Methoxsalen - Generic Drug Details

What are the generic sources for methoxsalen and what is the scope of patent protection?

Methoxsalen is the generic ingredient in five branded drugs marketed by Valeant Pharm Intl, Actavis Inc, Ani Pharms, Onesource Specialty, Bausch, and Therakos Development, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for methoxsalen. Two suppliers are listed for this compound.

Summary for methoxsalen

US Patents:	0
Tradenames:	5
Applicants:	6
NDAs:	6
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	26
Patent Applications:	6,839
Drug Prices:	Drug price trends for methoxsalen
What excipients (inactive ingredients) are in methoxsalen?	methoxsalen excipients list
DailyMed Link:	methoxsalen at DailyMed

See drug prices for methoxsalen

Recent Clinical Trials for methoxsalen

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

Sponsor	Phase
Therakos LLC	PHASE2
Georgetown University	Phase 2
European Organisation for Research and Treatment of Cancer - EORTC	Phase 2

See all methoxsalen clinical trials

Pharmacology for methoxsalen

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

Medical Subject Heading (MeSH) Categories for methoxsalen

Cross-Linking Reagents

Photosensitizing Agents

Anatomical Therapeutic Chemical (ATC) Classes for methoxsalen

D05AD	Psoralens for topical use
D05A	ANTIPSORIATICS FOR TOPICAL USE
D05	ANTIPSORIATICS
D	Dermatologicals

D05BA	Psoralens for systemic use
D05B	ANTIPSORIATICS FOR SYSTEMIC USE
D05	ANTIPSORIATICS
D	Dermatologicals

US Patents and Regulatory Information for methoxsalen

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Valeant Pharm Intl	8-MOP	methoxsalen	CAPSULE;ORAL	009048-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Onesource Specialty	METHOXSALEN	methoxsalen	CAPSULE;ORAL	202687-001	Jun 5, 2014	AB	RX	No	No
Therakos Development	UVADEX	methoxsalen	INJECTABLE;INJECTION	020969-001	Feb 25, 1999		RX	Yes	Yes
Bausch	OXSORALEN-ULTRA	methoxsalen	CAPSULE;ORAL	019600-001	Oct 30, 1986	AB	RX	Yes	Yes
Actavis Inc	METHOXSALEN	methoxsalen	CAPSULE;ORAL	202603-001	Jun 9, 2015		DISCN	No	No
Valeant Pharm Intl	OXSORALEN	methoxsalen	LOTION;TOPICAL	009048-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Ani Pharms	METHOXSALEN	methoxsalen	CAPSULE;ORAL	087781-001	Jun 8, 1982		DISCN	No	No

Expired US Patents for methoxsalen

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
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	5,036,102
Therakos Development	UVADEX	methoxsalen	INJECTABLE;INJECTION	020969-001	Feb 25, 1999	4,999,375

Methoxsalen Market Dynamics and Financial Trajectory

Last updated: February 13, 2026

Market Overview

Methoxsalen (product names include Uvadex andOxsoralen) is a psoralen derivative used primarily in combination with ultraviolet A (UVA) light therapy (PUVA) to treat skin conditions such as psoriasis, vitiligo, and cutaneous T-cell lymphoma. It has a long history of clinical use, with regulatory approval in multiple markets but limited recent innovation or expansions.

Market Size and Growth Trends

The global market for methoxsalen is estimated at approximately $20-$30 million annually. The segment is characterized by slow growth, driven largely by the prevalence of target conditions and the limited drug pipeline development.

Key market figures (2022-2023) [1]:

Indicator	Value
Global annual sales	~$25 million
CAGR (2018-2023)	2% (approximate)
Major markets	US, Europe, Japan

Factors influencing market size include:

• The aging global population increases disease prevalence.
• Adoption of alternative therapies limits methoxsalen usage.
• Patent expirations have led to generic competition, reducing prices.

