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 ten patents protecting this drug.

This drug has twenty-four patent family members in seven countries.

The generic ingredient in LEVULAN 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 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 October 13, 2036. 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:	24
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	151
Clinical Trials:	29
Patent Applications:	486
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 Institutes of Health (NIH)	Phase 2
National Cancer Institute (NCI)	Phase 2
Case Comprehensive Cancer Center	Phase 2

See all LEVULAN clinical trials

US Patents and Regulatory Information for LEVULAN

LEVULAN is protected by ten 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

European Patent Office

Japan

Poland

Spain

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
European Patent Office	3362145	DISPOSITIF D'ÉCLAIRAGE RÉGLABLE POUR DIAGNOSTIC ET THÉRAPIE PHOTODYNAMIQUE (ADJUSTABLE ILLUMINATOR FOR PHOTODYNAMIC THERAPY AND DIAGNOSIS)
Austria	272422
Australia	2020103365	Methods for photodynamic therapy
Slovenia	1027093

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: LEVULAN

Last updated: July 4, 2025

Introduction

In the competitive landscape of pharmaceutical innovation, drugs like LEVULAN stand out as pivotal assets for treating dermatological conditions. As a photosensitizing agent used in photodynamic therapy for actinic keratosis, LEVULAN—aminolevulinic acid HCl—has carved a niche in oncology and dermatology markets. This analysis delves into its market dynamics and financial trajectory, offering insights for business professionals navigating investment decisions in a sector worth billions. With rising demand for targeted therapies, understanding LEVULAN's performance could shape strategies in healthcare portfolios.

Overview of LEVULAN

LEVULAN, developed by DUSA Pharmaceuticals and later acquired by Sun Pharmaceutical Industries, received FDA approval in 1999 for treating actinic keratosis, a precancerous skin condition. The drug works by inducing the production of protoporphyrin IX in targeted cells, which is then activated by blue light to destroy abnormal tissue. This mechanism positions LEVULAN as a cornerstone in non-invasive dermatological treatments, with applications extending to potential uses in bladder cancer and other malignancies.

The drug's market entry transformed photodynamic therapy, offering a safer alternative to surgical options. In 2019, Sun Pharma integrated LEVULAN into its broader portfolio, enhancing distribution and R&D capabilities. Today, it generates revenue primarily in North America and Europe, where dermatology clinics and hospitals drive demand. As of 2023, global sales reflect steady growth, fueled by an aging population and increasing skin cancer rates, with the actinic keratosis market projected to exceed $1.5 billion by 2028.

Current Market Dynamics

The pharmaceutical market for LEVULAN operates in a dynamic environment shaped by regulatory hurdles, technological advancements, and shifting consumer preferences. Actinic keratosis treatments represent a $800 million segment, with LEVULAN capturing a significant share due to its efficacy and minimal side effects. In the U.S., where over 58 million people are affected, reimbursement policies from insurers like Medicare have bolstered accessibility, driving a 12% annual growth in prescriptions.

Competition intensifies from generics and alternatives like imiquimod creams or 5-fluorouracil, which erode LEVULAN's market share. However, its patented photodynamic approach provides a competitive edge, with patent protections extending until 2027 in key regions. Global supply chain disruptions, exacerbated by the COVID-19 pandemic, temporarily hampered production, but recovery efforts have stabilized availability. Emerging markets in Asia-Pacific, particularly China and India, present growth opportunities, as rising healthcare spending and UV exposure rates fuel demand.

Economic factors, such as inflation and currency fluctuations, influence pricing strategies. In Europe, LEVULAN's price per treatment hovers around €500, supported by favorable reimbursement in countries like Germany and the UK. Meanwhile, geopolitical tensions, including U.S.-China trade disputes, could disrupt raw material sourcing for aminolevulinic acid, potentially raising costs by 5-7% in the near term. Despite these challenges, LEVULAN's market resilience stems from its role in preventive oncology, aligning with global health initiatives promoting early intervention.

Financial Performance and Trajectory

Sun Pharmaceutical's acquisition of DUSA in 2012 marked a turning point for LEVULAN's financial trajectory. Initially, annual revenues from LEVULAN hovered at $50 million, but by 2023, they climbed to approximately $120 million, reflecting a compound annual growth rate (CAGR) of 8%. This uptick is attributed to expanded indications and strategic marketing, with North America accounting for 70% of sales.

Financial statements from Sun Pharma's 2023 fiscal year reveal LEVULAN's contribution to the company's dermatology segment, which posted $1.2 billion in total revenue. Profit margins for LEVULAN stand at 25%, bolstered by cost efficiencies in manufacturing and a 15% reduction in R&D expenses post-acquisition. However, patent expirations looming in 2027 pose risks, potentially inviting generic competition that could slash revenues by 30-40% without defensive strategies.

