OXSORALEN Drug Patent Profile

Which patents cover Oxsoralen, and what generic alternatives are available?

Oxsoralen is a drug marketed by Valeant Pharm Intl and Bausch and is included in two NDAs.

The generic ingredient in OXSORALEN is methoxsalen. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the methoxsalen profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Oxsoralen

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

Summary for OXSORALEN

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	111
Clinical Trials:	1
Patent Applications:	5,701
DailyMed Link:	OXSORALEN at DailyMed

Recent Clinical Trials for OXSORALEN

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 clinical trials

US Patents and Regulatory Information for OXSORALEN

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	OXSORALEN	methoxsalen	LOTION;TOPICAL	009048-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Bausch	OXSORALEN-ULTRA	methoxsalen	CAPSULE;ORAL	019600-001	Oct 30, 1986	AB	RX	Yes	Yes

OXSORALEN Market Dynamics, Patent Position, FDA Status, and Financial Trajectory

Last updated: September 19, 2026

Oxsoralen is the former U.S. brand for methoxsalen, a photosensitizing agent used with controlled ultraviolet A exposure in PUVA therapy. Its commercial position has deteriorated because the product is old, genericized, clinically replaced in many settings by narrowband UVB, and exposed to limited demand from dermatology and photopheresis centers. The brand has no meaningful modern exclusivity platform, no biosimilar issue, and limited disclosed revenue visibility.

What is Oxsoralen and how is it used?

Oxsoralen contains methoxsalen, also known as 8-methoxypsoralen. The drug increases skin sensitivity to UVA radiation and is administered before controlled phototherapy.

The main historical indications were:

• Severe psoriasis
• Vitiligo
• Cutaneous T-cell lymphoma
• Other disorders treated with PUVA
• Selected extracorporeal photopheresis protocols, depending on the device and treatment system

Oxsoralen-Ultra was the oral capsule formulation, generally supplied as 10 mg methoxsalen capsules. The product label requires carefully timed UVA treatment and extensive precautions against unintended sunlight exposure because methoxsalen can cause severe phototoxicity and long-term ocular and skin risks [1].

PUVA therapy has declined in many dermatology practices. Narrowband UVB is easier to administer, does not require oral psoralen, and has a more favorable operational profile for many psoriasis and vitiligo patients. PUVA remains relevant for selected indications, refractory disease, darker skin types, and conditions where narrowband UVB is less effective.

What is the FDA regulatory status of Oxsoralen?

Oxsoralen was approved through a legacy new drug application and has been marketed for decades. The U.S. branded product has been associated with NDA 018202, covering Oxsoralen-Ultra methoxsalen capsules.

The current regulatory picture is characterized by:

Regulatory issue	Status
Active ingredient	Methoxsalen
U.S. brand	Oxsoralen / Oxsoralen-Ultra
Dosage form	Oral capsules
Historical strength	10 mg
Primary pathway	Legacy NDA
FDA therapeutic area	Dermatology and photochemotherapy
Current commercial position	Mature, declining, and largely genericized
Biologic status	Not applicable
Biosimilar exposure	None
Regulatory exclusivity	Expired or no longer commercially meaningful

The product should be distinguished from methoxsalen used in extracorporeal photopheresis systems. Those systems may involve separate device, drug, and procedural economics. A decline in dermatology PUVA does not necessarily eliminate all methoxsalen demand.

FDA labeling identifies substantial risks, including phototoxic burns, cataracts, ocular injury, premature skin aging, and increased risk of nonmelanoma skin cancer with cumulative PUVA exposure [1]. These risks limit broad replacement of other phototherapy options with oral methoxsalen.

What patents protect Oxsoralen?

The principal Oxsoralen patent estate is effectively exhausted. Methoxsalen is an old small molecule with an extensive pre-generic history, and the core composition-of-matter protection expired many years ago.

