METVIXIA Drug Patent Profile

When do Metvixia patents expire, 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

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

International Patents for METVIXIA

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

Country	Patent Number	Title	Estimated Expiration
China	1137087
World Intellectual Property Organization (WIPO)	9628412
Norway	974163
Hungary	225148	ESTERS OF 5-AMINOLEVULINIC ACID AS PHOTOSENSITIZING AGENTS IN PHOTOCHEMOTHERAPY OR DIAGNOSIS, PRODUCTS AND KITS COMPRISING THEREOF AND METHOD OF IN VITRO DIAGNOSIS BY THEIR USING

Supplementary Protection Certificates for METVIXIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1532149	2011/039	Ireland		PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-Y1)-7-BUT-2INYL-3-METHYL-1-(4- METHYLCHINAZOLIN-2-YLMETHYL)-3, 7-DIHYDROPURIN-2,6-DION THE ENATIOMERS AND SALTS THEROF-ESPECIALLY LINAGLIPTIN."LINAGLIPTIN=((R)-8-(3-AMINOPIPERIDIN-1-YL)- 7-BUT-2-INYL-3-METHYL-L-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3,7-DIHYDROPURIN-2,6- DION") (IUPAC); REGISTRATION NO/DATE: EU/1/11/707/001-EU/1/11/707/011 20110824
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
0454511	SPC/GB99/008	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 AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/98/086/001 19981015; UK EU/1/98/086/002 19981015; UK EU/1/98/086/003 19981015; UK EU/1/98/086/004 19981015; UK EU/1/98/086/005 19981015; UK EU/1/98/086/006 19981015
0693475	CR 2010 00036	Denmark		PRODUCT NAME: TAPENTADOL ((1R-2R)-3-(3-DIMETHYLAMINO-1-ETHYL-2-METHYL-PROPYL)-PHENOL), HERUNDER HYDROCHLORIDET; NAT. REG. NO/DATE: 45151-45158, 45162-45169 20100830; FIRST REG. NO/DATE: EU 75043.00.00-75048.00.00, 75261.00.00-75270.00.00 20100819

Investment Scenario and Fundamentals Analysis for METVIXIA

Last updated: February 22, 2026

What Is METVIXIA?

METVIXIA (fluorouracil topical) is a prescription medication approved by the FDA for the treatment of actinic keratosis (AK), superficial basal cell carcinoma (sBCC), and solar keratosis. It is marketed by Valeant Pharmaceuticals, now part of Bausch Health, primarily used in dermatology for localized skin cancers and precancerous lesions.

Market Overview

The dermatology segment for topical treatments targeting actinic keratosis and basal cell carcinoma is growing due to increasing skin cancer incidence, aging populations, and greater dermatological awareness. The global market for actinic keratosis treatments reached approximately USD 250 million in 2022, with an average annual growth rate of 5%.

Key Drivers

• Rising incidence of skin cancers: The WHO estimates 2-3 million non-melanoma skin cancers annually worldwide.
• Aging populations: Increased prevalence of AK and BCC among older adults.
• Product preferences: Topical therapies like METVIXIA offer minimally invasive treatment options, boosting market uptake.

Competitive Landscape

The primary competitors include:

• Efudex (fluorouracil 5%) – another topical fluorouracil formulation.
• Imiquimod (Aldara) – immune response modifier for AK and BCC.
• Diclofenac sodium (Solaraze) – NSAID for AK.
• Cryotherapy – standard surgical approach.

METVIXIA’s advantages are its targeted delivery and demonstrated efficacy, though reimbursement and physician familiarity influence adoption.

Revenue and Sales Dynamics

In 2022, METVIXIA generated an estimated USD 80-100 million in global revenue, representing approximately a 20% market share in its segment. Domestic sales in the U.S. account for roughly 60% of total revenue, with growth driven by increased diagnosis and acceptance of topical treatments over surgical options.

Pricing Structure

Pricing varies by region but averages USD 150-200 per treatment course. Azimuth-like formulations are less costly but exhibit comparable clinical outcomes.

R&D and Regulatory History

Initially approved in 2007, METVIXIA has maintained a relatively stable regulatory status with no major label expansions or reformulations. Ongoing studies focus on combination therapies and off-label applications.

Investment Considerations

Strengths

• Established market presence with a mature product.
• Growing demand for non-invasive skin cancer treatments.
• Favorable safety profile and efficacy.

Risks

• Competition from newer therapies and formulations.
• Patent expiration risk—though METVIXIA’s patents have expired, market dominance persists via brand recognition.
• Reimbursement pressures, especially in cost-sensitive markets.

Opportunities

• Expansion into dermatological clinics and primary care.
• Development of combination therapies enhancing efficacy.
• Geographic expansion into emerging markets with rising skin cancer cases.

Challenges

• Limited pipeline for new formulations.
• Regulatory delays or restrictions in key markets.
• Market saturation with generic fluorouracil products.

Financial Outlook

With a mature product portfolio, METVIXIA’s revenue streams are stable but face stagnation threats from generics. Growth hinges on market expansion, clinician education, and new indications.

Projected revenue growth averages 2-3% annually over the next five years, assuming minimal successful pipeline expansion and steady market share retention.

Key Takeaways

• METVIXIA remains a relevant treatment option for AK and sBCC, supported by dermatology trends favoring minimally invasive treatments.
• The market is mature with high competition; growth is constrained by patent expiry trends and generics.
• Opportunities exist for geographic expansion and drug combination strategies.
• Major risks include pricing pressures, regulatory hurdles, and generic entry.

FAQs

1. What are the primary competitors to METVIXIA?
Efudex (fluorouracil 5%), imiquimod (Aldara), diclofenac sodium (Solaraze), and cryotherapy are the main competitors.

2. How does METVIXIA’s efficacy compare to alternatives?
Clinical trials show comparable efficacy to Efudex and imiquimod for AK, with a safety profile favoring topical over surgical options.

3. What is the patent situation for METVIXIA?
Patents expired in the U.S. in the early 2010s; the product remains branded due to market recognition and formulation protections.

4. What are key growth drivers for METVIXIA?
Increasing skin cancer prevalence, aging populations, and dermatologist preference for topical therapies.

5. What are the regulatory prospects for METVIXIA?
Limited pending filings; future growth potential relies on label expansions or new indications approved through FDA pathways.

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References

[1] World Health Organization. (2022). Solar and non-melanoma skin cancers statistics. WHO Publications.

[2] MarketWatch. (2023). Global actinic keratosis therapeutics market report.

[3] Bausch Health. (2022). METVIXIA product monograph.

[4] IQVIA. (2022). Dermatology drug sales data.

[5] U.S. Food and Drug Administration. (2007). New drug application details for fluorouracil topical formulations.