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:	68
Patent Applications:	6,639
DailyMed Link:	VERTEPORFIN at DailyMed

Recent Clinical Trials for VERTEPORFIN

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

Sponsor	Phase
Wake Forest University Health Sciences	Phase 4
National University Hospital, Singapore	N/A
Singapore National Eye Centre	N/A

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	5,798,349
Bausch Lomb Ireland	VISUDYNE	verteporfin	INJECTABLE;INJECTION	021119-001	Apr 12, 2000	5,214,036
Bausch Lomb Ireland	VISUDYNE	verteporfin	INJECTABLE;INJECTION	021119-001	Apr 12, 2000	5,770,619
Bausch Lomb Ireland	VISUDYNE	verteporfin	INJECTABLE;INJECTION	021119-001	Apr 12, 2000	4,833,790
Bausch Lomb Ireland	VISUDYNE	verteporfin	INJECTABLE;INJECTION	021119-001	Apr 12, 2000	5,707,608

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/000305 Visudyne 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 Experimental

Market Dynamics and Financial Trajectory for Verteporfin

Introduction to Verteporfin

Verteporfin is a benzoporphyrin derivative used in photodynamic therapy to treat abnormal blood vessels in the eye, particularly for conditions like wet macular degeneration, pathological myopia, and ocular histoplasmosis. This therapy combines light energy with the drug to destroy abnormal blood vessels, making it a critical treatment in ophthalmology[1].

Market Drivers

The global verteporfin market is driven by several key factors:

Diversified Use in Ophthalmology

Verteporfin's application in various ophthalmic conditions such as macular degeneration, pathologic myopia, and ocular histoplasmosis is a significant driver. Pharmaceutical companies are actively launching products and therapies that utilize verteporfin, enhancing its market presence. For instance, in 2019, CIBA Corp and QLT Inc. received authorization for marketing Visudyne (verteporfin) therapy for choroidal neovascularization from the European Medicine Evaluation Agency[1].

Research and Development

Research institutions are exploring verteporfin's potential beyond ophthalmology, particularly in oncology. For example, the Mayo Clinic and the National Cancer Institute (NCI) have conducted phase II clinical trials on ultrasound-guided verteporfin photodynamic therapy for treating solid pancreatic tumors. Such research expands the drug's potential applications and market scope[1].

Market Restraints

Despite its benefits, the verteporfin market faces several restraints:

Cost and Side Effects

Photodynamic therapy with verteporfin is more expensive than alternative treatments like pegaptanib for subfoveal wet macular degeneration. The cost of verteporfin treatment is approximately $59,039 in the U.S., compared to $49,052 for pegaptanib. Additionally, the intravenous administration of verteporfin can lead to side effects such as infection at the injection site, irritation, and redness of the skin[1].

COVID-19 Impact

The COVID-19 pandemic has negatively impacted ophthalmologic procedures due to social distancing measures and the risk of infection through aerosolized particles. This has affected the general procedures carried out during ophthalmic treatments, temporarily reducing the demand for verteporfin[1].

Regional Analysis

The global verteporfin market is segmented into several regions, each with its own dynamics:

North America

North America has a significant burden of age-related macular degeneration (AMD), with around 11 million individuals affected in the U.S. as of 2019. This has led pharmaceutical companies to focus on developing treatments for macular degeneration. For example, Bausch + Lomb and Modulight entered an agreement in 2018 to develop a novel laser for use with Visudyne (verteporfin injection) in photodynamic therapy[1].

Europe

Europe also has a substantial burden of age-related macular degeneration, with at least 33.6 million individuals above 60 years affected. Pharmaceutical companies are engaging in acquisitions and mergers to strengthen their market share. For instance, Cheplapharm Arzneimittel acquired the worldwide rights (except in the U.S.) for Visudyne (verteporfin injection) from Novartis Pharma AG in 2018[1].

Key Players

The global verteporfin market is dominated by several key players:

• Bausch Health Companies Inc.
• Cheplapharm Arzneimittel
• Novartis AG
• Novelion Therapeutics Inc.
• Ciba Corporation
• LGM Pharma, LLC[1].

