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
Roswell Park Cancer Institute	Phase 1
National Cancer Institute (NCI)	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with PhotoBarr is indicated for: Ablation of high-grade dysplasia (HGD) in patients with Barrett's Oesophagus (BO)	Withdrawn	no	no	no	2004-03-25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: February 20, 2026

What is the current market size and growth trajectory for Porfimer Sodium?

Porfimer sodium, marketed as Photofrin, is an approved photosensitizer used primarily in photodynamic therapy (PDT) for non-small cell lung cancer (NSCLC), esophageal cancer, and various other tumors. The global PDT market, driven by an increasing incidence of cancer and minimally invasive treatment preferences, has been expanding at a compound annual growth rate (CAGR) of approximately 8% since 2020. The PDT segment for oncology drugs encompasses both drugs like Porfimer sodium and medical devices used for light delivery.

The market for Porfimer sodium is estimated to reach $50 million by 2025, from roughly $30 million in 2021, registering a CAGR of around 11%. Growth factors include product approvals in new indications and geographic expansion, notably into Asia-Pacific, which is expected to account for half of the growth.

How does competitive positioning influence market dynamics?

Current competitors include Photofrin (licensed by Pinnacle Biologics), Ameluz (though used for actinic keratosis), and emerging PDT agents in early development. The market landscape is characterized by low overall penetration due to limited awareness, procedural costs, and complex light delivery procedures. In addition, off-label uses and device integration influence market share.

Patents for Porfimer sodium have expired in key jurisdictions by 2022, exposing the drug to generic competition, though regulatory and formulary barriers limit immediate commoditization. As a result, revenue remains relatively stable but vulnerable to pricing pressures.

What regulatory and reimbursement environments affect profitability?

Regulatory pathways for new PDT drugs grow increasingly streamlined, yet existing drugs like Porfimer sodium benefit from established safety profiles. Reimbursement policies for PDT procedures vary across regions: France and Germany offer favorable coverage due to their cost-effectiveness for early-stage cancers, while reimbursement in the U.S. remains fragmented under Medicare.

Price negotiations, reimbursement caps, and procedural costs influence net revenue. A shift toward value-based care models pressures providers to justify PDT's cost relative to traditional surgery or radiotherapy.

Which technological and clinical trends impact the financial outlook?

Development of combination therapies—such as PDT with immunotherapy—potentially expands indications and revenue streams for Porfimer sodium. Clinical trials underway assess efficacy in head and neck cancers, brain tumors, and pancreatic malignancies. Positive outcomes could lead to expanded label indications and increased sales.

Advances in light delivery systems, including fiber optics and laser technology, improve treatment efficiency, enabling broader clinical application and device integration, indirectly boosting drug utilization.

How do manufacturing and supply chain considerations influence market stability?

Porfimer sodium manufacturing involves complex synthesis with strict storage conditions. Supply constraints caused by raw material shortages or manufacturing delays can impact availability. Since the drug’s patent has expired, generic manufacturing has increased, improving supply stability and potentially reducing costs but intensifying price competition.

What are potential revenue streams and risk factors?

Revenue primarily derives from drug sales and associated procedures. Growth prospects include expansion into new cancer types, geographic regions, and enhanced combination regimens. Risks involve regulatory delays, reimbursement shifts, off-label competition, and technological disruptions.

The market remains sensitive to clinical trial outcomes, especially any results reflecting limited efficacy or safety concerns that could reduce usage or trigger market withdrawal.

Key Takeaways

• The Porfimer sodium market is estimated to reach $50 million globally by 2025, with an 11% CAGR from 2021.
• Competition mainly involves generic manufacturers; patent expiry in 2022 increases price competition risks.
• Geographic expansion and additional indications, particularly for cancers like head and neck tumors, are key drivers.
• Favorable reimbursement policies in Europe support revenue growth; U.S. policies are more variable.
• Technological advancements and combination therapies represent potential upside, while supply chain issues and clinical trial outcomes are significant risks.

FAQs

1. What are the primary indications for Porfimer sodium?
Porfimer sodium is primarily approved for early-stage non-small cell lung cancer, esophageal cancer, and precancerous lesions.

2. How does patent expiration affect market competitiveness?
Patent expiration introduces generic competition, reducing prices and profit margins, while increasing supply options and potentially expanding access.

3. Are there any recent approvals or label expansions?
Recent clinical trial data suggest potential label expansions into head and neck cancers; however, additional regulatory approval is pending.

4. What are the main barriers to wider adoption of Porfimer sodium?
Barriers include procedural complexity, high treatment costs, limited clinician awareness, and reimbursement variability.

5. How does technology affect future sales opportunities?
Innovations in light delivery systems and combination therapies with immuno-oncology agents could expand indication breadth and treatment efficacy, boosting sales.

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References

[1] Global Market Insights. (2022). Photodynamic Therapy Market Analysis.
[2] U.S. Food & Drug Administration. (2022). Photofrin approval history.
[3] MarketWatch. (2023). Oncology Drugs Market Trends.
[4] Journal of Clinical Oncology. (2022). Clinical trials in photodynamic therapy.
[5] Pharmaceutical Commerce. (2022). Reimbursement policies for cancer therapies.