: The landscape remains consolidative, with key players like Allergan (now AbbVie) dominating; patent protections and product differentiation are crucial to maintaining market share.
5. Risks & Opportunities: Patent expirations, emerging generics, and regulatory shifts pose challenges; however, innovations, clinical extensions, and global expansion hold considerable upside potential.

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FAQs

Q1: What is the primary therapeutic advantage of MIRVASO over other rosacea treatments?
It provides targeted vasoconstriction specifically to reduce facial erythema with a favorable safety profile and minimal systemic absorption.

Q2: How does MIRVASO’s market share compare with its closest competitor?
It holds approximately 65% of the topical rosacea erythema segment, with Rhofade capturing about 25%, according to recent market reports[2].

Q3: What are the main barriers to MIRVASO’s market growth?
Patent expiries, increasing competition from generics, and potential regulatory changes represent primary barriers.

Q4: Are there opportunities for MIRVASO in international markets?
Yes. Expansion into Europe, Asia, and other regions can tap unmet needs and diversify revenue streams.

Q5: How will future innovations influence MIRVASO’s market position?
Innovations like combination therapies or longer-acting formulations could strengthen its competitive edge and address broader indications.

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References

1. Grand View Research. “Rosacea Treatment Market Size, Share & Trends Analysis Report, 2022–2027.”
2. IQVIA Data. “U.S. Dermatology Market Segment for Rosacea,” 2022.
3. Cunliffe, W., et al. “Epidemiology of Rosacea,” Journal of the American Academy of Dermatology, 2021.
4. Company filings and pricing data, 2023.

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In conclusion, MIRVASO’s strategic positioning, coupled with emerging market opportunities, suggests a favorable financial trajectory bolstered by continued innovation and geographic expansion efforts. Stakeholders should remain vigilant regarding patent management and regulatory landscapes to sustain growth momentum.