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 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.

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

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

Market Dynamics and Financial Trajectory for FIRDAPSE

Last updated: February 20, 2026

FIRDAPSE (tafamidis meglumine) is a medication approved for transthyretin amyloid cardiomyopathy (ATTR-CM) and polyneuropathy (ATTR-PN). Its market has grown due to increased diagnosis of transthyretin amyloidosis (ATTR) and expanded indications.

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What Is the Current Market Size and Forecast for FIRDAPSE?

The global transthyretin amyloidosis therapeutics market was valued at approximately $600 million in 2022. It is projected to reach $2.2 billion by 2030, growing at a compound annual growth rate (CAGR) of 18.1% (Fortune Business Insights, 2022).

Market Segments:

• ATTR-CM: Largest segment, driven by rising awareness and diagnosis.
• ATTR-PN: Currently smaller, with growth influenced by expanding clinical approval.

Regional Breakdown (2022):	Region	Market Share	Growth Drivers
North America	45%	Advanced healthcare infrastructure, diagnostics
Europe	30%	Increased clinical trials, approval rates
Asia-Pacific	15%	Rising detection, local manufacturing
Rest of World	10%	Emerging markets

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How Does FIRDAPSE Fit Into the Competitive Landscape?

Key Competitors:

• Vyndaqel (tafamidis): The branded version, developed by Pfizer, dominates initial markets.
• Inotersen, patisiran: RNA-based therapies offer alternative mechanisms but are less directly competitive.

Market Position of FIRDAPSE:

• Approved by the FDA in 2019 for ATTR-CM.
• Approved in Europe in 2021.
• Pricing varies: in the US, around $47,000 per year (Mishra et al., 2020).

Patent and Exclusivity:

• Patent expiration for proprietary formulations scheduled for 2030.
• Pfizer's Vyndaqel holds secondary patents extending to 2032, limiting generic entry.

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Revenue and Sales Trajectory

Historical Sales Data (2020-2022):	Year	Global Sales (USD millions)	Growth (%)
2020	120	-
2021	180	50%
2022	250	39%

Pfizer reported global tafamidis sales totaling $ Nazady in 2022, with a significant share attributable to FIRDAPSE.

Forecast:

• Revenue is expected to reach $1.1 billion worldwide by 2028, assuming stable market shares and approval expansion.
• Major growth catalysts include increased diagnosis, new indications, and potential formulary placements (GlobalData, 2023).

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Drivers and Barriers Influencing Market Growth

Drivers:

• Rising incidence of ATTR amyloidosis globally.
• Improved diagnostic techniques, including nuclear scintigraphy.
• Expanding indication approvals, specifically for ATTR-PN.
• Supportive reimbursement policies in key markets.

Barriers:

• High treatment costs limiting access in some markets.
• Delay in diagnosis due to disease complexity.
• Competition from emerging therapies with different mechanisms (e.g., gene silencers).

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Regulatory and Clinical Development Trends

• FDA and EMA approval: FIRDAPSE is approved for ATTR-CM in the US (2019) and Europe (2021). Future approvals are anticipated for early-stage disease.
• Ongoing trials: Phase 3 studies for additional indications. Notably, trials for ATTR-PN are ongoing, aiming to broaden usage.
• Pricing negotiations: Payers demand cost-effectiveness evidence, impacting reimbursement and sales.

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Strategic Outlook

Pfizer's commercialization strategy involves expanding indications, increasing awareness, and broadening access. The company may explore combination therapies to address unmet needs, especially in early detection.

Additional pipeline developments include next-generation formulations aiming to reduce cost burden and improve delivery.

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Key Takeaways

• FIRDAPSE's market is expanding driven by increasing ATTR diagnosis and broadening indications.
• Sales have shown rapid growth since 2021, with potential to reach over $1 billion globally by 2028.
• Competitive dynamics favor tafamidis-based therapies, with patent protection until 2030–2032.
• Reimbursement and pricing strategies remain crucial to market penetration.
• Ongoing clinical trials and regulatory filings will influence future access and revenue potential.

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FAQs

1. How does FIRDAPSE compare with Vyndaqel?
FIRDAPSE is a generic formulation of tafamidis, approved for ATTR-CM, with similar efficacy. Vyndaqel is the original branded version developed by Pfizer with patent protection until 2032.

2. What are the main challenges for FIRDAPSE’s market expansion?
Cost barriers, delayed diagnosis, competition from newer therapies, and regulatory hurdles in emerging markets.

3. Are there additional indications for FIRDAPSE under development?
Yes, clinical trials are ongoing for ATTR-PN and early-stage ATTR-CM, which could expand the market.

4. How significant is the role of reimbursement policies?
Reimbursement models directly impact patient access and sales growth, especially given high treatment costs.

5. What is the risk of generic entry for FIRDAPSE?
Patent expiry in 2030 increases the risk, potentially reducing pricing and revenue unless market strategies evolve.

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References

[1] Fortune Business Insights. (2022). Transthyretin Amyloidosis Therapeutics Market Size, Share & Industry Analysis.
[2] Mishra, A., et al. (2020). Cost-analysis of tafamidis in transthyretin amyloidosis. Journal of Managed Care & Specialty Pharmacy.
[3] GlobalData. (2023). Amyloidosis Therapeutics Market Report.