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	8,053,427		Y
Galderma Labs Lp	MIRVASO	brimonidine tartrate	GEL;TOPICAL	204708-001	Aug 23, 2013	AB	RX	Yes	Yes	7,439,241
Galderma Labs Lp	MIRVASO	brimonidine tartrate	GEL;TOPICAL	204708-001	Aug 23, 2013	AB	RX	Yes	Yes	8,513,249		Y
Galderma Labs Lp	MIRVASO	brimonidine tartrate	GEL;TOPICAL	204708-001	Aug 23, 2013	AB	RX	Yes	Yes	8,410,102

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	8,859,551
Galderma Labs Lp	MIRVASO	brimonidine tartrate	GEL;TOPICAL	204708-001	Aug 23, 2013	7,439,241
Galderma Labs Lp	MIRVASO	brimonidine tartrate	GEL;TOPICAL	204708-001	Aug 23, 2013	8,426,410
Galderma Labs Lp	MIRVASO	brimonidine tartrate	GEL;TOPICAL	204708-001	Aug 23, 2013	8,410,102

International Patents for mirvaso

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

Country	Patent Number	Title	Estimated Expiration
South Korea	20170018974
Spain	2627405
Croatia	P20140811
European Patent Office	1631293	COMPOSES, PREPARATIONS ET METHODES DE TRAITEMENT OU DE PREVENTION DE LA ROSACEE (COMPOUNDS, FORMULATIONS, AND METHODS FOR TREATING OR PREVENTING ROSACEA)

Supplementary Protection Certificates for mirvaso

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1631293	14C0056	France		PRODUCT NAME: BRIMONIDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/904 20140225
1631293	122014000080	Germany		PRODUCT NAME: BRIMONIDIN UND PHARMAZEUTISCH AKZEPTABLE SALZE DAVON; REGISTRATION NO/DATE: EU/1/13/904 20140221
1631293	191 5019-2014	Slovakia		PRODUCT NAME: BRIMONIDIN; REGISTRATION NO/DATE: EU/1/13/904/001 - EU/1/13/904/003 20140221
1631293	2014/041	Ireland		PRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/904 20140221

Market Dynamics and Financial Trajectory for MIRVASO: A Comprehensive Analysis

Last updated: July 27, 2025

Introduction

MIRVASO (brimonidine) topical gel represents a significant advancement in the treatment of erythema associated with rosacea. Since its FDA approval in 2013, MIRVASO has carved out a distinct niche within dermatological therapeutics. Its market trajectory is shaped by evolving patient needs, competitive dynamics, regulatory developments, and broader healthcare trends. This analysis offers an in-depth review of MIRVASO's market environment, financial performance, and future growth prospects.

Product Profile and Clinical Positioning

MIRVASO is an alpha-2 adrenergic receptor agonist designed for topical application to reduce persistent facial erythema. It functions by constricting superficial blood vessels, leading to decreased redness. Its targeted mechanism and favorable safety profile differentiate it from systemic therapies and broader dermatological treatments. Its clinician-friendly profile has led to consistent prescribing, especially among patients seeking quick, non-invasive relief.

Market Landscape and Key Competitors

The dermatology market for rosacea treatments encompasses a variety of topical and systemic options, including ivermectin, metronidazole, azelaic acid, and oral tetracyclines. However, MIRVASO’s specificity provides a competitive edge. While other treatments address multiple rosacea symptoms, MIRVASO primarily targets erythema, anchoring its positioning as the go-to therapy for redness.

Emerging competitors, such as oxymetazoline-based formulations, are gradually entering the market, promising similar vasoconstrictive effects but with varied safety and efficacy profiles. The competitive landscape remains dynamic, necessitating continuous product innovation and effective marketing.

Regulatory and Reimbursement Considerations

Regulatory approvals have been stable, with positive safety data supporting MIRVASO's continued use. Reimbursement policies, predominantly through insurance providers, influence patient access. PATIENT adherence and prescription rates depend heavily on formulary placements and copayment structures. The potential for new indications or expanded labeling could further enhance market penetration.

Market Demand Drivers

Increasing awareness of rosacea and its psychosocial impact fuels demand for effective treatments. The rising prevalence of rosacea, estimated at roughly 5% of the adult population globally, sustains robust market potential. Patients and clinicians seek rapid, topical solutions with minimal adverse effects, aligning well with MIRVASO’s profile.

Moreover, aging populations in North America and Europe, along with rising cosmetic consciousness, bolster demand for dermatological therapies that effectively improve appearance without significant downtime.

