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 STRIDES PHARMA on June 5^th, 2014.

Summary for OXSORALEN-ULTRA

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1
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

International Patents for OXSORALEN-ULTRA

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

Country	Patent Number	Title	Estimated Expiration
South Africa	8102884
Denmark	193381
Philippines	18681	METHOXSALEM DOSAGE FORMS
European Patent Office	0039874
Australia	545363

OXSORALEN-ULTRA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Oxsoralen-Ultra

Introduction

Oxsoralen-Ultra, a brand name for the drug methoxsalen, is a photoactive compound used in conjunction with UVA light therapy to treat severe, recalcitrant, and disabling psoriasis. This article delves into the market dynamics and financial trajectory of Oxsoralen-Ultra, exploring its usage, generic availability, and the financial performance of the companies involved in its production and distribution.

Uses and Indications

Oxsoralen-Ultra is specifically indicated for the symptomatic control of severe psoriasis that has not responded adequately to other forms of therapy. It is administered in combination with long-wave UVA radiation, a treatment known as photochemotherapy or PUVA therapy[1].

Market Demand

The demand for Oxsoralen-Ultra is driven by the need for effective treatments for severe psoriasis. Psoriasis is a chronic skin condition affecting millions worldwide, and the severity of the condition can significantly impact the quality of life. The market for psoriasis treatments is substantial, with a growing need for therapies that can manage the symptoms effectively.

Generic Availability

Oxsoralen-Ultra has a generic version available, which was approved by the FDA in 2014. The generic version, also containing methoxsalen, is manufactured by Strides Pharma and is available in the same 10mg strength as the brand name version. This generic availability can impact the market dynamics by providing a more affordable alternative, potentially increasing access to the treatment[4].

Patient Safety and Dosage

The dosage of Oxsoralen-Ultra is carefully managed due to its photosensitizing properties. Patients must be evaluated to determine the minimum phototoxic dose (MPD) and the phototoxic peak time after drug administration. The drug's bioavailability and onset of photosensitization are significantly greater and faster than previous methoxsalen formulations, requiring precise dosing and monitoring[1].

Financial Performance of Manufacturers

Valeant Pharmaceuticals

Historically, Oxsoralen-Ultra was part of the product portfolio of Valeant Pharmaceuticals (now known as Bausch Health Companies). In the mid-2000s, Valeant experienced significant growth, partly due to the performance of its promoted brands, including Oxsoralen-Ultra. The company's restructuring plan in 2006 aimed to streamline operations, reduce costs, and enhance earnings performance. Despite challenges, Valeant's base business continued to perform better than the average for the pharmaceutical industry, with sales increasing by 13% in 2006 compared to 2005[2].

Restatements and Financial Adjustments

Valeant faced financial restatements due to errors in accounting for stock option grants and other issues. These restatements affected the company's financial statements for several years, including adjustments to revenue, cost of goods sold, and income tax expenses. However, these adjustments did not directly impact the sales performance of Oxsoralen-Ultra but reflected broader financial management issues within the company[5].

Competitive Landscape

The psoriasis treatment market is competitive, with various therapies available, including biologics, topical treatments, and other systemic agents. Oxsoralen-Ultra, while effective for severe cases, faces competition from newer and potentially more convenient treatments. The availability of generic methoxsalen further complicates the competitive landscape, as it offers a cost-effective alternative to the brand name product[4].

Market Position and Strategy

Companies like Mallinckrodt, which have expanded their product portfolios through acquisitions, also play a role in the market dynamics. Mallinckrodt's strategy includes increasing patient access to existing products, developing new formulations, and selectively acquiring or licensing products that align with their portfolio. This approach can influence the market position of Oxsoralen-Ultra by offering a broader range of treatment options to patients and healthcare providers[3].

Financial Impact of Generic Competition

The approval of generic methoxsalen has likely reduced the market share and revenue of the brand name Oxsoralen-Ultra. Generic competition typically leads to lower prices and increased accessibility, which can benefit patients but may reduce the financial returns for the original manufacturer. This shift can also prompt the original manufacturer to focus on other products or to develop new formulations to maintain market share[4].

Patient Resources and Access

Patient access to Oxsoralen-Ultra and its generic version is crucial. The drug's availability through reputable pharmacies and the guidance provided by healthcare professionals ensure that patients receive the necessary treatment while minimizing the risk of adverse effects. Resources such as patient safety features and dosage guidelines are essential for effective treatment management[1].

Regulatory Environment

The regulatory environment plays a significant role in the market dynamics of Oxsoralen-Ultra. FDA approvals, patent statuses, and the monitoring of generic versions ensure that the drug is safe and effective. Regulatory changes can impact the availability and pricing of the drug, affecting both the manufacturer and the patient[4].

Future Outlook

The future outlook for Oxsoralen-Ultra is influenced by several factors, including the continued demand for effective psoriasis treatments, the presence of generic competition, and the development of new therapies. As the pharmaceutical landscape evolves, companies may focus on innovative treatments or combination therapies to maintain their market position.

Key Takeaways

• Indications and Usage: Oxsoralen-Ultra is used for severe, recalcitrant psoriasis in conjunction with UVA light therapy.
• Generic Availability: A generic version of methoxsalen is available, impacting market dynamics and patient access.
• Financial Performance: Historically, Oxsoralen-Ultra contributed to the growth of companies like Valeant, but financial restatements and generic competition have affected its market position.
• Competitive Landscape: The psoriasis treatment market is highly competitive, with various therapies available.
• Regulatory Environment: FDA approvals and regulatory monitoring are crucial for the drug's availability and safety.

FAQs

What is Oxsoralen-Ultra used for?

Oxsoralen-Ultra is used for the symptomatic control of severe, recalcitrant, and disabling psoriasis in combination with long-wave UVA radiation.

Is there a generic version of Oxsoralen-Ultra available?

Yes, a generic version of methoxsalen, the active ingredient in Oxsoralen-Ultra, is available and was approved by the FDA in 2014.

How does the generic version affect the market dynamics of Oxsoralen-Ultra?

The generic version reduces the market share and revenue of the brand name Oxsoralen-Ultra by offering a more affordable alternative, increasing accessibility to the treatment.

What are the key safety considerations for Oxsoralen-Ultra?

Patients must be evaluated to determine the minimum phototoxic dose (MPD) and the phototoxic peak time after drug administration due to the drug's photosensitizing properties.

How has the financial performance of manufacturers been impacted by Oxsoralen-Ultra?

Historically, Oxsoralen-Ultra contributed to the growth of companies like Valeant, but financial restatements and generic competition have affected its market position and financial returns.

Sources

1. RxList: Oxsoralen-Ultra (Methoxsalen Capsules): Side Effects, Uses ...
2. Valeant Pharmaceuticals: Annual Report 2006
3. Mallinckrodt: Investor Relations - 2015
4. Drugs.com: Generic Oxsoralen-Ultra Availability
5. Valeant Pharmaceuticals: 2007 Annual Report