Patent protection by category

Patent category	Current commercial significance
Methoxsalen composition of matter	Expired
Oral capsule formulation	Expired or commercially immaterial
PUVA treatment method	Any historic protection is expired or difficult to enforce against generic sale
Manufacturing patents	Potentially relevant to cost and supply, but not a meaningful barrier to generic entry
Device-linked photopheresis rights	May remain relevant to specific systems, but do not recreate Oxsoralen exclusivity
Pediatric exclusivity	Not commercially relevant
Orphan exclusivity	No current broad Oxsoralen monopoly
Patent term extension	No meaningful current effect

There is no credible basis for treating Oxsoralen as a protected specialty product with a live, high-value patent moat. The remaining intellectual-property risks are more likely to involve manufacturing know-how, supplier qualifications, or device-linked treatment systems than blocking patents on the drug itself.

When did Oxsoralen lose exclusivity?

Oxsoralen lost practical exclusivity before the modern generic drug market matured. The drug’s age means that any relevant U.S. patent protection on methoxsalen itself expired decades ago. The product’s commercial decline reflects both generic entry and reduced use of PUVA.

The important exclusivity milestones are:

Milestone	Commercial effect
Original methoxsalen approval	Established the Oxsoralen franchise
Development of Oxsoralen-Ultra	Improved oral formulation and dosing convenience
Generic methoxsalen entry	Removed meaningful brand pricing power
Expansion of narrowband UVB	Reduced demand for oral psoralen therapy
Brand discontinuation or reduced distribution	Shifted demand toward generic or compounded supply
Present market	Mature, fragmented, and low-growth

No current statutory exclusivity period is expected to prevent generic methoxsalen competition.

What is the Orange Book status of Oxsoralen?

The Orange Book is relevant because it identifies approved drug products and listed patents or exclusivities associated with approved NDAs. Oxsoralen’s commercial significance in the Orange Book is limited by the age of the product and the absence of a current patent-based launch barrier.

The principal conclusions are:

1. Oxsoralen is not protected by a live composition-of-matter patent.
2. Any historical listed patents are expired, delisted, or no longer commercially determinative.
3. A generic applicant would not face the same type of Orange Book patent exposure associated with a recently approved branded specialty drug.
4. The primary market question is product availability, not patent validity.

A Paragraph IV challenge would have had little strategic value against an old methoxsalen product unless a later-listed formulation or method patent created a narrow commercial opportunity. No such patent position is central to the current market.

Are there Paragraph IV challenges to Oxsoralen?

No major current Paragraph IV campaign is central to the Oxsoralen market.

For an old oral methoxsalen product, generic entry would generally be based on an abbreviated new drug application referencing the approved product, subject to bioequivalence and applicable labeling requirements. The commercial case is weak for a large-scale Paragraph IV litigation strategy because:

• The molecule is old.
• The addressable market is small.
• The product has limited pricing power.
• The relevant patents are largely expired.
• PUVA use is declining relative to narrowband UVB.
• A successful challenge would not necessarily generate substantial sales.

The more material risk is ordinary generic substitution and supply competition rather than patent litigation.

What formulations are protected by Oxsoralen patents?

The commercial formulation historically associated with Oxsoralen was the oral 10 mg capsule. Its differentiation was mainly product development and dosing presentation, not durable patent protection.

Potential formulation categories include:

Formulation	Market relevance
Oral methoxsalen capsule	Core Oxsoralen product; generic competition
Liquid or compounded methoxsalen	Limited, institution-specific use
Topical psoralen preparations	Separate products and treatment practices
Device-associated methoxsalen systems	May involve separate photopheresis economics
UVA delivery systems	Device and service market, not Oxsoralen exclusivity

Oxsoralen’s capsule formulation does not provide a meaningful modern lifecycle-management platform. There is no widely recognized extended-release, pediatric, transdermal, or combination formulation that could materially reset its market trajectory.

How does Oxsoralen compare with competing phototherapy drugs?

Oxsoralen competes less with another oral drug than with alternative treatment modalities.

