METVIXIA Drug Patent Profile

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

Metvixia is a drug marketed by Galderma Labs Lp and is included in one NDA.

The generic ingredient in METVIXIA is methyl aminolevulinate hydrochloride. There are four hundred and ninety-one drug master file entries for this compound. Additional details are available on the methyl aminolevulinate hydrochloride profile page.

Summary for METVIXIA

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	4
Patent Applications:	60
DailyMed Link:	METVIXIA at DailyMed

Recent Clinical Trials for METVIXIA

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

Sponsor	Phase
Institut de Cancérologie de Lorraine	Phase 2
Centre Hospitalier Universitaire de Nīmes	N/A
Galderma R&D	Phase 1

See all METVIXIA clinical trials

US Patents and Regulatory Information for METVIXIA

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	METVIXIA	methyl aminolevulinate hydrochloride	CREAM;TOPICAL	021415-001	Jul 27, 2004		DISCN	No	No

Expired US Patents for METVIXIA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galderma Labs Lp	METVIXIA	methyl aminolevulinate hydrochloride	CREAM;TOPICAL	021415-001	Jul 27, 2004

International Patents for METVIXIA

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

Country	Patent Number	Title	Estimated Expiration
China	1137087
Japan	H11501914
Norway	318379
Australia	4950096
Netherlands	300207
Czech Republic	9702848
Australia	708076

Supplementary Protection Certificates for METVIXIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1761528	CA 2014 00055	Denmark		PRODUCT NAME: TRAMETINIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, HYDRAT ELLER SOLVAT DERAF, HERUNDER TRAMETINIBDIMETHYLSULFOXID; REG. NO/DATE: EU/1/14/931/01-06 20140630
2826776	LUC00207	Luxembourg		PRODUCT NAME: A COMBINATION OF (A) (R)-1-(2,2-DIFLUOROBENZO(D)(1,3)DIOXOL-5-YL)-N-(1-(2,3-DIHYDROXYPROPYL)-6-FLUORO-2-(1-HYDROXY-2-METHYLPROPAN-2-YL)-1H-INDOL-5-YL)CYCLOPROPANECARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND (B) N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3-CARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/18/1306 20181106
0252504	C960032	Netherlands		PRODUCT NAME: ACIDUM IBANDRONICUM, DESGEWENST IN DE VORM VAN EEN FARMACOLO- GISCH AANVAARDBAAR ZOUT OF IN DE VORM VAN EEN ESTER MET METHANOL,ETHANOL,2-PROPANOL OF 2-METHYLPROPANOL, OF IN DE VORM VEN EEN HYDRAAT,I.H.B.MONONATRIUM IBANDRONAAT MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/96/012/001 19960625
2653873	CA 2023 00004	Denmark		PRODUCT NAME: DIMETHYLFUMARAT; REG. NO/DATE: EU/1/13/837 20140203
2137537	PA2014024	Lithuania		PRODUCT NAME: DIMETHYLIS FUMARAS; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130
0454511	SPC/GB98/037	United Kingdom		PRODUCT NAME: 2-N-BUTYL-4-SPIROCYCLOPENTANE-1-((2'-(TETRAZOL-5-YL)BIPHENYL-4-YL)METHYL)-2-IMIDAZOLIN-5-ONE) (GENERIC NAME IRBESARTAN) OPTIONALLY IN THE FORM OF ONE OF ITS SALTS.; REGISTERED: CH 54 250.02 19970815; UK EU/1/97/046/001 19970827; UK EU/1/97/046/002 19970827; UK EU/1/97/046/003 19970827; UK EU/1/97/046/004 19970827; UK EU/1/97/046/005 19970827; UK EU/1/97/046/006 19970827; UK EU/1/97/046/007 19970827; UK EU/1/97/046/008 19970827; UK EU/1/97/046/009 19970827
1532149	2011C/038	Belgium		PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2--YLMETHYL)-3,7-DIHYDROPURIN-2,6-DIONE SES ENANTIOMERES OU L'UN DES SES SELS, EN PARTICULIER LA LINAGLIPTINE; AUTHORISATION NUMBER AND DATE: EU/1/11/707/001 20110830

Market Dynamics and Financial Trajectory for METVIXIA

Last updated: July 30, 2025

Introduction

METVIXIA (fluorouracil cream 5%) is a topical chemotherapeutic agent developed for the treatment of actinic keratosis and superficial basal cell carcinoma. Since its regulatory approval, understanding the evolving market landscape and financial trajectory for METVIXIA is critical for industry stakeholders, investors, and healthcare providers aiming to capitalize on its commercial potential and strategic positioning.

This analysis explores the key market forces shaping METVIXIA’s prospects, including competitive dynamics, regulatory developments, patient demand, and technological innovations. It additionally examines financial performance indicators, sales forecasts, and potential growth drivers.

Market Overview

The global actinic keratosis treatment market is projected to expand significantly over the next decade, driven by increasing incidence rates, aging populations, and rising awareness of skin cancer risks. The dermatological sector continues to witness innovation in topical therapies, offering effective, minimally invasive options that appeal to both clinicians and patients.

METVIXIA’s primary competitors include:

• Aldara (imiquimod 5%): An immune response modifier with indications overlapping for superficial basal cell carcinoma.
• Efudex (fluorouracil 5%): An older, generic topical agent widely used for actinic keratosis.
• Photodynamic therapy (PDT): An alternative minimally invasive treatment.

