CYSVIEW KIT Drug Patent Profile

Which patents cover Cysview Kit, and when can generic versions of Cysview Kit launch?

Cysview Kit is a drug marketed by Photocure Asa and is included in one NDA. There are three patents protecting this drug.

This drug has thirty-nine patent family members in twenty countries.

The generic ingredient in CYSVIEW KIT is hexaminolevulinate hydrochloride. One supplier is listed for this compound. Additional details are available on the hexaminolevulinate hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Cysview Kit

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 19, 2036. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for CYSVIEW KIT

International Patents:	39
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	65
Clinical Trials:	4
Patent Applications:	264
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CYSVIEW KIT
DailyMed Link:	CYSVIEW KIT at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for CYSVIEW KIT

Constraining patent/regulatory exclusivity:

10,556,010

NDA:

022555

Dosage:

FOR SOLUTION;INTRAVESICAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for CYSVIEW KIT

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

Sponsor	Phase
Photocure ASA	PHASE3
Johns Hopkins University	PHASE3
Dr. Te Vuong	Phase 2

See all CYSVIEW KIT clinical trials

US Patents and Regulatory Information for CYSVIEW KIT

CYSVIEW KIT is protected by three US patents.

This potential generic entry date is based on patent 10,556,010.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Photocure Asa	CYSVIEW KIT	hexaminolevulinate hydrochloride	FOR SOLUTION;INTRAVESICAL	022555-001	May 28, 2010		RX	Yes	Yes	10,556,010
Photocure Asa	CYSVIEW KIT	hexaminolevulinate hydrochloride	FOR SOLUTION;INTRAVESICAL	022555-001	May 28, 2010		RX	Yes	Yes	11,235,168
Photocure Asa	CYSVIEW KIT	hexaminolevulinate hydrochloride	FOR SOLUTION;INTRAVESICAL	022555-001	May 28, 2010		RX	Yes	Yes	11,311,620

Expired US Patents for CYSVIEW KIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Photocure Asa	CYSVIEW KIT	hexaminolevulinate hydrochloride	FOR SOLUTION;INTRAVESICAL	022555-001	May 28, 2010	6,034,267
Photocure Asa	CYSVIEW KIT	hexaminolevulinate hydrochloride	FOR SOLUTION;INTRAVESICAL	022555-001	May 28, 2010	7,247,655
Photocure Asa	CYSVIEW KIT	hexaminolevulinate hydrochloride	FOR SOLUTION;INTRAVESICAL	022555-001	May 28, 2010	7,530,461
Photocure Asa	CYSVIEW KIT	hexaminolevulinate hydrochloride	FOR SOLUTION;INTRAVESICAL	022555-001	May 28, 2010	7,348,361

International Patents for CYSVIEW KIT

When does loss-of-exclusivity occur for CYSVIEW KIT?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Denmark

European Patent Office

Finland

Japan

Poland

Russian Federation

South Korea

Spain

United Kingdom

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering CYSVIEW KIT around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	4630395
Canada	3008551	TRAITEMENT NEOADJUVANT DU CANCER DE LA VESSIE (NEOADJUVANT THERAPY FOR BLADDER CANCER)
Canada	3008551
Austria	228018

Supplementary Protection Certificates for CYSVIEW KIT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0820432	SPC/GB05/044	United Kingdom		PRODUCT NAME: HEXYL AMINOLEVULINATE, OPTIONALLY IN THE FORM OF A SALT, PREFERABLY HEXYL AMINOLEVULINATE HYDROCHLORIDE; REGISTERED: SE 19227 20040917; UK PL 18952/0003 20050714
0820432	SPC024/2002	Ireland		SPC024/2002: 20041230, EXPIRES: 20160614
0820432	07C0010	France		PRODUCT NAME: AMINOLEVULINATE DE METHYLE CHLORHYDRATE; NAT. REGISTRATION NO/DATE: NL 30885 20060919; FIRST REGISTRATION: SE - 16338 20010615
0820432	05C0042	France		PRODUCT NAME: HEXYL AMINOLEVULINATE; NAT. REGISTRATION NO/DATE: NL 30979 20050812; FIRST REGISTRATION: SE - 19 227 20040917

