PHOTOFRIN Drug Patent Profile

When do Photofrin patents expire, and when can generic versions of Photofrin launch?

Photofrin is a drug marketed by Pinnacle Biolgs and is included in one NDA.

The generic ingredient in PHOTOFRIN is porfimer sodium. One supplier is listed for this compound. Additional details are available on the porfimer sodium profile page.

Summary for PHOTOFRIN

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	26
What excipients (inactive ingredients) are in PHOTOFRIN?	PHOTOFRIN excipients list
DailyMed Link:	PHOTOFRIN at DailyMed

Recent Clinical Trials for PHOTOFRIN

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 1
Taoyuan General Hospital	Early Phase 1
Roswell Park Cancer Institute	Phase 1/Phase 2

See all PHOTOFRIN clinical trials

Pharmacology for PHOTOFRIN

Drug Class	Photoactivated Radical Generator
Mechanism of Action	Photoabsorption
Physiological Effect	Photosensitizing Activity

US Patents and Regulatory Information for PHOTOFRIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pinnacle Biolgs	PHOTOFRIN	porfimer sodium	INJECTABLE;INJECTION	020451-001	Dec 27, 1995		RX	No	No

Expired US Patents for PHOTOFRIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pinnacle Biolgs	PHOTOFRIN	porfimer sodium	INJECTABLE;INJECTION	020451-001	Dec 27, 1995	4,649,151
Pinnacle Biolgs	PHOTOFRIN	porfimer sodium	INJECTABLE;INJECTION	020451-001	Dec 27, 1995	5,438,071
Pinnacle Biolgs	PHOTOFRIN	porfimer sodium	INJECTABLE;INJECTION	020451-001	Dec 27, 1995	5,028,621
Pinnacle Biolgs	PHOTOFRIN	porfimer sodium	INJECTABLE;INJECTION	020451-001	Dec 27, 1995	5,145,863
Pinnacle Biolgs	PHOTOFRIN	porfimer sodium	INJECTABLE;INJECTION	020451-001	Dec 27, 1995	4,932,934

EU/EMA Drug Approvals for PHOTOFRIN

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pinnacle Biologics B.V.	PhotoBarr	porfimer sodium	EMEA/H/C/000493Photodynamic therapy (PDT) with PhotoBarr is indicated for: Ablation of high-grade dysplasia (HGD) in patients with Barrett's Oesophagus (BO)	Withdrawn	no	no	no	2004-03-25

International Patents for PHOTOFRIN

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

Country	Patent Number	Title	Estimated Expiration
Greece	3023978
Canada	1265450	PRODUIT PHARMACEUTIQUE, SA PREPARATION, ET SON EMPLOI POUR LE TRAITEMENT DE TUMEURS (DRUG, AND METHODS OF PREPARING AND USING IT FOR TREATMENT OF TUMORS)
South Korea	100221206
Australia	2032283
Japan	H06105921	APPARATUS FOR THERAPY OF TUMOR

Supplementary Protection Certificates for PHOTOFRIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0050800	96C0028	Belgium		PRODUCT NAME: PORFIMERE SODIQUE; NAT. REGISTRATION NO/DATE: NL 19150 19960409; FIRST REGISTRATION: NL - RVG 16652 19940411

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: PHOTOFRIN

Last updated: July 30, 2025

Introduction

PHOTOFRIN (porfimer sodium) is a photosensitizing agent used in photodynamic therapy (PDT) for treating various cancers, primarily esophageal and non-small cell lung cancers. Approved by the U.S. Food and Drug Administration (FDA) in 1994, PHOTOFRIN has carved a niche within the oncology therapeutic landscape, leveraging the growing demand for minimally invasive treatment modalities. This analysis explores the evolving market dynamics, competitive positioning, regulatory factors, and financial trajectory of PHOTOFRIN, providing a strategic outlook for stakeholders.

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Market Overview and Segmentation

1. Therapeutic Applications and Market Penetration

PHOTOFRIN’s primary indication involves PDT for early-stage and superficial cancers, notably esophageal carcinoma and non-small cell lung cancer (NSCLC). Its specificity and minimally invasive approach make it attractive for patients unsuitable for traditional surgery or radiotherapy. The global PDT market, valued at approximately USD 360 million in 2022, is projected to grow at a Compound Annual Growth Rate (CAGR) of around 10% through 2030 [1].

Within this, PHOTOFRIN holds a significant share in niche oncology indications. Its use is also expanding into the treatment of Barrett's esophagus and other premalignant conditions, though these indications are still emerging.

2. Regional Market Dynamics

• North America: The U.S. remains the dominant market, driven by high cancer prevalence, advanced medical infrastructure, and favorable reimbursement policies. The FDA's approval status and subsequent adoption rate significantly influence revenue trajectories.
• Europe: Countries such as Germany, France, and the UK exhibit increasing adoption, supported by progressive healthcare systems and awareness campaigns.
• Asia-Pacific: Rapid cancer incidence growth, especially in China and India, presents emerging opportunities. However, regulatory hurdles and local pricing dynamics influence market entry.

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Competitive Landscape

PHOTOFRIN faces competition from other PDT agents such as Levulan Kerastick (aminolevulinic acid) and Tookad (WST11). Technological advancements in laser and light delivery systems further shape the competitive environment.

Key players include:

• Meiji Seika Pharma
• Photocure ASA (with its prototype agents)
• North American-based biotech firms developing next-generation PDT agents

The market’s competitiveness hinges on drug efficacy, safety profiles, ease of administration, and reimbursement pathways.

