Safinamide mesylate - Generic Drug Details

What are the generic sources for safinamide mesylate and what is the scope of freedom to operate?

Safinamide mesylate is the generic ingredient in two branded drugs marketed by Aurobindo Pharma, Prinston Inc, and Mdd Us, and is included in three NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Safinamide mesylate has ninety-seven patent family members in thirty-one countries.

One supplier is listed for this compound.

Summary for safinamide mesylate

International Patents:	97
US Patents:	3
Tradenames:	2
Applicants:	3
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	79
Patent Applications:	68
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for safinamide mesylate
What excipients (inactive ingredients) are in safinamide mesylate?	safinamide mesylate excipients list
DailyMed Link:	safinamide mesylate at DailyMed

Pharmacology for safinamide mesylate

Drug Class	Monoamine Oxidase Type B Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Monoamine Oxidase-B Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for safinamide mesylate

N04BD	Monoamine oxidase B inhibitors
N04B	DOPAMINERGIC AGENTS
N04	ANTI-PARKINSON DRUGS
N	Nervous system

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
Prinston Inc	SAFINAMIDE MESYLATE	safinamide mesylate	TABLET;ORAL	215739-002	Apr 25, 2024	AB	RX	No	No
Mdd Us	XADAGO	safinamide mesylate	TABLET;ORAL	207145-001	Mar 21, 2017	AB	RX	Yes	No	8,076,515		Y	Y
Aurobindo Pharma	SAFINAMIDE MESYLATE	safinamide mesylate	TABLET;ORAL	215902-001	Jun 14, 2023		DISCN	No	No
Mdd Us	XADAGO	safinamide mesylate	TABLET;ORAL	207145-001	Mar 21, 2017	AB	RX	Yes	No	8,283,380
Mdd Us	XADAGO	safinamide mesylate	TABLET;ORAL	207145-002	Mar 21, 2017	AB	RX	Yes	Yes	8,283,380
Prinston Inc	SAFINAMIDE MESYLATE	safinamide mesylate	TABLET;ORAL	215739-001	Apr 25, 2024	AB	RX	No	No
Mdd Us	XADAGO	safinamide mesylate	TABLET;ORAL	207145-001	Mar 21, 2017	AB	RX	Yes	No	8,278,485			Y

International Patents for safinamide mesylate

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2342929	СПОСОБЫ ЛЕЧЕНИЯ БОЛЕЗНИ ПАРКИНСОНА (METHODS OF PARKINSON'S DISEASE TREATMENT)
Cyprus	1115951
Germany	602004021790
European Patent Office	2070526	Procedes de traitment de la maladie de Parkinson (Methods for treatment of Parkinson's disease)
Norway	20131417
Cyprus	1115286
Hungary	S1500043

Supplementary Protection Certificates for safinamide mesylate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1613296	241 50017-2015	Slovakia		PRODUCT NAME: SAFINAMID; REGISTRATION NO/DATE: EU/1/14/984/001 - EU/1/14/984/010 20150226
1613296	46/2015	Austria		PRODUCT NAME: SAFINAMIDE; REGISTRATION NO/DATE: EU/1/14/984 20150224
1613296	CA 2015 00042	Denmark		PRODUCT NAME: KOMBINATION AF SAFINAMID OG LEVOPODA/PDI; REG. NO/DATE: EU/1/14/984/001-010 20150224
1613296	15C0054	France		PRODUCT NAME: SAFINAMIDE; REGISTRATION NO/DATE: EU/1/14/984 20150224
1613296	C20150033 00258	Estonia		PRODUCT NAME: SAFINAMIID;REG NO/DATE: EU/1/14/984 26.02.2015
1613296	300752	Netherlands		PRODUCT NAME: SAFINAMIDE; REGISTRATION NO/DATE: EU/1/14/984 20150224
1613296	CR 2015 00042	Denmark		PRODUCT NAME: KOMBINATION AF SAFINAMID, HERUNDER SAFINAMID METHANSULFONAT, OG LEVODOPA/PDI; REG. NO/DATE: EU/1/14/984/001-010 20150226

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.