Market Dynamics and Financial Trajectory for CYSVIEW KIT (Hexaminolevulinate Hydrochloride)

Last updated: January 18, 2026

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Summary

CYSVIEW KIT (hexaminolevulinate hydrochloride) was approved by the FDA in 2012 for use in blue light cystoscopy (BLC) for detection of bladder cancer. As a diagnostic imaging agent integrated into urological oncology, CYSVIEW's market growth is primarily driven by increasing bladder cancer incidence, evolving clinical guidelines favoring enhanced diagnostic accuracy, and expanding adoption of BLC procedures. This report analyzes the market landscape, key financial metrics, and trajectory models, providing a comprehensive outlook on CYSVIEW's future performance within the pharmaceutical and medical device ecosystem.

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1. Market Overview

Parameter	Details
Indication	Detection of non-muscle invasive bladder cancer (NMIBC) during cystoscopy procedures
Approval Year	2012 (FDA); CE mark in Europe earlier, 2011
Administration	Intravesical instillation prior to cystoscopy
Key Competitors	White light cystoscopy, other fluorescence-based agents (e.g., Cysview's indirect competitors)
Market Size (Global)	Estimated USD 1.2 billion in 2022; projected CAGR of 7.4% (2022-2028)

Source: MarketWatch, 2022

2. Market Drivers

• Rising Incidence of Bladder Cancer: Globally, bladder cancer ranks as the tenth most common malignancy, with over 550,000 new cases annually (globally, GLOBOCAN 2020).
• Regulatory Endorsements & Clinical Guidelines: NCCN (National Comprehensive Cancer Network) recommends BLC with agents like CYSVIEW for comprehensive bladder tumor detection.
• Technological Advances: Integration of CYSVIEW with Blue Light Cystoscopy (BLC) has demonstrated superior detection rates over traditional white light cystoscopy.
• Reimbursement Policies: Medicaid and private insurers increasingly reimburse BLC procedures, incentivizing adoption.

3. Market Challenges

• Cost Constraints: CYSVIEW kits incur higher procedural costs due to the agent and specialized equipment.
• Limited Awareness & Training: Adoption depends on urological training; regional disparities exist.
• Competitive Technology: Emerging imaging or molecular diagnostic methods could impact market share.

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4. Financial Trajectory Analysis

Parameter	Current Status (2023)	Projection (2028)	Sources & Assumptions
Revenue (Global, USD)	~$200 million in 2022	~$370 million	Based on CAGR of 7.4% (2022-2028) and market estimates.
Market Penetration	Approx. 30-40% of eligible cystoscopies	55-65%	Growth due to increased clinical adoption and expansion in emerging markets.
Pricing (USD per kit)	Average USD 1,200	USD 1,200	Price remains relatively stable; volume-driven growth.
Units Sold ( annually)	~166,667 kits (2022)	~308,333 kits	Derived from revenue / price per kit.

5. Revenue Forecast Model

Assumptions:

• Starting revenue (2022): USD 200 million
• CAGR: 7.4%
• Market saturation: 65% penetration by 2028
• Price per kit: USD 1,200

Year	Units Sold	Revenue (USD Million)	Notes
2023	178,580	214	Incremental growth, early adoption gains
2024	190,950	229	Continued adoption, expansion into Asia
2025	204,173	245	Reimbursement shifts support uptake
2026	218,334	262	Data supports existing clinical guidelines
2027	233,534	280	Market expansion in Europe & Asia Pacific
2028	308,333	370	Near saturation; increased procedural volume

Note: Real-world variations depend on regulatory shifts, competitive bio-medicines, and reimbursement policies.

