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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 twenty-nine patent family members in seventeen 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.

Indicators of Generic Entry

Summary for CYSVIEW KIT

International Patents:	29
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	3
Patent Applications:	93
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
KARL STORZ Endoscopy-America, Inc.	Phase 2
Dr. Te Vuong	Phase 2
Photocure	Phase 3

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	7,530,461
Photocure Asa	CYSVIEW KIT	hexaminolevulinate hydrochloride	FOR SOLUTION;INTRAVESICAL	022555-001	May 28, 2010	7,348,361
Photocure Asa	CYSVIEW KIT	hexaminolevulinate hydrochloride	FOR SOLUTION;INTRAVESICAL	022555-001	May 28, 2010	7,247,655

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

European Patent Office

Japan

Russian Federation

South Korea

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
Australia	2016372575	Method of photodynamic therapy (PDT) for bladder cancer
Spain	2188146
World Intellectual Property Organization (WIPO)	9628412
Hungary	9800460
European Patent Office	0820432	ESTERS DE L'ACIDE 5-AMINOLEVULINIQUE EN TANT QU'AGENTS PHOTOSENSIBILISANTS EN PHOTOCHIMIOTHERAPIE (ESTERS OF 5-AMINOLEVULINIC ACID AS PHOTOSENSITIZING AGENTS IN PHOTOCHEMOTHERAPY)
Japan	4630395

Supplementary Protection Certificates for CYSVIEW KIT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0820432	300207	Netherlands		300207, 20160308, EXPIRES: 20190916
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	C00820432/02	Switzerland		FORMER REPRESENTATIVE: BOHEST AG, CH
0820432	300176	Netherlands		300176, 20160308, EXPIRES: 20160614

CYSVIEW KIT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Cysview Kit

Introduction to Cysview Kit

The Cysview kit, developed by Photocure ASA, is a crucial tool in the diagnosis and management of bladder cancer. It utilizes a fluorescent marker that highlights cancer cells when exposed to blue light during cystoscopy, enhancing the visibility and detection of tumors.

Market Growth and Drivers

Rising Demand for Advanced Diagnostic Tools

The market for bladder cancer detection kits, including the Cysview kit, is experiencing significant growth driven by the increasing prevalence of bladder cancer globally. Early detection is critical for improving survival rates, which has led to a heightened demand for advanced diagnostic tools like the Cysview kit[1].

Technological Advancements

Technological advancements, such as the integration of blue light cystoscopy (BLC), have significantly improved the accuracy and efficacy of bladder cancer detection. The Cysview kit, when used in conjunction with BLC, provides enhanced visualization of cancer cells, making it a preferred choice for healthcare providers[4].

Non-Invasive and Cost-Effective Diagnostics

The trend towards non-invasive and cost-effective diagnostics is another key driver. The Cysview kit, particularly when used in flexible cystoscopy, offers a less invasive alternative to traditional methods, aligning with patient preferences and contributing to its market growth[1].

Financial Performance

Revenue Growth

Photocure ASA has reported robust revenue growth for the Cysview kit. In the third quarter of 2024, Hexvix/Cysview revenues increased by 12% to NOK 120.1 million compared to the same period in 2023. This growth was driven by unit sales increases in both North America and Europe, as well as favorable foreign exchange impacts[2].

Regional Performance

North America and Europe are significant markets for the Cysview kit. In the third quarter of 2024, North American unit sales increased by 6%, while European unit sales grew by 9%. The strong performance in these regions is attributed to advanced healthcare infrastructure, high prevalence of bladder cancer, and favorable reimbursement policies[2].

Market Expansion

Photocure ASA has been actively expanding the market for the Cysview kit. The completion of a US market expansion study for blue light flexible cystoscopy (BLFC) with Cysview is a notable milestone. This study aims to seek FDA approval for the expanded use of BLFC with Cysview in the surveillance market, which could further boost sales[4].

Key Metrics and Trends

Unit Sales and Revenue

• Unit Sales Growth: Global in-market unit sales volume for Hexvix/Cysview increased by 8% in the third quarter of 2024 compared to the same period in 2023[2].
• Revenue Increase: Total Hexvix/Cysview revenue grew by 12% to NOK 120.1 million in the third quarter of 2024, up from NOK 107.3 million in the same period of 2023[2].

