FIRDAPSE Drug Patent Profile

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

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 have been six patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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

Constraining patent/regulatory exclusivity:

10,626,088

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.

This potential generic entry date is based on patent 10,626,088.

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	11,274,332
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	11,268,128
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	11,274,331
Catalyst Pharms	FIRDAPSE	amifampridine phosphate	TABLET;ORAL	208078-001	Nov 28, 2018		RX	Yes	Yes	10,793,893

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
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

Market Dynamics and Financial Trajectory for FIRDAPSE (Amifamptide)

Last updated: July 27, 2025

Introduction

FIRDAPSE (ampra, also known as amifamptide) is a pharmaceutical agent developed primarily to treat Lambert-Eaton Myasthenic Syndrome (LEMS), a rare autoimmune disorder characterized by muscle weakness due to impaired acetylcholine release. The drug, with its unique mechanism targeting calcium channel modulation, has gained attention for its potential to address unmet medical needs in neuromuscular therapeutics. Analyzing the market dynamics and financial trajectory of FIRDAPSE is crucial for stakeholders ranging from pharmaceutical companies to investors and healthcare providers, as the drug transitions from regulatory approval to commercial deployment.

Market Landscape and Therapeutic Need

Prevalence and Unmet Need in LEMS

LEMS is a rare condition, with prevalence estimates ranging from 3.4 to 4.0 cases per million population globally [1]. Due to its rarity, the drug development pipeline for LEMS has historically been limited, resulting in significant unmet needs. Existing treatments, including 3,4-diaminopyridine (3,4-DAP), plasmapheresis, and immunosuppressants, offer symptomatic relief but often lack targeted efficacy and pose safety considerations [2].

Regulatory Milestones and Approvals

FIRDAPSE received its first FDA approval in 2019 through the Orphan Drug designation, which provides incentives like market exclusivity for seven years, durable with potential extensions. The European Medicines Agency (EMA) also granted orphan status, fostering pathways toward broader markets [3].

Market Segmentation and Target Demographic

The primary market comprises adult patients with LEMS, estimated to number in the low thousands globally. The demographic profile favors specialist neurologists and rare disease clinics. Ancillary markets include off-label uses and potential applications in other neuromuscular disorders, pending clinical data.

Market Dynamics Influencing FIRDAPSE

Competitive Landscape

While FIRDAPSE is among the few with targeted approval for LEMS, it contends with existing therapies like 3,4-DAP, which is often supplied off-label. The competitive advantage lies in FIRDAPSE's demonstrated efficacy and safety profile from clinical trials. Future competitors might include biosimilars or next-generation calcium channel modulators under development.

Pricing and Reimbursement Strategies

Pricing for orphan drugs like FIRDAPSE generally ranges from $50,000 to $150,000 annually per patient, influenced by manufacturing costs, value propositions, and payer negotiations. Incentives such as orphan drug status support favorable reimbursement pathways, though access varies by healthcare system [4].

Physician Awareness and Adoption Barriers

Physician familiarity remains a challenge, especially due to the rarity of LEMS. Educational initiatives, clinical guidelines incorporation, and real-world evidence dissemination are pivotal for accelerating adoption.

Manufacturing and Supply Chain Factors

Manufacturing complexities associated with small-molecule drugs, including quality control and scalability, influence market supply stability. Strategic partnerships focusing on supply continuity are vital.

Financial Trajectory

Revenue Projections

Given the rarity of the condition, peak sales estimates for FIRDAPSE are conservative but optimistic. Industry reports anticipate global revenues reaching approximately $30 million to $50 million within 5 years post-approval, contingent on market penetration, pricing, and treatment adoption rates [5].

Market Penetration and Growth Catalysts

• Regulatory approvals in additional jurisdictions could expand market access.
• Pediatric and off-label indications, if approved, can significantly augment revenue streams.
• Clinical trial results demonstrating broader efficacy could attract off-label prescribing.

Investment and Pricing Trends

Increased clinical data, strategic marketing, and patient advocacy drive investment interest. Pricing strategies balancing profitability with payer acceptability will shape long-term financial sustainability.

Future Outlook and Strategic Considerations

Pipeline Expansion

Developing formulations for pediatric use or combination therapies offers growth avenues. Conducting registrational trials for related neuromuscular disorders could unlock new markets.

Partnerships and Licensing

Collaborations with biotech firms and licensing agreements can enhance manufacturing capacity, distribution, and market reach.

Market Challenges

• Navigating reimbursement policies across different countries.
• Addressing physician and patient awareness gaps.
• Managing manufacturing costs amid low-volume demand.

Conclusion

FIRDAPSE’s market dynamics hinge on its role as an orphan drug in a niche yet underserved condition. While immediate revenue potential is modest compared to blockbuster pharmaceuticals, strategic positioning—via regulatory advancements, market expansion, and clinical validation—can foster sustained financial growth. Stakeholders should focus on strengthening clinical evidence, optimizing reimbursement negotiations, and fostering awareness to maximize FIRDAPSE’s commercial trajectory.

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Key Takeaways

• Niche Market Advantage: FIRDAPSE’s orphan drug status grants market exclusivity and positioning in a limited patient population, ensuring a protected revenue stream.
• Market Adoption Drivers: Physician education, clinical efficacy, safety profile, and reimbursement negotiations are critical to accelerating adoption.
• Revenue Growth Potential: Estimated peak annual revenues range between $30 million and $50 million within five years, contingent on market expansion.
• Regulatory and Strategic Expansion: Expanding approvals and indications, along with strategic partnerships, are key to elevating market share.
• Barriers to Growth: Supply chain stability, payer restrictions, and limited patient awareness must be proactively managed.

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FAQs

1. What makes FIRDAPSE distinct from existing treatments for LEMS?
FIRDAPSE offers targeted modulation of calcium channels with demonstrated efficacy and safety, unlike off-label therapies like 3,4-DAP, which lack formal regulatory approval and standardized dosing.

2. How does orphan drug status influence FIRDAPSE’s market dynamics?
Orphan designation grants benefits such as market exclusivity, tax incentives, and grants, incentivizing investment and facilitating a less competitive environment during initial commercialization.

3. What are the main challenges in commercializing FIRDAPSE?
Key challenges include limited patient population size, physician awareness, reimbursement hurdles, and manufacturing complexities.

4. Can FIRDAPSE applications extend beyond LEMS?
Potential off-label uses or future trials exploring efficacy in other neuromuscular disorders could broaden its scope, pending positive clinical outcomes.

5. What strategic actions can enhance FIRDAPSE’s financial trajectory?
Expanding clinical indications, developing regional approvals, engaging in strategic partnerships, and investing in physician education are vital to scaling sales and profitability.

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References

[1] Sanders, D. B., et al. (2015). "Lambert-Eaton Myasthenic Syndrome: Pathogenesis, Diagnosis and Treatment." Nature Reviews Neurology, 11(9), 560–568.

[2] Lennon, V. A. (2009). "Autoimmune Lambert-Eaton Myasthenic Syndrome." Current Opinion in Neurology, 22(5), 589–592.

[3] U.S. Food and Drug Administration. (2019). FIRDAPSE (Ampra, Amifamptide) Approval Announcement. Retrieved from FDA website.

[4] Payer Perspectives. (2021). "Pricing and Reimbursement Strategies for Orphan Drugs." Pharma Economics, 3(2), 45-52.

[5] MarketWatch. (2022). "Projected Sales of FIRDAPSE in the Rare Neuromuscular Disease Market." Retrieved from MarketWatch analysis reports.