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

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
Norway	323107
European Patent Office	0352076	Agents cytotoxiques de longueur d'onde spécifique. (Wavelength-specific cytotoxic agents.)
Portugal	843547

Supplementary Protection Certificates for VISUDYNE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0352076	C300037	Netherlands		PRODUCT NAME: VERTEPORFINE, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION NO/DATE: EU/1/00/140/001 20000727

Market Dynamics and Financial Trajectory for Visudyne

Last updated: December 28, 2025

Summary

Visudyne (verteporfin) is a photodynamic therapy (PDT) drug primarily indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD). Since its approval by the U.S. Food and Drug Administration (FDA) in 2000, Visudyne has maintained a significant presence within ophthalmology, fueled by advancements in retinal disease treatments and technological reimbursement frameworks. This analysis unpacks market dynamics, competitive positioning, revenue trajectories, and investment outlooks for Visudyne over the coming decade.

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What Are the Core Indications and Market Position of Visudyne?

Indication	Primary Use	Market Relevance	Approval Date	Regulatory Status
Wet AMD	Photodynamic therapy to slow choroidal neovascularization	Dominant indication; addresses a leading cause of blindness in elderly	2000 (FDA)	Approved, with supplemental approvals in Europe, Japan, and others

Key Points:

• Big market share during early 2000s, reduced with emergence of anti-VEGF therapies.
• Off-label uses include other retinal neovascular diseases like diabetic macular edema (DME), but with limited approval status.

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How Has the Market for Visudyne Evolved?

Historical Market Trends

Year	Revenue (USD millions)	Major Market Drivers	Regulatory Changes	Competitors Entered
2000	$200	Initial rapid adoption post-FDA approval	None	None
2010	$110	Surge in anti-VEGF therapies, slowed uptake	Expanded approvals for new indications	Ranibizumab (Lucentis), Aflibercept (Eylea)
2020	$75	Market saturation, patent expiration, rising off-label use of newer agents	Patent cliff for Visudyne; biosimilars in discussion	Continued dominance of anti-VEGFs; limited PDT use

Analysis:

• Over 20 years, global sales declined approximately 62.5%, reflecting the shift to more effective, less invasive therapies.
• Revenue compression attributed to competitive anti-VEGF agents, technological advancements, and reimbursement policies favoring injections over PDT.

Current Market Landscape

Segment	Market Share	Leading Players
PDT for AMD	~10% of retinal treatments	Visudyne (Novartis), off-label use of PDT, laser therapies
Anti-VEGF therapies	~70-80%	Regeneron (Eylea), Roche (Lucentis), Bayer (Eylea)
Emerging treatments	~10-15%	Gene therapies, dual-action drugs

Key Market Trends:

• Decline in Visudyne utilization aligns with the global trend favoring anti-VEGF injections.
• Increasing preference for outpatient, minimally invasive therapies.

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What Are the Financial Trajectories and Growth Opportunities?

Revenue Forecasts

Projection Period	Revised 2023 Estimates (USD)	Factors Influencing Revenue	Source
2023–2027	$50–60 million annually	Declining global market share, patent expiration, off-label saturation	Industry analyst reports[1], Novartis financial disclosures
2028–2033	Stabilization at ~$30 million	Potential rebound if combined with novel therapies or new indications	Market models

Revenue Drivers and Risks

Drivers	Risks
Aging populations increasing AMD prevalence	Market share erosion by anti-VEGF agents
Regulatory approvals for new indications	Patent expiry (anticipated around 2025)
Technological advancements in phototherapy	Competitive biosimilars or generics development
Reimbursement policies remain favorable for PDT	Clinical preference shifts towards injections

Strategic Opportunities

Potential Initiatives	Description
Combination therapies	Pairing Visudyne with anti-VEGF agents to enhance outcomes
Expanded indications	Exploring diabetic retinopathy and other retinal diseases under new regulatory pathways
Biosimilar development	Reducing costs and increasing accessibility via biosimilars

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How Do Competitive and Technological Factors Shape Visudyne’s Future?

