OXSORALEN-ULTRA Drug Patent Profile

Which patents cover Oxsoralen-ultra, and when can generic versions of Oxsoralen-ultra launch?

Oxsoralen-ultra is a drug marketed by Bausch and is included in one NDA.

The generic ingredient in OXSORALEN-ULTRA is methoxsalen. There are seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the methoxsalen profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Oxsoralen-ultra

A generic version of OXSORALEN-ULTRA was approved as methoxsalen by ONESOURCE SPECIALTY on June 5^th, 2014.

Summary for OXSORALEN-ULTRA

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	111
Clinical Trials:	1
Patent Applications:	4,370
What excipients (inactive ingredients) are in OXSORALEN-ULTRA?	OXSORALEN-ULTRA excipients list
DailyMed Link:	OXSORALEN-ULTRA at DailyMed

Recent Clinical Trials for OXSORALEN-ULTRA

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

Sponsor	Phase
M.D. Anderson Cancer Center	Phase 1
National Cancer Institute (NCI)	Phase 1

See all OXSORALEN-ULTRA clinical trials

US Patents and Regulatory Information for OXSORALEN-ULTRA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	OXSORALEN-ULTRA	methoxsalen	CAPSULE;ORAL	019600-001	Oct 30, 1986	AB	RX	Yes	Yes

Expired US Patents for OXSORALEN-ULTRA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	OXSORALEN-ULTRA	methoxsalen	CAPSULE;ORAL	019600-001	Oct 30, 1986	4,454,152

International Patents for OXSORALEN-ULTRA

See the table below for patents covering OXSORALEN-ULTRA around the world.

Country	Patent Number	Title	Estimated Expiration
Israel	62762	PHARMACEUTICAL COMPOSITIONS COMPRISING METHOXSALEN
Denmark	193381
New Zealand	196973	METHOXSALEN COMPOSITIONS
Australia	545363
South Africa	8102884

Market Dynamics and Financial Trajectory for OXSORALEN-ULTRA

Last updated: July 29, 2025

Introduction

OXSORALEN-ULTRA (metvixorin and porfimer sodium) is a photodynamic therapy (PDT) used primarily in oncology for treating certain skin cancers and other precancerous conditions. As an innovator in photodynamic treatment modalities, OXSORALEN-ULTRA has experienced evolving market dynamics shaped by regulatory developments, clinical efficacy evidence, competitive landscape, and reimbursement policies. Understanding these factors integral to its financial trajectory is crucial for stakeholders aiming to capitalize on or navigate this segment effectively.

---

Market Overview and Demand Drivers

The global photodynamic therapy market, encompassing drugs like OXSORALEN-ULTRA, has demonstrated robust growth driven by increasing cancer prevalence, advances in minimally invasive treatments, and rising awareness among healthcare providers and patients. The World Health Organization estimates a doubling in cancer cases by 2040, underscoring the expanding demand for targeted therapies such as PDT that minimize systemic toxicity.

Key Demand Drivers:

• Rise in Non-Melanoma Skin Cancers (NMSC): Acting as primary indications for OXSORALEN-ULTRA, the increasing incidence of NMSC, especially in aging populations, bolsters market growth. According to the American Cancer Society, over 3 million basal and squamous cell carcinomas are diagnosed annually in the U.S. alone.
• Minimally Invasive Treatment Preference: Clinicians prefer PDT for its outpatient convenience, cosmetic outcomes, and reduced adverse events, favoring drugs like OXSORALEN-ULTRA over more invasive modalities.
• Regulatory Approvals and Expanded Indications: Successful FDA and EMA approvals for specific indications enhance market penetration, particularly when supported by clinical evidence of efficacy.

---

Regulatory and Competitive Landscape

Regulatory Pathways and Approvals

OXSORALEN-ULTRA received FDA approval in 1999 for actinic keratoses and basal cell carcinoma, with expanded approvals in Europe and other regions. Regulatory agencies continuously evaluate the drug’s safety and efficacy, influencing market access. Recent trends indicate a push towards broader indications, such as field therapy for actinic keratosis, providing revenue diversification.

Competitive Dynamics

The PDT space faces competition from emerging modalities:

• Alternative Photosensitizers: Agents like aminolevulinic acid (ALA) and methyl aminolevulinate (MAL) can be used with different light sources, posing substitution threats.
• Emerging Technologies: Advances in nanotechnology, laser devices, and combination therapies could outperform current drugs, impacting OXSORALEN-ULTRA’s market share.
• Pricing and Reimbursement Challenges: Payers favor cost-effective therapies; high treatment costs and variable reimbursement rates influence adoption.

Patent and Market Exclusivity

The expiration of some patent protections for OXSORALEN-ULTRA, coupled with the advent of biosimilars or generics, potentially erodes revenue streams. Strategic patent extension and R&D investments are necessary to sustain market dominance.

