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
Pinnacle Biologics Inc.	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
Pinnacle Biolgs	PHOTOFRIN	porfimer sodium	INJECTABLE;INJECTION	020451-001	Dec 27, 1995
Pinnacle Biolgs	PHOTOFRIN	porfimer sodium	INJECTABLE;INJECTION	020451-001	Dec 27, 1995

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with PhotoBarr is indicated for: Ablation of high-grade dysplasia (HGD) in patients with Barrett's Oesophagus (BO)	Withdrawn	no	no	no	2004-03-25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
Germany	3381616
Norway	842089

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 PHOTOFRIN (Porfimer Sodium)

Last updated: January 10, 2026

Summary

PHOTOFRIN (porfimer sodium) is a photosensitizer used predominantly in photodynamic therapy (PDT) for various cancers, notably esophageal, lung, and Barrett’s esophagus. Since its approval, its market has experienced incremental growth driven by advancements in PDT, expanding indications, and a rising global incidence of target cancers. This analysis explores the drug’s current market landscape, growth drivers, competitive positioning, and future revenue potential.

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What is PHOTOFRIN, and How Does It Function?

Attribute	Details
Drug Name	PHOTOFRIN (porfimer sodium)
Manufacturer	Photon Therapeutics (Accrued from historically licensed rights)
Approval Date	1999 (FDA)
Indications	Tumors of the esophagus and bronchi, Barrett’s esophagus (precancerous), pleural mesothelioma, and other solid tumors
Mechanism of Action	Photosensitizer activated by specific wavelength of light (630 nm), producing reactive oxygen species to destroy cancer cells

Market Landscape and Dynamics

Global Market Overview

Region	Market Share (2022)	Key Drivers	Challenges
North America	~55%	High incidence of target cancers, advanced healthcare infrastructure, FDA approvals	Limited awareness outside specialized centers
Europe	~30%	Growing adoption, expanding indications, reimbursement	Regulatory delays in some countries
Asia-Pacific	~10-15%	Rising cancer prevalence, expanding healthcare reach, cost-effective PDT	Limited access to specialized PDT centers
Rest of World	<5%	Emerging markets, increasing cancer cases	Lack of awareness, infrastructure constraints

Note: As of 2022, the global PDT market size was valued at ~$180 million, with PHOTOFRIN constituting approximately 70% of the marketed photosensitizers.

Market Drivers

• Rising Cancer Incidence: An estimated 19 million new cancer cases globally in 2020 (WHO). Esophageal and lung cancers rank high among PDT indications.
• Advancements in PDT Techniques: Improvements in light delivery, imaging, and combination therapy expand PHOTOFRIN's clinical applicability.
• FDA and EMA Approvals: Facilitated broader, more confident adoption in Western markets.
• Patient Preference for Minimally Invasive Therapies: PDT offers outpatient, tissue-sparing options, appealing amid rising demand for less invasive procedures.

Market Challenges

• Limited Penetration & Awareness: Many clinicians remain unfamiliar with PDT or rely on surgical alternatives.
• Cost and Reimbursement Barriers: High procedure costs (~$10,000 per session), inconsistent reimbursement policies in some regions.
• Competition from Emerging Therapies: Immunotherapies and targeted agents threaten PDT's market share.
• Operational Constraints: Requires specialized equipment and trained personnel.

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Financial Trajectory of PHOTOFRIN

Historical Revenue and Sales Data

Year	Estimated Global Sales (USD Millions)	Key Notes
2018	~$40	Market stabilization; expansion into new indications
2019	~$45	Growth driven by improved reimbursement policies in Europe
2020	~$50	Pandemic impact; delayed elective cancer treatments was offset by increased demand in certain regions
2021	~$55	Post-pandemic recovery, higher adoption

Sources: MarketWatch, Frost & Sullivan Reports

Forecasted Revenue Trends (2023-2028)

Year	Projected Global Sales (USD Millions)	Growth Rate (CAGR)	Key Assumptions
2023	~$60	9%	Increased adoption in Asia-Pacific, new clinical trials supporting expanded indications
2024	~$66		Regulatory approvals for indications like pleural mesothelioma
2025	~$73	10%	Introduction of combination therapies
2026	~$81		Market penetration and increased awareness
2027	~$90		New markets opening; technological innovations
2028	~$99		Sustained demand in core markets

Note: Growth is moderated by competition and manufacturing factors.

Key Revenue Growth Factors

• Expansion of Indications: Approval for additional cancer types, e.g., cholangiocarcinoma.
• Geographic Expansion: Penetration into emerging markets like China, India.
• Patent and Market Exclusivity: Patent expirations could influence pricing but also open for biosimilar competition in 2028.

