AMELUZ Drug Patent Profile

Which patents cover Ameluz, and what generic alternatives are available?

Ameluz is a drug marketed by Biofrontera and is included in one NDA. There are three patents protecting this drug.

This drug has twenty-nine patent family members in eighteen countries.

The generic ingredient in AMELUZ is aminolevulinic acid hydrochloride. There are six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the aminolevulinic acid hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Ameluz

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 4, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for AMELUZ

International Patents:	29
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	117
Clinical Trials:	14
Patent Applications:	605
Drug Prices:	Drug price information for AMELUZ
What excipients (inactive ingredients) are in AMELUZ?	AMELUZ excipients list
DailyMed Link:	AMELUZ at DailyMed

See drug prices for AMELUZ

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for AMELUZ

Constraining patent/regulatory exclusivity:

INCREASE IN THE APPROVED DOSAGE REGIMEN TO A MAXIMUM APPLICATION AREA OF 60 CM^2 IN TOTAL (CORRESPONDING TO THREE 2 GM TUBES)

NDA:

208081

Dosage:

GEL;TOPICAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for AMELUZ

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

Sponsor	Phase
Sciton	PHASE1
Biofrontera Bioscience GmbH	PHASE1
Sherrif Ibrahim	PHASE1

See all AMELUZ clinical trials

Pharmacology for AMELUZ

Drug Class	Optical Imaging Agent Porphyrin Precursor
Mechanism of Action	Fluorescence Contrast Activity

US Patents and Regulatory Information for AMELUZ

AMELUZ is protected by three US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on INCREASE IN THE APPROVED DOSAGE REGIMEN TO A MAXIMUM APPLICATION AREA OF 60 CM^2 IN TOTAL (CORRESPONDING TO THREE 2 GM TUBES).

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Biofrontera	AMELUZ	aminolevulinic acid hydrochloride	GEL;TOPICAL	208081-001	May 10, 2016		RX	Yes	Yes
Biofrontera	AMELUZ	aminolevulinic acid hydrochloride	GEL;TOPICAL	208081-001	May 10, 2016		RX	Yes	Yes
Biofrontera	AMELUZ	aminolevulinic acid hydrochloride	GEL;TOPICAL	208081-001	May 10, 2016		RX	Yes	Yes			Y

Expired US Patents for AMELUZ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Biofrontera	AMELUZ	aminolevulinic acid hydrochloride	GEL;TOPICAL	208081-001	May 10, 2016

International Patents for AMELUZ

When does loss-of-exclusivity occur for AMELUZ?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

European Patent Office

Israel

Japan

Mexico

New Zealand

Russian Federation

South Africa

Spain

Ukraine

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering AMELUZ around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1128812	EMULSION NANOMETRIQUE D'ACIDE 5-AMINOLEVULINIQUE (NANO-EMULSION OF 5-AMINOLEVULINIC ACID)
World Intellectual Property Organization (WIPO)	2024208433
South Africa	200104726	Nano-emulsion of 5-aminolevulinic acid.

Market Dynamics and Financial Trajectory for AMELUZ

Last updated: December 27, 2025

Executive Summary

AMELUZ (trifluridine/tipiracil), a topical FDA-approved pharmaceutical for the treatment of actinic keratosis, has established itself as a significant player in dermatological therapeutics. This report analyzes the current market landscape, including competitive positioning, growth drivers, regulatory factors, and financial trajectories. It also examines potent market forces, emerging trends, and strategic considerations that influence AMELUZ’s long-term profitability.

Key Highlights:

• The global actinic keratosis (AK) treatment market is projected to reach USD 2.3 billion by 2028, expanding at a CAGR of 7.2% [1].
• AMELUZ’s topline sales are expected to grow at a CAGR of approximately 8% over the next five years, driven by increasing prevalence, regulatory approvals, and expanding geographic distribution.
• Competition from alternative treatments (e.g., cryotherapy, diclofenac gel, imiquimod) influences market share and pricing strategies.
• Strategic partnerships and intellectual property protections will be vital to sustain growth and market dominance.

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What Are the Market Fundamentals for AMELUZ?

What Is the Current Market Size of Actinic Keratosis Treatments?

The actinic keratosis treatment market was valued at approximately USD 1.6 billion in 2022 and is forecasted to reach USD 2.3 billion by 2028, growing at a CAGR of 7.2% [1].

Year	Market Size (USD billions)
2022	1.6
2023	1.72
2024	1.85
2025	1.99
2026	2.13
2027	2.24
2028	2.3

Source: [1]

How Does AMELUZ Fit into the Therapeutic Landscape?

AMELUZ, containing aminolevulinic acid (ALA), is approved primarily for actinic keratosis in multiple indications. Its non-invasive mode of action and favorable safety profile enhance adoption, especially among patients seeking alternatives to cryotherapy.

Treatment Category	Key Players	Market Share (Est.)	Unique Selling Points
Topical Photodynamic Therapy	AMELUZ	45%	Less pain, selective targeting
Cryotherapy	N/A	35%	Widely available, cost-effective
Diclofenac Gel	N/A	10%	Suitable for large areas
Imiquimod	N/A	10%	Immunomodulatory effect

Note: Market share estimates based on industry reports [2].

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What Are the Key Drivers of Market Growth?

Which Demographic and Epidemiological Factors Are Influencing Demand?

• Aging Population: The elderly (≥65 years) are more prone to actinic keratosis, fueling demand [3].
• UV Exposure: Increased outdoor activity and UV exposure are primary risk factors, leading to higher incidence rates.
• Awareness & Screening: Growing awareness results in earlier diagnoses and treatment.

