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FIRDAPSE Drug Patent Profile

When do Firdapse patents expire, and when can generic versions of Firdapse launch?

Firdapse is a drug marketed by Catalyst Pharms and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has three patent family members in two countries.

The generic ingredient in FIRDAPSE is amifampridine phosphate. One supplier is listed for this compound. Additional details are available on the amifampridine phosphate profile page.

DrugPatentWatch^® Generic Entry Outlook for Firdapse

Firdapse was eligible for patent challenges on November 28, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 25, 2037. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for FIRDAPSE

International Patents:	3
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	170
Clinical Trials:	3
Drug Prices:	Drug price information for FIRDAPSE
What excipients (inactive ingredients) are in FIRDAPSE?	FIRDAPSE excipients list
DailyMed Link:	FIRDAPSE at DailyMed

See drug prices for FIRDAPSE

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for FIRDAPSE

NDA:

208078

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for FIRDAPSE

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

Sponsor	Phase
Wake Forest University Health Sciences	Phase 1
Augusta University	Phase 2
Centre Hospitalier Universitaire, Amiens	Phase 2/Phase 3

See all FIRDAPSE clinical trials

Pharmacology for FIRDAPSE

Drug Class	Potassium Channel Blocker
Mechanism of Action	Potassium Channel Antagonists

Paragraph IV (Patent) Challenges for FIRDAPSE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FIRDAPSE	Tablets	amifampridine phosphate	10 mg	208078	3	2022-11-28

US Patents and Regulatory Information for FIRDAPSE

FIRDAPSE is protected by six US patents and two FDA Regulatory Exclusivities.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Catalyst Pharms	FIRDAPSE	amifampridine phosphate	TABLET;ORAL	208078-001	Nov 28, 2018		RX	Yes	Yes
Catalyst Pharms	FIRDAPSE	amifampridine phosphate	TABLET;ORAL	208078-001	Nov 28, 2018		RX	Yes	Yes
Catalyst Pharms	FIRDAPSE	amifampridine phosphate	TABLET;ORAL	208078-001	Nov 28, 2018		RX	Yes	Yes

International Patents for FIRDAPSE

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2013003708
Canada	2840591	METHODES D'ADMINISTRATION DE 3,4-DIAMINOPYRIDINE (METHODS OF ADMINISTERING 3,4-DIAMINOPYRIDINE)
World Intellectual Property Organization (WIPO)	2017214504

FIRDAPSE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for FIRDAPSE (Amifampridine)

Introduction

FIRDAPSE, also known as amifampridine, is a drug approved for the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS), a rare autoimmune disorder. Here, we delve into the market dynamics and financial trajectory of FIRDAPSE, highlighting its current status, market forecasts, and the factors influencing its growth.

Mechanism of Action and Clinical Use

FIRDAPSE works by increasing the release of acetylcholine, a neurotransmitter, at the neuromuscular junction, thereby improving muscle strength and function in patients with LEMS. This mechanism is crucial for managing the symptoms of LEMS, making FIRDAPSE a vital treatment option[4].

Market Overview

The market for FIRDAPSE is analyzed across seven major markets: the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan. The market scenario is expected to evolve due to extensive research in treating LEMS and increasing healthcare spending globally. This trend is anticipated to expand the market size, allowing drug manufacturers to penetrate deeper into the market[1][4].

Financial Performance

Catalyst Pharmaceuticals, the manufacturer of FIRDAPSE, has reported strong financial results in recent quarters. For Q3 2024, FIRDAPSE net product revenues reached a record $79.3 million, reflecting a 19.7% year-over-year (YoY) increase. This growth is driven by the robust organic growth of the drug in the U.S. market and successful international expansion through strategic partnerships[2][3].

Quarterly and Annual Revenue

• Q3 2024: Total revenues increased by 25.3% YoY to $128.7 million, with FIRDAPSE revenues contributing significantly to this growth.
• Full-Year Guidance: The company has revised its full-year 2024 net product revenue guidance for FIRDAPSE to be between $300 million and $310 million[2][3].

