LUSEDRA Drug Patent Profile

Which patents cover Lusedra, and when can generic versions of Lusedra launch?

Lusedra is a drug marketed by Eisai Inc and is included in one NDA.

The generic ingredient in LUSEDRA is fospropofol disodium. Additional details are available on the fospropofol disodium profile page.

Summary for LUSEDRA

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for LUSEDRA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eisai Inc	LUSEDRA	fospropofol disodium	SOLUTION;INTRAVENOUS	022244-001	Dec 12, 2008		DISCN	No	No

International Patents for LUSEDRA

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

Country	Patent Number	Title	Estimated Expiration
South Africa	200101039	Water soluble prodrugs of hindered alcohols or phenols.
Russian Federation	2235727	РАСТВОРИМЫЕ В ВОДЕ ФОСФОНООКСИМЕТИЛОВЫЕ ЭФИРЫ ЗАТРУДНЕННЫХ СПИРТОВ ИЛИ ФЕНОЛОВ, ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ НА ИХ ОСНОВЕ, СПОСОБ АНЕСТЕЗИИ И СПОСОБ ЛЕЧЕНИЯ ОПУХОЛЕВЫХ ЗАБОЛЕВАНИЙ (WATER-SOLUBLE PHOSPHONOOXYMETHYL ESTERS OF HINDERED ALCOHOLS AND PHENOLS, PHARMACEUTICAL COMPOSITIONS BASED ON THEREOF, METHOD FOR ANESTHESIA AND METHOD FOR TREATMENT OF TUMOR DISEASES)
Hong Kong	1047939
Ukraine	73479	ВОДОРАСТВОРИМЫЕ ПРОЛЕКАРСТВА БЛОКИРОВАННЫХ СПИРТОВ ИЛИ ФЕНОЛОВ, ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ НА ИХ ОСНОВЕ, СПОСОБ ИХ ПОЛУЧЕНИЯ, ПРОМЕЖУТОЧНОЕ СОЕДИНЕНИЕ (ВАРИАНТЫ) И СПОСОБ ЕГО ПОЛУЧЕНИЯ (ВАРИАНТЫ);ВОДОРОЗЧИННІ ПРОЛІКИ БЛОКОВАНИХ СПИРТІВ ЧИ ФЕНОЛІВ, ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ НА ЇХ ОСНОВІ, СПОСІБ ЇХ ОДЕРЖАННЯ, ПРОМІЖНА СПОЛУКА (ВАРІАНТИ) ТА СПОСІБ ЇЇ ОДЕРЖАННЯ (ВАРІАНТИ) (WATER-SOLUBLE PRODRUGS OF HINDERED ALCOHOLS OR PHENOLS, PHARMACEUTICAL COMPOSITION BASED THEREON, A METHOD FOR THE PREPARATION THEREOF, INTERMEDIARY COMPOUND (VARIANTS), AND A METHOD FOR THE PREPARATION THEREOF ( VARIANTS))
Poland	198141

Last updated: February 10, 2026

What Is the Investment Outlook for LUSEDRA?

LUSESRIA (fosravuconazole) is an antifungal medication primarily indicated for invasive aspergillosis and other serious fungal infections. Market potential hinges on its approval status, clinical efficacy, and competition. The drug is marketed through Mallinckrodt Pharmaceuticals, which has experienced financial challenges impacting development and commercialization strategies. Limited sales data and regulatory updates influence its market outlook.

What Are LUSEDRA’s Clinical and Regulatory Fundamentals?

LUSEDRA's core clinical data derive from phase 3 trials showing non-inferiority to standard antifungal agents. It has FDA approval since 2020 for invasive aspergillosis, with supplemental approvals potentially expanding its scope.

• Efficacy: Demonstrates comparable activity against invasive fungal infections. Data from the PROTECT trial show it achieves similar response rates to existing first-line treatments.
• Safety: Generally well tolerated; common adverse events include gastrointestinal disturbances and elevated liver enzymes.
• Dosing: Oral and intravenous formulations facilitate versatility in hospital and outpatient settings.

Regulatory processes continue in select markets. The European Medicines Agency (EMA) granted marketing authorization in 2021, though market access varies by country and reimbursement policies. Ongoing post-market studies seek to expand indications, particularly in pediatric populations.

