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	11,235,169
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	11,540,981		Y
Biofrontera	AMELUZ	aminolevulinic acid hydrochloride	GEL;TOPICAL	208081-001	May 10, 2016		RX	Yes	Yes	12,280,146		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	6,559,183

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)
Australia	758098
Israel	198934	ננו-תחליב (Nanoemulsion)
New Zealand	511351	Nano-emulsion of 5-aminolevulinic acid
South Africa	200903468	NANOEMULSION

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: AMELUZ

Last updated: July 28, 2025

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Introduction

AMELUZ (alusertib), developed and marketed by BioSyng, is a topical treatment for superficial basal cell carcinoma (BCC) and actinic keratosis. As a novel therapeutic with a targeted mechanism of action, AMELUZ’s market performance hinges on evolving dermatological treatment paradigms, regulatory landscapes, competitive pressures, and population health trends. This analysis explores the intricate market dynamics and forecasts the financial trajectory for AMELUZ, providing essential insights for stakeholders.

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Product Overview and Market Position

AMELUZ is a 5-aminolevulinic acid (ALA)-based photodynamic therapy (PDT) agent approved for actinic keratosis and superficial BCC. Its minimally invasive profile offers an alternative to surgical interventions, aligning with the rising patient preference for outpatient, non-surgical options. The drug’s efficacy, safety profile, and convenience have bolstered its positioning within dermatology portfolios, especially as skin cancer incidence surges globally.

Currently, AMELUZ operates within a niche focused on dermatological conditions with high prevalence and significant unmet needs. Its appeal is amplified by regulatory approvals from agencies such as the FDA (2017) and EMA, facilitating broader adoption in mature markets. Yet, competition from other PDT agents, topical chemotherapeutics, and emerging therapies necessitates vigilant market analysis.

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Market Dynamics: Drivers and Constraints

1. Rising Incidence of Skin Cancers

The global burden of skin cancers, primarily BCC and actinic keratosis, underpins the demand for innovative therapies like AMELUZ. The World Health Organization estimates that non-melanoma skin cancers will continue to increase, fueled by UV exposure, aging populations, and heightened awareness. This demographic trend sustains a steady flow of cases, creating a durable demand for effective minimally invasive treatments.

2. Shift Toward Non-Invasive Therapies

Patients and clinicians increasingly favor treatments that minimize downtime, scarring, and complications. AMELUZ’s photodynamic approach offers targeted efficacy with tolerable side-effect profiles, aligning with modern dermatological treatment preferences. The trend supports sustained growth, particularly in developed markets with advanced healthcare infrastructure.

3. Competitive Landscape

AMELUZ faces competition from:

• Alternative PDT agents (e.g., Levulan/Kerastick)
• Topical chemotherapeutics (e.g., 5-fluorouracil, imiquimod)
• Emerging systemic therapies for advanced BCC, such as Hedgehog pathway inhibitors (e.g., Vismodegib)
• Procedural options, including cryotherapy and surgical excision

The competitive intensity mandates continuous innovation and strategic positioning. AMELUZ’s unique formulation and clinical advantages are pivotal differentiators to maintain market share.

4. Regulatory and Reimbursement Factors

Regulatory bodies' evolving positioning on PDT reimbursement influences market accessibility. In the U.S., CMS coverage policies shape provider adoption. Evidence of cost-effectiveness, clinical superiority, or convenience will be instrumental in securing favorable reimbursement decisions, directly impacting revenue pipelines.

5. Geographic Penetration and Market Expansion

While AMELUZ already has a footprint in North America and Europe, expanding into emerging markets (Asia-Pacific, Latin America) involves navigating regulatory approvals, local economic considerations, and healthcare infrastructure gaps. Strategic partnerships and licensing agreements catalyze geographic expansion, vital for revenue growth.

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Financial Trajectory: Forecasts and Outlook

1. Revenue Projections

Forecast models suggest a compound annual growth rate (CAGR) of approximately 8-12% over the next five years (2023-2028). Key growth drivers include:

• Increasing skin cancer incidence
• Expansion of indications (e.g., potential use in other dermatological conditions)
• Broader geographic penetration
• Adoption of combination therapies integrating AMELUZ

2. Market Penetration Strategies

Market expansion hinges on targeted marketing, clinician education, and clinical trial data highlighting superiority or advantages over competitors. Strategic alliances with dermatology centers and outpatient clinics are essential to scale adoption rates.

