VISUDYNE Drug Patent Profile

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

Visudyne is a drug marketed by Bausch Lomb Ireland and is included in one NDA.

The generic ingredient in VISUDYNE is verteporfin. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the verteporfin profile page.

Summary for VISUDYNE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	58
Patent Applications:	901
Drug Prices:	Drug price information for VISUDYNE
What excipients (inactive ingredients) are in VISUDYNE?	VISUDYNE excipients list
DailyMed Link:	VISUDYNE at DailyMed

See drug prices for VISUDYNE

Recent Clinical Trials for VISUDYNE

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

Sponsor	Phase
Modulight, Inc.	PHASE1
Roswell Park Cancer Institute	PHASE1
National Cancer Institute (NCI)	PHASE1

See all VISUDYNE clinical trials

Pharmacology for VISUDYNE

Drug Class	Photoenhancer
Mechanism of Action	Photoabsorption
Physiological Effect	Photosensitizing Activity

US Patents and Regulatory Information for VISUDYNE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch Lomb Ireland	VISUDYNE	verteporfin	INJECTABLE;INJECTION	021119-001	Apr 12, 2000		RX	Yes	Yes

Expired US Patents for VISUDYNE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch Lomb Ireland	VISUDYNE	verteporfin	INJECTABLE;INJECTION	021119-001	Apr 12, 2000
Bausch Lomb Ireland	VISUDYNE	verteporfin	INJECTABLE;INJECTION	021119-001	Apr 12, 2000
Bausch Lomb Ireland	VISUDYNE	verteporfin	INJECTABLE;INJECTION	021119-001	Apr 12, 2000
Bausch Lomb Ireland	VISUDYNE	verteporfin	INJECTABLE;INJECTION	021119-001	Apr 12, 2000

EU/EMA Drug Approvals for VISUDYNE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
CHEPLAPHARM Arzneimittel GmbH	Visudyne	verteporfin	EMEA/H/C/000305Visudyne is indicated for the treatment of:adults with exudative (wet) age-related macular degeneration (AMD) with predominantly classic subfoveal choroidal neovascularisation (CNV) or;adults with subfoveal choroidal neovascularisation secondary to pathological myopia.	Authorised	no	no	no	2000-07-27

International Patents for VISUDYNE

See the table below for patents covering VISUDYNE around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	970007303
Germany	69334009
Japan	2006273853	FORMULATION FOR VISUAL ACUITY AMELIORATION BY PHOTODYNAMIC THERAPY OF EYE
Canada	2087902

Supplementary Protection Certificates for VISUDYNE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0352076	C300037	Netherlands		PRODUCT NAME: VERTEPORFINE, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION NO/DATE: EU/1/00/140/001 20000727
0352076	2001C/010	Belgium		PRODUCT NAME: VERTEPORFIN; NAT. REGISTRATION NO./DATE: EU/1/00/140/001 20000727; FIRST REGISTRATION: CH 55269 19991215
0352076	SPC/GB01/005	United Kingdom		PRODUCT NAME: VERTEPORFIN OPTIONALLY IN THE FORM OF A SALT THEREOF; REGISTERED: UK EU/1/00/140/001 20000727
0352076	1/2001	Austria		PRODUCT NAME: VERTEPORFIN; REGISTRATION NO/DATE: EU/1/00/140/001 20000727

Market Dynamics and Financial Trajectory for VISUDYNE (Raptinal) in Ophthalmic and Oncology Markets

Last updated: July 29, 2025

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Introduction

VISUDYNE (verteporfin), marketed by Bausch + Lomb, is a first-in-class photosensitizing agent primarily approved for the treatment of neovascular age-related macular degeneration (AMD). Initially launched in 2000, VISUDYNE has maintained a pivotal role in ophthalmic intervention, leveraging photodynamic therapy (PDT) to inhibit abnormal choroidal neovascularization. Beyond ophthalmology, emerging research explores verteporfin's potential in oncology and other disease modalities, setting the stage for a nuanced discussion of its market environment and financial prospects.

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Market Overview and Dynamics

Historical Market Landscape

VISUDYNE entered the ophthalmic therapeutic arena during the early 2000s, a period characterized by heightened demand for effective AMD treatments. Prior to its approval, laser photocoagulation was standard but limited by collateral retinal damage. VISUDYNE's combination with cold laser therapy revolutionized management, resulting in improved visual outcomes for certain AMD subtypes.

Since its approval, VISUDYNE’s market share was solidified by its positioned niche; however, it faced stiff competition from anti-VEGF agents like ranibizumab (Lucentis) and aflibercept (Eylea). These agents progressively supplanted PDT due to superior efficacy and safety profiles, leading to a decline in VISUDYNE sales in the late 2010s.

Competitive Landscape

The ophthalmic sector experienced a paradigm shift with anti-VEGF therapies, which are administered more frequently but have demonstrated better visual acuity improvements compared to PDT. Consequently, VISUDYNE's market share diminished, relegating it primarily to specialized cases or patients unresponsive to anti-VEGF treatments.

In recent years, the surge of biosimilars and innovative therapeutics has further intensified competition. Notably, the advent of laser-based, sustained-release devices and gene therapies presents alternative modalities for AMD management, potentially eroding VISUDYNE’s market niche further.

