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Last Updated: December 22, 2024

8-MOP Drug Patent Profile


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Which patents cover 8-mop, and what generic alternatives are available?

8-mop is a drug marketed by Valeant Pharm Intl and is included in one NDA.

The generic ingredient in 8-MOP 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 8-mop

A generic version of 8-MOP was approved as methoxsalen by STRIDES PHARMA on June 5th, 2014.

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Summary for 8-MOP
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 150
Patent Applications: 4,093
DailyMed Link:8-MOP at DailyMed
Drug patent expirations by year for 8-MOP

US Patents and Regulatory Information for 8-MOP

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 ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

8-MOP Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for 8-Methoxypsoralen (8-MOP)

Introduction

8-Methoxypsoralen (8-MOP), also known as methoxsalen, is a photochemotherapeutic agent used primarily in the treatment of various skin disorders, including psoriasis and cutaneous T-cell lymphoma. This article delves into the market dynamics and financial trajectory of 8-MOP, exploring its indications, market trends, and the economic implications of its use.

Indications and Usage

8-MOP is indicated for the symptomatic control of severe, recalcitrant, and disabling psoriasis, as well as for the repigmentation of idiopathic vitiligo. It is administered in conjunction with long-wave ultraviolet radiation (UVA) in a treatment regimen known as PUVA therapy[4].

Market Demand

The demand for 8-MOP is driven by the prevalence of skin disorders such as psoriasis and vitiligo. Psoriasis, for instance, affects approximately 2-3% of the global population, creating a significant market for treatments like PUVA therapy[4].

Competitive Landscape

The market for psoriasis treatments is highly competitive, with various therapeutic options available, including biologics, topical treatments, and other systemic therapies. However, PUVA therapy remains a viable option for patients who do not respond to other treatments or have severe forms of the disease.

Economic Impact

The economic impact of 8-MOP is multifaceted:

Treatment Costs

PUVA therapy, which includes 8-MOP and UVA radiation, can be costly due to the need for repeated treatments and specialized equipment. However, it is often covered by health insurance, making it more accessible to patients[4].

Healthcare System Costs

The overall cost to healthcare systems can be significant, especially considering the long-term nature of psoriasis and the need for ongoing treatment. However, effective management of psoriasis can reduce other healthcare costs associated with complications and comorbidities.

Patient Outcomes and Quality of Life

Effective treatment with 8-MOP can significantly improve patient outcomes and quality of life, reducing the economic burden associated with lost productivity and other indirect costs.

Financial Trajectory

Historical Sales

Historical sales data for 8-MOP have been influenced by its use in PUVA therapy and the availability of generic versions. The brand name "8-MOP" has been discontinued in the U.S., but generic equivalents are available, which can affect pricing and market dynamics[4].

Market Trends

The market for 8-MOP is influenced by several trends:

Generic Competition

The availability of generic versions of 8-MOP has increased competition, potentially reducing prices and affecting the financial trajectory of the drug.

Regulatory Environment

Regulatory changes, such as those related to the packaging and dosing of 8-MOP, can impact its market dynamics. For example, the FDA has specific guidelines for the use of 8-MOP to minimize risks such as skin burning[4].

Technological Advancements

Advancements in treatment technologies, including new biologic agents and other therapeutic options, can influence the demand for 8-MOP. However, PUVA therapy remains a valuable treatment option for certain patient populations.

Drug Interactions and Metabolic Effects

8-MOP has significant metabolic effects that can impact its financial trajectory:

Induction of Drug-Metabolizing Enzymes

8-MOP induces the expression of various drug-metabolizing enzymes, including CYP3A4 and HCE2, which can lead to drug-drug interactions and affect the pharmacokinetics of other drugs. This can result in additional healthcare costs due to the need for monitoring and adjusting other medications[1].

Mechanism-Based Inactivation

8-MOP can inactivate certain enzymes, such as CYP2A6, which is involved in nicotine metabolism. This can prolong the effects of nicotine and decrease smoking frequency, but it also highlights the potential for complex drug interactions that may require additional medical management[1].

Regulatory and Safety Considerations

Safety Profile

The safety profile of 8-MOP includes risks such as skin burning, eye damage, and increased risk of skin cancer. These risks necessitate careful patient monitoring and adherence to treatment protocols, which can add to the overall cost of treatment[4].

Regulatory Actions

Regulatory actions, such as the limitation on package sizes to prevent misuse, can impact the availability and cost of 8-MOP. For instance, the FDA has limited loperamide package sizes to reduce inappropriate use, a precedent that could influence other drugs with similar concerns[4].

Market Projections

Future Demand

The future demand for 8-MOP is expected to remain stable, driven by the ongoing need for effective treatments for psoriasis and vitiligo. However, the market share may be influenced by the introduction of new therapeutic options and changes in treatment guidelines.

Pricing Strategies

Pricing strategies for 8-MOP will need to balance the need for affordability with the costs associated with its development, production, and regulatory compliance. Generic competition is likely to continue influencing pricing dynamics.

Conclusion

The market dynamics and financial trajectory of 8-MOP are shaped by its indications, competitive landscape, economic impact, and regulatory environment. While it remains a valuable treatment option for certain skin disorders, its market share and financial performance will be influenced by various factors, including generic competition, technological advancements, and regulatory actions.

Key Takeaways

  • Indications: 8-MOP is used for treating severe psoriasis and vitiligo.
  • Market Demand: Driven by the prevalence of skin disorders.
  • Competitive Landscape: Highly competitive with various therapeutic options.
  • Economic Impact: Significant costs associated with treatment and healthcare system burdens.
  • Financial Trajectory: Influenced by generic competition, regulatory changes, and technological advancements.
  • Drug Interactions: Induces drug-metabolizing enzymes and can inactivate certain enzymes.
  • Regulatory and Safety Considerations: Safety risks and regulatory actions impact market dynamics.

FAQs

What is 8-MOP used for?

8-MOP is used for the symptomatic control of severe, recalcitrant, and disabling psoriasis, as well as for the repigmentation of idiopathic vitiligo.

How is 8-MOP administered?

8-MOP is administered in conjunction with long-wave ultraviolet radiation (UVA) in a treatment regimen known as PUVA therapy.

What are the potential side effects of 8-MOP?

Potential side effects include skin burning, eye damage, and an increased risk of skin cancer.

How does 8-MOP affect drug metabolism?

8-MOP induces the expression of various drug-metabolizing enzymes and can inactivate certain enzymes, leading to potential drug-drug interactions.

Is 8-MOP available in generic form?

Yes, generic versions of 8-MOP are available, which can affect pricing and market dynamics.

What regulatory actions have been taken regarding 8-MOP?

Regulatory actions include specific guidelines for use to minimize risks such as skin burning, and the brand name "8-MOP" has been discontinued in the U.S.

Sources

  1. Photochemotherapeutic Agent 8-Methoxypsoralen Induces... - Academic.oup.com
  2. Prevention | National Institute on Drug Abuse (NIDA) - NIDA.nih.gov
  3. Misuse of prescription and over-the-counter drugs to obtain illicit highs - Pharmaceutical-journal.com
  4. 8-MOP: Package Insert / Prescribing Information - Drugs.com
  5. Steroids and Other Drugs Used to Treat Graft-versus-Host Disease - Bmtinfonet.org

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