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
National Cancer Institute (NCI)	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	5,028,621
Pinnacle Biolgs	PHOTOFRIN	porfimer sodium	INJECTABLE;INJECTION	020451-001	Dec 27, 1995	5,438,071
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	4,932,934
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	4,866,168

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with PhotoBarr is indicated for: Ablation of high-grade dysplasia (HGD) in patients with Barrett's Oesophagus (BO)	Withdrawn	no	no	no	2004-03-25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
Austria	53204
Australia	2032283
Australia	4246185
Australia	581840
Australia	588806
Canada	1265450	PRODUIT PHARMACEUTIQUE, SA PREPARATION, ET SON EMPLOI POUR LE TRAITEMENT DE TUMEURS (DRUG, AND METHODS OF PREPARING AND USING IT FOR TREATMENT OF TUMORS)
Canada	1271746	DERIVE D'HEMATOPORPHYRINE PURIFIEE POUR LE DIAGNOSTIC ET LE TRAITEMENT DES TUMEURS, ET METHODE (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 (porfimer sodium) market dynamics and financial trajectory: sales trends, exclusivity, generic/biosimilar risk, and competitive landscape

Last updated: June 10, 2026

Executive summary: PHOTOFRIN (porfimer sodium; Toray/and legacy QLT legacy brands) is a niche oncology photodynamic-therapy product tied to limited indications and aging regulatory history. Its commercial trajectory is constrained by (1) narrow treatment scope, (2) long-running use patterns and clinician switching costs, (3) limited penetration of alternative photodynamic/vascular-targeted modalities, and (4) the absence of recent, high-volume new indications. Patent and regulatory barriers remain central to generic entry risk, with the primary near-term market question focused on whether any Paragraph IV (or earlier reliance-based) pathways have been pursued and whether competitor photodynamic agents or non-PDT modalities erode share.

No complete, auditable financial dataset (U.S. and major ex-U.S. revenue, segment reporting, payer utilization, and unit sales) is available in the provided context to quantify PHOTOFRIN’s year-by-year financial trajectory or forecasted peak-to-decline curve.

How has PHOTOFRIN (porfimer sodium) sales trended over time and what drives revenue decline or growth?

Featured snippet answer: PHOTOFRIN’s sales have followed a niche-product lifecycle: incremental volume changes from clinician adoption, restricted indication scope, and competitive photodynamic alternatives, with limited upside from label expansion.

What typically drives PHOTOFRIN revenue in real-world oncology

• Indication width and dosing cadence: Photodynamic therapy usage is procedure-driven and tends to grow slowly versus chronic oncology drugs.
• Clinic-level protocol stability: Once centers standardize PDT workflows (laser setup, photosensitizer handling, light-source availability), switching costs can stabilize demand even when new agents appear.
• Reimbursement and prior authorization behavior: Procedure reimbursement and hospital coding practices drive utilization more than marketing.
• Therapy-line placement: PDT often sits in specific therapeutic sequences where guideline sensitivity can limit broad uptake.

What typically changes the revenue path

• Competitor adoption: Alternatives using different photosensitizers or devices can replace PHOTOFRIN where outcomes are comparable or where logistics are easier.
• Regulatory and labeling: Changes in indication scope, risk language, or administration recommendations can affect penetration.
• Supply and manufacturing: Drug availability and consistent manufacturing can create short-term swings in procedure volume.

Which patents protect PHOTOFRIN and how long does exclusivity last?

Featured snippet answer: PHOTOFRIN’s protection is assessed via legacy composition and method patents plus any formulation or process patents listed in regulatory drug-status sources. Without a mapped Orange Book dataset and litigation docket context for PHOTOFRIN, exact expiration dates cannot be stated accurately.

Patent estate map categories to evaluate for PHOTOFRIN

• Composition of matter (porfimer sodium salt/form)
• Method-of-treatment claims (PDT protocols tied to specific cancers or anatomic sites)
• Administration/handling steps (dosage regimens, light activation timing, shielding and safety steps)
• Manufacturing/process claims (sterility, purity, particle-size range, crystallization steps)
• Formulation patents (vehicle, lyophilization, stability, reconstitution)

Exclusivity concepts that matter for a legacy oncology product

• Regulatory exclusivity vs. patent exclusivity: FDA exclusivity can extend market protection even after patent expiry in some scenarios, but PHOTOFRIN’s age makes patent term the usual binding constraint.
• Biosimilar framework does not apply: PHOTOFRIN is a small-molecule/porphyrin derivative drug product, not a biologic, so biosimilar exclusivity risk is not the correct framework.

What is the Orange Book status of PHOTOFRIN and are there generic Paragraph IV challenges?

Featured snippet answer: Orange Book status and any Paragraph IV challenges must be verified against the U.S. FDA Orange Book listings and the associated litigation dockets. No Orange Book listing content is included in the provided context, so the number of listed patents, expirations, and whether any FDA certifications exist cannot be stated.

What to extract when auditing Orange Book risk for PHOTOFRIN

• Listed patent count by type: composition vs method vs formulation vs process
• Patent-by-patent expiration dates: including any PTA/adjustment if applicable
• FDA application types: ANDA vs 505(b)(2) vs reliance pathways
• Certification types: I, II, III, IV
• Patent dispute filings: if Paragraph IV, identify case numbers, parties, and settlement terms.

Why this drives market dynamics

• If no Paragraph IV exists: generic entry is slower and tends to be driven by later non-infringing strategies or expiry-driven demand shifts.
• If Paragraph IV exists: launch timing becomes a function of stay/settlement terms and court schedules.

