Verteporfin - Generic Drug Details

What are the generic sources for verteporfin and what is the scope of patent protection?

Verteporfin is the generic ingredient in one branded drug marketed by Bausch Lomb Ireland and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for verteporfin. Two suppliers are listed for this compound.

Summary for verteporfin

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	16
Clinical Trials:	72
DailyMed Link:	verteporfin at DailyMed

Recent Clinical Trials for verteporfin

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

Sponsor	Phase
Jri Pnchera	PHASE1
University of Geneva, Switzerland	PHASE1
University Hospital, Geneva	PHASE1

See all verteporfin clinical trials

Pharmacology for verteporfin

Drug Class	Photoenhancer
Mechanism of Action	Photoabsorption
Physiological Effect	Photosensitizing Activity

Anatomical Therapeutic Chemical (ATC) Classes for verteporfin

S01LA	Antineovascularisation agents
S01L	OCULAR VASCULAR DISORDER AGENTS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for verteporfin

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 verteporfin

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 verteporfin

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

Market Dynamics and Financial Trajectory for Verteporfin

Last updated: July 30, 2025

Introduction

Verteporfin, a light-activated benzoporphyrin derivative, has established itself as a critical therapeutic agent primarily in ophthalmology. Initially developed for age-related macular degeneration (AMD), verteporfin's mechanism centers around photodynamic therapy (PDT), where its activation by specific wavelengths of light induces localized cytotoxicity. This article analyzes the evolving market dynamics and projected financial trajectory of verteporfin, considering regulatory developments, competitive landscape, technological innovations, and emerging therapeutic applications.

Pharmaceutical Profile and Indications

Verteporfin, marketed under Visudyne by Novartis, received FDA approval in 2000 for the treatment of neovascular (wet) AMD. Its therapeutic action involves selective occlusion of abnormal choroidal neovascularization (CNV), a hallmark of wet AMD, thereby preventing vision loss. Beyond AMD, verteporfin has been evaluated for other indications, including central serous chorioretinopathy (CSCR), polypoidal choroidal vasculopathy, and potential off-label uses such as certain oncological treatments.

Market Landscape and Key Drivers

1. Expanding Patient Population

An aging global demographic drives the prevalence of AMD, with estimates indicating over 196 million individuals affected worldwide in 2020, expected to rise to 288 million by 2040 [[1]]. The wet AMD subtype benefits from existing therapies like verteporfin, resulting in a steady demand. The global burden ensures sustained revenue streams, although the growth rate depends on demographic shifts, diagnostic accuracy, and treatment uptake.

2. Competition and Alternative Therapies

The emergence of anti-vascular endothelial growth factor (anti-VEGF) agents such as ranibizumab and aflibercept has reshaped the therapeutic landscape. These intravitreal injections have become first-line treatments owing to superior efficacy and simplified administration protocols. Consequently, verteporfin's market share has declined, confined primarily to cases unresponsive to anti-VEGF therapy or where PDT remains indicated.

Emerging treatments, including port delivery systems, gene therapies, and biosimilars, threaten verteporfin's dominance. The competitive pressure necessitates strategic positioning, such as combination therapies or new indications, to sustain revenue.

3. Regulatory and Patent Dynamics

Verteporfin's patent protection has long expired, transitioning its market into a generic era. While generics lower treatment costs—broadening access—they also compress profit margins for manufacturers. Novartis and other players explore formulations and delivery mechanisms to extend exclusivity. Regulatory approval for new indications or delivery methods (e.g., sustained-release implants) could extend market viability.

Technological and Clinical Innovation

Photodynamic Therapy Advancements

Advances in PDT techniques—such as targeted light delivery, combination therapies, and multimodal imaging—enhance verteporfin's efficacy and safety profile. These innovations can open new markets, especially if clinical trials validate superior outcomes or reduced side effects.

Novel Indications and Repurposing

Research into verteporfin’s role beyond ophthalmology, particularly in oncology, presents growth opportunities. Its capacity for tumor ablation via PDT, especially in surface or accessible tumors, is under investigation. Successful clinical trials could diversify revenue streams and extend market lifespan.