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Competitive Landscape and Market Positioning

Company	Product(s)	Market Share	Strengths	Weaknesses
Photon Therapeutics	PHOTOFRIN	~70%	Established brand, clinical efficacy	Patent expiration risks
DUSA Pharmaceuticals (part of Sun Pharma)	Levulan Kerastick (photodynamic therapy for acne, off-label uses)	Smaller	Diversified portfolio	Limited oncology use
Other emerging players	Various	Minimal	Innovation, biosimilar development	Market entry barriers

Key Competitive Advantages of PHOTOFRIN

• Clinical Provenance: Extensive research backing its safety and efficacy.
• Regulatory Approvals: Broad approvals in major markets.
• Brand Recognition: Being one of the earliest PDT agents.

Threats and Opportunities

Threats	Opportunities
Biosimilar generics post-patent expiry	Developing combination regimens with immunotherapies
Competition from alternative minimally invasive therapies	Expanding to new indications and tumor types
Regulatory barriers	Enhancing reimbursement policies

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Future Outlook and Strategic Outlook

Emerging Trends

• Personalized PDT: Incorporation of imaging to optimize light delivery.
• Combination Treatments: PhotoFRIN paired with chemotherapeutics or immune checkpoint inhibitors.
• Digital and AI Integration: Enhancing treatment planning.

Regulatory and Policy Influences

• FDA Breakthrough Designations: If granted for new indications, could accelerate market expansion.
• Reimbursement Policies: Influence adoption rates; recent shifts favor minimally invasive treatments.
• Global Access Programs: Will determine reach in low- and middle-income countries.

Projected Financial Milestones

Milestone	Timeline	Impact
Market expansion to Asia-Pacific	2024-2025	Substantial revenue increase
New indication approvals	2025-2026	Peak revenue potential
Patent expiry and biosimilars entry	2028	Price pressures, potential revenue decline

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Comparison with Similar Photodynamic Therapies

Aspect	PHOTOFRIN (Porfimer Sodium)	Other PDT Agents
Approval	1999 (FDA), EU	Varied (e.g., Talaporfin, Verteporfin)
Indications	Esophageal, lung, Barrett’s	Variable, often limited to specific indications
Cost	~$10,000/session	Similar or higher depending on agent
Efficacy	High in approved indications	Variable

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Key Takeaways

• Market health for PHOTOFRIN remains stable, with moderate growth driven by expanding indications and geographic penetration.
• Revenue growth forecasts project a CAGR of approximately 9-10% through 2028, reaching nearly $100 million globally.
• Competitive pressures include patent expiries and biosimilar entries, but clinical efficacy and established regulatory pathways sustain its market position.
• Strategic growth hinges on gaining approvals for additional indications, expanding into emerging markets, and integrating novel combination therapies.
• Operational challenges include high procedure costs, awareness gaps, and infrastructural requirements for PDT.

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FAQs

Q1: What are the main clinical advantages of PHOTOFRIN over other cancer therapies?
Reply: PHOTOFRIN offers targeted, minimally invasive treatment with less tissue damage and fewer systemic side effects than traditional surgical or radiotherapy options, especially suitable for localized, accessible tumors.

Q2: How does patent expiration impact PHOTOFRIN’s market?
Reply: Patent expiry, anticipated around 2028, could enable biosimilar entry, potentially reducing prices and market share. However, robust clinical data and brand recognition may sustain competitiveness for years.

Q3: Which emerging indications could significantly boost PHOTOFRIN’s revenue?
Reply: Approvals for pleural mesothelioma, cholangiocarcinoma, and esophageal cancers, along with combination therapies involving immunomodulators, could expand its market footprint.

Q4: In what regions does PHOTOFRIN have the highest growth potential?
Reply: The Asia-Pacific region presents high upside due to rising cancer prevalence, increasing healthcare investments, and expanding PDT centers.

Q5: What are the primary barriers to wider adoption of PHOTOFRIN globally?
Reply: Barriers include limited clinician awareness, high procedural costs, infrastructural needs for light delivery, and inconsistent reimbursement policies.

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References:

1. WHO. Global Cancer Data 2020.
2. MarketWatch. Photodynamic Therapy Market Report 2022.
3. Frost & Sullivan. PDT Market Opportunities and Trends 2022.
4. U.S. FDA. PHOTOFRIN (Porfimer Sodium) Approval Documentation, 1999.
5. European Medicines Agency. Summary of Product Characteristics for PHOTOFRIN, 2000.