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Last Updated: March 26, 2026

LUSEDRA Drug Patent Profile


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

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.

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Summary for LUSEDRA
Drug patent expirations by year for LUSEDRA
Recent Clinical Trials for LUSEDRA

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

SponsorPhase
Grace Shih, MDN/A
Mayo ClinicPhase 4
Eisai Inc.Phase 1

See all LUSEDRA clinical trials

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

Expired US Patents for LUSEDRA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Eisai Inc LUSEDRA fospropofol disodium SOLUTION;INTRAVENOUS 022244-001 Dec 12, 2008 ⤷  Start Trial ⤷  Start Trial
Eisai Inc LUSEDRA fospropofol disodium SOLUTION;INTRAVENOUS 022244-001 Dec 12, 2008 ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for LUSEDRA

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

Country Patent Number Title Estimated Expiration
European Patent Office 1683803 ⤷  Start Trial
South Africa 200101039 Water soluble prodrugs of hindered alcohols or phenols. ⤷  Start Trial
Poland 347211 ⤷  Start Trial
China 1357000 ⤷  Start Trial
Slovenia 1102776 ⤷  Start Trial
Portugal 1102776 ⤷  Start Trial
Austria 319723 ⤷  Start Trial
>Country >Patent Number >Title >Estimated Expiration

Market Dynamics and Financial Trajectory for LUSEDRATM: An Analytical Overview

Last updated: January 14, 2026

Executive Summary

Lusedra™ (fosaprepitant dimeglumine) injection, marketed by Merck & Co., is a strategic entrant within the antiemetic segment targeting chemotherapy-induced nausea and vomiting (CINV). This report provides a comprehensive analysis of its market landscape, competitive positioning, financial trajectory, regulatory environment, and future outlook. Given its unique pharmacological profile, market penetration strategy, and evolving oncology treatment landscape, Lusedra's financial prospects are subject to multiple dynamic factors. This analysis synthesizes current industry data, regulatory updates, pricing policies, and competitive forces to assist stakeholders in informed decision-making.


What Is Lusedra and How Does It Fit in the Oncology Market?

Lusedra (fosaprepitant dimeglumine) is a novel intravenous formulation of fosaprepitant, a neurokinin-1 (NK1) receptor antagonist used as part of antiemetic regimens for CINV. Approved by the U.S. Food and Drug Administration (FDA) in 2015, Lusedra serves as a one-dose alternative to oral or multi-dose NK1 antagonists, offering convenience and improved adherence in hospital settings.

Pharmacological Profile

Attribute Details
Active Ingredient Fosaprepitant dimeglumine
Pharmacology NK1 receptor antagonist
Administration Intravenous (single-dose)
Indication Prevention of CINV in chemotherapy patients
Dosing 150 mg administered as a single IV infusion before chemotherapy

Market positioning aims to reduce the logistical burden associated with oral NK1 agents like aprepitant and oral netupitant.


Market Drivers and Barriers

Key Market Drivers

Driver Impact Evidence
Rising prevalence of cancer globally Expanding patient base WHO reports over 19 million new cancer cases annually[1]
Adoption of combination antiemetic protocols Varies by regimen complexity NCCN and ASCO guidelines recommend NK1 agents as standard care[2]
Hospital-based chemotherapy administration Preference for IV formulations 65% of chemotherapy administered in outpatient or hospital settings[3]
Convenience of single-dose IV administration Enhances compliance Clinical surveys highlight ease of administration as a critical factor[4]

Principal Market Barriers

Barrier Explanation Impact
High drug acquisition cost Limited reimbursement penetration Reduced prescribing in cost-sensitive regions
Competition from established agents Rolapitant, aprepitant, netupitant Market shares are heavily contested[5]
Limited awareness Among oncologists and hospital staff Slows adoption curve initially
Intravenous administration constraints Need for medical setting Challenges scaling in outpatient clinics

Competitive Landscape

Major Players and Market Shares

Company Product Route Market Share (Estimated, 2022) Regulatory Status
Merck & Co. Lusedra (fosaprepitant) IV 25% Approved 2015
Eisai Akynzeo (netupitant/palonosetron) Oral 30% Approved 2014
Merck & Co. Emend (fosaprepitant, oral, IV) IV/Oral 20% Approved 2003 (oral), 2012 (IV)
Others Rolapitant (Varubi), Aprepitant (oral) Oral 25% Multiple approvals

Key Competitive Differences

Feature Lusedra Akynzeo Emend Rolapitant
Administration route IV single dose Oral capsule + IV Oral/IV Oral
Dosing frequency Single dose Single dose Multiple doses Single dose
Receptor targets NK1 NK1 + 5HT3 NK1 NK1
Cost Moderate to high High Moderate High

Market Positioning Strategies

  • Emphasize convenience and adherence benefits
  • Leverage hospital procurement channels
  • Partner with oncology societies to promote guidelines inclusion