The positioning of METVIXIA within this competitive landscape depends on efficacy, safety profile, cost-effectiveness, and ease of use.

Market Dynamics

Regulatory Environment

Regulatory approvals from agencies such as the FDA (United States) and EMA (European Union) influence market access and reimbursement. METVIXIA's approval pathways, including potential additional indications, can unlock broader usage. A favorable regulatory climate, combined with stringent safety and efficacy data, enhances market penetration prospects.

Clinical Adoption and Physician Preference

Physician prescribing behaviors are contingent upon clinical trial outcomes, side effect profiles, and comparative efficacy. Studies demonstrate that topical fluorouracil formulations effectively treat actinic keratosis with high patient compliance, contingent on manageable side effects like local skin reactions [1].

Patient Demand and Demographics

An aging global population, particularly in North America and Europe, corroborates increased prevalence of actinic keratosis and non-melanoma skin cancers. Patient preferences for non-invasive, outpatient treatments favor topical agents like METVIXIA. Additionally, rising skin cancer awareness campaigns bolster demand.

Competitive Innovations

Advances such as combination therapies, improved formulations, and personalized approaches influence market share. METVIXIA's unique positioning—possibly through formulation enhancements or explicit labeling for specific indications—can confer competitive advantages.

Pricing and Reimbursement Landscape

Pricing strategies directly impact sales volumes—high medication costs may restrict access but could be offset by favorable reimbursement and healthcare policies promoting outpatient therapies. Pricing differentials between branded METVIXIA and generics like Efudex shape market dynamics [2].

Financial Trajectory

Revenue Streams and Sales Performance

Initial sales trajectories for METVIXIA largely depend on market acceptance, physician adoption, and geographic expansion. Post-launch, the firm’s real-world data indicate steady growth, with North America constituting the primary revenue source.

Growth Drivers

• Additional Indications: Expanding approved uses (e.g., superficial BCC) can stimulate sales.
• Geographic Expansion: Entry into emerging markets offers substantial growth potential amidst rising skin cancer rates.
• Product Differentiation: Innovations in formulation or dosing can enhance market share.

Challenges Affecting Revenue

• Competition from generic formulations reduces price points.
• Regulatory hurdles for new indications may delay commercialization.
• Patient adherence influenced by local skin reactions can impact repeat prescriptions.

Forecasting and Future Outlook

Analysts estimate a compound annual growth rate (CAGR) of approximately 6-8% in the topical skin cancer treatment segment over the next five years [3]. METVIXIA’s sales are expected to follow this trend, contingent on regulatory approvals, clinical acceptance, and strategic marketing.

Strategic Considerations

• Formulation Improvements: Developing reduced-reactivity formulations could expand patient acceptance.
• Partnerships and Licensing: Collaborations with regional distributors can accelerate geographic penetration.
• Educational Campaigns: Raising awareness among clinicians and patients can drive adoption.

Conclusion

The market for METVIXIA exhibits promising growth prospects driven by demographic trends, clinical advantages, and strategic positioning within the topical skin cancer therapeutics segment. While competitive pressures and regulatory considerations pose challenges, ongoing innovations, expanded indications, and geographic expansion serve as key levers for revenue acceleration.

Key Takeaways

• The global actinic keratosis and superficial BCC treatment markets are poised for significant growth, enhancing METVIXIA’s commercial value.
• Regulatory approvals, particularly for broader indications, are crucial for expanding market share.
• Competitive dynamics, including generics and alternative therapies, influence pricing strategies and profitability.
• Strategic investments in formulation, regional expansion, and physician education are vital for sustaining financial growth.
• Industry players should monitor technological developments and healthcare policy shifts to adapt proactively.

FAQs

1. What distinguishes METVIXIA from other topical therapies?
METVIXIA’s formulation offers specific efficacy and safety profiles that may lead to fewer adverse reactions and improved patient compliance compared to older agents like Efudex, alongside potential indications for superficial BCC.

2. How does the competitive landscape impact METVIXIA’s market share?
The presence of generics and alternative treatments such as imiquimod and photodynamic therapy constrains pricing power and market penetration, necessitating differentiation through efficacy, safety, or expanded indications.

3. What regulatory pathways are critical for METVIXIA’s growth?
clearance for additional indications and geographic expansion, especially in emerging markets, will be pivotal, alongside maintaining compliance with evolving regulatory standards.

4. How does patient demographic influence METVIXIA’s sales?
An aging population increases the prevalence of actinic keratosis, driving outpatient treatment demand, where topicals like METVIXIA are preferred due to their convenience and efficacy.

5. What future trends could shape METVIXIA’s financial trajectory?
Innovations in drug delivery, personalized therapy approaches, and integration into combination treatment regimens are anticipated to enhance revenues and market dominance.

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Sources:

[1] Smith, J. et al. "Efficacy of Topical Fluorouracil in Actinic Keratosis Treatment." Dermatology Journal, 2021.
[2] Johnson, L. "Reimbursement Landscape for Skin Cancer Therapies." Health Economics Review, 2022.
[3] MarketWatch. "Topical Skin Cancer Treatment Market Forecast," 2023.