Market Forecast

The market forecast for FIRDAPSE is positive, driven by several factors:

• Increasing Demand: Growing awareness and diagnosis of LEMS are expected to increase the demand for FIRDAPSE.
• Regulatory Approvals: Recent regulatory approvals, such as in Japan, are expanding the drug's geographic footprint[2][3].
• Competitive Landscape: While other approved products and emerging therapies pose competition, FIRDAPSE's established market presence and ongoing research into novel treatment approaches are expected to maintain its market position[1][4].

Competitive Landscape

The market for LEMS treatments is competitive, with other approved products and late-stage emerging therapies. However, FIRDAPSE's dominance is supported by its strong clinical profile and the company's strategic efforts to expand its market reach. The launch of new therapies will continue to impact the market, but Catalyst Pharmaceuticals' diversified portfolio, including AGAMREE, helps mitigate these risks[1][4].

Regulatory Milestones

Regulatory milestones play a crucial role in the market dynamics of FIRDAPSE. Recent approvals, such as the regulatory approval in Japan, have significantly expanded the drug's market potential. These milestones, along with ongoing development activities, are key to the drug's continued success[2][3].

Development Activities and Research

Companies and academics are actively involved in assessing challenges and seeking opportunities to improve the treatment of LEMS. Research is focused on novel approaches, which could influence FIRDAPSE's market position. However, Catalyst Pharmaceuticals' commitment to R&D, albeit with some delays, ensures that the company remains competitive in the market[1][4].

Financial Highlights and Operational Efficiency

Catalyst Pharmaceuticals' financial performance highlights operational excellence and strong commercial execution. Key financial highlights include:

• GAAP Net Income: Improved to $43.9 million from a loss of $30.8 million in Q3 2023.
• Cash Position: Strengthened to $442.3 million.
• Research and Development Expenses: Decreased significantly due to the timing of certain R&D initiatives[2][3].

Strategic Partnerships and Global Expansion

The company's strategic partnerships, such as the arrangement with DyDo in Japan, have been instrumental in expanding FIRDAPSE's global presence. These partnerships not only include milestone payments but also facilitate the commercialization of the drug in new territories, contributing to its overall revenue growth[3].

SWOT Analysis

A SWOT analysis of FIRDAPSE reveals:

• Strengths: Strong clinical profile, robust commercial strategy, and successful international expansion.
• Weaknesses: Increasing competition from emerging therapies and higher selling, general, and administrative expenses.
• Opportunities: Growing demand for LEMS treatments, incremental healthcare spending, and potential for new indications.
• Threats: Market competition, regulatory challenges, and delays in R&D initiatives[1][4].

Key Takeaways

• FIRDAPSE has demonstrated strong financial performance with record quarterly revenues.
• The drug's market is expected to grow due to increasing healthcare spending and expanding geographic footprint.
• Regulatory approvals and strategic partnerships are crucial for its continued success.
• The competitive landscape is evolving with new therapies, but FIRDAPSE's established position and ongoing research ensure its market dominance.

FAQs

What is FIRDAPSE used for?

FIRDAPSE (amifampridine) is used for the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS), a rare autoimmune disorder.

How has FIRDAPSE performed financially in recent quarters?

FIRDAPSE reported record quarterly net product revenues of $79.3 million in Q3 2024, reflecting a 19.7% YoY increase.

What are the key factors driving the growth of FIRDAPSE?

Key factors include increasing demand for LEMS treatments, regulatory approvals in new territories, and the company's robust commercial strategy.

How does FIRDAPSE compete in the market?

FIRDAPSE competes with other approved products and emerging therapies but maintains its market position through its strong clinical profile and ongoing research into novel treatment approaches.

What are the recent regulatory milestones for FIRDAPSE?

Recent regulatory milestones include the approval of FIRDAPSE in Japan, which has expanded its geographic footprint.

Sources

1. ResearchAndMarkets.com: Firdapse (Amifampridine) - Drug Insight and Market Forecast - 2030
2. StockTitan: Catalyst Pharmaceuticals Reports Strong Third Quarter 2024 Financial Results
3. BioSpace: Catalyst Pharmaceuticals Reports Strong Third Quarter 2024 Financial Results and Provides Corporate Update
4. BusinessWire: Firdapse (Amifampridine) Market Study 2020: Historical (2017-2019) and Projected Sales to 2030
5. Catalyst Pharmaceuticals: Catalyst Pharmaceuticals Reports Strong Third Quarter 2023 Financial Results