Porfimer sodium - Generic Drug Details

What are the generic drug sources for porfimer sodium and what is the scope of patent protection?

Porfimer sodium is the generic ingredient in one branded drug marketed by Pinnacle Biolgs and is included in one NDA. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for porfimer sodium

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	6
Clinical Trials:	32
What excipients (inactive ingredients) are in porfimer sodium?	porfimer sodium excipients list
DailyMed Link:	porfimer sodium at DailyMed

Recent Clinical Trials for porfimer sodium

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

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

See all porfimer sodium clinical trials

Pharmacology for porfimer sodium

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

Anatomical Therapeutic Chemical (ATC) Classes for porfimer sodium

L01XD	Sensitizers used in photodynamic/radiation therapy
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for porfimer sodium

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 porfimer sodium

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 porfimer sodium

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with PhotoBarr is indicated for: Ablation of high-grade dysplasia (HGD) in patients with Barrett's Oesophagus (BO)	Withdrawn	no	no	no	2004-03-25

Market Dynamics and Financial Trajectory for Porfimer Sodium

Last updated: August 1, 2025

Introduction

Porfimer sodium, marketed under brand names such as Photofrin, is a photosensitizing agent primarily used in photodynamic therapy (PDT) for certain cancers and precancerous conditions. Its unique mechanism involving light activation makes it a specialized treatment modality, with a niche yet strategically significant market position. Understanding its market dynamics and financial trajectory involves an analysis of regulatory approvals, technological innovations, competitive landscape, and evolving clinical indications.

Regulatory and Clinical Landscape

Initially approved in the late 1990s, porfimer sodium’s primary indication was for the treatment of non-small cell lung carcinoma, esophageal cancer, and Barrett’s esophagus-related dysplasia (early-stage precancerous changes) [1]. Subsequent regulatory approvals expanded its application scope, especially in Asia and Europe, where PDT’s adoption increased. However, the drug's market penetration remains constrained by factors such as the requirement for specialized administration, the limited availability of optimized light-delivery systems, and emerging alternative therapies.

Recent clinical trials focusing on PDT for head and neck cancers and certain skin malignancies continue to support its therapeutic value. Yet, regulatory stagnation in some jurisdictions restricts broad market expansion, emphasizing the significance of regional regulatory landscapes.

Market Size and Key Drivers

Global Market Valuation

The global market for porfimer sodium is niche but notable. As of 2022, the photodynamic therapy market, which includes porfimer sodium as a key agent, was valued at approximately USD 257 million, with projections reaching over USD 360 million by 2027, representing a CAGR of around 7% [2].

Porfimer sodium accounts for a significant share of this market, especially in countries with established PDT protocols. North America and Europe are its primary markets, driven by higher adoption rates, advanced healthcare infrastructure, and ongoing clinical research.

Key Market Drivers

• Emerging Clinical Indications: Expanding applications in esophageal, lung, bladder, and head and neck cancers bolster demand.

• Regulatory Approvals & Reimbursement Policies: Favorable policies and reimbursement frameworks in specific regions enhance market stability.

• Technological Advancements: Improved light-delivery systems and imaging enhance treatment precision and outcomes, encouraging clinician adoption.

• Convenience and Patient Acceptance: As a minimally invasive technique, PDT offers reduced recovery times, which appeals to both clinicians and patients.

Market Restraints and Challenges

• Limited Awareness & Clinical Adoption: A lack of widespread clinician familiarity hinders broader use.

• Operational Complexity: Requires specialized equipment and trained personnel, constraining deployment especially in low-resource settings.

• Competing Technologies: Alternative treatments such as immunotherapy, targeted therapies, and newer photodynamic agents challenge porfimer sodium's market share.

• Regulatory Hurdles: Variability in approvals impairs international expansion.

Competitive Landscape

Major pharmaceutical companies, such as Pinnacle Biogroup and Photocure ASA, hold key positions in the porfimer sodium segment. Pinnacle Biogroup's Photofrin remains the most prominent product, with a dominant market share. Entry of newer PDT agents and technological platforms presents both a threat and an opportunity for differentiation.

