MIRVASO Drug Patent Profile

When do Mirvaso patents expire, 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-five 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:	125
US Patents:	11
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	104
Clinical Trials:	12
Patent Applications:	1,741
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
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

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

International Patents for MIRVASO

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

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2013123042	КОМПОЗИЦИИ ГЕЛЯ С БРИМОНИДИНОМ И СПОСОБЫ ПРИМЕНЕНИЯ
South Korea	20070032716
Portugal	2388007
Spain	2547336
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)
China	101816793	Compounds, formulations, and methods for treating or preventing rosacea
Cyprus	1114372

Supplementary Protection Certificates for MIRVASO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1631293	2014/041	Ireland		PRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/904 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	C01631293/01	Switzerland		PRODUCT NAME: BRIMONIDIN; REGISTRATION NO/DATE: SWISSMEDIC 65180 21.11.2014
1631293	300683	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	C 2014 030	Romania		PRODUCT NAME: BRIMONIDINA SI SARURILE FARMACEUTICE ALE ACESTEIA5-BROMO-N-(4,5-DIHIDRO-1-H-IMIDAZOL-2-IL)QUINOXALIN-6-AMINA; NATIONAL AUTHORISATION NUMBER: EU/1/13/904; DATE OF NATIONAL AUTHORISATION: 20140221; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/904; DATE OF FIRST AUTHORISATION IN EEA: 20140221
1631293	122014000080	Germany		PRODUCT NAME: BRIMONIDIN UND PHARMAZEUTISCH AKZEPTABLE SALZE DAVON; REGISTRATION NO/DATE: EU/1/13/904 20140221
1631293	CR 2014 00031	Denmark		PRODUCT NAME: BRIMONIDIN OG ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER BRIMONIDIN TARTRAT; REG. NO/DATE: EU/1/13/904/001-003 20140221

Market Dynamics and Financial Trajectory for Mirvaso

Overview of Mirvaso

Mirvaso, a brand name for the drug brimonidine, is a topical alpha-2 adrenergic receptor agonist used primarily for the treatment of facial erythema (redness) associated with rosacea. Here’s a detailed look at the market dynamics and financial trajectory of Mirvaso.

Market Dynamics

Growing Demand for Rosacea Treatments

The global rosacea treatment market is driven by several key factors, including the increasing prevalence of rosacea and rising public awareness of the condition. Rosacea affects over 400 million people worldwide, with a global disease incidence estimated at 5%[1][4].

Competitive Landscape

Mirvaso operates in a competitive market dominated by a few key players. Nestlé S.A. (through its Galderma division) is a major player and holds a significant market share, partly due to the strong commercial performance of Mirvaso, along with other products like Oracea, MetroGel, and Soolantra[1].

Drug Class and Market Share

Mirvaso belongs to the alpha agonists drug class, which is the fastest-growing segment in the rosacea treatment market, with an estimated CAGR of more than 8% during the forecast period. This class includes two key revenue generators: Mirvaso and Rhofade[1].

Regional Performance

North America, particularly the U.S., accounts for a substantial market share, driven by factors such as growing consumer awareness, new drug developments, and technological advancements in diagnosis. The Asia Pacific region is also expected to show significant growth due to improving economic conditions and a growing emphasis on healthcare infrastructure[1].

Financial Trajectory

Revenue Contribution

Mirvaso is one of the significant revenue contributors in the rosacea treatment market. As part of Nestlé S.A.'s Galderma division, Mirvaso's commercial success has helped maintain the division's market leadership. The drug's revenue is bolstered by its effectiveness in treating rosacea-associated erythema and its preference among dermatologists and patients alike[1].

Market Growth Projections

The global rosacea treatment market, which includes Mirvaso, is anticipated to register a CAGR of 6.8% from 2019 to 2025. This growth is driven by proactive government initiatives, advanced formulations, and high disease prevalence. The market size was valued at USD 1.5 billion in 2017 and is expected to grow significantly over the forecast period[1].

Generic Penetration and Pipeline Candidates

Despite the presence of generic products that pose competition, the market is projected to be driven by the impending launch of promising pipeline candidates. However, Mirvaso's unique positioning as an alpha agonist and its strong brand presence help it maintain a competitive edge[1].

Key Financial Highlights

Market Share and Leadership

Nestlé S.A.'s Galderma division, which markets Mirvaso, is forecasted to continue holding the largest market share. This is supported by the strong commercial performances of Mirvaso and other key products like Oracea and Soolantra[1].

Regional Revenue

North America, where Mirvaso has a strong presence, accounted for nearly 50% of the market share in 2017. This region continues to drive growth due to various factors including new drug approvals and technological advancements[1].

Future Outlook

Technological Advancements and Combination Therapies

The rosacea treatment market is witnessing a paradigm shift towards combination therapies for more effective results. Mirvaso, being a topical drug, benefits from this trend as it is often used in combination with oral medications on a case-to-case basis. Technological innovations in drug formulations and delivery systems are expected to further enhance Mirvaso's market position[1][3].

Regulatory and Competitive Landscape

The market faces regulatory challenges and competitive pressure from alternative drug delivery systems. However, Mirvaso's established brand and clinical efficacy help it navigate these challenges. The ongoing exploration and development of various drug delivery systems by pharmaceutical companies may also present opportunities for Mirvaso to adapt and innovate[3].

Key Takeaways

• Market Growth: The rosacea treatment market, including Mirvaso, is expected to grow at a CAGR of 6.8% from 2019 to 2025.
• Competitive Edge: Mirvaso is part of the fastest-growing drug class (alpha agonists) and benefits from its strong brand presence and clinical efficacy.
• Regional Performance: North America, particularly the U.S., is a key market for Mirvaso, driven by consumer awareness and new drug developments.
• Future Outlook: The market is shifting towards combination therapies and technological innovations, which are expected to enhance Mirvaso's market position.

FAQs

What is Mirvaso used for?

Mirvaso is used for the treatment of facial erythema (redness) associated with rosacea.

Which company markets Mirvaso?

Mirvaso is marketed by Nestlé S.A.'s Galderma division.

What is the growth rate of the alpha agonists drug class in the rosacea treatment market?

The alpha agonists drug class, which includes Mirvaso, is expected to grow at a CAGR of more than 8% during the forecast period.

What are the key factors driving the rosacea treatment market?

The market is driven by increasing prevalence of rosacea, rising public awareness, and advanced formulations.

How does Mirvaso fit into the overall rosacea treatment market?

Mirvaso is a significant revenue contributor and part of the fastest-growing drug class (alpha agonists) in the rosacea treatment market.

Sources

1. Grand View Research: Rosacea Treatment Market Size & Share | Industry Report, 2019-2025
2. Mirvac: ANNUAL REPORT 2024
3. GlobeNewswire: Topical Drug Delivery Market is expected to generate a revenue of USD 177.97 Billion by 2031
4. Data Bridge Market Research: Global Rosacea Treatment Market – Industry Trends and Forecast to 2030
5. GlobalData: Mirvac Group Financial Report Information