HEXAMINOLEVULINATE HYDROCHLORIDE - Generic Drug Details

What are the generic sources for hexaminolevulinate hydrochloride and what is the scope of freedom to operate?

Hexaminolevulinate hydrochloride is the generic ingredient in one branded drug marketed by Photocure Asa and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Hexaminolevulinate hydrochloride has thirty-nine patent family members in twenty countries.

One supplier is listed for this compound.

Summary for HEXAMINOLEVULINATE HYDROCHLORIDE

International Patents:	39
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	11
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for HEXAMINOLEVULINATE HYDROCHLORIDE
What excipients (inactive ingredients) are in HEXAMINOLEVULINATE HYDROCHLORIDE?	HEXAMINOLEVULINATE HYDROCHLORIDE excipients list
DailyMed Link:	HEXAMINOLEVULINATE HYDROCHLORIDE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for HEXAMINOLEVULINATE HYDROCHLORIDE

Constraining patent/regulatory exclusivity:

10,556,010

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 HEXAMINOLEVULINATE HYDROCHLORIDE

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

Sponsor	Phase
KARL STORZ Endoscopy-America, Inc.	Phase 2
Dr. Te Vuong	Phase 2
Photocure	Phase 2/Phase 3

See all HEXAMINOLEVULINATE HYDROCHLORIDE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for HEXAMINOLEVULINATE HYDROCHLORIDE

V04CX	Other diagnostic agents
V04C	OTHER DIAGNOSTIC AGENTS
V04	DIAGNOSTIC AGENTS
V	Various

US Patents and Regulatory Information for HEXAMINOLEVULINATE HYDROCHLORIDE

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	11,311,620
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	10,556,010

Expired US Patents for HEXAMINOLEVULINATE HYDROCHLORIDE

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 HEXAMINOLEVULINATE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Mexico	385912	METODO DE TERAPIA FOTODINAMICA (PDT) PARA EL CANCER DE VEJIGA (METHOD OF PHOTODYNAMIC THERAPY (PDT) FOR BLADDER CANCER)
South Korea	20180094987	방광암에 대한 신보조 요법
Russian Federation	2018124868	НЕОАДЪЮВАНТНАЯ ТЕРАПИЯ ДЛЯ РАКА МОЧЕВОГО ПУЗЫРЯ
Russian Federation	2745194	СПОСОБ ФОТОДИНАМИЧЕСКОЙ ТЕРАПИИ (ФДТ) ДЛЯ РАКА МОЧЕВОГО ПУЗЫРЯ (METHOD OF PHOTODYNAMIC THERAPY (PDT) OF BLADDER CANCER)

Market Dynamics and Financial Trajectory for Hexaminolevulinate Hydrochloride

Last updated: July 28, 2025

Introduction

Hexaminolevulinate hydrochloride (HAL) is a photosensitizing agent primarily used in photodynamic diagnosis (PDD) of bladder cancer. It is a derivative of aminolevulinic acid (ALA), tailored for visualizing malignant tissues during cystoscopy. As a specialized pharmaceutical, its market trajectory is influenced by technological advances, regulatory landscapes, and clinical adoption patterns. This report examines the current market dynamics, growth drivers, challenges, and future financial outlook for HAL.

Regulatory Environment and Market Approval

Hexaminolevulinate hydrochloride gained FDA approval in 2010 under the brand name Cysview (marketed by Photocure), marking a significant milestone in the bladder cancer diagnostic landscape. Similarly, the European Medicines Agency licensed it as Hexvix. Regulatory reinforcement enhances clinical acceptance and supports market expansion. However, regulatory pathways for biosimilar entries remain complex, impacting pricing and competition.

Market Drivers

Increasing Incidence of Bladder Cancer

Bladder cancer is among the most common urological malignancies. The American Cancer Society estimates approximately 81,000 new cases in the U.S. in 2022, with a significant proportion of diagnoses occurring at early stages where TURBT (transurethral resection of bladder tumor) with photodynamic diagnosis can improve detection (1). The aging population further inflates the prevalence, elevating demand for accurate diagnostic tools like HAL.

Technological Advancements in Diagnostic Procedures

Enhanced imaging techniques such as blue light cystoscopy facilitated by HAL have substantially improved tumor visualization, reducing recurrence rates and enabling complete resection. The integration of HAL into standard protocols augments clinical outcomes, incentivizing hospitals and clinicians to adopt this technology.

Reimbursement and Healthcare Economics

Reimbursement policies in developed markets support the utilization of innovative diagnostics like HAL, especially when they demonstrate cost savings through reduced recurrence and re-treatment rates. Payers increasingly recognize the value of precise diagnostics, reinforcing HAL’s market position.

Growing Awareness Among Healthcare Providers

Educational initiatives regarding the benefits of PDD over white-light cystoscopy are driving adoption. Continued clinical research underscores HAL’s superiority in detecting carcinoma in situ and flat lesions, further cementing its clinical use.

