PORFIMER SODIUM - Generic Drug Details

What are the generic sources for porfimer sodium and what is the scope of freedom to operate?

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	5,145,863
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

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/000493 Photodynamic 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with PhotoBarr is indicated for: Ablation of high-grade dysplasia (HGD) in patients with Barrett's Oesophagus (BO)	Withdrawn	no	no	no	2004-03-25

PORFIMER SODIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Porfimer Sodium

Introduction to Porfimer Sodium

Porfimer sodium, commonly known by its brand name Photofrin, is a hematoporphyrin derivative used in photodynamic therapy (PDT) to treat various types of cancer and other conditions. It is the first drug approved for use in PDT in the United States[5].

Market Size and Growth

The photodynamic therapy market, which includes porfimer sodium, is projected to experience significant growth over the coming years. Here are some key statistics:

• The photodynamic therapy market is estimated to grow from USD 1.1 billion in 2024 to USD 3.0 billion by 2035, with a CAGR of 9.7% during the forecast period[1].
• For the period 2025-2030, the market is expected to grow at a CAGR of 6.4%, reaching a value of $1.4 billion in 2025[1].

Key Drivers

Several factors are driving the growth of the market for porfimer sodium and other photodynamic therapies:

Increasing Adoption of Advanced Laser-Based Treatments

The increasing adoption of advanced laser-based treatments is a significant driver. Photodynamic therapy, which uses light-sensitive drugs like porfimer sodium, is becoming more popular due to its efficacy in treating various cancers and other conditions[4].

Rising Prevalence of Cancer

The growing prevalence of cancer, particularly skin cancers and other target indications such as esophageal and lung cancers, is driving the demand for effective treatments like PDT. According to the World Health Organization, around 2 million to 3 million individuals suffer from various forms of skin cancers annually, and one in every five Americans is likely to develop some form of skin cancer in their lifetime[1].

Advancements in Technology

Advancements in laser delivery procedures and the development of new photosensitizing agents are enhancing the efficacy and safety of PDT. This technological progress is attracting more patients and healthcare providers to opt for these treatments[4].

Increased Awareness and Funding

Increased awareness about non-invasive procedures and rising funding from public and private organizations for R&D in photomedicine are also contributing to the market growth. For instance, the Wellman Center for Photomedicine at Massachusetts General Hospital is actively involved in researching new diagnostic and therapeutic uses of light[4].

Market Restraints

Despite the positive trends, there are several challenges that could impact the financial trajectory of porfimer sodium and the broader photodynamic therapy market:

High Cost of Photomedicine Procedures

The high cost of photomedicine devices and procedures is a significant restraint. This can limit access to these treatments, especially in regions with limited healthcare budgets[4].

Safety Issues

Safety issues related to photomedicine devices and the potential side effects of PDT can also hinder market growth. Patients treated with porfimer sodium, for example, need to avoid sunlight for several weeks to prevent skin reactions[5].

Target Indications and Market Segmentation

Porfimer sodium is approved for several target indications, which are key segments of the photodynamic therapy market:

Esophageal Cancer

Porfimer sodium is used to treat esophageal cancer and high-grade dysplasia in Barrett's Esophagus. It works by destroying the blood vessels in the tumor, starving it of nutrients and leading to its death[5].

Endobronchial Cancer

It is also used to treat endobronchial cancer, which affects the airways in the lungs[5].

Other Indications

Other target indications include actinic keratosis, bladder cancer, and certain types of skin cancers. The market is segmented by these target indications, as well as by key players and geographies such as North America, Europe, and Asia Pacific[1].

Competitive Landscape

The photodynamic therapy market, including porfimer sodium, is competitive with several global and local companies involved:

Key Players

Companies like ADVANZ PHARMA, Biofrontera, Biolitec Pharma, and Sun Pharma are key players in the market. These companies are continuously innovating and launching new products, which is driving market growth[1][4].

Technological Shifts

The market is observing significant technological shifts, with companies competing on the basis of product advancements such as increased efficacy and ease of operation. This competition is likely to further fuel market growth over the forecast period[4].

Financial Projections

Given the growth drivers and market dynamics, here are some financial projections for the photodynamic therapy market, which includes porfimer sodium:

• The market is expected to grow significantly, with a projected value of $3.0 billion by 2035[1].
• The CAGR of 9.7% during the forecast period indicates robust financial growth, driven by increasing adoption and technological advancements[1].

Key Takeaways

• Market Growth: The photodynamic therapy market, including porfimer sodium, is expected to grow significantly, driven by increasing adoption of advanced laser-based treatments and rising prevalence of cancer.
• Target Indications: Porfimer sodium is approved for several target indications, including esophageal cancer, endobronchial cancer, and high-grade dysplasia in Barrett's Esophagus.
• Competitive Landscape: The market is competitive, with several key players innovating and launching new products.
• Financial Projections: The market is projected to reach $3.0 billion by 2035, with a CAGR of 9.7% during the forecast period.

FAQs

Q: What is porfimer sodium used for? A: Porfimer sodium, known by its brand name Photofrin, is used in photodynamic therapy to treat various types of cancer, including esophageal cancer, endobronchial cancer, and high-grade dysplasia in Barrett's Esophagus[5].

Q: What is the projected growth rate of the photodynamic therapy market? A: The photodynamic therapy market is expected to grow at a CAGR of 9.7% from 2024 to 2035[1].

Q: What are the key drivers of the photodynamic therapy market? A: Key drivers include the increasing adoption of advanced laser-based treatments, rising prevalence of cancer, and advancements in technology[1][4].

Q: What are the main restraints to the market growth of porfimer sodium and other photodynamic therapies? A: The high cost of photomedicine procedures and safety issues related to these devices are significant restraints[4].

Q: Which regions are expected to dominate the photodynamic therapy market? A: North America is expected to retain the largest market share during the forecast period due to the availability of advanced diagnostic tools and high awareness about these products[4].