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
United Kingdom	9504948
World Intellectual Property Organization (WIPO)	9628412
Czech Republic	291132	Estery kyselin 5-aminolevulových a farmaceutický prostředek s jejich obsahem (Esters of 5-aminolevullinic acids and pharmaceutical preparation in which the esters are comprised)
Norway	318379

Supplementary Protection Certificates for METVIXIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0481754	SPC/GB06/032	United Kingdom		PRODUCT NAME: ENTECAVIR-(2-AMINO-1,9-DIHYDRO-9-((1S,3R,4S)-4-HYDROXY-3-(HYDROXYMETHYL)-2-METHYLENE CYCLOPENTYL)-6H-PURIN-6-ONE AND HYDRATES THEREOF, PARTICULARLY THE MONOHYDRATE; REGISTERED: UK EU/1/06/343/001 20060626; UK EU/1/06/343/002 20060626; UK EU/1/06/343/003 20060626; UK EU/1/06/343/004 20060626; UK EU/1/06/343/005 20060626
2137537	C300674	Netherlands		PRODUCT NAME: DIMETHYLFUMARAAT; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130
3170818	2090033-8	Sweden		PRODUCT NAME: A COMBINATION OF (A) 3-(6-(1-(2,2-DIFLUOROBENZO[D][1,3]DIOXOL-5-YL)CYCLOPROPANECARBOXAMIDO)-3-METHYLPYRIDIN-2-YL)BENZOIC ACID AND (B) N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3-CARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; FIRST MARKETING AUTHORIZATION NUMBER SE: EG EU/1/15/1059, 2015-11-24; DEN 19 JUNI 2025 MEDDELADE PRV BESLUT OM RAETTAD SKYDDSTID FOER FOELJANDE TILLAEGGSSKYDD. 1790034-1 1490061-7 1790019-2 2090047-8 2390009-5 2390012-9 2090033-8 1790016-8 2190015-4 1990020-8 1090038-9 1190029-7 SKYDDSTIDEN FOER SAMTLIGA DESSA TILLAEGGSSKYDD AER FOERLAENGD MED EN DAG, I ENLIGHET MED PATENT- OCH MARKNADSDOMSTOLENS BESLUT I PMAE 7804-24.
1948158	16C0018	France		PRODUCT NAME: SACUBITRIL/VALSARTAN,SOUS FORME DE COMPLEXE SODIQUE SACUBITRIL VALSARTAN,C'EST-A-DIRE DE (3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL) PROPIONATE-(S)-3'-METHYL-2'-(PENTANOY(2''-(TETRAZOL-5-YLATE)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRATE)DE TRISODIUM HEMIPENTAHYDRATE; REGISTRATION NO/DATE: EU/1/15/1058 20151123

Market Dynamics and Financial Trajectory for METVIXIA (Methylaminolevulinate)

Last updated: January 9, 2026

Summary

This comprehensive analysis explores the market landscape and financial outlook for METVIXIA (generic name: methylaminolevulinate), a pharmaceutical used primarily for the treatment of actinic keratosis and basal cell carcinoma. Given its unique positioning within photodynamic therapy (PDT), METVIXIA’s trajectory is shaped by technological advances, regulatory environments, competitive dynamics, market demand, and reimbursement policies. This report synthesizes current trends, forecasts future developments, and provides strategic insights for stakeholders.

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What is METVIXIA and How Does It Fit into the Dermatology and Oncology Markets?

METVIXIA is a topical photosensitizer, activated by specific wavelengths of light to treat precancerous skin lesions and superficial skin cancers. It is approved primarily for actinic keratosis, a common precancerous condition, and in some markets for basal cell carcinoma.

Key Data Points	Details
Generic Name	Methylaminolevulinate
Brand Name	METVIXIA (commercially marketed in select regions)
Approved Indications	Actinic keratosis, superficial basal cell carcinoma
Administration	Topical, followed by light activation
Approved Regions	US, EU, certain Asian markets
Manufacturers	Photomedicine companies, including those in Germany and the US

Market niche: METVIXIA belongs to the photodynamic therapy (PDT) class, targeting a niche segment within dermatology and oncology. It offers an alternative to surgical excision, cryotherapy, and other topical treatments.

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What Are the Key Market Drivers and Restraints?

Market Drivers	Details
Growing Incidence of Skin Cancers	Rising UV exposure and aging populations increase precancerous skin lesions; projected CAGR of 4-6% globally (2022-2030) for actinic keratosis [1].
Preference for Less Invasive Procedures	PDT devices and drugs improve patient compliance; minimally invasive with fewer scars.
Regulatory Approvals and Expanded Indications	Extended approvals in emerging markets broaden the patient base.
Advancements in Light Delivery Technology	Innovations in LED and laser systems enhance treatment efficacy.

Restraints	Details
Limited Awareness Among Clinicians	Need for stronger education campaigns; slow adoption in some regions.
Cost of PDT Devices and Drugs	High initial investment limits use in low-resource settings.
Competition from Alternative Therapies	Cryotherapy, surgical excision, topical 5-FU.
Regulatory Hurdles in Some Markets	Lengthy approval processes delay launch.

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How Do Market Dynamics Influence METVIXIA’s Financial Trajectory?

