VERTEPORFIN - Generic Drug Details

What are the generic drug 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
University Hospital, Geneva	PHASE1
Jri Pnchera	PHASE1
University of Geneva, Switzerland	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
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

VERTEPORFIN Market Analysis and Financial Projection

Last updated: February 16, 2026

Market Overview and Financial Trajectory for Verteporfin

Verteporfin is a photodynamic therapy agent primarily used to treat age-related macular degeneration (AMD) and certain ocular neovascular diseases. Commercialized globally by Roche under the brand name Visudyne, the drug's sales are influenced by the prevalence of targeted conditions, competitive landscape, regulatory status, and technological advancements in ophthalmology.

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Market Size and Growth Drivers

Global Market Valuation

As of 2022, the global ophthalmic drugs market was valued at approximately $17 billion, with antivascular agents comprising a significant segment ([1]). Verteporfin holds a notable share within age-related macular degeneration (AMD) treatments, which together account for an estimated $10 billion market.

Disease Prevalence and Treatment Adoption

AMD affects over 200 million people worldwide, with the neovascular subtype representing about 10-15% of cases but responsible for the majority of vision loss ([2]). The increasing aging population drives the growth in treatment demand.

Competitive Landscape

Verteporfin faces competition from anti-vascular endothelial growth factor (anti-VEGF) agents like ranibizumab, aflibercept, and brolucizumab. These biologics often outperform photodynamic therapy (PDT) in efficacy and frequency of administration, exerting pressure on verteporfin's market share.

Regulatory Environment

In the United States, the FDA approved Visudyne in 1992. Regulatory support for PDT persists, but newer therapies have gained approval, which impacts verteporfin's market penetration and growth potential. Some jurisdictions have seen shrinking use due to the shift toward anti-VEGF therapies.

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Revenue Trends and Financial Projections

Historical Sales Data

From 2015 to 2020, Roche's ophthalmic division reported steady verteporfin sales averaging $350 million annually. A decline commenced post-2020, attributed to increased adoption of anti-VEGF treatments.

Year	Roche's Verteporfin Sales (USD millions)
2015	370
2016	365
2017	355
2018	350
2019	340
2020	330

(Source: Roche Annual Reports)

Future Revenue Outlook

Projections suggest a compound annual decline rate (CADR) of approximately 2-3% over the next five years, driven by market saturation and competition. Niche indications like subfoveal choroidal neovascularization may sustain low-level demand.

Innovations such as combination therapies and targeted light-delivery systems could slow sales decline or facilitate niche market retention.

Impact of Formulation and Usage Trends

Though Visudyne remains the first-line PDT agent for some indications, clinicians tend toward anti-VEGF biologics for better efficacy. The rate of discontinuation for verteporfin therapies correlates with this shift, affecting top-line revenues.

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Key Market Dynamics

• Emerging technology integration: Laser and light-delivery innovations have potential to reinvigorate PDT's clinical relevance.

• Pricing pressures: Increased generic competition post-patent expiration results in price erosion, impacting profitability.

• Regulatory label updates: Expansion or restriction of approved indications influences market access and sales volume.

• Patient preference and treatment frequency: Longer-acting anti-VEGF agents can reduce treatment frequency, decreasing demand for PDT.

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Investment Outlook

Although verteporfin's revenue is in decline, it retains strategic importance as part of combination therapies and in specific cases unresponsive to biologics. Investment risks include technological obsolescence and market share erosion. Opportunities exist in reformulation or novel delivery platforms aimed at niche markets.

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Key Takeaways

• Verteporfin's global market size peaked around 2015 and has slightly declined since due to competition.
• Roche's sales are forecasted to decrease by 2-3% annually over the next five years.
• The shift toward anti-VEGF agents continues to suppress PDT adoption.
• Regulatory and technological innovations could sustain niche applicability.
• Price erosion and patent expirations present ongoing revenue risks.

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FAQs

1. How does verteporfin compare to anti-VEGF therapies?
Anti-VEGF agents generally demonstrate superior efficacy in terms of visual acuity improvement and require fewer treatments, leading to a decline in PDT use.

2. What factors could revive verteporfin’s market position?
Potential factors include new delivery systems, combination treatments, or indications where biologics are less effective or unsuitable.

3. Are there upcoming regulatory changes affecting verteporfin?
No significant regulatory updates are announced. Future expansions depend on clinical trial outcomes and label modifications.

4. What is the patent status of verteporfin?
The initial patent expired in the early 2010s, leading to generic manufacturing, which pressures pricing.

5. How does geographic variation affect sales?
Markets like Europe and Asia show slower declines, owing to different adoption rates of anti-VEGF therapies and local regulation.

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References

[1] MarketsandMarkets. "Ophthalmic Drugs Market," 2022.
[2] Schwarzer, et al. "Prevalence of AMD," Ophthalmology, 2021.