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LEVULAN Drug Patent Profile

When do Levulan patents expire, and what generic alternatives are available?

Levulan is a drug marketed by Sun Pharm Inds Inc and is included in one NDA. There are five patents protecting this drug.

This drug has eleven patent family members in three countries.

The generic ingredient in LEVULAN 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 Levulan

Levulan was eligible for patent challenges on December 3, 2003.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 12, 2038. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for LEVULAN

International Patents:	11
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	151
Clinical Trials:	29
Patent Applications:	307
Drug Prices:	Drug price information for LEVULAN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LEVULAN
DailyMed Link:	LEVULAN at DailyMed

See drug prices for LEVULAN

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

NDA:

020965

Dosage:

SOLUTION;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 LEVULAN

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 2
National Institutes of Health (NIH)	Phase 2
Case Comprehensive Cancer Center	Phase 2

See all LEVULAN clinical trials

US Patents and Regulatory Information for LEVULAN

LEVULAN is protected by five US patents.

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
Sun Pharm Inds Inc	LEVULAN	aminolevulinic acid hydrochloride	SOLUTION;TOPICAL	020965-001	Dec 3, 1999		RX	Yes	Yes
Sun Pharm Inds Inc	LEVULAN	aminolevulinic acid hydrochloride	SOLUTION;TOPICAL	020965-001	Dec 3, 1999		RX	Yes	Yes
Sun Pharm Inds Inc	LEVULAN	aminolevulinic acid hydrochloride	SOLUTION;TOPICAL	020965-001	Dec 3, 1999		RX	Yes	Yes
Sun Pharm Inds Inc	LEVULAN	aminolevulinic acid hydrochloride	SOLUTION;TOPICAL	020965-001	Dec 3, 1999		RX	Yes	Yes

Expired US Patents for LEVULAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sun Pharm Inds Inc	LEVULAN	aminolevulinic acid hydrochloride	SOLUTION;TOPICAL	020965-001	Dec 3, 1999
Sun Pharm Inds Inc	LEVULAN	aminolevulinic acid hydrochloride	SOLUTION;TOPICAL	020965-001	Dec 3, 1999
Sun Pharm Inds Inc	LEVULAN	aminolevulinic acid hydrochloride	SOLUTION;TOPICAL	020965-001	Dec 3, 1999
Sun Pharm Inds Inc	LEVULAN	aminolevulinic acid hydrochloride	SOLUTION;TOPICAL	020965-001	Dec 3, 1999

International Patents for LEVULAN

When does loss-of-exclusivity occur for LEVULAN?

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

Australia

Canada

Japan

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 LEVULAN around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2461070	METHODE PHOTOCHIMIOTHERAPEUTIQUE FAISANT APPEL A DES PRECURSEURS DE LA PROTOPORPHYRINE (PHOTOCHEMOTHERAPEUTIC METHOD USING PRECURSORS OF PROTOPORPHYRIN IX)
Australia	2021102111	Methods for photodynamic therapy
New Zealand	251284	USE OF A PROTOPORPHYRIN IX PRECURSOR (PREFERABLY 5-AMINOLEVULINIC ACID) TO PREPARE PHARMACEUTICAL COMPOSITIONS
Canada	3029792	METHODES DE THERAPIE PHOTODYNAMIQUE (METHODS FOR PHOTODYNAMIC THERAPY)

LEVULAN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for LEVULAN

Introduction to LEVULAN

LEVULAN, also known as aminolevulinic acid (ALA), is a photosensitizing agent used in the treatment of actinic keratosis (AK), a precursor to skin cancer. It is commonly used in conjunction with photodynamic therapy (PDT) to target and destroy abnormal cells.

Market Size and Growth

The market for actinic keratosis treatments, which includes LEVULAN, has seen significant growth in recent years. The global photodynamic therapy market, which is a key segment for LEVULAN, was valued at $1.77 billion in 2023 and is projected to grow to $3.43 billion by 2032, with a compound annual growth rate (CAGR) of 7.7% from 2024 to 2032[4].

Regional Market Performance

• North America: This region dominates the photodynamic therapy market, including treatments like LEVULAN, due to the high prevalence of chronic disorders such as actinic keratosis. The increasing number of inpatient and outpatient admissions in healthcare settings further supports this dominance[4].
• Europe: Europe is also a significant market, driven by the growing prevalence of chronic skin disorders and the increasing focus of key players on research and development to launch novel products[4].