Market Size and Forecast

Global Verteporfin Market

As of the latest reports, the global verteporfin market is valued based on its applications and distribution channels. While specific current market values are not provided, the market is expected to grow driven by the increasing prevalence of ophthalmic conditions and ongoing research.

Liposomal Verteporfin Market

The global liposomal verteporfin market, a subset of the verteporfin market, was valued at $50 million in 2023 and is forecasted to reach $37 million by 2030, with a CAGR of -4.3% during the forecast period. This decline is likely due to the specific formulation and application of liposomal verteporfin, which may face competition from other treatments or formulations[4].

Clinical Evidence and Approval

The efficacy of verteporfin in photodynamic therapy is well-documented through clinical trials:

TAP and VIP Trials

The TAP (Treatment of Age-related Macular Degeneration with Photodynamic Therapy) trials and VIP (Verteporfin in Photodynamic Therapy) trials have shown that photodynamic therapy with verteporfin significantly reduces the risk of vision loss in patients with subfoveal classic choroidal neovascularization caused by AMD. These trials led to the FDA approval and Medicare coverage of verteporfin for predominantly classic CNV[3].

Financial Considerations

The financial trajectory of the verteporfin market is influenced by several factors:

Cost-Benefit Analysis

The cost of verteporfin treatment is higher compared to some alternative treatments, which can impact its adoption. However, the benefits in terms of improved vision outcomes and the potential for use in other medical conditions make it a valuable investment for pharmaceutical companies and healthcare systems.

Market Trends

The market trends indicate a focus on research and development, strategic partnerships, and acquisitions to strengthen market positions. For instance, the agreement between Bausch + Lomb and Modulight to develop a novel laser for photodynamic therapy highlights the ongoing investment in this area[1].

Future Outlook

The future outlook for the verteporfin market is promising despite current challenges:

Expanding Applications

Research into new applications, such as oncology, could significantly expand the market for verteporfin. The ongoing clinical trials and the potential for new approvals will drive growth in the coming years.

Technological Advancements

Advancements in laser technology and delivery systems, such as the development of novel lasers, will enhance the efficacy and safety of photodynamic therapy with verteporfin.

Key Takeaways

• Diversified Use: Verteporfin's use in various ophthalmic conditions drives market demand.
• Research and Development: Ongoing research in oncology and other areas expands the drug's potential applications.
• Cost and Side Effects: Higher costs and potential side effects are restraints to market growth.
• Regional Dynamics: North America and Europe are key regions due to the high prevalence of age-related macular degeneration.
• Clinical Evidence: Strong clinical evidence supports the use of verteporfin in photodynamic therapy.
• Financial Considerations: The market is influenced by cost-benefit analyses and strategic investments.

FAQs

Q: What is verteporfin used for? Verteporfin is used in photodynamic therapy to treat abnormal blood vessels in the eye, particularly for conditions like wet macular degeneration, pathological myopia, and ocular histoplasmosis[1].

Q: How does verteporfin work? Verteporfin accumulates in abnormal blood vessels and, when stimulated with non-thermal laser light, produces reactive oxygen molecules that block these vessels[1].

Q: What are the main drivers of the verteporfin market? The main drivers include the diversified use of verteporfin in ophthalmology, ongoing research and development, and strategic partnerships among pharmaceutical companies[1].

Q: What are the restraints to the verteporfin market? The restraints include the higher cost of treatment compared to alternatives, potential side effects, and the impact of the COVID-19 pandemic on ophthalmologic procedures[1].

Q: Who are the key players in the verteporfin market? Key players include Bausch Health Companies Inc., Cheplapharm Arzneimittel, Novartis AG, Novelion Therapeutics Inc., Ciba Corporation, and LGM Pharma, LLC[1].

Sources

1. Coherent Market Insights: Verteporfin Market - Share, Size and Industry Analysis[1].
2. Stanford Profiles: Dr. Michael T. Longaker[2].
3. CMS: Centers for Medicare & Medicaid Services - Verteporfin Therapy[3].
4. Valuates Reports: Global Liposomal Verteporfin Market Research Report 2024[4].