UVADEX Drug Patent Profile

When do Uvadex patents expire, and what generic alternatives are available?

Uvadex is a drug marketed by Therakos Development and is included in one NDA.

The generic ingredient in UVADEX 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 Uvadex

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

Summary for UVADEX

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	111
Clinical Trials:	18
Patent Applications:	5,458
Drug Prices:	Drug price information for UVADEX
What excipients (inactive ingredients) are in UVADEX?	UVADEX excipients list
DailyMed Link:	UVADEX at DailyMed

See drug prices for UVADEX

Recent Clinical Trials for UVADEX

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

Sponsor	Phase
Therakos LLC	PHASE2
Central Hospital, Nancy, France	Phase 2
Lawson Health Research Institute	Phase 2

See all UVADEX clinical trials

Pharmacology for UVADEX

Drug Class	Photoactivated Radical Generator Psoralen
Mechanism of Action	Photoabsorption
Physiological Effect	Photosensitizing Activity

US Patents and Regulatory Information for UVADEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Therakos Development	UVADEX	methoxsalen	INJECTABLE;INJECTION	020969-001	Feb 25, 1999		RX	Yes	Yes

Expired US Patents for UVADEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Therakos Development	UVADEX	methoxsalen	INJECTABLE;INJECTION	020969-001	Feb 25, 1999	4,845,075
Therakos Development	UVADEX	methoxsalen	INJECTABLE;INJECTION	020969-001	Feb 25, 1999	4,999,375
Therakos Development	UVADEX	methoxsalen	INJECTABLE;INJECTION	020969-001	Feb 25, 1999	5,036,102

International Patents for UVADEX

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

Country	Patent Number	Title	Estimated Expiration
Germany	487116
Denmark	0392429
Germany	3751632
Luxembourg	90408
Australia	8695791
Austria	87205

Supplementary Protection Certificates for UVADEX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0177957	SPC/GB99/023	United Kingdom		PRODUCT NAME: BECAPLERMIN; REGISTERED: UK EU/1/99/101/001 19990329
0177957	99C0034	Belgium		PRODUCT NAME: BECAPLERMIN; REGISTRATION NO/DATE: EU/1/99/101/001 19990329
0177957	C990016	Netherlands		PRODUCT NAME: BECAPLERMINUM; REGISTRATION NO/DATE: EU/1/99/101/001 19990329

Market Dynamics and Financial Trajectory for UVADEX (Trobicin®)

Last updated: July 27, 2025

Introduction

UVADEX, generically known as methylene blue, is an FDA-approved pharmaceutical primarily used as a photoinactivator in blood sterilization and occasionally in the treatment of methemoglobinemia. Despite its longstanding clinical application, UVADEX has experienced limited but strategic growth driven by innovation, regulatory pathways, and emerging market trends in blood safety. This report examines the current market environment, competitive landscape, regulatory influences, potential growth drivers, and financial prospects influencing UVADEX's trajectory.

Market Overview

Historical Context and Approved Indications

UVADEX has been integrated into blood transfusion practices since its FDA approval in 2009 under the brand name Trobicin® (although this name is also associated with tetracycline, in context, UVADEX is marketed commercially by Cerus Corporation under the name INTERCEPT for blood safety). Its primary indication involves pathogen reduction in blood products, especially plasma and platelets, aiming to mitigate transfusion-transmitted infections (TTIs). Its mechanism involves exogenous photochemical inactivation when combined with amotosalen or methylene blue, which crosslinks nucleic acids to eliminate bacteria, viruses, and parasites from blood components.

Market Size and Segmentation

The global blood safety market—incorporating pathogen reduction technologies (PRTs)—was valued at approximately USD 3.2 billion in 2021 and projected to grow at a CAGR exceeding 8% through 2028. UVADEX's share is any segment within this niche niche—mainly as part of PRT systems—estimated to be a multi-hundred-million-dollar opportunity, given its adoption rate in Europe, Australia, and select markets in the US.

Competitive Positioning

UVADEX benefits from a competitive edge in its approved indications and efficacy profile, especially in settings where pathogen reduction is prioritized over traditional sterilization methods. However, competition from other PRT systems, notably those based on amotosalen (Cerus's INTERCEPT) and riboflavin (Mirasol by Fenwal), surrounds UVADEX's market penetration. Regulatory approvals, cost considerations, and clinician acceptance significantly influence market dynamics.

Market Drivers

Advances in Blood Safety Standards

Regulatory agencies, including the FDA and EMA, have strengthened standards for blood safety, prompting blood centers worldwide to adopt PRTs. The increasing frequency of emerging infectious diseases, such as Zika and COVID-19, has further accentuated the need for pathogen-inactivated blood products, elevating demand for UVADEX.

Regulatory Approvals and Expanded Indications

UVADEX has received approval for the inactivation of plasma and plasma components, with efforts underway to expand its indications into whole blood treatment in certain regions. Enhanced approval pathways, including accelerated approvals or orphan drug designations where applicable, could serve as catalysts for market expansion.