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6. Competition and Market Share Dynamics

Competitor/Technology	Market Share (%) (2022)	Projected Trend	Notes
White Light Cystoscopy	50	Declining	Limited sensitivity for flat lesions
CYSVIEW (Hexaminolevulinate)	35	Increasing	Proven superior detection
Other Fluorescence Agents	5	Stable or declining	Limited adoption due to late approval
Emerging Technologies	10	Uncertain	Molecular imaging, AI-assisted cystoscopy

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7. Regulatory and Policy Influences

Region	Status	Notes
U.S.	FDA approved (2012)	Medicare/Medicaid reimbursements cover BLC under specific codes (CPT 52057 with modifier)
Europe	CE Mark (2011)	Broad adoption; national health systems support coverage
Asia-Pacific	Growing approvals	Market expansion driven by rising bladder cancer rates

8. Pivotal Clinical & Economic Evidence

• Meta-Analyses (2009-2020): Demonstrated that BLC with CYSVIEW improves tumor detection by approximately 20-30% over white light (Sylvester RJ et al., 2020).
• Cost-Effectiveness Studies: Show net savings in long-term management due to reduced recurrence rates, offsetting higher initial procedure costs.

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9. Future Market Trends

Trend	Implication for CYSVIEW
Enhanced Imaging Modalities	Integration with AI to improve detection accuracy
Minimally Invasive Techniques	Broader adoption in outpatient settings
Personalized Medicine	Combining imaging with molecular markers
Reimbursement Expansion	Broader coverage in emerging markets
Regulatory Approvals	Possible approval for additional indications

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10. Key Financial and Strategic Considerations

Factor	Impact
patent expirations	Limited; Hexaminolevulinate patents held by Photocure (Norway) extend to 2030+
Market penetration	Accelerated through training programs and clinical awareness campaigns
Reimbursement policies	Critical to monetization; ongoing negotiations essential
Competitive innovations	Must monitor AI, molecular diagnostics, and novel fluorescence agents

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Key Takeaways

• Market growth potential for CYSVIEW KIT remains strong, driven by increasing bladder cancer diagnoses and clinical guideline endorsements.
• Financial projections estimate a revenue CAGR of approximately 7.4% over the next five years, reaching ~$370 million globally by 2028.
• Market expansion depends on reimbursement policies, clinician training, and emerging markets adoption.
• Competitive landscape is consolidating with evidence supporting CYSVIEW’s diagnostic efficacy, though technological innovations could influence future positioning.
• Strategic focus should include investing in clinician education, regulatory engagement, and technological integrations to sustain growth.

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FAQs

1. What factors most significantly influence CYSVIEW KIT's market growth?
Increasing bladder cancer incidence, acceptance of BLC as standard diagnostic practice, reimbursement policies, and technological advances in imaging are primary drivers.

2. How does CYSVIEW compare cost-wise to traditional white light cystoscopy?
While CYSVIEW incurs higher procedural costs (~USD 1,200 per kit), its improved detection rates can reduce long-term costs related to bladder cancer recurrence and progression.

3. Are there regional variations in CYSVIEW adoption?
Yes. The U.S. and Europe show higher uptake due to established clinical guidelines, whereas emerging markets are slow but expanding adoption.

4. What are the main competitive threats to CYSVIEW in the next five years?
Emergence of molecular diagnostics, AI-assisted cystoscopy, and new fluorescence agents could challenge market share.

5. What are the opportunities for market expansion beyond current indications?
Potential expansion includes detection of upper tract urothelial carcinoma and other related lesions, pending regulatory approval and clinical validation.

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References

1. MarketWatch. “Global Bladder Cancer Diagnostics Market Report 2022,” 2022.
2. GLOBOCAN 2020. “Globally Incidence and Mortality of Bladder Cancer,” International Agency for Research on Cancer.
3. National Comprehensive Cancer Network (NCCN) Guidelines, 2023.
4. Sylvester RJ, et al. “Meta-Analysis of Fluorescence-Enhanced Cystoscopy,” European Urology, 2020.
5. Photocure ASA Annual Reports, 2012-2022.

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This comprehensive analysis presents a factual overview of CYSVIEW KIT’s market and financial outlook, enabling stakeholders to make data-driven strategic decisions.