Market Drivers

1. Prevalence of Psoriasis and Vitiligo: Growing patient populations sustain demand for PUVA therapy, where methoxsalen is a key component.
2. Clinical Acceptance: Long-term safety and efficacy data support continued use despite competition.
3. Regulatory Status: Approved in multiple regions; no recent regulatory restrictions.

Market Barriers

1. Alternative Treatments: Biologics and other systemic therapies (e.g., immunosuppressants) provide easier administration routes and more favorable side-effect profiles.
2. Limited Novelty: The absence of new formulations or indications hampers growth prospects.
3. Pricing Pressure: Increased generic availability exerts downward pressure on prices.

Financial Trajectory Analysis

Revenue Projections

Given the saturated market and minimal innovation, revenues are projected to grow slowly or plateau. A conservative estimate anticipates 1-2% annual growth over the next five years, driven solely by global population increases and regional adoption rates.

Projected revenue estimates (2024-2028) [2]:

Year	Estimated Revenue	Notes
2024	$26 million	Slight increase from previous year
2025	$26.5 million	Based on demographic trends
2026	$27 million	Continued slow growth
2027	$27.5 million	Market saturation persists
2028	$28 million	Marginal gains

Profitability Outlook

Margins for methoxsalen are shrinking due to generic competition and price erosion. Operating margins are estimated at 15-20%. The drug’s low R&D investment requirements for manufacturing might sustain modest profitability, but the overall financial impact remains limited.

Pipeline and Innovation Considerations

There is scant evidence of ongoing R&D aimed at methoxsalen reformulation or new indications. Existing patents have long expired, capping exclusivity benefits. Without renewal or new patent claims, investments yield low returns.

Competitive Landscape

The market features:

• Generic Manufacturers: Several globally, offering low-cost versions.
• Alternative Therapies: Biologics (e.g., infliximab, adalimumab), phototherapy variants, and new small molecules.
• Emerging Technologies: No significant pipeline targeting psoriasis or vitiligo with methoxsalen-specific New Chemical Entities (NCEs).

Regulatory and Policy Environment

• Regulatory agencies (FDA, EMA) have not introduced significant barriers or incentives specifically affecting methoxsalen.
• Some countries advocate for minimizing phototherapy in favor of systemics with better side-effect profiles.
• Price caps in certain jurisdictions further constrain revenue potential.

Summary

Methoxsalen's market is mature, with slow, steady revenue that is unlikely to grow significantly. The core demand stems from established indications, but emerging competition and innovation deficits limit upside. Financial prospects for developers or manufacturers rely on maintaining low-cost production and exploring secondary indications or formulations.

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Key Takeaways

• The global market for methoxsalen remains stable but stagnant, with revenues averaging around $25 million annually.
• Growth is limited due to competition from non-phototherapeutic treatments, patent expirations, and lack of innovation.
• Margins are under pressure, and future revenue growth will likely depend on regional adoption and demographic trends.
• The absence of ongoing R&D or patent protection constrains the financial upside for manufacturers.
• Regulatory policies do not presently favor or hinder the drug significantly, but market dynamics favor cost-effective generic options.

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FAQs

1. Is there any ongoing development for new formulations or indications of methoxsalen?
No, current R&D efforts are minimal, and there is no significant pipeline targeting new formulations or indications.

2. Could patent protections or exclusivity periods recur for methoxsalen?
Unlikely, as existing patents have expired, and reformulations unlikely meet the criteria for patentability or regulatory exclusivity.

3. What factors could disrupt the current market trajectory?
Introduction of significantly safer or more effective therapies, or regulatory changes favoring alternative treatments, could further diminish methoxsalen’s market share.

4. How does the competition from biologics impact methoxsalen?
Biologics offer easier administration and favorable safety profiles, making them preferred options over phototherapy with methoxsalen in many cases.

5. Are there opportunities for niche or regional markets?
Yes, markets with limited access to advanced biologics or where phototherapy options are preferred may sustain some demand, but overall growth remains limited.

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References

[1] MarketWatch, "Global Psoralen Market," 2023.
[2] Statista, "Pharmaceutical Market Size and Growth," 2023.