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Last Updated: December 22, 2024

SAFINAMIDE MESYLATE Drug Patent Profile


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

Safinamide Mesylate is a drug marketed by Aurobindo Pharma and Prinston Inc and is included in two NDAs.

The generic ingredient in SAFINAMIDE MESYLATE is safinamide mesylate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the safinamide mesylate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Safinamide Mesylate

A generic version of SAFINAMIDE MESYLATE was approved as safinamide mesylate by PRINSTON INC on April 25th, 2024.

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Drug patent expirations by year for SAFINAMIDE MESYLATE
Anatomical Therapeutic Chemical (ATC) Classes for SAFINAMIDE MESYLATE

US Patents and Regulatory Information for SAFINAMIDE MESYLATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma SAFINAMIDE MESYLATE safinamide mesylate TABLET;ORAL 215902-001 Jun 14, 2023 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Prinston Inc SAFINAMIDE MESYLATE safinamide mesylate TABLET;ORAL 215739-002 Apr 25, 2024 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Aurobindo Pharma SAFINAMIDE MESYLATE safinamide mesylate TABLET;ORAL 215902-002 Jun 14, 2023 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

SAFINAMIDE MESYLATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Safinamide Mesylate

Introduction to Safinamide Mesylate

Safinamide mesylate, marketed under the brand name Xadago, is a drug used in the treatment of Parkinson's disease. It is a selective monoamine oxidase B (MAO-B) inhibitor, which plays a crucial role in managing the symptoms of Parkinson's disease.

Mechanism of Action and Clinical Significance

Safinamide mesylate works by inhibiting the MAO-B enzyme, thereby reducing the breakdown of dopamine in the brain. This mechanism helps in increasing the levels of dopamine, which is essential for controlling the motor symptoms associated with Parkinson's disease. The drug is available in 50 mg and 100 mg film-coated tablets for oral administration[4].

Market Overview

The market for safinamide mesylate is primarily driven by the increasing prevalence of Parkinson's disease and the need for effective treatments. Here are some key points regarding the market dynamics:

Global Market Assessment

The global market for safinamide mesylate is expected to grow significantly over the next few years. The market assessment includes detailed forecasts for the seven major markets: the United States, Germany, France, Italy, Spain, the United Kingdom, and Japan. These forecasts indicate a steady increase in market size due to extensive research and incremental healthcare spending[4].

Regional Market Analysis

  • United States: The U.S. market is one of the largest for safinamide mesylate, driven by a high prevalence of Parkinson's disease and advanced healthcare infrastructure.
  • EU4 and UK: Countries like Germany, France, Italy, Spain, and the UK also show promising growth due to their robust healthcare systems and increasing awareness about Parkinson's disease treatments.
  • Japan: Japan is another significant market, with a growing elderly population that contributes to the increasing demand for Parkinson's disease treatments[4].

Financial Trajectory

Revenue Growth

The revenue from safinamide mesylate has been steadily increasing. For instance, Newron Pharmaceuticals, the developer of Xadago, reported an increase in revenues from EUR 5.3 million in 2020 to EUR 5.8 million in 2021[5].

Market Forecast

The market forecast for safinamide mesylate from 2024 to 2032 indicates a positive growth trajectory. The report by ResearchAndMarkets.com provides detailed sales data forecasts, suggesting that the market will expand due to the increasing need for effective Parkinson's disease treatments and the ongoing research in this area[4].

Competitive Landscape

The competitive landscape for safinamide mesylate includes both marketed therapies and late-stage emerging therapies. While Xadago is a prominent player, other emerging products are expected to provide significant competition. The market is dynamic, with companies focusing on novel approaches to treat Parkinson's disease, which could influence the dominance of Xadago[4].

Regulatory Milestones and Developmental Activities

Clinical Trials and Development

Safinamide mesylate has undergone extensive clinical trials to establish its safety and efficacy. The drug has received regulatory approvals in several countries, and ongoing developmental activities include further clinical studies and regulatory milestones. These activities are crucial for maintaining and expanding the market presence of Xadago[4].

SWOT Analysis

A SWOT analysis of the market for safinamide mesylate highlights the strengths, such as its selective MAO-B inhibition mechanism and the growing demand for Parkinson's disease treatments. However, it also points out weaknesses, such as potential competition from emerging therapies, and opportunities, like the expanding global healthcare market. Threats include regulatory challenges and the high cost of research and development[4].

Key Takeaways

  • Growing Market Demand: The market for safinamide mesylate is driven by the increasing prevalence of Parkinson's disease and the need for effective treatments.
  • Regional Growth: The U.S., EU4, UK, and Japan are key markets with significant growth potential.
  • Financial Growth: Revenue from Xadago has been increasing, with positive forecasts up to 2032.
  • Competitive Landscape: The market is competitive, with both existing and emerging therapies.
  • Regulatory and Developmental Activities: Ongoing clinical trials and regulatory milestones are crucial for the drug's market presence.

FAQs

What is safinamide mesylate used for?

Safinamide mesylate, marketed as Xadago, is used in the treatment of Parkinson's disease. It works by inhibiting the MAO-B enzyme to increase dopamine levels in the brain.

What are the key markets for safinamide mesylate?

The key markets include the United States, Germany, France, Italy, Spain, the United Kingdom, and Japan.

How does safinamide mesylate work?

Safinamide mesylate inhibits the MAO-B enzyme, reducing the breakdown of dopamine in the brain and thereby helping to manage the motor symptoms of Parkinson's disease.

What is the financial outlook for safinamide mesylate?

The financial outlook is positive, with increasing revenues and forecasted growth up to 2032 due to the expanding global healthcare market and the increasing prevalence of Parkinson's disease.

What are the potential competitors to safinamide mesylate?

Other emerging therapies for Parkinson's disease are expected to provide significant competition to safinamide mesylate in the coming years.

Sources

  1. Market Research Reports: Pharmaceutical Grade Safinamide Mesylate - Global Market Share and Ranking, Overall Sales and Demand Forecast 2024-2030.
  2. CONICET Digital: A combined theoretical and experimental study on the structure and properties of safi- namide and its mesylate salt.
  3. DelveInsight: Xadago (safinamide) Drug Insight Market Forecast.
  4. Business Wire: XADAGO for Parkinson's Disease Market Set to Shape the Future of Treatment Landscape by 2032.
  5. Newron Pharmaceuticals: Newron announces 2021 financial results and provides outlook for 2022.

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