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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 two patents protecting this drug.

This drug has twenty-six 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. Three 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 February 7, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for AMELUZ

International Patents:	26
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	151
Clinical Trials:	13
Patent Applications:	307
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:

11,540,981

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
Biofrontera, Inc.	Phase 2
Case Comprehensive Cancer Center	Phase 2
The Cleveland Clinic	Phase 2

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 two US patents.

This potential generic entry date is based on patent 11,540,981.

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	11,540,981		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
World Intellectual Property Organization (WIPO)	2022078955
Chile	2007003730	Nanoemulsion que comprende a) componente acuoso y b) un vehiculo con i) 0,1-15% de un componente lipofilico, ii) un tensoactivo y iii) un alcohol c3-c5; composicion que la comprende opcionalmente con un agente activo; proceso de preparacion de la nanoemulsion y de la composicion; kit; y uso para diagnosticar enfermedades dermicas y proliferativas, y tratar enfermedades virales, dermicas y proliferativas.
Spain	2602107
Australia	758098
China	101588792	Nanoemulsion
Australia	1271000
South Africa	200903468	NANOEMULSION

AMELUZ Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Ameluz

Introduction to Ameluz

Ameluz, a photodynamic therapy (PDT) drug developed by Biofrontera AG, is primarily used for the treatment of actinic keratosis (AK), a common precursor to skin cancer. Here, we delve into the market dynamics and financial trajectory of Ameluz, highlighting key strategies, market performance, and financial insights.

Market Positioning of Ameluz

Biofrontera AG has been actively positioning Ameluz as the leading PDT drug in both European and U.S. markets. In Europe, Ameluz has already achieved the number one position in Germany and Spain, with a strategy to expand the PDT market by competing with topical drugs and cryotherapy[1].

European Market

In Europe, Ameluz has seen significant growth, particularly in the UK where sales increased by 9.3% in the recent financial year. The German market also showed a substantial increase of over 30% compared to the previous year. The European approval for the treatment of AK with artificial daylight has further boosted its market presence[4].

U.S. Market

In the U.S., Biofrontera Inc., the sales partner, has generated substantial sales growth. The U.S. market saw a 34.3% increase in sales compared to the previous year, with total revenues reaching EUR 22.1 million. The company is also pursuing label expansion through multiple clinical studies, aiming to increase the drug's market potential[3][5].

Market Share and Competition

Actinic Keratosis Market

The AK market is dominated by topical treatments and cryotherapy, but Ameluz is gaining ground. In the U.S., for instance, PDT treatments represent only 3% of the AK market, but this segment still translates to an estimated $130 million in annual sales. Biofrontera aims to capture more market share from topicals and cryotherapy by leveraging new CPT codes and the medical need for field therapy[1].

Competitive Advantage

Ameluz has several competitive advantages, including its efficacy and the recent approval for use in combination with daylight PDT, which makes it more accessible and reimbursable. This has shifted preferences among dermatologists, who previously favored cryotherapy due to reimbursement issues[1].

Financial Performance

Revenue Growth

Biofrontera has reported significant revenue growth driven by Ameluz sales. For the first nine months of 2024, total revenues increased by 5.6% to $24.8 million, despite shipment delays due to Hurricane Milton. Without these delays, the increase would have been 12%[5].

Cost Structure and Profitability

The recent restructuring of the supply agreement between Biofrontera AG and Biofrontera Inc. has reduced the transfer price of Ameluz from 50% to 25% for 2024 and 2025. This reduction is expected to lower the cost of goods sold (COGS) and enhance gross margins, potentially leading to improved profitability[2].

Operational Efficiency

Biofrontera Inc. has taken over clinical operations for Ameluz, which is expected to result in better cost management and faster execution of trials. This shift towards greater operational autonomy could accelerate the time to market for new drug indications and improve overall efficiency[2][5].

Clinical Development and Label Expansion

Biofrontera is actively engaged in several clinical studies to expand the label for Ameluz. This includes phase III clinical trials for the treatment of AK on the extremities, neck, and trunk, as well as trials for basal cell carcinoma and squamous cell carcinoma in situ. The potential approval for the use of up to three tubes per treatment, currently under review by the FDA, could significantly increase the drug's market potential[3][4].

Reimbursement and Regulatory Environment

The approval of new CPT codes in January 2019 has improved the reimbursement landscape for PDT treatments with Ameluz in the U.S. This has made the treatment more financially viable for both dermatologists and patients. In Europe, the removal of pricing decrees in Spain has also positively impacted sales[1].

Financial Outlook

Short-Term Prospects

The reduced transfer price and improved operational efficiency are expected to enhance profitability in the short term. Biofrontera believes that these changes, combined with simultaneous financing, could be sufficient for the company to achieve profitability by 2025[2].

Long-Term Prospects

The long-term outlook is promising, with potential label expansions and new indications expected to open up additional revenue streams. The company's focus on clinical development and market growth strategies is likely to sustain its market position and drive further growth[3][4].

Key Takeaways

• Market Positioning: Ameluz is positioned as the leading PDT drug in Europe and is gaining traction in the U.S. market.
• Revenue Growth: Significant revenue growth has been reported, driven by increased sales in both European and U.S. markets.
• Cost Structure: The reduced transfer price and improved operational efficiency are expected to enhance profitability.
• Clinical Development: Ongoing clinical studies aim to expand the label for Ameluz, potentially increasing its market potential.
• Regulatory Environment: Improved reimbursement through new CPT codes and regulatory approvals has boosted sales.

FAQs

What is Ameluz used for?

Ameluz is used for the treatment of actinic keratosis (AK), a common precursor to skin cancer, through photodynamic therapy (PDT).

How is Ameluz positioned in the market?

Ameluz is positioned as the leading PDT drug in Europe, particularly in Germany and Spain, and is expanding its market share in the U.S.

What are the key financial highlights for Ameluz in 2024?

In 2024, Ameluz achieved record volume sales, and total revenues for the first nine months increased by 5.6% despite shipment delays. The company also reduced its transfer price, which is expected to enhance profitability.

What are the ongoing clinical studies for Ameluz?

Biofrontera is conducting several clinical studies, including phase III trials for the treatment of AK on the extremities, neck, and trunk, as well as trials for basal cell carcinoma and squamous cell carcinoma in situ.

How has the reimbursement environment impacted Ameluz sales?

The approval of new CPT codes and the removal of pricing decrees in Spain have improved the reimbursement landscape, making Ameluz more financially viable for both dermatologists and patients.

Sources

1. Biofrontera AG Investor Presentation - January 2020
2. Biofrontera Inc. Announces Restructuring of Supply Agreement - February 2024
3. Biofrontera AG Annual Report 2022
4. Biofrontera Reports Results for the Financial Year - April 2024
5. Biofrontera Inc. Reports Third Quarter and Nine-Month 2024 Financial Results - November 2024