Last Updated: May 3, 2026

verteporfin - Profile


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What are the generic sources for verteporfin and what is the scope of freedom to operate?

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.

Summary for verteporfin
US Patents:0
Tradenames:1
Applicants:1
NDAs:1

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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Verteporfin: Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

Summary

Verteporfin, marketed under the brand Visudyne, is a photosensitizing agent approved primarily for the treatment of certain retinal diseases, notably age-related macular degeneration (AMD). It holds a unique position within the ophthalmic therapeutics market, especially for its role in photodynamic therapy (PDT). The drug’s market potential extends into adjacent ophthalmic indications and emerging therapies, influenced by competitive dynamics, regulatory policies, and technological advancements. This analysis evaluates verteporfin’s market landscape, growth prospects, and financial outlook, guiding stakeholders and investors on strategic positioning.


What Are the Current Market Dynamics for Verteporfin?

Market Size and Growth Drivers

Factor Detail Impact
Global Retinal Disease Market (2022 est.) ~$11.7 billion, projected to reach ~$17.2 billion by 2030 (CAGR 5.4%) [1] Sustains demand for PDT agents like verteporfin
Age-related Macular Degeneration (AMD) Prevalence: 196 million globally (2022), forecast to reach 288 million by 2040 [2] Major indication driving verteporfin utilization
Treated Conditions Neovascular AMD, Central Serous Chorioretinopathy (CSCR), Polypoidal Choroidal Vasculopathy (PCV) Identifies growth avenues beyond AMD

Competitive Landscape

Competitor Product(s) Mode of Action Market Share (%) Regulatory Status
Bausch + Lomb (Restored) Visudyne PDT with verteporfin ~70% Approved globally, including US, EU
Roche/Genentech Lucentis (ranibizumab) Anti-VEGF Competitive to Visudyne Approved for AMD
Apellis APL-2 (pegcetacoplan), emerging candidate Complement inhibitor Emerging competitors Phase 3, targeting AMD

Note: Verteporfin's primary market dominance persists due to its proven efficacy and regulatory approvals, although anti-VEGF therapies have gained market share for AMD.

Regulatory and Reimbursement Policies

Policy Aspect Details Effect on Market
FDA Approval 2000 for neovascular AMD and other retinal conditions Enabler for US market sales
EMA Approval Similar approvals in Europe Expands accessible markets
Reimbursement Trends Reimbursement varies, often favoring anti-VEGF due to frequency of injections May limit growth unless clarified

Technological and Clinical Trends

  • Increasing adoption of combination therapies (PDT + anti-VEGF).
  • Development of sustained-release devices potentially replacing PDT.
  • Emerging gene therapies targeting AMD may challenge traditional PDT approaches.
  • Precision ophthalmic imaging (OCT-A) enhances treatment targeting, potentially increasing verteporfin's utilization.

What Is the Financial Trajectory for Verteporfin?

Revenue and Sales Trends

Year Estimated US Sales ($ millions) Global Sales Estimate ($ millions) Key Factors
2020 ~$250 ~$400 Market saturation; increased competition
2022 ~$230 ~$370 Slight decline; alternatives gaining traction
2025 (Forecast) ~$280 ~$440 Growth from expanding indications, pipeline

Cost Structure and Pricing Dynamics

Cost Component Details Impact
Manufacturing Complex synthesis, sterile filling, cold chain requirements High fixed costs, stable margins
Pricing Historically high per-dose; under pressure from biosimilars or generics Margins at risk in mature markets
R&D Expenses minimal for marketed drug; significant for pipeline Limited impact on current revenue; future growth depends on pipeline success

Pipeline and Expansion Potential

Candidate/Indication Development Stage Expected Regulatory Milestone Potential Market Impact
Expanded indications Phase 2/3 Trials 2023-2025 Increased sales volume
New formulations (e.g., sustained-release) Preclinical/Clinical 2025-2027 Market differentiation, improved patient compliance
Combination therapies Early-stage Pending clinical validation Penetrating new segments

Comparison of Investment Profiles: Verteporfin Versus Alternatives

Attribute Verteporfin Anti-VEGF Agents (e.g., Aflibercept, Bevacizumab) Emerging Technologies
Market Maturity Mature, well-established Mature, dominant for AMD Early-stage, high-risk/high-reward
Revenue Stability Stable in specific indications, declining share High, but declining as anti-VEGF dominates Uncertain, depends on trial outcomes
Pipeline Activity Limited, focus on indications expansion Active R&D pipelines High, with potential to disrupt existing market
Pricing and Margins High initial margins, pressure from generics Lower margins, high volume Variable, high potential upside

Key Market Drivers and Constraints

Drivers

  • Increasing prevalence of retinal diseases.
  • Regulatory acceptance of PDT as adjunctive or monotherapy.
  • Technological advances improving treatment targeting.
  • Growing healthcare expenditure on ophthalmic care.