How does PHOTOFRIN compete against other photodynamic therapy agents or non-PDT modalities?

Featured snippet answer: PHOTOFRIN’s competitive set is procedural and guideline-driven: photodynamic therapy options, alternative photosensitizers, and competing local-regional oncology treatments.

Key competitive dynamics that typically determine share

• Device-compatibility and workflow fit: light source availability and compatibility affect clinician selection.
• Clinical outcomes and toxicity profiles: differences in photosensitivity duration, dosing convenience, and lesion response can change practice.
• Institutional experience: centers with established PDT protocols often keep continuity unless outcomes or logistics shift.

Where market share loss usually comes from

• Less complex logistics: products that reduce photosensitivity duration or simplify administration can displace older workflows.
• Broader eligibility: if another agent has label breadth across sites or lines, it can capture referrals.

What generic entry risks exist for PHOTOFRIN and what would a launch scenario look like?

Featured snippet answer: Generic entry risk depends on patent expiry, Orange Book certifications, and whether generics can design around method claims. Without a patent-by-patent Orange Book and litigation map, launch scenario timing cannot be quantified.

Scenario framework used in technical licensing and litigation planning

• Scenario A: Expiry-only entry
  • Entry occurs when the last blocking patent expires, assuming no court injunction.
• Scenario B: Design-around method claims
  • Entry proceeds with a non-infringing clinical protocol, often requiring training and clinical buy-in.
• Scenario C: Early generic via Paragraph IV
  • Entry is delayed or blocked by a 30-month stay or injunction until resolution.

Economic impact mechanics for a niche PDT product

• Volume sensitivity: even small share changes can materially affect revenue because base volumes are limited.
• Price erosion pattern: procedure-driven drugs often see slower price drops than chronic oral drugs, but hospitals still pressure acquisition costs.

Which companies are challenging PHOTOFRIN and what patent litigation affects market timing?

Featured snippet answer: Identify challengers via Paragraph IV filings and court dockets, not marketing claims. Litigation-specific parties and case outcomes are not provided in the context, so they cannot be listed accurately.

What litigation records typically influence

• Injunction scope: whether it blocks supply entirely or only certain protocols.
• Settlement agreement terms: whether there is a “carve-out” for dates, sites, or labeling.
• Appeals status: continued appeals can extend market protection.

How do manufacturer contracts, distribution structure, and hospital procurement affect PHOTOFRIN financial performance?

Featured snippet answer: For procedure-based oncology products, net sales often track procurement behavior more than patient-level demand.

Commercial levers that shift net revenue

• GPO contracting: group purchasing organization agreements can compress realized prices.
• Hospital formularies: preferred product lists can drive utilization.
• Tendering and supply continuity: stockouts can reduce procedures even if demand exists.
• Support services: reimbursement support and training for PDT administration can reduce friction.

What revenue exposure does PHOTOFRIN have across geographies and key oncology markets?

Featured snippet answer: PHOTOFRIN’s geographic exposure is typically concentrated where PDT infrastructure and clinician familiarity exist and where local regulatory authorizations support use. Exact revenue by geography requires financial reporting that is not included in the provided context.

Typical geographic drivers

• Regulatory authorizations for the same indications
• Availability of compatible light delivery systems
• Oncology center density and referral patterns

How strong is the patent estate for PHOTOFRIN compared with newer photodynamic competitors?

Featured snippet answer: A legacy product’s estate strength is usually driven by whether method-of-use and manufacturing/process patents remain enforceable. Without a verifiable patent list and claim analysis, estate strength cannot be graded.

Patent-strength indicators used in diligence

• Number of unexpired blocking patents
• Claim breadth of method-of-use coverage
• Whether key patents are likely enforceable (clear claim scope, minimal design-around paths)
• Litigation history: prior determinations on claim construction and noninfringement

PHOTOFRIN versus competing photodynamic agents: which has better IP defensibility and commercial resilience?

Featured snippet answer: Competitive defensibility depends on each product’s remaining patent term and whether method claims restrict clinical protocols. A proper comparison requires product-by-product Orange Book and patent expiry mapping that is not included in the provided context.

Side-by-side comparison fields used for business decisions

• Unexpired patents and expiration dates
• Method claims that constrain protocol changes
• Exclusivity periods
• Evidence of generic challenges and outcomes
• Device/workflow integration advantages

Key takeaways

• PHOTOFRIN is a niche, procedure-driven oncology photodynamic therapy with revenue dynamics dominated by limited indication scope, clinician workflow inertia, and reimbursement/procurement behavior.
• Market downside risk is anchored in patent expiry timing and any Paragraph IV/generic challenge posture, which must be verified via Orange Book and litigation records.
• Upside is usually capped absent meaningful label expansion or competitive displacement of non-PDT modalities through superior clinical or operational profiles.
• A quantified sales and forecast trajectory cannot be provided from the current input because auditable financial and regulatory listing data is not included.

FAQs

1. What Orange Book patents are listed for PHOTOFRIN porfimer sodium, and what are their expiration dates?
2. Have any ANDAs filed to challenge PHOTOFRIN via Paragraph IV, and what were the court outcomes or settlement dates?
3. What method-of-use or protocol elements in PHOTOFRIN patents most constrain generic design-around strategies?
4. How does hospital procurement pricing typically change for niche PDT drugs after generic entry?
5. Which non-PDT oncology modalities most directly substitute for PHOTOFRIN-treated indications, and how does that affect procedure demand?

References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. (Orange Book database access required for product-specific listings.)