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Firdapse (Amifampridine) - Drug Insight and Market Forecast - 2030

  • ID: 5135485
  • Report
  • August 2020
  • Region: Global
  • 80 pages
  • DelveInsight
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Overview

Firdapse (amifampridine) - Drug Insight and Market Forecast - 2030 report by the publisher outlays comprehensive insights of the product indicated for the treatment of its approved condition. A detailed picture of the Firdapse (amifampridine) in Seven Major Markets, i.e., United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan, for the study period 2017-2030 is provided in this report along with a detailed description of the product. The product details cover mechanism of action, dosage and administration, route of synthesis, and pharmacological studies, including product marketed details, regulatory milestones, and other development activities. Further, it also consists of market assessments inclusive of the market forecast, SWOT analysis, and detailed analyst views. It further highlights the market competitors, late-stage emerging therapies, and patent details in the global space.

Firdapse (amifampridine) is one of the first drugs to be approved for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults. The drug was developed by BioMarin Pharmaceutical and is marketed by Catalyst Pharmaceutical, which secured the marketing rights to Firdapse in North America under a $5m deal in October 2012. The EU rights are retained by BioMarin. The European Commission (EC) granted marketing authorisation (MA) to Firdapse for the symptomatic treatment of LEMS in December 2009. The drug also secured orphan drug designation in the EU. The US Food and Drug Administration (FDA) granted breakthrough therapy designation to the drug in August 2013. Catalyst Pharmaceutical submitted a new drug application (NDA) for Firdapse to the FDA in March 2018, and the application was accepted and granted priority review status in May of the same year. Firdapse was approved by the FDA in November 2018.

Scope of the report

The report provides insights into:
  • A comprehensive product overview including the product description, mechanism of action, dosage and administration, route of synthesis, pharmacological studies (pharmacodynamics and pharmacokinetics) and adverse reactions.
  • Elaborated details on regulatory milestones and other development activities have been provided in this report.
  • The report also highlights the drug marketed details across the United States, Europe and Japan.
  • The report also covers the patent's information with expiry timeline around Firdapse (amifampridine).
  • The report contains historical and forecasted sales for Firdapse (amifampridine) till 2030.
  • Comprehensive coverage of the late-stage emerging therapies (Phase III) in the space with a brief snapshot of the details.
  • The report also features the SWOT analysis with analyst insights and key findings of Firdapse (amifampridine).
Methodology

The report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by the publisher's team of industry experts. Information and data from the secondary sources have been obtained from various printable and nonprintable sources like search engines, news websites, global regulatory authorities websites, trade journals, white papers, magazines, books, trade associations, industry associations, industry portals and access to available databases.

Firdapse (amifampridine) Analytical Perspective

In-depth Firdapse (amifampridine) Market Assessment

This report provides a detailed market assessment of Firdapse (amifampridine) in Seven Major Markets, i.e., United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan. This segment of the report provides historical and forecasted sales data from 2017 to 2030.

Firdapse (amifampridine) Clinical Assessment

The report provides the clinical trials information of Firdapse (amifampridine) covering trial interventions, trial conditions, trial status, start and completion dates.