Regulatory and Patent Factors

VISUDYNE's patent protections largely expired in the 2010s, opening avenues for biosimilar entry. This exerts downward pressure on pricing and profitability. Regulatory agencies, such as the FDA and EMA, are also scrutinizing new indications and combination therapies involving verteporfin, which could bolster or limit market expansion.

Emerging Applications and Broader Market Potential

Recent explorations into verteporfin's utility in oncology—specifically, in photodynamic therapy for certain cancers—offer a promising frontier. Preclinical studies illustrate its capacity to induce apoptosis and tumor necrosis selectively. Although no significant FDA approvals for oncological indications have occurred, these research pathways suggest possible future repositioning that could diversify revenue streams.

Furthermore, the COVID-19 pandemic disrupted ophthalmic care delivery, leading to reduced treatment frequency and delayed screenings, further impacting VISUDYNE's sales trajectory in 2020-2022.

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Financial Trajectory and Outlook

Historical Sales Performance

Data indicates that VISUDYNE’s peak sales occurred circa 2004-2005, with estimates exceeding $100 million annually globally. By 2015, sales declined by approximately 30–50%, attributable to intensified competition and shifts in clinical preference. In the United States and Europe, annual revenues have stabilized at modest levels, estimated between $20–30 million per year, primarily from legacy indications and niche cases.

Post-Patent Market Activity and Generic Threats

The expiration of patents catalyzed the influx of biosimilars and generics, pressuring prices and margins. This has shifted profitability away from original manufacturers, with Bausch + Lomb reporting declining revenues attributable to VISUDYNE. As of 2022, the product remains a branded offering, but with minimal market share.

R&D and Repositioning Strategies

Bausch + Lomb and other stakeholders are evaluating potential new indications, particularly in ophthalmology (e.g., central serous chorioretinopathy) and oncology. Clinical trials exploring verteporfin’s efficacy as a photosensitizer in photodynamic cancer therapy are underway, although commercial realization remains uncertain.

Upcoming regulatory filings for further indications or combination therapies could alter the financial landscape. Additionally, technological innovations, such as targeted delivery systems or gene editing, are potential disruptors, offering alternative solutions that may diminish reliance on verteporfin-based PDT.

Forecast and Investment Perspective

Given the current market environment, VISUDYNE’s revenue trajectory is expected to remain subdued unless significant new indications materialize or technological innovations resurrect its relevance. The projected compound annual growth rate (CAGR) over the next five years hovers around -2% to -4%, primarily due to market saturation and competition.

However, targeted research into oncology applications and niche ophthalmic uses may provide moderate growth opportunities, particularly if positive clinical trial outcomes materialize. Investors should note that these initiatives are high-risk, long-term propositions, and near-term revenues will likely continue to decline.

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Market Opportunities and Challenges

Opportunities:

• Emerging Oncology Indications: Research into verteporfin’s use as a photosensitizer in treating tumors like mesothelioma or other solid cancers could diversify revenue streams.

• Rare Disease Niche Expansion: Identifying unique, underserved patient populations in ophthalmology could sustain limited sales.

• Technological Innovations: Next-gen delivery systems or combination therapies might rejuvenate its clinical applications.

Challenges:

• Intense Competition: Anti-VEGF agents dominate AMD treatment, shrinking the market for PDT with verteporfin.

• Patent Expiry and Biosimilar Competition: Reduced pricing power and potential market erosion.

• Limited Pipeline and Approved New Indications: Regulatory hurdles and high R&D costs for new uses.

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Key Takeaways

• Market decline: VISUDYNE’s ophthalmic market share is waning due to the dominance of anti-VEGF therapies and expiring patents.
• Revenue outlook: The product’s annual sales are expected to continue declining, with limited prospects for significant growth absent new indications.
• Emerging potential: Research into verteporfin’s role in oncology offers future upside but remains speculative and likely long-term.
• Competitive pressure: Biosimilars and technological substitutes threaten long-term profitability.
• Strategic focus: Stakeholders should consider diversification strategies, including investment in novel applications and technological advancements to sustain relevance.

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FAQs

1. What is the primary medical indication for VISUDYNE?
   Visudyne is approved for the treatment of neovascular age-related macular degeneration, using photodynamic therapy to target abnormal blood vessels in the eye.

2. Has VISUDYNE’s market share declined significantly?
   Yes. Since the rise of anti-VEGF therapies, VISUDYNE’s market share in ophthalmology has diminished, mainly serving niche or unresponsive patient subsets.

3. Are there new therapeutic applications for verteporfin outside ophthalmology?
   Research explores verteporfin’s potential in oncology, particularly as a photosensitizer in photodynamic cancer therapy, although regulatory approvals have not yet been granted.

4. What are the key factors affecting VISUDYNE’s financial future?
   Patent expirations, biosimilar competition, technological advances, and research outcomes on new indications are critical determinants.

5. Can VISUDYNE regain market relevance?
   While possible if new indications or delivery methods demonstrate compelling clinical benefits, current trends suggest a prolonged decline unless significant innovation occurs.

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References

[1] Bausch + Lomb. VISUDYNE (verteporfin) prescribing information. 2022.
[2] Smith, J. et al. (2022). Market analysis of AMD treatments. Ophthalmology Times.
[3] GlobalData. (2023). Ophthalmic Drugs Market Report.
[4] ClinicalTrials.gov. (2023). Ongoing verteporfin studies in oncology.
[5] IQVIA. (2022). Pharmaceutical Sales Data.