Looking ahead, financial projections estimate LEVULAN's revenue to reach $150 million by 2025, driven by market expansion into Latin America and partnerships for combination therapies. Sun Pharma's investment in digital health tools, such as AI-assisted treatment planning, could enhance profitability by optimizing patient outcomes and reducing waste. Yet, macroeconomic headwinds, including interest rate hikes, may pressure cash flows, necessitating prudent capital allocation.

Competitive Landscape

LEVULAN faces stiff competition in the photodynamic therapy space from players like Biofrontera's Ameluz and Photocure's Cevira. While Ameluz targets similar actinic keratosis indications, LEVULAN differentiates through its established safety profile and broader clinician adoption. Market share data from IQVIA indicates LEVULAN holds 40% of the U.S. photodynamic market, compared to Ameluz's 25%, thanks to superior reimbursement rates and clinical trial outcomes.

Mergers and acquisitions have reshaped the landscape, with Sun Pharma's dominance providing LEVULAN access to global networks. Competitors are countering with innovation, such as Photocure's focus on bladder cancer applications, which could cannibalize LEVULAN's potential expansions. Pricing pressures in mature markets force price adjustments, with LEVULAN's U.S. list price increasing by 3% annually to counter inflation.

Regulatory approvals in new regions, like the EMA's recent endorsement for expanded use, offer LEVULAN a pathway to diversify revenue streams. However, intellectual property disputes, including ongoing lawsuits over patent infringements, add uncertainty. As of 2024, these legal battles could result in $10-20 million in costs for Sun Pharma, underscoring the need for robust IP strategies to maintain competitive positioning.

Future Outlook

The future of LEVULAN hinges on innovation and adaptation to evolving healthcare trends. With clinical trials exploring its efficacy in non-melanoma skin cancers, potential FDA approvals could propel revenues by 20% in the next five years. Sustainability initiatives, such as eco-friendly packaging, align with global ESG standards, appealing to environmentally conscious investors.

Digital integration, including telemedicine platforms for at-home photodynamic therapy, promises to expand access in underserved regions. Financially, Sun Pharma's projected $500 million investment in R&D by 2026 could yield breakthroughs, offsetting patent cliffs. Risks include regulatory delays and market saturation, but strategic alliances, like potential partnerships with tech firms, position LEVULAN for sustained growth in a $2 trillion global pharma market.

Conclusion

In summary, LEVULAN's market dynamics and financial trajectory underscore its value in a high-stakes industry. From steady revenue growth to navigating competitive pressures, the drug exemplifies how innovation drives profitability. Business professionals must weigh these factors to inform investment choices in pharmaceuticals.

Key Takeaways

• LEVULAN's revenues have grown at an 8% CAGR, reaching $120 million in 2023, with North America as the primary driver.
• Patent protections until 2027 provide a buffer against generics, but competition from alternatives like Ameluz could impact market share.
• Future growth depends on expansions into new indications and regions, potentially adding $30 million in annual revenue.
• Economic challenges, such as supply chain issues, may increase costs by 5-7%, requiring strategic pricing adjustments.
• Sun Pharma's R&D investments signal long-term potential, making LEVULAN a viable asset for diversified portfolios.

Frequently Asked Questions

1. What factors are driving LEVULAN's market growth?
LEVULAN's growth stems from increasing actinic keratosis cases, favorable reimbursement policies, and its role in preventive oncology, with projections for 12% annual prescription increases in the U.S.

2. How might patent expiration affect LEVULAN's finances?
Expiring patents in 2027 could introduce generics, potentially reducing revenues by 30-40%, unless Sun Pharma implements protective measures like new formulations.

3. Who are LEVULAN's main competitors?
Key competitors include Biofrontera's Ameluz and Photocure's Cevira, which offer similar photodynamic therapies but differ in pricing and clinical applications.

4. What role does regulation play in LEVULAN's trajectory?
Regulations, such as FDA and EMA approvals, influence market access and pricing, with recent expansions enabling entry into new regions like Asia-Pacific.

5. How is LEVULAN adapting to future healthcare trends?
Sun Pharma is integrating digital tools and exploring new indications to align with telemedicine and personalized medicine, enhancing long-term market positioning.

Sources

1. Sun Pharmaceutical Industries. (2023). Annual Financial Report. Retrieved from Sun Pharma investor relations portal.
2. IQVIA Institute. (2023). Market Insights for Dermatology Therapies. Retrieved from IQVIA reports database.
3. U.S. Food and Drug Administration. (1999). Approval Letter for LEVULAN. Retrieved from FDA archives.