Other players focusing on enhanced photosensitizers with superior depth of penetration or reduced side effects are gradually penetrating the space, intensifying competition.

Financial Trajectory and Revenue Projections

Historical Performance

Over the past decade, revenue streams from porfimer sodium have demonstrated modest growth, primarily buoyed by clinical adoption in specific cancer treatments. For instance, Pinnacle Biogroup reported steady sales driven by North American licensing agreements. However, periodical setbacks due to regulatory delays impact financial stability.

Forecasted Growth

Forecast models project a Compound Annual Growth Rate (CAGR) of approximately 6-8% from 2022 to 2027, driven by new clinical indications and technological upgrades [2]. Projected revenues in this period could reach USD 100-150 million globally, with growth concentrated in Asia-Pacific markets owing to rising healthcare investments and disease prevalence.

Impact of Industry Trends

• Integration with Precision Medicine: Linking porfimer sodium-based PDT with molecular diagnostics may improve patient selection, leading to better outcomes and increased adoption.

• Emerging Light Technologies: Innovations like fractionated illumination and novel light sources could significantly improve treatment efficacy and patient throughput, boosting revenues.

• Strategic Collaborations: Partnerships with academic institutions and biotech firms to expand TMZ protocols and new indications will be critical.

Future Outlook

While the current landscape indicates steady market growth, future opportunities hinge on overcoming operational challenges and broadening indication horizons. The integration of porfimer sodium with emerging treatment paradigms, including combination therapies and personalized oncology, is poised to elevate its financial trajectory.

Furthermore, regional market expansion, especially into emerging markets such as Asia, Latin America, and the Middle East, offers considerable upside. As healthcare infrastructure matures and awareness increases, porfimer sodium's niche but pivotal role in PDT will become more pronounced.

Key Market Influences

• Regulatory reforms and expedited approval pathways for PDT agents are expected to facilitate market entry for new indications.

• Patient-centric trends favor minimally invasive treatments like PDT over traditional surgeries, supporting market viability.

• Competitive pressures from newer photosensitizers and alternative modalities necessitate continuous innovation and strategic positioning.

Key Takeaways

• Porfimer sodium remains a specialized yet pivotal agent within the photodynamic therapy landscape, with a projected CAGR of 6-8% through 2027.

• Growth prospects are driven by expanding clinical applications, technological advancements, and regional market growth, notably in Asia-Pacific.

• Factors limiting market expansion include operational complexity, insufficient clinician awareness, and competition from emerging therapies.

• Strategic alliances, technological innovation, and regulatory support are critical to enhancing the financial trajectory.

• The future of porfimer sodium hinges on its integration into precision oncology and minimally invasive treatment paradigms.

FAQs

1. What are the main therapeutic indications for porfimer sodium?
Porfimer sodium is primarily used in photodynamic therapy for non-small cell lung carcinoma, esophageal cancer, Barrett’s esophagus with dysplasia, and certain head and neck cancers.

2. How does porfimer sodium compare with newer photodynamic agents?
While established and well-characterized, newer agents aim to improve tissue penetration, reduce photosensitivity duration, and expand indications. Porfimer sodium’s side-effect profile and operational requirements may be less favorable compared to newer agents under development.

3. What are the primary regional markets for porfimer sodium?
North America and Europe are the leading markets due to infrastructure and regulatory factors, with significant growth potential in Asia-Pacific, fueled by rising cancer incidence and healthcare investments.

4. How do technological innovations impact its market growth?
Advancements such as improved light-delivery systems and combination treatment protocols enhance efficacy, safety, and patient acceptance, fostering increased adoption.

5. What strategic moves could expand porfimer sodium’s market share?
Expanding clinical indications, securing regulatory approvals in new regions, integrating with precision medicine approaches, and forming strategic collaborations are key to increasing its market footprint.

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Sources

[1] European Medicines Agency filings and approvals for porfimer sodium.
[2] Market Research Future, “Photodynamic Therapy Market Outlook”, 2022-2027.