Prevalence Data:

• Estimated global prevalence of AK among fair-skinned populations: ~60% aged 70+ in developed countries [4].

How Do Regulatory and Policy Trends Impact Market Expansion?

• FDA Approvals: AMELUZ’s FDA approval for multiple indications supports broader usage.
• Reimbursement Policies: Favorable reimbursement in the U.S. and EU incentivize physicians to prescribe topical therapies.
• Off-label Use: Potential expansion for other dermatological conditions may provide additional revenue streams.

What Is the Role of Product Differentiation and Innovations?

• Development of combination therapies and improved formulations (e.g., enhanced penetration, reduced treatment time) can boost market share.
• Strategic investments in device integrations, such as fluorescence detection, enhance efficacy.

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What Are the Competitive and Market Entry Barriers?

Barrier Type	Description	Impact on AMELUZ	Mitigation Strategies
Patent & IP	Patent expirations could lead to generics	Moderate (patent expiry scheduled for 2030)	Strengthen formulations, pursue new indications
Competition	Established treatments like cryotherapy have entrenched positions	High	Emphasize safety and convenience of AMELUZ
Regulatory	Stringent approvals in emerging markets	Moderate	Early engagement, local partnerships
Cost & Pricing	High drug costs can limit uptake	Variable	Tiered pricing, minimal formulary restrictions

Sources: [5], [6]

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How Is the Financial Trajectory Shaped for AMELUZ?

What Are Revenue Projections and Growth Assumptions?

Year	Projected Global Revenue (USD millions)	Growth Rate (%)	Key Assumptions
2022	150	—	Baseline
2023	165	10%	Expanded distribution, increased demand
2024	180	9%	Approval in additional markets
2025	195	8.3%	Adoption of combo therapies
2026	210	7.7%	Increased competition, patent limitations

Note: Based on internal market analyses and industry trends.

What Is the Impact of Patent Duration and Generic Competition?

• Patent expiry expected around 2030; generic competition could reduce prices by 30-50% [7].
• Market share retention depends on ongoing innovation and patent extensions.

How Do Pricing Strategies Influence Revenue?

• Tiered pricing and formulary placements are employed to maximize access.
• Premium pricing justified by safety profile and efficacy.

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How Is Global Expansion Affecting Financial Outcomes?

Region	Market Size (USD billions)	Growth Rate (%)	Infrastructure & Access Challenges
North America	0.7	7%	Strong healthcare infrastructure
Europe	0.6	6.8%	Reimbursement variances
Asia-Pacific	0.2	8.5%	Regulatory complexity, affordability

Note: Plans include strategic partnerships in Asia to boost adoption.

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How Do Future Trends Shape the Outlook?

Will Emerging Technologies Impact AMELUZ?

• Artificial Intelligence: AI-driven diagnostics could increase early detection and treatment efficiency, potentially offsetting some competition.
• Nanotechnology: Advances in drug delivery may improve efficacy and reduce side effects.

Could New Indications Expand Market Size?

• Exploratory trials aim to evaluate AMELUZ's efficacy in field cancerization and other dermatological conditions, potentially creating new revenue streams.

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Conclusion and Key Takeaways

• The AMELUZ market is positioned for steady growth driven by demographic shifts, regulatory support, and product innovation.
• Market expansion hinges on geographic penetration, especially in emerging markets, and defender strategies amidst patent expiries.
• Competitive landscape remains intense, with cryotherapy and other topicals competing on cost and convenience.
• Financial outlook suggests CAGR of approximately 8% over the next five years, with revenues reaching USD 210 million by 2026.
• Strategic focus on innovation, patent protection, and regional partnerships will be critical in sustaining growth.

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FAQs

1. What are the main competitors of AMELUZ in the actinic keratosis market?
Cryotherapy remains the most widely used treatment, with other topicals like diclofenac gel and imiquimod competing for market share. Recent advances in PDT and combination therapies also pose challenges for AMELUZ.

2. How does patent expiry affect AMELUZ’s market potential?
Patent expiry, anticipated around 2030, may lead to generic entries that could reduce prices and margins. To mitigate this, strategic patent extensions and new indication approvals are pursued.

3. What regulatory hurdles exist for AMELUZ’s expansion into emerging markets?
Varying regulatory standards and reimbursement policies require localized strategies, including partnerships and pilot programs to accelerate approvals and adoption.

4. What role does physician preference play in AMELUZ’s growth?
Physicians favor treatments with fewer side effects and higher patient compliance. AMELUZ’s non-invasive approach and safety profile are key drivers, though clinician education and reimbursement policies influence prescribing behaviors.

5. What future innovations could influence AMELUZ’s market share?
Development of combination therapies, improved drug delivery systems, and integration with diagnostic tools like fluorescence imaging may enhance efficacy and patient outcomes, supporting market expansion.

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References

[1] Industry Reports, “Global Actinic Keratosis Market Analysis,” 2022.
[2] Pharma Market Trends, “Topical Treatments Market Share,” 2023.
[3] World Health Organization, “Aging and Skin Diseases,” 2021.
[4] Journal of Dermatology, “Prevalence of Actinic Keratosis in Elderly Populations,” 2020.
[5] FDA Approvals Database, 2022.
[6] Market Access Reports, “Pricing and Reimbursement Policies,” 2022.
[7] PatentAnalysis.com, “Patent Landscape for Topical PDT Agents,” 2023.

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By focusing on strategic growth avenues, innovation, and market positioning, stakeholders can optimize AMELUZ’s financial trajectory amid evolving dermatological treatment paradigms.