Therapy	Main advantage over oral Oxsoralen	Main limitation
Narrowband UVB	No psoralen ingestion; simpler safety management	May be less effective for selected diseases
Topical psoralen plus UVA	Limits systemic exposure	More labor-intensive and less practical for large areas
Excimer laser	Targeted treatment	Limited coverage and higher procedural burden
Biologic psoriasis therapies	High efficacy and convenience for eligible patients	High cost and systemic safety monitoring
Janus kinase inhibitors for vitiligo	Systemic or topical targeted therapy	Safety, reimbursement, and monitoring issues
Extracorporeal photopheresis	Important in selected hematologic conditions	Specialized infrastructure and high treatment cost

For psoriasis, biologics and targeted small molecules have reduced the role of PUVA in patients who qualify for systemic therapy. For vitiligo, treatment remains more heterogeneous, and phototherapy continues to have a role, although narrowband UVB is usually preferred. In cutaneous T-cell lymphoma, PUVA remains clinically relevant in selected patients.

What is the financial trajectory of Oxsoralen?

Public companies do not generally disclose Oxsoralen revenue as a separate product line. That prevents a reliable standalone estimate of sales, gross margin, or product-level profitability from public filings.

The financial trajectory can be assessed through market structure:

Revenue direction

Oxsoralen revenue has likely followed a long-term decline because of:

• Generic substitution
• Reduced PUVA utilization
• Migration to narrowband UVB
• Competition from biologic and targeted therapies
• Limited new patient growth
• Low prescribing frequency outside specialized centers

The remaining demand is concentrated in hospitals, academic dermatology practices, photopheresis centers, and patients with disease-specific reasons to use PUVA.

Pricing dynamics

Generic methoxsalen pricing may be volatile despite low underlying demand. Small markets can experience intermittent shortages when only a few suppliers remain. A supply disruption can produce short-term price increases without creating durable market expansion.

The brand lacks the characteristics that support strong price increases:

• No active exclusivity
• No broad prescriber loyalty
• No major clinical differentiation
• No large population indication
• No high-value reimbursement strategy

Cost structure

Manufacturing economics are affected by:

• Low production volumes
• Specialized raw-material sourcing
• Quality-control requirements
• Limited approved suppliers
• Packaging and stability requirements
• Distribution to a narrow institutional customer base

Those factors can make the product commercially unattractive even when the active ingredient itself is inexpensive.

Which companies manufacture or challenge Oxsoralen?

The historical brand was associated with Valeant Pharmaceuticals, now Bausch Health Companies. Current methoxsalen supply may involve generic manufacturers, contract manufacturers, or specialty distributors rather than a single dominant branded company.

The competitive field is fragmented. The relevant competitors are:

• Generic methoxsalen capsule suppliers
• Compounding pharmacies
• Phototherapy centers using narrowband UVB
• Manufacturers of photopheresis systems
• Pharmaceutical companies selling biologic or targeted therapies for psoriasis and vitiligo

There is no major public evidence of an active branded challenger attempting to rebuild Oxsoralen as a growth product.

What patent litigation and settlement agreements affect Oxsoralen?

No major recent patent litigation or settlement agreement appears to define the commercial market for Oxsoralen. The product’s patent risk is low because the core technology is old and the market is too small to support extensive litigation.

Potential legal disputes would be more likely to concern:

• Product shortages
• Manufacturing compliance
• Contract supply
• Pharmacy compounding
• Product liability
• Device-linked photopheresis rights

Those issues differ from a conventional branded-drug patent dispute over launch timing.

What generic entry risks exist for Oxsoralen?

Generic entry risk is high because the product has little remaining intellectual-property protection. The more important risk to suppliers is not the first generic launch but the instability of a small market.

Generic-market risks include:

1. Price erosion after additional suppliers enter.
2. Supplier exit when margins fall below manufacturing and compliance costs.
3. Periodic shortages caused by limited inventory or production interruptions.
4. Substitution by non-drug phototherapy options.
5. Hospital formulary decisions favoring alternative treatment systems.
6. Compounding substitution where commercial supply is unavailable.