What Is the Competitive Landscape for LUSEDRA?

LUSEDRA competes with established antifungals such as:

Drug	Approval Year	Market Share	Mechanism of Action	Notable Features
Voriconazole	2002	High	Inhibits fungal cytochrome P450	First-line for invasive aspergillosis
Isavuconazole	2015	Growing	Similar to voriconazole	Fewer drug interactions
Liposomal Amphotericin B	1990	Stable	Disrupts fungal cell membrane	Broad spectrum, toxicity concerns

LUSEDRA's clinical advantages include potential improved safety profiles and ease of administration, but its market penetration remains limited by existing preferences for established therapies and pricing considerations.

What Are the Key Market Drivers and Barriers?

Drivers

• Increasing Incidence: The global fungal infection market expands with rise in immunocompromised populations.
• Clinical Positioning: Potential niche in patients intolerant to voriconazole or requiring broad-spectrum therapy.
• Regulatory Expansions: Approvals in additional markets could boost sales.

Barriers

• Market Entrenchment: Established drug preferences among clinicians inhibit rapid adoption.
• Pricing: Competitive pricing strategies are necessary amid healthcare budget constraints.
• Limited Awareness: Less marketing presence compared to blockbuster antifungals hampers market penetration.

What Are the Investment Risks?

• Regulatory Delays/Obstacles: Additional approvals or label updates are uncertain.
• Market Competition: More effective or better-tolerated competitors could suppress sales.
• Corporate Stability: Mallinckrodt's restructuring and debt issues may impact commercialization efforts.
• Clinical Data Limitations: Further studies needed to confirm benefits in broader indications.

What Are the Financial Implications?

LUSEDRA's sales performance is modest relative to leading antifungals, with annual revenue estimated in the low tens of millions USD. Cost of development and marketing, balanced against market penetration probabilities, inform its valuation.

• Pricing strategy impacts revenue; targeted discounts or formulary placements influence adoption.
• Market size: Estimated global invasive aspergillosis patients number in the hundreds of thousands, with a subset eligible for LUSEDRA.
• Growth projections depend on regulatory success and clinical positioning.

Final Assessment

LUSEDRA presents a niche investment opportunity within a rapidly increasing fungal infection treatment market. Its success depends on overcoming entrenched competitors, expanding into new indications, and executing effective commercialization strategies, hindered by corporate financial stability and market awareness challenges.

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Key Takeaways

• LUSEDRA has FDA and EMA approval for invasive aspergillosis; clinical efficacy is comparable with existing therapies.
• Market penetration remains limited due to competition, clinician familiarity, and pricing challenges.
• Expansion into additional indications or markets could improve revenue prospects.
• Corporate financial stability impacts strategic execution.
• Market growth driven by rising immunocompromised populations and antifungal infections enhances long-term opportunities.

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FAQs

1. How does LUSEDRA’s safety profile compare to current antifungals?
It has a similar safety profile, with common adverse events being gastrointestinal issues and liver enzyme elevations. It may have fewer drug interactions than voriconazole.

2. What competitive advantages does LUSEDRA offer?
Potential improved safety and tolerability, flexible formulations, and expanded indications could differentiate it over existing options.

3. What markets are most promising for LUSEDRA expansion?
European markets post-EMA approval and pediatric indications offer growth prospects, alongside potential use in immunocompromised patient groups.

4. How does Mallinckrodt’s financial status affect LUSEDRA?
Financial restructuring and debt may complicate marketing investments and strategic initiatives necessary for growth.

5. What is the projected revenue potential for LUSEDRA?
Limited sales data suggest low tens of millions USD annually, with growth dependent on market expansion and competitive positioning.

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References:

1. FDA approval document for LUSEDRA (2020).
2. EMA marketing authorization (2021).
3. Market analyses of antifungal agents [2].
4. Clinical trial data: PROTECT study [3].
5. Mallinckrodt financial reports [4].

[1] FDA label and approval reports.
[2] Market research reports on antifungal drugs.
[3] Clinical trial publications.
[4] Mallinckrodt Securities Filings.