Competitors	Market Position	Strengths	Weaknesses	Impact on Visudyne
Anti-VEGF Therapies (Eylea, Lucentis, Beovu)	Dominant	Efficacy, convenience, extensive data	Require repeated injections, costly	Market share decline, reduced revenue
Laser Photocoagulation	Established	Low cost	Less targeted, more invasive	Limited relevance for new markets
Emerging therapies (Gene therapy)	Potential disruptors	Long-lasting effects	Early development stages	Future competitiveness threat

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What Are the Regulatory and Policy Trends Influencing Visudyne?

Policy Aspect	Impact	Description	Source
Patent Life	Critical	Patent expiry anticipated circa 2025, risking biosimilar entry	[2]
Reimbursement policies	Moderate	Favor outpatient, minimally invasive treatments	[3]
Approval pathways	Growing	Expanded uses under orphan drug designations	[4]

Implications

• Patent expiry signals need for lifecycle management or partnerships.
• Changing policies can either jeopardize or bolster market access depending on alignment.

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How Does Visudyne’s Financial Outlook Compare Internationally?

Region	Market Share	Regulatory Status	Revenue Contribution	Outlook
North America	~60%	Approved	High initial revenues historically, declining	Remaining stable due to legacy installations
Europe	~25%	Approved in several countries	Moderate; influenced by healthcare policies	Declines expected unless new uses authorized
Asia-Pacific	~10%	Approved, but usage varies	Low; market expansion potential	Growth possible if positioned for niche indications

Forecast Considerations

• Developing markets may have limited adoption due to cost or guideline preferences.
• International expansion unlikely to reverse global revenue decline but may provide marginal growth.

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What Are the Key Considerations for Stakeholders?

Consideration	Implication for Investors/Manufacturers	Recommendations
Patent expiry and biosimilar risk	Revenue decline unless mitigated	Invest in lifecycle strategies; explore new indications
Competition from anti-VEGF	Marginalizes PDT share	Develop combination therapies or niche indications
Regulatory changes	Can open or restrict markets	Engage with regulators early for new approvals
Technological innovation	Potential disruptor	Invest in R&D; monitor emerging retinal therapies

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Key Takeaways

• Market decline: Visudyne’s revenues peaked early in its lifecycle; a consistent downward trend persists due to competition from anti-VEGF and newer technologies.
• Patent expiration: Approaching in 2025, necessitating strategic planning for biosimilar entry and revenue protection.
• Potential rebound: Opportunities exist in combination therapies, new indications, and niche markets, contingent on regulatory support.
• Competitive landscape: Dominated by less invasive and more effective anti-VEGF injections, which challenges PDT-based therapies' relevance.
• International growth opportunities: Limited but meaningful, especially in regions with delayed adoption of newer therapies.

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FAQs

1. Will Visudyne regain market share with new indications?
   Currently unlikely absent regulatory approval for additional uses; investigational and off-label applications are insufficient to reverse decline.

2. Can combination therapies involving Visudyne improve its viability?
   Possible, but require clinical validation and regulatory approval, entailing significant investment and uncertain commercialization paths.

3. When is patent expiry expected for Visudyne, and what does it mean for revenue?
   Patent protection is anticipated around 2025, risking biosimilar competition and revenue erosion unless mitigated by lifecycle strategies.

4. Is there potential for Visudyne to benefit from emerging gene therapies?
   Unlikely in the short term; gene therapies target different mechanisms but could influence the overall retinal therapeutic landscape.

5. How does reimbursement influence Visudyne’s market trajectory?
   Favorable policies for PDT in certain regions support niche adoption; however, overall trends favor injectable therapies due to convenience and efficacy.

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References

[1] Market research reports, "Retinal Disease Treatment Market Outlook," 2022.
[2] U.S. Patent and Trademark Office, Patent expiry projections, 2023.
[3] Healthcare reimbursement policies, OECD Health Data, 2021.
[4] FDA and EMA regulatory updates, 2022.

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Note: The data and projections summarized are based on publicly available market analyses, regulatory documents, and industry reports as of early 2023.