For an investor, the market is more suitable for a niche-supply or shortage-management thesis than for a traditional branded-drug growth thesis.

How strong is the Oxsoralen patent estate?

The Oxsoralen patent estate is weak as a current commercial asset.

Strength factor	Assessment
Core molecule protection	None of current commercial value
Formulation protection	Weak or expired
Method-of-use protection	Limited and difficult to monetize
Regulatory exclusivity	None of strategic importance
Biosimilar barrier	Not applicable
Manufacturing barrier	Moderate only if qualified supply is scarce
Brand differentiation	Low
Litigation leverage	Low
Revenue protection	Low

The strongest residual barrier is operational rather than legal: a supplier with an approved, reliable, and scalable manufacturing process may benefit from limited competition. That advantage can disappear if another manufacturer qualifies and maintains supply.

What is the outlook for Oxsoralen revenue?

The base-case outlook is continued structural decline or stagnation at a small specialty-market level. A material rebound would require one of the following:

• Increased PUVA use in a specific disease area
• A shortage of competing methoxsalen suppliers
• New evidence supporting methoxsalen in a narrowly defined population
• Expansion of photopheresis demand
• A commercial relaunch with reliable supply and institutional contracting

None of those drivers currently provides a clear basis for sustained high growth.

The most likely market scenarios are:

Scenario	Expected effect
Stable generic supply	Low, declining revenue
Supplier shortage	Temporary price and revenue increase
Further migration to narrowband UVB	Accelerated decline
Increased photopheresis use	Localized demand support
Branded relaunch	Limited upside without new clinical differentiation
New formulation approval	Potential niche expansion, but high development risk

Key Takeaways

• Oxsoralen is methoxsalen, an old oral photosensitizer used with UVA therapy.
• Its core patents and practical exclusivity have expired.
• No meaningful current Paragraph IV or patent-litigation threat defines the market.
• The product competes mainly with narrowband UVB, biologics, targeted therapies, and photopheresis systems.
• Public companies do not disclose reliable standalone Oxsoralen revenue.
• The financial trajectory is structurally weak because of genericization, declining PUVA use, and limited patient growth.
• Residual commercial value depends on approved manufacturing capacity, supply reliability, and niche institutional demand.
• The product has no biosimilar risk because methoxsalen is a small molecule.
• The market is more exposed to generic supply disruption than to patent expiry.
• A branded relaunch would require a new formulation, indication, or distribution strategy to produce meaningful growth.

FAQs About Oxsoralen

Is Oxsoralen still available in the United States?

Availability has been limited and may vary by supplier, pharmacy, and institutional channel. Generic methoxsalen availability is more relevant than broad branded Oxsoralen distribution.

Is methoxsalen the same drug as Oxsoralen?

Yes. Oxsoralen is the brand name historically used for methoxsalen, also called 8-methoxypsoralen.

Does Oxsoralen have patent protection today?

No current patent position appears capable of protecting the core drug from ordinary generic competition. Any residual rights would be narrow and product- or process-specific.

Can methoxsalen be used with narrowband UVB?

Methoxsalen is primarily associated with UVA-based PUVA treatment. Narrowband UVB generally does not require oral psoralen and is a separate phototherapy approach.

Is Oxsoralen an attractive pharmaceutical acquisition target?

As a standalone branded asset, it has limited appeal. Its value would depend on supply scarcity, institutional contracts, manufacturing capability, or integration with a broader phototherapy or photopheresis platform.

References

1. U.S. Food and Drug Administration. (n.d.). Oxsoralen-Ultra (methoxsalen) capsule prescribing information. FDA.
2. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA.
3. National Library of Medicine. (n.d.). Methoxsalen capsule drug label. DailyMed.
4. Bausch Health Companies Inc. (2024). Annual report on Form 10-K. U.S. Securities and Exchange Commission.
5. American Academy of Dermatology. (n.d.). Phototherapy and psoriasis treatment guidance. AAD.