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:	23
Clinical Trials:	57
Patent Applications:	7,070
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
Wake Forest University Health Sciences	Phase 4
Tan Tock Seng Hospital	N/A
National University Hospital, Singapore	N/A

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
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/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

International Patents for VISUDYNE

See the table below for patents covering VISUDYNE around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	5460094
Hong Kong	1025059
Germany	68924215
Denmark	0569113
Canada	2149636	METHODE D'ACTIVATION D'AGENS PHOTOSENSIBLES (METHOD OF ACTIVATING PHOTOSENSITIVE AGENTS)

Supplementary Protection Certificates for VISUDYNE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0352076	1/2001	Austria		PRODUCT NAME: VERTEPORFIN; REGISTRATION NO/DATE: EU/1/00/140/001 20000727
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	2001C/010	Belgium		PRODUCT NAME: VERTEPORFIN; NAT. REGISTRATION NO./DATE: EU/1/00/140/001 20000727; FIRST REGISTRATION: CH 55269 19991215
0352076	C300037	Netherlands		PRODUCT NAME: VERTEPORFINE, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION NO/DATE: EU/1/00/140/001 20000727

VISUDYNE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for VISUDYNE (Verteporfin)

Introduction

VISUDYNE, also known as verteporfin, is a drug used in photodynamic therapy (PDT) primarily for the treatment of age-related macular degeneration (AMD), pathologic myopia, and ocular histoplasmosis. Here, we delve into the market dynamics and financial trajectory of this crucial ophthalmologic treatment.

Market Segmentation

The global verteporfin market is segmented based on indication and distribution channel. The key indications include macular degeneration, pathologic myopia, and ocular histoplasmosis. Distribution channels are primarily through hospitals and other healthcare facilities[1].

Demand Drivers

The demand for verteporfin is driven by its diversified use in ophthalmology. The increasing prevalence of age-related macular degeneration, particularly in North America and Europe, is a significant factor. For instance, in the U.S., around 11 million individuals are affected by AMD, prompting pharmaceutical companies to focus on developing and marketing verteporfin-based treatments[1].

Regulatory Approvals and Agreements

Regulatory approvals play a crucial role in the market dynamics of verteporfin. For example, in 2019, CIBA Corp and QLT Inc. received authorization for marketing VISUDYNE therapy for choroidal neovascularization from the European Medicine Evaluation Agency. Additionally, agreements between companies, such as the one between Bausch + Lomb and Modulight to develop a novel laser for use with VISUDYNE, further support market growth[1].

Research and Clinical Trials

Beyond ophthalmology, research is ongoing to explore the use of verteporfin in other medical fields, such as oncology. For example, the Mayo Clinic and the National Cancer Institute are conducting phase II clinical trials on ultrasound-guided verteporfin photodynamic therapy for treating solid pancreatic tumors. These advancements could expand the market potential of verteporfin[1].

Impact of COVID-19

The COVID-19 pandemic has had a negative impact on ophthalmologic procedures, including those involving verteporfin. Social distancing measures and the risk of infection through aerosolized particles have reduced the number of procedures performed, affecting the market's growth trajectory[1].

Cost and Reimbursement Challenges

One of the significant restraints on the market is the high cost of verteporfin treatment compared to other alternatives. For instance, the cost of photodynamic treatment with verteporfin is approximately $59,039 in the U.S., compared to $49,052 for pegaptanib. Additionally, the intravenous administration of verteporfin can lead to site infections, further complicating its financial viability[1].

Financial Impact on Practices

The financial impact of VISUDYNE on ophthalmology practices is complex. Initially, practices could realize a profit by carefully tracking purchasing and reimbursement. However, changes in reimbursement policies by the Centers for Medicare and Medicaid Services (CMS) have made it challenging for practices to maintain profitability. Dr. Carl D. Regillo notes that practices must rethink their internal financial distribution to physicians due to the reduced profit margins associated with VISUDYNE treatments[4].

Strategies for Financial Efficiency

To maintain financial efficiency, practices employ several strategies:

• Close Tracking of Purchasing and Reimbursement: Practices must track purchasing and reimbursement closely to avoid financial losses.
• Streamlining Operations: Reducing expenses by streamlining operations is crucial.
• Optimizing Patient Scheduling: Treating multiple patients in a single session can help reduce costs.
• Diagnostic Tests: Performing additional diagnostic tests, such as optical coherence tomographies and fluorescein angiograms, can help offset losses associated with VISUDYNE[4].

Regional Analysis

The global verteporfin market is segmented into regions such as North America, Europe, Asia Pacific, Latin America, Middle East, and Africa. North America and Europe have a significant burden of age-related macular degeneration, driving the demand for verteporfin in these regions. Pharmaceutical companies are focusing on agreements and acquisitions to strengthen their market share, such as Cheplapharm Arzneimittel's acquisition of worldwide rights for VISUDYNE from Novartis Pharma AG[1].

Key Players

Key players in the global verteporfin market include Bausch Health Companies Inc., Cheplapharm Arzneimittel, Novartis AG, Novelion Therapeutics Inc., Ciba Corporation, and LGM Pharma, LLC. These companies are involved in various strategies such as product launches, agreements, and acquisitions to dominate the market[1].

Market Outlook

Despite the challenges posed by COVID-19 and cost reimbursement issues, the market for verteporfin is expected to grow driven by the increasing prevalence of age-related macular degeneration and other ophthalmic conditions. The focus on research and development, particularly in expanding the use of verteporfin into other medical fields, also presents potential growth opportunities.

"Most people would argue, depending on how you work your costs, that it then became a money loser," - Dr. Carl D. Regillo, Wills Eye Hospital[4].

Key Takeaways

• Diversified Use: Verteporfin is used in various ophthalmic conditions, driving demand.
• Regulatory Approvals: Recent approvals and agreements support market growth.
• COVID-19 Impact: The pandemic has negatively affected ophthalmologic procedures.
• Cost Challenges: High treatment costs and reimbursement issues are significant restraints.
• Financial Efficiency: Practices must employ strategies to maintain profitability.
• Regional Focus: North America and Europe are key markets due to the high prevalence of AMD.
• Key Players: Major pharmaceutical companies are actively involved in the market.

FAQs

What is VISUDYNE used for?

VISUDYNE (verteporfin) is used in photodynamic therapy primarily for the treatment of age-related macular degeneration, pathologic myopia, and ocular histoplasmosis.

How has COVID-19 impacted the verteporfin market?

COVID-19 has negatively impacted ophthalmologic procedures, including those involving verteporfin, due to social distancing measures and the risk of infection through aerosolized particles.

What are the cost challenges associated with VISUDYNE?

The cost of photodynamic treatment with VISUDYNE is higher than some alternative treatments, and the intravenous administration can lead to site infections, complicating its financial viability.

How do ophthalmology practices manage the financial impact of VISUDYNE?

Practices manage the financial impact by closely tracking purchasing and reimbursement, streamlining operations, and optimizing patient scheduling. They also perform additional diagnostic tests to offset losses.

Who are the key players in the global verteporfin market?

Key players include Bausch Health Companies Inc., Cheplapharm Arzneimittel, Novartis AG, Novelion Therapeutics Inc., Ciba Corporation, and LGM Pharma, LLC.

Sources

1. Coherent Market Insights: Verteporfin Market - Share, Size and Industry Analysis.
2. RBC Direct Investing: Canadian Research Updates.
3. Inderes: Inderes Yhtiöraportti.
4. Retinal Physician: The Economics of Visudyne.
5. Bausch and Lomb: Ordering and patient assistance for VISUDYNE.