Financial Trajectory Analysis

Revenue Trends

Despite initial dominance, verteporfin’s revenue trajectory has plateaued globally due to competition from anti-VEGF agents and generic pricing pressures. In 2021, global sales were estimated around USD 150-200 million, primarily driven by established markets such as the US, Europe, and Japan [[2]]. Future growth hinges on expanding indications, technological enhancements, and geographic penetration into emerging markets.

Cost Dynamics and Pricing Pressures

Generic competition reduces per-unit pricing, compelling manufacturers to innovate or reposition products. Cost-cutting measures and efficiency improvements are vital to sustain profitability. Markets with lower healthcare expenditure, such as parts of Asia and Latin America, are increasingly important for volume-based growth.

Potential Growth Catalysts

• New indications: Approval for conditions like CSCR or age-related macular degenerations beyond neovascular AMD can rejuvenate sales.
• Combination therapies: Trials combining verteporfin PDT with anti-VEGF agents aim to optimize treatment efficacy and, potentially, command premium pricing.
• Technological upgrades: Novel light delivery systems or formulations enhancing safety and convenience can boost adoption.

Regulatory and Market Outlook

The regulatory environment is pivotal. Approval of new delivery methods or expanded indications by agencies like the FDA and EMA can significantly influence revenue trajectories. Conversely, regulatory hurdles or unfavorable trial outcomes can suppress market prospects.

Growth forecasts suggest a cautious but positive outlook, with compound annual growth rates (CAGR) in the 2-4% range over the next five years, assuming successful clinical development and adoption of innovative approaches [[3]].

Conclusion

Verteporfin's market dynamics are characterized by initial dominance, subsequent erosion due to competitors, and ongoing opportunities through technological innovation and expanded indications. The revenue trajectory remains cautiously optimistic, contingent on clinical advancements, regulatory approvals, and strategic repositioning amid intense competition. Companies investing in research to unlock new therapeutic potential may capitalize on the evolving landscape and sustain financial growth.

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Key Takeaways

• Market Potential: The global burden of AMD ensures a steady demand for verteporfin, especially in cases unresponsive to first-line therapies.
• Competitive Pressure: Anti-VEGF agents and emerging therapies have limited verteporfin's market share; differentiation via new indications or technologies is essential.
• Innovation and Diversification: Expanding indications, especially in oncology, and technological improvements can rejuvenate revenue streams.
• Pricing and Cost Management: Generic competition compresses margins; efficiency improvements and strategic pricing are vital.
• Regulatory Navigation: Success hinges on favorable regulatory decisions for new uses or delivery systems.

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FAQs

1. What are the primary therapeutic indications for verteporfin?
Verteporfin is principally indicated for the treatment of neovascular (wet) age-related macular degeneration through photodynamic therapy, and has been explored for other ocular conditions such as central serous chorioretinopathy and certain polypoidal choroidal vasculopathies.

2. How has the competitive landscape affected verteporfin’s market share?
The advent of anti-VEGF injectable therapies has significantly reduced verteporfin’s market share in AMD treatment but residual demand persists in cases where anti-VEGF therapy is unsuitable or ineffective.

3. What future growth opportunities exist for verteporfin?
Potential growth avenues include regulatory approval for new ocular indications, development of combination therapies with anti-VEGF agents, and exploration of oncological applications leveraging PDT mechanisms.

4. How do patent expirations influence verteporfin’s financial trajectory?
Patent expiry has shifted verteporfin into the generic market, reducing prices and margins. Innovation in delivery methods and new indications are strategies to mitigate revenue loss.

5. What technological innovations could impact verteporfin’s market in the future?
Advancements such as targeted light delivery systems, sustained-release formulations, and novel imaging techniques can enhance efficacy, safety, and convenience, fostering broader adoption and new market segments.

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References

[1] Wong WL, et al. (2014). Global prevalence of age-related macular degeneration and disease burden projection. Ophthalmology, 121(11), 2288-2294.
[2] MarketWatch. (2022). Global Verteporfin Market Size, Trends, and Forecasts.
[3] ResearchAndMarkets. (2022). Ophthalmology Drugs Market Forecast.