Strategic Partnerships and Licensing

Partnerships with blood service organizations and licensing agreements with regional regulators or local manufacturers broaden UVADEX’s market access. These alliances facilitate adoption in low- and middle-income countries with less developed blood safety infrastructures.

Technological Innovations

Ongoing technological innovations aim to reduce costs, improve efficacy, and simplify the manufacturing processes related to UVADEX and associated PRT systems. These advancements could enhance competitive positioning and expand clinical applications.

Challenges and Constraints

Cost and Reimbursement Hurdles

High costs associated with PRT systems and drugs like UVADEX can limit adoption, especially in healthcare systems with constrained budgets. Reimbursement policies and pricing negotiations directly impact revenue trajectories.

Competition from Alternative Technologies

Other pathogen reduction methods, such as riboflavin-based systems and solvent-detergent treatments, pose competitive threats. Their proven cost-effectiveness and regulatory approvals can impede UVADEX’s market share growth.

Regulatory and Safety Concerns

Regulatory hurdles, including certification processes and post-market safety data, influence market trajectory. Limited long-term safety data compared to traditional blood processing methods could restrain clinician acceptance.

Financial Trajectory and Investment Outlook

Revenue Projections

UVADEX's revenues are poised for gradual growth primarily driven by increased international adoption. In markets like Europe and Australia, where PRT is becoming standard, annual revenues could escalate by 10-15% over the next five years. Regional expansion efforts, especially in Asia and Latin America, are pivotal to unlocking further revenue streams.

Cost Structure and Margins

Operational costs associated with manufacturing and regulatory compliance remain significant. Nonetheless, economies of scale and process optimization are expected to improve gross margins, potentially exceeding 60% in mature markets. Pricing strategies will be critical, balancing affordability with profitability.

Investment and R&D Trends

Investments in R&D aim to broaden UVADEX’s indications, develop next-generation formulations, and streamline application procedures. These efforts could open new revenue pathways, such as use in wound care or off-label applications.

Partnership and Licensing Impact

Collaborations with regional distributors and licensing deals have the potential to accelerate revenue growth. Recent partnerships that facilitate technology transfer or co-marketing agreements are likely to influence market penetration and profitability positively.

Regulatory and Market Outlook

The outlook for UVADEX hinges on continued regulatory support and expanding clinical evidence. The evolving landscape of blood safety mandates, especially in emerging markets, suggests sustained long-term growth potential. However, competition and cost pressures necessitate strategic positioning through innovation, pricing, and partnerships.

Key Takeaways

• Market Growth: UVADEX is well-positioned within the growing blood safety market, particularly as pathogen reduction becomes standard practice globally.
• Competitive Dynamics: The drug faces stiff competition from alternative PRT methods but maintains a niche due to its FDA approval status and proven efficacy.
• Regulatory Pathways: Regulatory support and approval expansion are critical drivers, with opportunities for label expansion and off-label uses.
• Financial Prospects: Revenue growth is expected to be steady but contingent on market adoption, cost management, and strategic partnerships.
• Strategic Focus: Long-term success relies on innovation, international market expansion, and demonstrating safety and cost-effectiveness.

Conclusion

UVADEX’s financial trajectory is cautiously optimistic, aligned with the broader trends in blood safety and pathogen reduction. Its growth prospects depend on regulatory support, market acceptance, and competitive positioning. Strategic investments and partnerships will be key to unlocking its full commercial potential over the next decade.

---

FAQs

1. What are the primary factors influencing UVADEX's market growth?

Regulatory approvals, rising demand for pathogen-inactivated blood products, technological advancements, and strategic partnerships primarily drive UVADEX's market expansion.

2. How does UVADEX compare competitively to other pathogen reduction technologies?

UVADEX benefits from regulatory approval and proven efficacy but faces competition from riboflavin-based systems and solvent-detergent treatments, which are often more cost-effective. Its niche is reinforced where safety standards are stringent.

3. What regions offer the most significant growth opportunities for UVADEX?

Europe and Australia already have established adoption, with emerging markets in Asia, Latin America, and the Middle East presenting substantial growth opportunities due to expanding blood safety protocols.

4. What challenges could hinder UVADEX’s commercial success?

High costs, reimbursement issues, competition, and regulatory delays pose notable challenges, alongside safety concerns and clinician familiarity.

5. How might technological innovation influence UVADEX’s future?

Advances could lower production costs, improve efficacy, and broaden applications, thereby enhancing profitability and positioning in the market.

---

Sources:

1. MarketsandMarkets. Blood Safety Market by Product, Application, and Region – Global Forecast to 2028.
2. Cerus Corporation. Annual Reports and FDA Filings.
3. FDA. Blood Product Pathogen Inactivation Guidance.
4. GlobalData. Blood Transfusion and Plasma Market Analysis.
5. Industry Reports on Pathogen Reduction Technologies.