Geographic Expansion

• North America: The region saw a 6% increase in unit sales, contributing significantly to the overall revenue growth[2].
• Europe: European unit sales increased by 9%, with growth in Germany and other priority growth markets being key contributors[2].

Financial Health

• EBITDA: The EBITDA for the commercial franchise in the third quarter of 2024 was NOK 6.9 million, an increase from NOK 6.1 million in the third quarter of 2023[2].
• Cash Balance: At the end of the fourth quarter of 2023, Photocure ASA had a cash balance of NOK 259.5 million, indicating a strong financial position[5].

Challenges and Opportunities

Challenges

• Operating Expenses: Operating expenses for the commercial franchise increased by 12% year-over-year in the third quarter of 2024, partly due to timing of project expenses, foreign exchange, and inflation[2].
• Decline in Flexible Cystoscopy: There was a decline in kits used for flexible cystoscopy, which partially offset the growth in rigid cystoscopy procedures[2].

Opportunities

• Surveillance Market: The potential expansion into the surveillance market in the US, with an estimated 1.4 million surveillance cystoscopies performed annually, presents a significant growth opportunity[4].
• Technological Innovations: Continued advancements in diagnostic technologies, such as AI integration and biomarker-based tests, could further enhance the market position of the Cysview kit[1].

Competitive Landscape

The bladder cancer detection kit market is competitive, with various technologies vying for market share. However, the Cysview kit's integration with blue light cystoscopy and its proven efficacy have established it as a leading product.

• Cystoscopy Dominance: Cystoscopy, including the use of Cysview, remains the gold standard for bladder cancer diagnosis, capturing a significant portion of the market revenue[1].
• Emerging Technologies: Other technologies like urine lab tests and biomarker-based kits are growing rapidly, but the Cysview kit's established position and ongoing innovations keep it competitive[1].

Regulatory and Clinical Developments

FDA Approvals and Designations

• Market Expansion Studies: Photocure ASA has completed enrollment in a US market expansion study for BLFC with Cysview, aiming to seek FDA approval for expanded use in the surveillance market[4].
• Breakthrough Designations: Other companies, like Pangea Laboratory, have received FDA Breakthrough Device Designations for their bladder cancer detection assays, indicating a dynamic regulatory environment that could impact market dynamics[1].

Key Takeaways

• The Cysview kit is a key player in the bladder cancer detection market, driven by technological advancements and increasing demand for early diagnostic tools.
• Strong revenue growth in North America and Europe underscores its market position.
• Opportunities in the surveillance market and ongoing clinical studies are expected to further boost its adoption.
• Despite challenges like increasing operating expenses, the kit's proven efficacy and expanding market reach position it for continued success.

FAQs

1. What is the Cysview kit used for?

   • The Cysview kit is used for the diagnosis and management of bladder cancer, utilizing a fluorescent marker to highlight cancer cells during cystoscopy.

2. What are the key drivers of the Cysview kit market?

   • The market is driven by the increasing prevalence of bladder cancer, technological advancements, and the demand for non-invasive and cost-effective diagnostics.

3. How has the revenue for the Cysview kit performed recently?

   • In the third quarter of 2024, Hexvix/Cysview revenues increased by 12% to NOK 120.1 million compared to the same period in 2023.

4. What are the main regions contributing to the growth of the Cysview kit market?

   • North America and Europe are the primary regions driving the growth, with significant contributions from countries like the US, Germany, and other European markets.

5. What are the future growth opportunities for the Cysview kit?

   • The potential expansion into the surveillance market in the US and ongoing technological innovations present significant growth opportunities.

Sources

1. GlobeNewswire: Bladder Cancer Detection Kit Market to Hit USD 2.99 Billion by 2032, Driven by Advancements in Non-Invasive Technologies[1].
2. Cision: Photocure – Results for third quarter and the first nine months of 2024[2].
3. Annual Reports: BioSyent, 2022 Annual Report[3].
4. Photocure: Photocure Completes Enrollment in US Market expansion study of Blue Light Flexible Cystoscopy (BLFC) with Cysview[4].
5. PR Newswire: Photocure ASA: Results for the fourth quarter of 2023[5].