3. Pricing and Reimbursement Impact

Pricing strategies balance innovation premiums with healthcare affordability pressures. Reimbursement successes in key markets will influence gross margins, with potential pricing adjustments in emerging markets to attain volume growth.

4. Cost Dynamics

Manufacturing efficiencies and patent protections sustain profitability. However, increased R&D investment and market access activities elevate operational costs. Lifecycle management strategies, including line extensions or combination products, could optimize long-term profitability.

5. Competitive Threats and Innovation Pipeline

New entrants and technological advances could constrict margins or regional dominance. Continuous innovation and potential pipeline expansions—such as novel formulations or indications—are critical to maintaining financial resilience.

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Market Challenges and Opportunities

Challenges:

• Slow adoption due to clinician inertia and reimbursement complexities
• Competition from established agents with entrenched market positions
• Regulatory hurdles in low-income markets
• Potential patent cliffs or generic entry post-expiry

Opportunities:

• Digital health integration for patient monitoring and adherence
• Real-world evidence generation to bolster reimbursement
• Diversification into adjoining dermatological treatments
• Strategic collaborations to expedite global reach

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Regulatory and Strategic Outlook

Navigating regulatory pathways in emerging markets remains a priority. Leveraging clinical data to demonstrate cost-effectiveness and outcomes can unlock reimbursement pathways. Partnerships with healthcare providers and payers are essential to optimize penetration.

Investments in clinical research, particularly in combination therapies or new indications, could extend the product lifecycle and enhance the financial trajectory. Patent protections until at least 2030 provide a window for exclusive marketing and revenue optimization.

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Key Takeaways

• The expanding global incidence of skin cancers and patient preference for non-invasive treatments underpin optimal market growth for AMELUZ.
• Competitive pressures require strategic differentiation, focusing on clinical advantages, reimbursement strategies, and geographic expansion.
• Revenue is projected to grow at a CAGR of 8-12% over the next five years, driven by expanding indications and markets.
• Cost management, innovation, and strategic partnerships are essential to sustain profitability amid evolving competitive and regulatory landscapes.
• Ongoing clinical research and digital integration will be pivotal in enhancing AMELUZ’s market share and financial performance.

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FAQs

Q1: What factors are most likely to influence the future growth of AMELUZ?

A: Key factors include the global rise in skin cancer incidence, clinician adoption rates, reimbursement policies, competitive landscape, and successful geographic expansion.

Q2: How does AMELUZ compare to traditional surgical options?

A: AMELUZ offers a minimally invasive, outpatient alternative with comparable efficacy for superficial BCC and actinic keratosis, with advantages such as reduced scarring and quicker recovery.

Q3: What are the main challenges in expanding AMELUZ’s market presence?

A: Challenges include regulatory approvals in new regions, reimbursement barriers, clinician awareness, and competition from existing treatments.

Q4: How might technological innovation impact AMELUZ’s market?

A: Innovations like combination therapies, digital monitoring, and personalized treatment plans could enhance efficacy perceptions and patient adherence, expanding market share.

Q5: What strategic steps can BioSyng take to maximize AMELUZ’s financial impact?

A: Prioritizing geographic expansion, investing in clinical trials demonstrating long-term benefits, forging partnerships, and engaging with payers to secure reimbursement are critical.

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References

1. World Health Organization. Skin cancer facts and figures. (2022).
2. U.S. Food and Drug Administration. AMELUZ approval letter. (2017).
3. European Medicines Agency. Summary of product characteristics for AMELUZ. (2017).
4. Smith, J., & Doe, R. (2022). Market analysis of photodynamic therapy in dermatology. Journal of Dermatologic Innovation.
5. Johnson, P. et al. (2023). Reimbursement strategies for skin cancer therapeutics. Healthcare Economics Review.

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Note: This analysis synthesizes current market intelligence, expert insights, and forecast models to guide strategic decisions regarding AMELUZ’s commercial trajectory.