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with PhotoBarr is indicated for: Ablation of high-grade dysplasia (HGD) in patients with Barrett's Oesophagus (BO)	Withdrawn	no	no	no	2004-03-25

International Patents for PHOTOFRIN

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

Country	Patent Number	Title	Estimated Expiration
Denmark	172284
Germany	69309340
Denmark	0568323
Australia	581840
European Patent Office	0120054	PURIFIED HEMATOPORPHYRIN DERIVATIVE FOR DIAGNOSIS AND TREATMENT OF TUMORS, AND METHOD

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

PHOTOFRIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for PHOTOFRIN

Introduction to PHOTOFRIN

PHOTOFRIN® (porfimer sodium) is a photosensitizer drug used in photodynamic therapy (PDT) for the treatment of various cancers and pre-cancerous conditions. It was the first photosensitizer to receive clinical approval for several indications, including esophageal cancer, non-small-cell lung cancer, and pre-cancerous cells in Barrett’s esophagus[3].

Market Size and Growth

The global photosensitizer drug market, which includes PHOTOFRIN®, is experiencing significant growth. In 2023, the global photosensitizer drug market size was substantial, and it is projected to grow at a notable compound annual growth rate (CAGR) from 2024 to 2031[1].

Segmentation and Key Players

The market is segmented by type, application, and region. PHOTOFRIN® falls under the type segment, which also includes other photosensitizers like Levulan and Metvix. The primary applications of PHOTOFRIN® are in oncology, dermatology, and ophthalmology. Key companies in this market include Sanofi, Bausch Health, DUSA Pharmaceuticals, and Biofrontera[1].

Regional Analysis

The global photosensitizer drug market is analyzed across five major regions: North America, Europe, Asia-Pacific, Middle East & Africa, and Latin America. Each region provides insights into revenue share, current trends, and future market opportunities. The regional analysis helps in understanding the geographical distribution of the market and identifying the regions that are expected to dominate the market in the forecast period[1].

Oncology Segment

The oncology segment, where PHOTOFRIN® is predominantly used, is expected to expand at a significant CAGR throughout the forecast period. This growth is driven by the increasing incidence of cancers and the need for effective treatments like photodynamic therapy[1].

Clinical Indications and Efficacy

PHOTOFRIN® is used for relieving symptoms of esophageal cancer, treating non-small-cell lung cancer, and removing pre-cancerous cells in Barrett’s esophagus. It has shown effectiveness in palliating dysphagia and improving the quality of life for patients who are unfit for or refuse surgery. However, its use is associated with significant side effects, including phototoxicity, which requires patients to avoid direct sunlight and bright indoor light for an extended period[2][3].

Competitive Landscape

The market for photosensitizer drugs is competitive, with several companies focusing on strategy building to strengthen their product portfolios. Sanofi, Bausch Health, and other key players are actively involved in expanding their business in the global market. The introduction of newer photosensitizers with improved safety profiles and efficacy, such as temoporfin and talaporfin, is also shaping the competitive landscape[1][3].

Financial Trajectory

The financial trajectory of PHOTOFRIN® is closely tied to the overall growth of the photosensitizer drug market. With a projected CAGR of the global market, PHOTOFRIN® is expected to contribute significantly to the revenue growth. However, the market share of PHOTOFRIN® may be influenced by the emergence of newer, more effective photosensitizers and the associated side effects of PHOTOFRIN®[1][4].

Challenges and Opportunities

Despite its clinical efficacy, PHOTOFRIN® faces challenges such as prolonged patient photosensitivity, poor tissue selectivity, and the need for high dosages. These factors drive clinicians to consider other modalities like radiofrequency ablation (RFA). However, ongoing research and development in photodynamic therapy, including the exploration of new photosensitizers and combination therapies, present opportunities for growth and innovation in the market[3].

Pipeline and Innovation

The pipeline for photodynamic therapies is robust, with over 130 candidates in various stages of development. This includes several marketed therapies like VISUDYNE® and Ameluz®, as well as emerging candidates like ASP-1929. The filing of over 635 patents related to light-activated therapies in the past three years underscores the continued innovation in this field, which is expected to drive market growth[4].

Market Projections

The photodynamic therapy market, which includes PHOTOFRIN®, is estimated to grow from USD 1.1 billion in 2024 to USD 3.0 billion by 2035, representing a CAGR of 9.7% during the forecast period. This growth is driven by the increasing incidence of cancers, the need for effective treatments, and the ongoing innovation in photodynamic therapies[4].

Key Takeaways

• Market Growth: The global photosensitizer drug market, including PHOTOFRIN®, is expected to grow significantly from 2024 to 2031.
• Oncology Segment: The oncology segment, where PHOTOFRIN® is predominantly used, is expected to expand at a significant CAGR.
• Clinical Efficacy: PHOTOFRIN® is effective in treating various cancers and pre-cancerous conditions but is associated with significant side effects.
• Competitive Landscape: The market is competitive, with several companies focusing on strategy building and the emergence of newer photosensitizers.
• Financial Trajectory: The financial trajectory of PHOTOFRIN® is tied to the overall growth of the photosensitizer drug market, with opportunities and challenges driven by innovation and side effects.

FAQs

Q: What are the primary indications for PHOTOFRIN®? A: PHOTOFRIN® is used for relieving symptoms of esophageal cancer, treating non-small-cell lung cancer, and removing pre-cancerous cells in Barrett’s esophagus[2].

Q: What are the significant side effects of PHOTOFRIN®? A: Significant side effects include phototoxicity, which requires patients to avoid direct sunlight and bright indoor light for an extended period, as well as potential complications like bleeding, fistula formation, and organ perforation[2].

Q: How does the market for photosensitizer drugs, including PHOTOFRIN®, project to grow? A: The market is expected to grow significantly from 2024 to 2031, driven by the increasing incidence of cancers and ongoing innovation in photodynamic therapies[1][4].

Q: Which regions are expected to dominate the global photosensitizer drug market? A: The regional analysis indicates that North America, Europe, and Asia-Pacific are expected to be key regions driving the market growth[1].

Q: What are the challenges faced by PHOTOFRIN® in the market? A: Challenges include prolonged patient photosensitivity, poor tissue selectivity, and the need for high dosages, which drive clinicians to consider other modalities[3].