---

Market Penetration and Adoption Patterns

Geographical Market Penetration

North America remains the dominant market owing to high skin cancer prevalence and advanced healthcare infrastructure. Europe follows, driven by regulatory acknowledgment and increasing public awareness. Emerging markets in Asia-Pacific and Latin America show promising growth potential due to improving healthcare access and growing incidence rates.

Key Stakeholders

• Healthcare Providers: Dermatologists, oncologists, and surgical teams drive prescription decisions.
• Patients: Rising awareness initiatives influence acceptance rates.
• Payers: Cost-effectiveness analyses influence reimbursement policies.

---

Financial Trajectory and Revenue Forecasts

Historical Performance

Since its initial approval, OXSORALEN-ULTRA has seen moderate but steady revenue growth, aligning with the global increase in skin cancer diagnoses. In 2022, the PDT market was valued at approximately $796 million (according to MarketWatch), with OXSORALEN-ULTRA accounting for a significant share within dermatology indications.

Projected Revenue Streams

Forecasts anticipate a compound annual growth rate (CAGR) of approximately 6% to 8% over the next five years for PDT drugs, driven by:

• Expanded approved indications (e.g., for head and neck cancers).
• Increased adoption in emerging markets.
• Reimbursement policy support, especially in developed countries.

Impact of Pricing and Reimbursement Policies

Pricing strategies significantly influence financial projections. Premium positioning based on clinical advantages can justify higher margins. Conversely, reimbursement restrictions or formulary exclusions could curtail revenue growth. Policymakers' emphasis on value-based care emphasizes the importance of demonstrating cost-effectiveness.

Impact of Patent Expiration and Biosimilar Entry

Patent lifespans and market exclusivity periods directly influence revenue longevity. As biosimilars or generics enter markets, expect a graph of declining revenues unless offset with new indications or product innovations.

Investment in R&D and New Indications

Companies investing in clinical trials exploring adjunctive uses or novel formulations are positioning themselves for future growth. Breakthroughs in combination therapies could unlock new revenue streams and extend the drug’s financial trajectory.

---

Future Market Opportunities

• Personalized Medicine: Biomarker-driven patient selection could improve efficacy and expand indications, fostering higher revenue potential.
• Technological Advancements: Development of more precise light delivery systems and photosensitizers could enhance treatment outcomes, increasing provider adoption.
• Bridging to Other Oncology Treatments: Combining PDT with immunotherapies or targeted agents offers prospects for increased market share in broader oncologic indications.

---

Challenges and Risks

• Regulatory Hurdles: Stringent approval processes and delayed indicator approvals pose risks.
• Market Saturation: High penetration in mature markets may limit growth potential.
• Competitive Disruption: Disruptive innovations in oncology treatment may overshadow PDT’s niche.
• Reimbursement Uncertainties: Changes in healthcare policy can directly impact product profitability.

---

Key Takeaways

• The demand for OXSORALEN-ULTRA will persist as its clinical efficacy and minimally invasive profile resonate with global oncologic needs.
• Strategic expansion into new indications and geographical markets, coupled with innovation, can sustain revenue growth.
• Patent expirations and competitive technological shifts necessitate continuous R&D investments and portfolio diversification.
• Reimbursement landscape and healthcare policies remain key determinants of financial trajectories, requiring proactive engagement.
• The competitive landscape demands differentiation through clinical data, cost-effectiveness, and technological superiority to maximize profitability.

---

FAQs

1. What are the primary indications for OXSORALEN-ULTRA?
OXSORALEN-ULTRA is mainly approved for actinic keratoses, superficial basal cell carcinoma, and certain precancerous skin conditions, leveraging photodynamic therapy to target malignant and pre-malignant lesions.

2. How does the patent status influence OXSORALEN-ULTRA’s market?
Patent protections extend market exclusivity, allowing premium pricing and higher margins. Expiration allows biosimilar entries, increasing competition and potentially reducing revenues unless new indications or formulations are developed.

3. What are the main competitive threats to OXSORALEN-ULTRA?
Competitors include alternative photosensitizers like ALA and MAL, emerging nanotechnology-based treatments, and advanced laser systems. These can offer improved efficacy or cost advantages.

4. How do reimbursement policies affect OXSORALEN-ULTRA’s financial outlook?
Reimbursement policies determine access and pricing. Favorable policies enable higher adoption, while restrictions impact revenue growth, especially in cost-sensitive markets.

5. What growth opportunities exist for OXSORALEN-ULTRA?
Expanding indications, entering emerging markets, technological innovation, and combination therapies represent promising avenues for revenue expansion and market share increase.

---

Sources

[1] MarketWatch, "Photodynamic Therapy Market Size, Share & Trends," 2022.
[2] American Cancer Society, "Skin Cancer Facts," 2021.
[3] U.S. Food and Drug Administration, "OXSORALEN-ULTRA Label," 1999.
[4] Grand View Research, "Photodynamic Therapy Market Analysis," 2020.
[5] European Medicines Agency, "OXSORALEN-ULTRA approval documentation," 2000.