Market Challenges

Competitive Landscape

Other fluorescence agents, such as 5-aminolevulinic acid (ALA), are in use, though HAL's targeted formulation offers distinct advantages. Nonetheless, emerging optical imaging technologies and alternative biomarkers threaten to displace HAL in certain applications.

Pricing and Cost Constraints

High costs associated with HAL and proprietary formulations can limit adoption, especially in low- and middle-income regions. Manufacturers face pressure to balance patent protection with competitive pricing strategies to expand global access.

Regulatory and Reimbursement Variability

Differences in approval timelines and reimbursement policies across countries impact international market penetration. Uncertain regulatory pathways for generic or biosimilar versions further complicate market dynamics.

Clinical Adoption Hurdles

Transition resistance from traditional white-light cystoscopy practices slows momentum. Additionally, the need for specialized equipment and training constitutes barriers, especially in resource-limited settings.

Financial Trajectory and Market Forecast

The global photodynamic diagnosis market, valued at approximately USD 1.1 billion in 2021, is projected to grow at a compounded annual growth rate (CAGR) of around 6% through 2030 (2). HAL, being a primary agent in PDD, is positioned to capitalize on this expansion, with the following considerations:

• Market Penetration: The North American and European markets dominate due to high bladder cancer incidence, robust healthcare infrastructure, and favorable reimbursement. Emerging markets, notably Asia-Pacific, present growth opportunities driven by increasing healthcare expenditure and urbanization.

• Revenue Streams: Sales are primarily driven by clinical adoption, repeat procedures, and potential brand extensions. Increasing recognition of HAL’s clinical benefits catalyzes demand growth.

• Research and Development: Ongoing clinical trials exploring HAL’s applications in other cancer types and imaging modalities could open new revenue pathways. Additionally, process innovations aimed at reducing costs may improve margins.

• Projected Growth: By 2030, global sales of HAL could exceed USD 500 million, contingent upon regulatory approvals, competitive dynamics, and broadening clinical use. Sales growth may mirror the broader market CAGR, with accelerated adoption in underpenetrated regions.

Strategic Factors Influencing Future Market Size

• Patent Expirations and Biosimilars: Patent exclusivity extending until 2027 provides market protection. Post-expiry, biosimilar competition could reduce prices, necessitating strategic positioning.

• Strategic Partnerships: Collaborations with medical device manufacturers and healthcare providers facilitate integration into standard care pathways, boosting market share.

• Clinical Evidence and Guidelines: Strong evidence and inclusion in clinical guidelines (e.g., NCCN, EAU) are critical for sustained growth.

• Regulatory Approvals for New Indications: Expansion into diagnostics for other cancers or imaging modalities could significantly enhance revenue streams.

Conclusion

Hexaminolevulinate hydrochloride is poised for steady growth within the niche of fluorescence-guided bladder cancer diagnosis. Its trajectory hinges on technological acceptance, regulatory consistency, reimbursement support, and clinical validation. As the global healthcare system continues to prioritize precision medicine, HAL’s role is expected to expand, delivering both improved patient outcomes and market value.

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Key Takeaways

• Market growth for HAL is driven by increasing bladder cancer incidence, diagnostic innovations, and favorable reimbursement environments in advanced economies.
• Competition from similar agents and emerging imaging technologies presents challenges, necessitating strategic differentiation.
• Global expansion opportunities are substantial, especially in Asia-Pacific and other emerging markets, contingent on regulatory approvals and cost management.
• Patent protection until approximately 2027 offers a window for maximizing revenue before biosimilar entries influence pricing.
• Investment in clinical evidence, stakeholder education, and technology integration will be vital for sustaining growth and capturing new indications.

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FAQs

1. What is the primary clinical use of Hexaminolevulinate Hydrochloride?
Hexaminolevulinate hydrochloride is mainly used as an intravesical agent in photodynamic diagnosis during cystoscopy to improve visualization of bladder tumors, particularly carcinoma in situ.

2. How does HAL compare to other diagnostic agents for bladder cancer?
HAL offers superior tumor detection under blue light versus white-light cystoscopy, lowering recurrence rates by enabling more complete tumor resection. Its targeted formulation provides distinct diagnostic clarity compared to alternatives like 5-aminolevulinic acid.

3. What factors could influence HAL’s market growth in the next decade?
Key factors include clinical adoption rates, regulatory approvals, reimbursement policies, competition from biosimilars, technological advances, and expansion into new oncology indications.

4. Are there geographical regions with high growth potential for HAL?
Yes, emerging markets such as China, India, and Southeast Asia offer significant growth potential due to rising bladder cancer prevalence and expanding healthcare infrastructure, provided regulatory and cost barriers are addressed.

5. What strategic actions can pharmaceutical companies undertake to sustain HAL’s market position?
Companies should invest in robust clinical research, pursue regulatory approvals across regions, foster partnerships with healthcare providers, optimize pricing strategies, and explore new indications to maintain a competitive edge.

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References:

1. American Cancer Society. Cancer Facts & Figures 2022.
2. MarketsandMarkets. Photodynamic diagnosis market forecast, 2021-2030.