METHOXSALEN - Generic Drug Details

What are the generic drug 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, Strides Pharma, Bausch, and Mallinckrodt Hosp, 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:	150
Clinical Trials:	25
Patent Applications:	6,395
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
Georgetown University	Phase 2
European Organisation for Research and Treatment of Cancer - EORTC	Phase 2
Tyme, Inc	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
Strides Pharma	METHOXSALEN	methoxsalen	CAPSULE;ORAL	202687-001	Jun 5, 2014	AB	RX	No	No
Bausch	OXSORALEN-ULTRA	methoxsalen	CAPSULE;ORAL	019600-001	Oct 30, 1986	AB	RX	Yes	Yes
Valeant Pharm Intl	8-MOP	methoxsalen	CAPSULE;ORAL	009048-001	Approved Prior to Jan 1, 1982		DISCN	Yes	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
Mallinckrodt Hosp	UVADEX	methoxsalen	INJECTABLE;INJECTION	020969-001	Feb 25, 1999	5,036,102
Mallinckrodt Hosp	UVADEX	methoxsalen	INJECTABLE;INJECTION	020969-001	Feb 25, 1999	4,999,375

METHOXSALEN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Methoxsalen

Introduction to Methoxsalen

Methoxsalen is a small molecule drug that targets DNA and is utilized in the treatment of various therapeutic areas, including neoplasms, immune system diseases, hemic and lymphatic diseases, and skin and musculoskeletal diseases. It has been approved for conditions such as graft vs host disease, cutaneous T-cell lymphoma, psoriasis, and vitiligo[4].

Global Export Market

Export Volume and Growth

Methoxsalen exports have shown significant growth over the past year. From March 2023 to February 2024, there were 190 shipments of methoxsalen globally, marking a 34% growth rate compared to the preceding twelve months. In February 2024 alone, 13 export shipments were made, indicating a year-on-year growth of 30% and a sequential decline of 7% from January 2024[1].

Key Exporters

India is the largest exporter of methoxsalen, accounting for 1,288 shipments, which translates to a significant market share of 94%. The United Kingdom and Austria follow, with 33 and 15 shipments, respectively, holding 2% and 1% of the market share[1].

Principal Importers

The primary importers of methoxsalen are Tanzania, Singapore, and Yemen, collectively consuming 48% of all global exports. Tanzania leads with 128 shipments, followed by Singapore with 116 shipments, and Yemen with 110 shipments[1].

Market Distribution

Geographic Reach

Methoxsalen is exported to over 78 countries worldwide, with additional key markets including Kenya, Malaysia, the United States, Brazil, Mauritius, and Iraq. This widespread distribution underscores the drug's global demand and utility[1].

Buyer Profile

Volza's database includes detailed information on over 417 active global buyers of methoxsalen. Prominent buyers such as Singapore Post Ltd, Al-Noor for Drugs Medical Appliances, and Nila Jamal Enterprise are among the top purchasers, highlighting the diverse and extensive buyer base[1].

Mechanism of Action and Therapeutic Use

Methoxsalen works by binding to DNA and forming covalent bonds, inhibiting DNA synthesis and cell division. This mechanism makes it effective in treating diseases involving abnormal cell growth, such as cancer and autoimmune disorders[4].

Regulatory and Clinical Status

Methoxsalen was first approved in the United States in December 1954 and is currently marketed by Bausch Health Americas, Inc. It has undergone extensive clinical trials and has reached the highest phase of approval globally, ensuring its safety and efficacy[4].

Financial Performance of Key Players

Bausch Health Americas, Inc.

While specific financial data for methoxsalen is not readily available, Bausch Health Americas, Inc., the primary marketer of methoxsalen, reports revenue and operational performance through its broader portfolio. The company's financial health is influenced by the performance of its various therapeutic products, including those in the dermatology segment where methoxsalen is categorized.

Medexus Pharmaceuticals

Medexus Pharmaceuticals, another player in the pharmaceutical market, provides insights into the financial dynamics of specialty pharmaceuticals. Although they do not specifically market methoxsalen, their financial reports highlight the importance of R&D investments and the impact of regulatory approvals on financial performance. For instance, Medexus reported revenue of $17.9 million in the three-month period ending September 30, 2021, driven by strong sales of other products, and significant investments in R&D and future product launches[2].

Research and Development Trends

Methoxsalen has been extensively studied and approved for various therapeutic uses. The R&D focus for such drugs typically involves clinical trials to expand indications and improve safety profiles. Companies like Mallinckrodt plc, which is involved in the development of various pharmaceutical products, emphasize the importance of R&D in maintaining a competitive edge and expanding product portfolios. This includes investments in clinical and health economic activities to support regulatory approvals and market authorization[3].

Pricing and Market Dynamics

The pricing of methoxsalen varies based on the form and dosage. For example, methoxsalen tablets and lotions are priced differently, with significant variations depending on the supplier and the market. Volza's data indicates that the pricing can range from a few dollars per unit to hundreds of dollars per shipment, reflecting the diverse market dynamics and the different uses of the drug[1].

Future Outlook

Given the established therapeutic uses and the ongoing demand for methoxsalen, the market is expected to continue growing. The drug's effectiveness in treating conditions like psoriasis and cutaneous T-cell lymphoma ensures a steady demand. Additionally, the expansion of export markets and the increasing number of buyers globally suggest a positive trajectory for methoxsalen in the pharmaceutical market.

Key Takeaways

• Global Export Growth: Methoxsalen exports have grown by 34% over the past year, with India being the largest exporter.
• Principal Importers: Tanzania, Singapore, and Yemen are the top importers, consuming 48% of global exports.
• Therapeutic Use: Methoxsalen is used in treating various diseases, including neoplasms and immune system diseases.
• Regulatory Status: The drug has been extensively clinically tested and approved globally.
• Financial Performance: The financial health of companies marketing methoxsalen is influenced by broader portfolio performance and R&D investments.
• Market Distribution: Methoxsalen is exported to over 78 countries, with a diverse buyer base.

FAQs

1. What is methoxsalen used for? Methoxsalen is used in the treatment of various therapeutic areas, including neoplasms, immune system diseases, hemic and lymphatic diseases, and skin and musculoskeletal diseases[4].

2. Who are the top exporters of methoxsalen? India is the largest exporter of methoxsalen, followed by the United Kingdom and Austria[1].

3. Which countries are the primary importers of methoxsalen? The primary importers are Tanzania, Singapore, and Yemen, collectively consuming 48% of all global exports[1].

4. How does methoxsalen work? Methoxsalen works by binding to DNA and forming covalent bonds, inhibiting DNA synthesis and cell division[4].

5. Who markets methoxsalen? Methoxsalen is currently marketed by Bausch Health Americas, Inc.[4].

Sources

1. Volza.com - Methoxsalen Exports from World
2. Medexus Pharmaceuticals - Financial and Operational Results for the Three- and Six-Month Periods Ending September 30, 2021
3. Mallinckrodt plc - Annual Reports
4. Synapse by Patsnap - Decoding Methoxsalen: A Comprehensive Study of its R&D Trends
5. Annual Reports - 2019 Annual Report