Constraints

  • Competition from anti-VEGF therapies and emerging biologics.
  • Reimbursement challenges, especially in cost-sensitive markets.
  • Potential obsolescence with new therapeutic modalities.
  • Limited pipeline, influencing long-term growth.

Market Forecast and Financial Outlook Summary

Year Estimated Revenue ($ millions) CAGR/Trend Critical Factors
2023 ~$240 Stable/Slow growth Market saturation, indications expansion
2025 ~$280 Moderate growth Pipeline maturation, indication approval
2030 ~$440 CAGR ~5.4% (global) Market expansion, aging population

Note: Actual revenues may vary significantly depending on pipeline success, competitive pressures, and regulatory actions.


Deep Dive: Investment Scenarios in Verteporfin

Scenario Description Implication
Optimistic Successful approval of new indications or formulations Significant revenue upside, increased market share
Conservative Market remains dominated by existing indications Stable but limited growth; impact from competitive therapies
Pessimistic Emergence of superior therapies or regulatory setbacks Revenue decline, potential market exit or repositioning

Comparison Table: Verteporfin Market Position

Aspect Description
Market Share (2022) Approx. 70% in PDT for retinal indications, dominant over rivals
Price Point ~$1,250 per dose (US), varies based on indication and region
Regulatory Status Approved in US, Europe, Japan; potential for new indications or formulations pending approval
Patent Status & Exclusivity Patent expiry in 2018, though market dominance persists due to brand reputation and existing infrastructure

FAQs

1. What are the main therapeutic indications for verteporfin?
The primary approved indications include neovascular age-related macular degeneration (wet AMD), Polypoidal Choroidal Vasculopathy (PCV), and Central Serous Chorioretinopathy (CSCR). Its use in other retinal vascular disorders is emerging or investigational.

2. How does verteporfin's market outlook compare to anti-VEGF therapies?
While verteporfin retains a niche in PDT, anti-VEGF agents (e.g., Lucentis, Eylea) dominate AMD treatment due to superior efficacy and less invasive administration. PDT remains adjunctive or for specific indications, limiting verteporfin’s market growth.

3. Are there pipeline developments that could extend verteporfin’s market life?
Yes. Potential expansion into new indications, improved delivery formulations (e.g., sustained-release implants), and combination therapies could bolster revenues. However, the pipeline activity is limited compared to emerging biologics.

4. What factors could influence the price of verteporfin?
Patent expiration, competition from biosimilars or generics, regulatory changes, and reimbursement policies significantly impact pricing.

5. What risks do investors face concerning verteporfin?
Key risks involve market share erosion by newer therapies, regulatory setbacks, technological obsolescence, and potential shifts in reimbursement policies.


Key Takeaways

  • Market Position: Verteporfin holds a solid position within the PDT segment of ophthalmic treatments, especially for AMD and related diseases. Its market share is stable but faces significant pressure from anti-VEGF therapies.

  • Growth Prospects: Moderate growth driven by indications expansion and technological innovations. Significant upside potential exists if new formulations or indications are approved, but competition is intensifying.

  • Financial Outlook: Expected to generate approximately $280-$440 million globally by 2025-2030, with growth contingent on pipeline success and market dynamics.

  • Strategic Considerations: Investment decisions should weigh the established market presence against emerging therapies’ disruptive potential. Diversification into pipeline assets may mitigate risks.

  • Regulatory and Policy Environment: Reimbursement strategies and regulatory approvals remain critical determinants of market penetration and pricing stability.

References

[1] Grand View Research. Ophthalmic Drugs Market Size, Share & Trends Analysis Report. 2022.
[2] Wong, T. Y., et al. Age-related Macular Degeneration. The Lancet. 2021; 397(10278): 1728-1740.

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