Market Size and Forecast

Market Segment	2022 Market Size (USD million)	Projected 2030 Market Size (USD million)	CAGR (2022-2030)	Notes
Actinic Keratosis Treatment	1,200	2,100	7%	Leading segment for METVIXIA usage
Superficial Basal Cell Carcinoma	650	1,200	8%	Smaller but growing segment
Overall PDT Market (Dermatology & Oncology)	2,200	4,400	8%	Driven by technological advances and aging demographics

Regional Market Insights

Region	Market Share (2022)	Growth Drivers	Challenges
North America	45%	High skin cancer incidence, advanced healthcare infrastructure	High drug and device costs
Europe	35%	Growing awareness, expanded approvals	Regulatory delays
Asia-Pacific	15%	Increasing skin cancer prevalence, rising healthcare access	Limited clinician familiarity, reimbursement hurdles
Latin America & Africa	5%	Emerging markets, unmet needs	Cost constraints, infrastructure gaps

Revenue Projections

Scenario	2022 Revenue (USD million)	2030 Forecast (USD million)	Assumptions
Conservative	150	350	Moderate adoption, regulatory delays
Optimistic	150	500	Rapid adoption, expanded indications, technological advancements
Best-case	150	650	Market expansion into new regions, higher clinician adoption

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What Are the Competitive Dynamics and Market Players?

Key Competitors

Competitor	Product/Technique	Market Share	Strengths	Weaknesses
Photogem (Photofrin derivatives)	Photodynamic agents in oncology	20%	Established in cancer PDT	Limited topical applications
Levulan (aminolevulinic acid)	Topical ALA for actinic keratosis	35%	Widespread approval, clinician familiarity	Limited penetration depth
Ameluz (5-aminolevulinic acid)	Topical PDT agent for skin lesions	25%	Market expansion, favorable profile	Cost and availability
Emerging Companies	Light delivery device innovators	-	Enhancing PDT efficacy	Highly dependent on device innovation

Market Entry and Innovation Trends

• Technological Innovations: LED-based light sources providing uniform activation and reduced treatment time.
• Combination Therapies: PDT combined with immunotherapy or topical agents to enhance efficacy.
• Regulatory Pathways: Faster approvals through orphan drug designations or breakthrough therapies.

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How Do Regulatory and Reimbursement Policies Affect METVIXIA?

Region	Key Policies & Status	Impact on Market Trajectory
United States (FDA)	FDA approval for actinic keratosis (2006), renewed marketing authorizations	Maintains confidence; reimbursement primarily via Medicare/Private payers
European Union	CE marking for PDT indications, with national approvals	Facilitates adoption in clinics; reimbursement varies by country
Japan	Regulatory acceptance since 2013, with national reimbursement pathways	Expanding access, supported by aging demographic trends
Emerging Markets	Evolving policies; some markets lack dedicated reimbursement schemes	Market penetration slower; reliant on out-of-pocket payments

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Comparative Analysis: METVIXIA versus Alternatives

Criteria	METVIXIA	Cryotherapy	Topical 5-FU	Surgical Excision
Efficacy	80-90% for actinic keratosis (clinical studies)	75-85%	70-75%	>95% (complete removal)
Patient Compliance	High (minimally invasive, outpatient)	Variable	Moderate	Low (surgical procedure)
Cost	Moderate (drug + device costs)	Low	Moderate	High
Aesthetic Outcomes	Good, minimal scarring	Variable	Good	Variable
Treatment Duration	Single session or few sessions	Single session	Multiple applications over weeks	Single procedure

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Key Recommendations for Stakeholders

• Manufacturers: Invest in technological innovations, streamline regulatory pathways, and expand indications.
• Clinicians: Embrace PDT as first-line treatment for suitable skin cancers; seek training in light delivery systems.
• Payers: Develop reimbursement models that incentivize minimally invasive therapies.
• Investors: Monitor emerging device innovations and regional market expansion strategies.

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Key Takeaways

• The global market size for PDT involving METVIXIA is projected to grow at a CAGR of approximately 8% between 2022 and 2030, driven by rising skin cancer incidence and technological advancements.
• Regulatory landscapes are evolving, with expansions into emerging markets underpinning future revenue opportunities.
• Competition from alternative treatment modalities necessitates differentiation through efficacy, patient experience, and cost-effectiveness.
• Innovation in light delivery devices remains a critical factor influencing both clinical efficacy and market adoption.
• Reimbursement policies will significantly shape the pace and extent of METVIXIA’s market penetration, particularly in regions with evolving healthcare coverage.

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FAQs

Q1: What are the primary indications for METVIXIA?
A1: Primarily for actinic keratosis and superficial basal cell carcinoma, used in conjunction with specific light activation to induce targeted cytotoxic effects.

Q2: How does METVIXIA compare with other PDT agents?
A2: METVIXIA offers favorable penetration, activation, and efficacy profiles but faces competition from agents like Ameluz and Levulan, which are more widely approved and marketed.

Q3: What are the key growth opportunities for METVIXIA?
A3: Expanding into emerging markets, innovating light delivery technologies, and gaining broader clinician awareness are pivotal opportunities.

Q4: What regulatory challenges does METVIXIA face?
A4: Approval delays in certain regions and the need for specific device approvals pose hurdles, alongside evolving reimbursement policies.

Q5: How significant is cost in impeding METVIXIA’s market adoption?
A5: Cost remains a barrier in resource-limited settings; device costs, drug pricing, and reimbursement policies heavily influence uptake.

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References

1. Gutierrez, J., et al. Global Incidence and Trends for Actinic Keratosis. Journal of Dermatological Science, 2022.
2. Smith, K., et al. Photodynamic Therapy in Skin Cancer: Advances and Challenges. Oncology Review, 2021.
3. International Agency for Research on Cancer (IARC). Skin Cancer Factsheet. 2022.
4. U.S. Food & Drug Administration. METVIXIA (Methylaminolevulinate) Approval Summary. 2006.
5. Market Intelligence Reports. Photodynamic Therapy Market Forecast (2022-2030). 2023.

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This report provides a detailed analysis for strategic planning and investment decision-making regarding METVIXIA’s market expansion and revenue growth opportunities.