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Regulatory and Reimbursement Factors

1. Regulatory Environment

Post-approval, PHOTOFRIN's regulatory status remains stable in major markets, though ongoing research seeks expanded indications, which could influence future approvals. Regulatory bodies increasingly emphasize evidence-based expansion, necessitating robust clinical trial data on efficacy and safety.

2. Reimbursement Landscape

Insurance coverage and reimbursement rates heavily influence adoption rates. In the U.S., Medicare and private payers have historically reimbursed PDT procedures, but reimbursement levels fluctuate across regions, directly impacting revenue potential.

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Market Drivers

• Increasing Oncology Incidence: Rising prevalence of early-stage cancers suitable for PDT boosts demand.
• Minimally Invasive Healthcare Trend: Growing preference for outpatient, minimally invasive treatments favors PHOTOFRIN.
• Technological Integration: Innovations in light delivery and imaging systems enhance therapeutic precision, expanding credible use cases.
• Aging Population: Older populations with complex health profiles are less suitable for invasive surgery, making PDT an attractive alternative.

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Market Challenges

• Limited Indications: PHOTOFRIN’s current approvals are restricted, reducing potential revenue streams.
• Competition from Emerging Therapies: Immunotherapies and targeted agents, with broader or more aggressive indications, threaten market share.
• Cost and Reimbursement Uncertainties: High procedural costs and variable reimbursement policies impede widespread adoption.
• Operational Logistics: Specialized equipment and trained personnel are required, complicating widespread facility integration.

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Financial Trajectory and Future Outlook

1. Revenue Trends

Historically, PHOTOFRIN’s revenue has seen modest growth, primarily within North America and select European countries, driven by procedural volume and expanding indications [2].

• 2020-2022: Stabilization due to regulatory hurdles and pandemic disruptions.
• 2023-2025: Anticipated growth as clinical trials for new indications mature and technological improvements lower procedural barriers.

2. Research and Development Investment

Investments in clinical trials aiming for expanded indications (e.g., dermatological, pancreatic, or prostate cancers) could unlock new revenue streams. However, R&D costs are substantial, and success is contingent on clinical trial outcomes.

3. Strategic Partnerships and Licensing

Collaborations with medical device companies or regional distributors could accelerate market penetration, particularly in emerging markets. Licensing deals may mitigate manufacturing and regulatory costs, improving financial stability.

4. Impact of Technological Innovation

Emerging light-delivery systems and combination therapies (e.g., photodynamic therapy coupled with immunotherapy) could augment efficacy, broadening PATIENT populations, and enhancing financial returns.

5. Market Growth Projections

Given the anticipated expansion, PHOTOFRIN’s sales are expected to grow at a CAGR of approximately 8-12% over the next five years, aligning with the broader PDT and oncology markets’ momentum [1].

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Regulatory and Market Expansion Opportunities

• Indication Expansion: Pursuing approvals in indications such as Barrett’s esophagus or early-stage pancreatic cancers could markedly increase revenue.
• Geographical Diversification: Entry into emerging markets with growing cancer burdens could diversify revenue streams.
• Integration with Advanced Technologies: Combining PHOTOFRIN with laser-based imaging and precision delivery can enhance therapeutic outcomes, supporting market expansion.

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Conclusion

PHOTOFRIN remains a specialized but important asset within the minimally invasive oncology treatment arsenal. Its market dynamics are shaped by legislative, technological, and competitive factors, with growth prospects buoyed by rising cancer incidence and shifts toward outpatient therapies. Its financial trajectory will depend heavily on regulatory success in new indications, technological advancements, payer reimbursement policies, and strategic collaborations. Stakeholders should monitor these factors closely to optimize investment and market expansion strategies.

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Key Takeaways

• PHOTOFRIN’s niche within PDT positions it for steady, moderate growth, particularly as new indications and technological advancements emerge.
• Market expansion hinges on successful clinical trials, regulatory approvals, and reimbursement policies, especially in emerging markets.
• Competition from other PDT agents and the rise of immunotherapy may influence future market share.
• Strategic partnerships and technological integration are vital to enhanced adoption and revenue growth.
• Continuous innovation, clinical validation, and regional expansion are critical pathways to capitalize on PHOTOFRIN’s therapeutic potential.

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FAQs

1. What are the primary indications for PHOTOFRIN?
PHOTOFRIN is primarily indicated for the treatment of early-stage and superficial cancers, notably esophageal and non-small cell lung cancers, through photodynamic therapy.

2. How does PHOTOFRIN compare to other cancer treatments?
As a photosensitizer used in PDT, PHOTOFRIN offers a minimally invasive option with targeted tumor destruction, potentially reducing recovery times and side effects compared to traditional surgery or radiotherapy.

3. What are the main challenges facing PHOTOFRIN’s market growth?
Limited indications, competition from emerging therapies, reimbursement uncertainties, and logistical complexities in light delivery systems challenge growth prospects.

4. Are there ongoing efforts to expand PHOTOFRIN’s indications?
Yes. Clinical trials are investigating its efficacy in other cancers, such as pancreatic and prostate cancers, which could broaden its approved uses.

5. What is the outlook for PHOTOFRIN’s financial performance?
With a projected CAGR of approximately 8-12% over the next five years, driven by indication expansion and technological advancements, PHOTOFRIN’s revenue trajectory appears cautiously optimistic.

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References

[1] MarketsandMarkets. "Photodynamic Therapy Market by Application, End User - Global Forecast to 2030," 2023.

[2] Company Reports and Market Data. "PHOTOFRIN Revenue and Market Share Analysis," 2022.