Product Approval and Regulatory Environment

LEVULAN is approved for the lesion-directed therapy of actinic keratosis on the face and scalp. The regulatory environment plays a crucial role in its market dynamics. For instance, Biofrontera, the company behind LEVULAN, has coordinated with regulatory bodies such as the FDA to ensure compliance and expand indications. In 2017, Biofrontera received written confirmation from the FDA for the approval path of Ameluz® (another product related to LEVULAN) to treat basal cell carcinoma, highlighting the ongoing regulatory efforts[3].

Sales and Revenue Performance

Biofrontera, the company associated with LEVULAN, has seen significant revenue growth. In the first half of 2017, the company's sales revenue leaped by 193% year-on-year, reaching EUR 5.0 million. This growth was partly due to the expansion of sales and marketing activities in the USA and the resolution of initial reimbursement difficulties[3].

Challenges and Opportunities

• Reimbursement Issues: One of the challenges faced by LEVULAN is the complexity of reimbursement processes. For example, in the USA, reimbursement was initially time-consuming and costly for physicians until a specific J-code was allocated to Ameluz®, which simplified billing[3].
• Generic Competition: The actinic keratosis treatment market, including LEVULAN, faces competition from generic drugs. The loss of patent exclusivities for many treatment options has led to the penetration of generics, which can lower revenue generation capacity[1].

End-User Segments

The hospitals segment is a major end-user for LEVULAN and other actinic keratosis treatments. In 2022, hospitals captured the largest revenue share of 30.4% in the U.S. actinic keratosis treatment market, driven by factors such as treatment accessibility and the increasing number of photodynamic therapy procedures performed in hospitals[1].

Competitive Landscape

The market for photodynamic therapy and actinic keratosis treatments is consolidated with a few key players. Companies like Biofrontera are focusing on expanding their product portfolios and geographical reach. The competitive landscape is characterized by strong commercial performance of products like Fluroplex, Carac, and Efudex, which are also used to treat actinic keratosis[1].

Research and Development

Continuous research and development are crucial for the growth of LEVULAN and related products. Biofrontera has been involved in various clinical trials and has received approvals for new indications, such as the use of Ameluz® for basal cell carcinoma. These efforts help in expanding the market opportunities and sales revenues[3].

Financial Trajectory

• Revenue Growth: The revenue growth for LEVULAN is tied to the overall growth of the photodynamic therapy market. With a projected CAGR of 7.7% from 2024 to 2032, the financial trajectory looks promising[4].
• Operational Costs: Despite revenue growth, operational costs such as research and development expenses and sales costs are significant. For instance, Biofrontera's research and development costs were EUR 2.185 million in the first half of 2017[3].

Key Takeaways

• LEVULAN is a key player in the photodynamic therapy market for treating actinic keratosis.
• The market is driven by increasing prevalence of chronic skin disorders and expanding regulatory approvals.
• Challenges include generic competition and reimbursement complexities.
• Hospitals are a significant end-user segment.
• Continuous R&D and strategic market expansion are crucial for growth.

FAQs

Q: What is LEVULAN used for? A: LEVULAN is used in the treatment of actinic keratosis, a precursor to skin cancer, often in conjunction with photodynamic therapy.

Q: What is the current market size of the photodynamic therapy market? A: The global photodynamic therapy market was valued at $1.77 billion in 2023[4].

Q: What is the projected growth rate of the photodynamic therapy market? A: The market is projected to grow at a CAGR of 7.7% from 2024 to 2032[4].

Q: What are the main challenges faced by LEVULAN in the market? A: The main challenges include generic competition and reimbursement complexities[1][3].

Q: Which region dominates the photodynamic therapy market? A: North America dominates the market due to the high prevalence of chronic disorders such as actinic keratosis[4].

Cited Sources

1. Grand View Research - U.S. Actinic Keratosis Treatment Market Size Report, 2030
2. Sun Pharmaceutical Industries Limited - Annual Report 2023-24
3. Biofrontera AG - Half-year financial report as at June 30, 2017
4. Fortune Business Insights - Photodynamic Therapy Market Size, Share | Global Report, 2032
5. Bloomberg Quint - VOICES, Motilal Oswal Strategy Voices