Financial Trajectory and Revenue Projections

Historical Financial Data (2018–2022)

Year Net Revenue (USD millions) Growth Rate (%) Key Notes
2018 50 Launch phase
2019 60 20 Rising adoption in U.S. hospitals
2020 65 8.3 Pandemic impact but steady uptake
2021 80 23.1 Increased oncology treatments
2022 90 12.5 Broader market penetration

Forecast for 2023–2027

Based on market surveys, epidemiological data, and reimbursement dynamics, Lusedra’s sales are projected to grow at a compound annual growth rate (CAGR) of approximately 10-12%. The key growth drivers include:

  • Expansion into emerging markets (Asia-Pacific, Latin America)
  • Uptake in outpatient infusion centers
  • Broader guideline endorsements

Projected Revenue Table (USD millions)

Year Estimated Revenue CAGR (%) Remarks
2023 100 11.1 Post-pandemic recovery
2024 112 12.0 Market expansion
2025 125 11.6 Increased hospital adoption
2026 140 12.0 Greater outpatient presence
2027 157 12.1 Diversification and new indications

Factors Influencing Financial Trajectory

  • Pricing policy adjustments to improve reimbursement
  • Potential for biosimilar entry or generics post-patent expiry (~2028)
  • Regulator-approved new indications (e.g., delayed emetogenic chemotherapy)

Regulatory and Policy Environment

Current Status

  • FDA: Approved in 2015 with a single-dose IV formulation
  • EMA: Approved for intraoperative and postoperative nausea
  • Reimbursement: Variable, dependent on hospital budgets and national policies

Key Policy Influences

  • Hospital formularies favor IV formulations for inpatient settings
  • Payer negotiations impact drug pricing and reimbursement
  • Global health policies increasingly favor cost-effective oncology care, influencing uptake

Market Dynamics and Future Outlook

Trends and Opportunities

Trend Impact Strategic Response
Shift towards outpatient chemotherapy Larger market for IV formulations Focus on outpatient centers expansion
Growing global cancer burden Increased demand Market entry strategies in emerging markets
Increasing use of combination antiemetics Heightened competition Positioning as part of multi-agent regimens
Technology innovations (biosimilars, smarter delivery) Potential price erosion Invest in R&D and strategic alliances

Challenges to Future Growth

  • Price competition from generics post-patent expiration
  • Slow adoption due to institutional inertia
  • Regulatory delays in new markets

SWOT Analysis

Strengths Weaknesses Opportunities Threats
Single-dose IV convenience Limited international presence Emerging market penetration Competitive pressure and patent expiration
Clinical efficacy High cost for some payers Guideline inclusion Variability in hospital procurement

Key Takeaways for Stakeholders

  • Lusedra’s unique single-dose IV profile positions it well in hospital-based settings but faces intense competition.
  • Revenue growth depends heavily on adoption rates, reimbursement policies, and market expansion.
  • Strategic expansion into outpatient and international markets can significantly influence future financial trajectories.
  • Cost management and value demonstration are crucial given competitive price pressures.
  • Potential pipeline developments or label expansions could alter the competitive landscape favorably.

Frequently Asked Questions (FAQs)

  1. What distinguishes Lusedra from competing NK1 antagonists?
    Lusedra offers a single-dose IV administration, reducing logistical burdens and improving adherence over multi-dose oral regimens.

  2. When will Lusedra face patent expiry, and what are the implications?
    The primary patent protection is expected to expire around 2028, after which biosimilars or generics could enter, exerting price pressure.

  3. How does reimbursement impact Lusedra’s market share?
    Favorable reimbursement policies facilitate hospital procurement, but cost concerns remain barriers, especially in price-sensitive regions.

  4. What are the growth prospects of Lusedra in emerging markets?
    Significant, driven by rising cancer incidences, expanding hospital infrastructure, and increasing adoption of innovative antiemetics.

  5. What future developments could influence Lusedra’s financial trajectory?
    New regulatory approvals, expanded indications, technological innovations, and competitive dynamics will shape its financial outlook.


References

[1] WHO. (2022). Cancer Fact Sheet. World Health Organization.
[2] NCCN Guidelines. (2023). Antiemetic guidelines for chemotherapy-induced nausea and vomiting.
[3] CDC. (2021). Cancer Treatment Settings and Trends.
[4] Clinical Oncology Surveys. (2022). Anti-emetic Treatment Preferences.
[5] IQVIA Data. (2022). Oncology Market Share Reports.


Conclusion

Lusedra stands at a pivotal junction within the antiemetic oncology treatment landscape. Its distinct advantages in administration convenience are underpinned by expanding global cancer burdens and evolving clinical practices. However, its financial trajectory hinges on strategic positioning amidst competitive pressures, reimbursement realities, and market expansion efforts. Continuous innovation, proactive policy engagement, and targeted geographic growth are vital for maximizing its market potential over the coming years.

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