Financial Trajectory and Sales Performance

Since launch, MIRVASO has demonstrated steady revenue growth, driven by consistent prescription refill rates and expanding geographic reach. Key factors influencing sales include:

• Market Penetration: MIRVASO has achieved significant adoption within dermatology practices, supported by targeted marketing efforts and favorable clinical data.

• Pricing Strategy: Premium pricing reflects its novel mechanism and clinical niche, ensuring healthy margins for manufacturer Valeant Pharmaceuticals (now Bausch Health). Nonetheless, price sensitivity in payers exerts pressure to demonstrate cost-effectiveness.

• Reimbursement Dynamics: Favorable insurance coverage enhances patient access, translating into stable sales volumes.

In recent fiscal reports, MIRVASO contributed approximately $XXX million in annual revenue, reflecting consistent growth, with a compound annual growth rate (CAGR) of roughly X% since launch (as of 2022 data). The product's financial success exemplifies its market acceptance and clinical relevance.

Emerging Opportunities and Growth Strategies

Future growth hinges on several strategic initiatives:

• New Indications: Investigating MIRVASO's efficacy in other vascular or inflammatory dermatological conditions could diversify revenue streams.

• Formulation Enhancements: Developing lower-dose, combination, or extended-release formulations could improve patient convenience and adherence.

• Geographic Expansion: Penetration into emerging markets such as Asia-Pacific and Latin America involves regulatory approval and localized marketing strategies, promising substantial upside.

• Digital Health Integration: Leveraging teledermatology and mobile applications could increase prescription rates, especially post-pandemic.

Challenges and Risks

Market expansion faces obstacles such as:

• Competitive Entry: Newer vasoconstrictor agents could erode MIRVASO’s market share if they demonstrate superior efficacy or affordability.

• Regulatory Capabilities: Stringent compliance requirements, especially in international markets, could delay introductions.

• Pricing Pressures: Payers may negotiate discounts or prefer generics if biosimilar or alternative products emerge.

Conclusion

MIRVASO's market dynamics reflect a well-positioned product in a growing dermatological sector. Its steady financial trajectory signals strong demand, buttressed by targeted mechanisms and clinical specificity. However, ongoing innovation, regulatory navigation, and competitive vigilance are essential to sustain and grow its market presence. The product exemplifies how niche therapies can generate robust revenue streams within the personalized medicine paradigm.

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Key Takeaways

• MIRVASO has established a solid market presence, with consistent revenue growth driven by dermatology-specific demand.
• Competitive dynamics are intensifying with emerging vasoconstrictive agents, necessitating innovation and strategic marketing.
• Regulatory stability and favorable reimbursement policies are critical to expanding MIRVASO’s reach, especially internationally.
• Future growth hinges on exploring new indications, formulations, and geographic markets, amidst an evolving clinical landscape.
• Vigilance against pricing pressures and competitive threats remains essential to safeguard profitability.

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FAQs

1. What are the main factors contributing to MIRVASO’s market stability?
MIRVASO’s targeted efficacy for facial erythema, favorable safety profile, and clinician familiarity underpin its steady demand. Its positioning as a specialized product reduces direct competition, fostering consistent prescriptions.

2. How does MIRVASO compare to emerging vasoconstrictive therapies?
While MIRVASO’s topical formulation offers localized action with minimal systemic exposure, newer agents may provide longer-lasting effects or broader indications. Differentiation depends on efficacy, safety, convenience, and cost considerations.

3. What are the regulatory prospects for MIRVASO’s expansion into new indications?
Clinical trials demonstrating efficacy beyond erythema could facilitate label extensions. Regulatory approval would depend on demonstrating safety and effectiveness in new dermatologic conditions, potentially unlocking additional revenue streams.

4. How does reimbursement policy influence MIRVASO’s market growth?
Insurance coverage and formulary positioning directly impact patient access. Favorable reimbursement encourages prescribers and patients to choose MIRVASO over competing therapies, sustaining sales momentum.

5. What are the key risks facing MIRVASO’s financial outlook?
The primary risks include market entry by biosimilars or alternative therapies, regulatory delays in new markets, pricing pressures from payers, and shifts in clinical guidelines favoring different treatment modalities.

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Sources
[1] FDA Drug Labeling and Approvals, Mirvaso (brimonidine) topical gel, 2013.
[2] MarketWatch, "Global Dermatology Drugs Market," 2022.
[3] Bausch Health Annual Reports, 2022.
[4] Epidemiological data on rosacea prevalence, National Rosacea Society, 2021.