UVADEX Drug Patent Profile

When do Uvadex patents expire, and what generic alternatives are available?

Uvadex is a drug marketed by Therakos Development and is included in one NDA.

The generic ingredient in UVADEX 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 Uvadex

A generic version of UVADEX was approved as methoxsalen by STRIDES SOFTGELS on June 5^th, 2014.

Summary for UVADEX

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	150
Clinical Trials:	17
Patent Applications:	4,170
Drug Prices:	Drug price information for UVADEX
What excipients (inactive ingredients) are in UVADEX?	UVADEX excipients list
DailyMed Link:	UVADEX at DailyMed

See drug prices for UVADEX

Recent Clinical Trials for UVADEX

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

Sponsor	Phase
Central Hospital, Nancy, France	Phase 2
Lawson Health Research Institute	Phase 2
European Organisation for Research and Treatment of Cancer - EORTC	Phase 2

See all UVADEX clinical trials

Pharmacology for UVADEX

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

US Patents and Regulatory Information for UVADEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Therakos Development	UVADEX	methoxsalen	INJECTABLE;INJECTION	020969-001	Feb 25, 1999		RX	Yes	Yes

Expired US Patents for UVADEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Therakos Development	UVADEX	methoxsalen	INJECTABLE;INJECTION	020969-001	Feb 25, 1999
Therakos Development	UVADEX	methoxsalen	INJECTABLE;INJECTION	020969-001	Feb 25, 1999
Therakos Development	UVADEX	methoxsalen	INJECTABLE;INJECTION	020969-001	Feb 25, 1999

International Patents for UVADEX

See the table below for patents covering UVADEX around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	5488590
Australia	641816
Austria	131532
Denmark	0392429
European Patent Office	0392429	PSORALEN-REAGENS
Germany	59001061
Germany	19975042

Supplementary Protection Certificates for UVADEX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0177957	99C0034	Belgium		PRODUCT NAME: BECAPLERMIN; REGISTRATION NO/DATE: EU/1/99/101/001 19990329
0177957	C990016	Netherlands		PRODUCT NAME: BECAPLERMINUM; REGISTRATION NO/DATE: EU/1/99/101/001 19990329
0177957	SPC/GB99/023	United Kingdom		PRODUCT NAME: BECAPLERMIN; REGISTERED: UK EU/1/99/101/001 19990329

Market Dynamics and Financial Trajectory for UVADEX (Methoxsalen)

Introduction

UVADEX (methoxsalen) is a crucial drug in the treatment of various conditions, including cutaneous T-cell lymphoma (CTCL) and chronic graft-versus-host disease (cGvHD). Here, we delve into the market dynamics and financial trajectory of UVADEX, highlighting key factors influencing its growth and usage.

Regulatory Approvals and Indications

UVADEX has received significant regulatory approvals that have expanded its market reach. Notably, it was approved in Australia by the Therapeutic Goods Administration (TGA) for use with the THERAKOS CELLEX Photopheresis System. This approval includes indications for the treatment of steroid-refractory and steroid-intolerant chronic graft-versus-host disease (cGvHD) in adults and for the palliative treatment of skin manifestations of CTCL that are unresponsive to other forms of treatment[4].

Market Impact of Regulatory Approvals

The regulatory approvals, particularly the first combined indication label for UVADEX with the THERAKOS Photopheresis System, have opened up new treatment options for patients. This has positively impacted the market by providing a therapeutic option for patients who are refractory to or intolerant of steroid treatments, thereby increasing the drug's demand and market share[4].

Market Size and Growth

The North America CTCL therapeutics market, in which UVADEX is a key player, is projected to grow significantly. The market size was USD 225.9 million in 2020 and is expected to reach USD 587.4 million by 2028, growing at a CAGR of 13.6% during the 2021-2028 period. This growth is driven by increasing diagnoses of CTCL and the development of new therapeutics[1].

Distribution Channels

The distribution of UVADEX is primarily through retail pharmacies and drug stores, which held a major market share in North America. However, the online pharmacies segment is expected to grow at a higher CAGR during the forecast period due to the increasing shift of patients toward e-commerce platforms for drug procurement[1].

Competitive Landscape

UVADEX is part of a competitive market with several major players. Companies like Mallinckrodt plc, which manufactures UVADEX, are key players in the CTCL therapeutics market. Other significant players include Kyowa Kirin Co., Ltd., Bausch Health (Ortho Dermatologics), and Helsinn Healthcare SA[1].

Financial Performance of Mallinckrodt plc

Mallinckrodt plc, the manufacturer of UVADEX, has faced various financial challenges, including emerging from bankruptcy. Despite these challenges, the company has made significant strides in its financial performance. The approval and market expansion of UVADEX have contributed to the company's revenue growth. However, the company's financial statements post-bankruptcy are not comparable to those pre-bankruptcy due to the adoption of fresh-start accounting[2].

Revenue Streams

The revenue generated by UVADEX is part of Mallinckrodt's broader pharmaceutical portfolio. The company's financial reports indicate that its pharmaceutical segment, which includes UVADEX, has been a significant contributor to its overall revenue. The approval of UVADEX for additional indications has likely enhanced its revenue contribution to the company's financial performance[2].

Future Outlook

The future outlook for UVADEX is promising, driven by the increasing demand for effective treatments for CTCL and cGvHD. The drug's unique mechanism of action and its use in conjunction with the THERAKOS CELLEX Photopheresis System position it well in the market. As the North America CTCL therapeutics market continues to grow, UVADEX is expected to remain a key player, contributing to the financial growth of Mallinckrodt plc and other stakeholders involved in its distribution and development[1][4].

Key Takeaways

• Regulatory Approvals: UVADEX has received critical regulatory approvals, including the first combined indication label for use with the THERAKOS Photopheresis System.
• Market Growth: The North America CTCL therapeutics market is projected to grow at a CAGR of 13.6% from 2021 to 2028.
• Distribution Channels: Retail pharmacies and drug stores currently dominate, but online pharmacies are expected to grow significantly.
• Competitive Landscape: UVADEX competes in a market with major players like Kyowa Kirin Co., Ltd., Bausch Health, and Helsinn Healthcare SA.
• Financial Performance: Mallinckrodt plc's financial performance is influenced by UVADEX's market expansion and regulatory approvals.

FAQs

Q: What are the primary indications for UVADEX (methoxsalen)? A: UVADEX is indicated for the treatment of steroid-refractory and steroid-intolerant chronic graft-versus-host disease (cGvHD) and for the palliative treatment of skin manifestations of cutaneous T-cell lymphoma (CTCL) that are unresponsive to other forms of treatment[4].

Q: Which regulatory body approved UVADEX for these indications in Australia? A: The Therapeutic Goods Administration (TGA) in Australia approved UVADEX for these indications[4].

Q: How is UVADEX administered for these conditions? A: UVADEX is administered extracorporeally with the THERAKOS CELLEX Photopheresis System[4].

Q: What is the projected growth rate of the North America CTCL therapeutics market? A: The market is projected to grow at a CAGR of 13.6% from 2021 to 2028[1].

Q: What are the major distribution channels for UVADEX in North America? A: Retail pharmacies and drug stores currently hold a major market share, but online pharmacies are expected to grow at a higher CAGR during the forecast period[1].

Sources

1. Fortune Business Insights - North America Cutaneous T-Cell Lymphoma Therapeutics Market
2. Mallinckrodt plc - Investor Relations, Annual Report
3. Johnson & Johnson - 2019 Annual Report
4. PR Newswire - Mallinckrodt Announces UVADEX (Methoxsalen) Approved in Australia