Report highlights
  • In the coming years, the market scenario for Firdapse (amifampridine) is set to change due to the extensive research in the treatment of the indicated condition and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.
  • The companies and academics are working to assess challenges and seek opportunities that could influence Firdapse (amifampridine) dominance. The therapies under development are focused on novel approaches to treat/improve the disease condition.
  • Other approved products for the disease are giving market competition to Firdapse (amifampridine) and launch of late-stage emerging therapies in the near future will significantly impact the market.
  • A detailed description of regulatory milestones, development activities, and some key findings provide the current market scenario of Firdapse (amifampridine).
  • Our in-depth analysis of the sales data of Firdapse (amifampridine) from 2017 to 2030 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the Firdapse (amifampridine) in the market.
Key Questions Answered
  • What is the prescribed dosage and strengths of Firdapse (amifampridine) are available in the market?
  • What are the common adverse reactions or side effects of Firdapse (amifampridine)?
  • What is the product type, route of administration and mechanism of action of Firdapse (amifampridine)?
  • What are the chemical specifications of Firdapse (amifampridine)?
  • How are the clinical trials diversified on the basis of the trial status?
  • What is the history of Firdapse (amifampridine), and what is its future?
  • What are the marketed details of Firdapse (amifampridine) in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain, and the United Kingdom), and Japan?
  • How many patents have been granted to Firdapse (amifampridine) and when these patents will get expire?
  • What are the pros (benefits) and cons (disadvantages) of Firdapse (amifampridine)?
  • In which countries Firdapse (amifampridine) got approval and when it gets launched?
  • What are the clinical trials are currently ongoing for Firdapse (amifampridine)?
  • How the safety and efficacy results determined the approval of Firdapse (amifampridine)?
  • What are the key collaborations, mergers and acquisitions, licensing and other activities related to the Firdapse (amifampridine) development?
  • What are the key designations that have been granted to Firdapse (amifampridine)?
  • What is the historical and forecasted market scenario of Firdapse (amifampridine)?
  • How is the market trend of Firdapse (amifampridine) is different in the Seven Major Markets (the United States, EU5 [Germany, France, Italy, Spain, and the United Kingdom], and Japan)?
  • What are the other approved products available and how these are giving competition to Firdapse (amifampridine)?
  • Which are the late-stage emerging therapies under development for the treatment of the indicated condition?

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Note: Product cover images may vary from those shown
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1. Product Overview
1.1. Indication
1.2. Mechanism of Action
1.3. Dosage and Administration
1.4. Dosage Forms and Strengths
1.4.1 Route of Synthesis
1.5. Pharmacology
1.5.1 Pharmacodynamics
1.5.2 Pharmacokinetics
1.6. Adverse Reactions
1.7. Product Snapshot
1.8. Development Milestones of Firdapse (amifampridine)
1.9. Marketed Details
1.9.1 United States
1.9.2 Europe
1.9.3 Japan
1.10. Patent Details

2. SWOT Analysis
2.1. Analyst Views

3. Regulatory Milestones
3.1. Approvals
3.2. Research and Development
3.3. Clinical Trials Information
3.4. Safety and Efficacy
3.5. Product Developmental Activities

4. Market Assessment
4.1. 7MM Market Analysis
4.2. United States
4.3. Europe
4.4. Japan
4.5. Key Findings

5. Market Competitors

6. Emerging Therapies

7. Appendix
7.1. Report Purchase Options

List of Tables
Table 1 Firdapse (amifampridine), Description
Table 2 Firdapse (amifampridine), Trial Diversification
Table 3 Firdapse (amifampridine), Marketed Details United States
Table 4 Firdapse (amifampridine), Marketed Details Europe
Table 5 Firdapse (amifampridine), Marketed Details Japan
Table 6 Patent Details: Firdapse (amifampridine)
Table 7 Firdapse (amifampridine), Clinical Trial Description, 2020
Table 8 Safety and Efficacy Results for Firdapse (amifampridine)
Table 9 Firdapse (amifampridine), 7MM Market Size from 2017 to 2030 (in Million USD)
Table 10 Firdapse (amifampridine), US Market Size from 2017 to 2030 (in Million USD)
Table 11 Firdapse (amifampridine), EU Market Size from 2017 to 2030 (in Million USD)
Table 12 Firdapse (amifampridine), EU5 Market Size from 2017 to 2030 (in Millions USD)
Table 13 Firdapse (amifampridine), Japan Market Size from 2017 to 2030 (in Million USD)
Table 14 Market Competitors
Table 15 Emerging Therapies

List of Figures
Figure 1 The Development Timeline of Firdapse (amifampridine)
Figure 2 Patent Details, Firdapse (amifampridine)
Figure 3 Firdapse (amifampridine), 7MM Market Size from 2017 to 2030 (in Million USD)
Figure 4 Firdapse (amifampridine), US Market Size from 2017 to 2030 (in Millions USD)
Figure 5 Firdapse (amifampridine), EU Market Size from 2017 to 2030 (in Millions USD)
Figure 6 Firdapse (amifampridine), EU5 Market Size from 2017 to 2030 (in Millions USD)
Figure 7 Firdapse (amifampridine), Japan Market Size from 2017 to 2030 (in Millions USD)
Note: Product cover images may vary from those shown
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