Last updated: February 25, 2026
What Is the Product Associated with NDC 42794-0080?
NDC 42794-0080 refers to Firdapse (amifampridine) 10 mg. Firdapse is an oral medication approved by the FDA for the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS). It is marketed predominantly by Catalyst Pharmaceuticals.
Market Size and Incidence
Patient Population
- Prevalence of LEMS: Estimated at 3-4 cases per million population.
- Target Population in the U.S.: Approximately 1,000 - 1,500 patients.
Market Penetration
- Current Prescriptions: Firdapse commands most prescriptions in the U.S. for LEMS, with an increasing number due to increased awareness.
- Off-label use: Limited, but potential exists.
Competitive Landscape
Main Competitors
- Phenytoin: Off-label use for LEMS, but with safety concerns.
- 3,4-DAP (Amifampridine overseas): Available outside U.S. under different formulations or experimental use.
- Emerging therapies: Clinical trials for similar agents predicted to enter the market over the next 5-10 years.
Market Share Dynamics
- Firdapse: Monopoly in U.S. market for LEMS until potential generics or new therapies emerge.
- Other Drugs: Limited penetration due to efficacy or safety profiles.
Pricing Strategy and Historical Data
Current Pricing
- Wholesale Acquisition Cost (WAC): Estimated at approximately $15,000 - $20,000 per 30-day supply.
- List Price: Retail pricing aligns with WAC, with discounts and rebates impacting net prices.
Price Trends
- Since FDA approval in 2018, Firdapse’s price has remained relatively stable.
- The FDA-approved generic version hasn't materialized yet; patent exclusivity persists.
Price Sensitivity & Market Entry Constraints
- Reimbursement: Insurance coverage is generally favorable due to FDA approval.
- Patient Access Programs: Catalyst Pharmaceuticals facilitates co-pay assistance, mitigating patient financial barriers.
Price Projections (Next 5 Years)
| Year |
Projected WAC per 30-day Supply |
Assumptions |
| 2023 |
$16,500 |
Current pricing maintained with minor inflation (~3%) annually |
| 2024 |
$17,000 |
Small price increase reflecting inflation and market stability |
| 2025 |
$17,500 |
Potential marginal increase as market stabilizes |
| 2026 |
$18,000 |
No significant market disruptors; patent protection remains |
| 2027 |
$18,500 |
Price increase aligned with market trends |
Risks to Price Stability
- Patent Litigation/Challenges: Potential for generic entry reduces pricing power.
- New Competitors: Emergence of alternative therapies could erode market share.
- Regulatory Changes: Impact on Medicaid or Medicare reimbursement policies could affect net price.
Regulatory and Patent Landscape
- Patent for Firdapse extends until 2028, providing market exclusivity.
- Catalyst holds orphan drug designation, which supports market protection and incentives.
Key Market Drivers
- Rising awareness and diagnosis of LEMS.
- Limited therapeutic options outside Firdapse.
- Continued approval and favorable reimbursement policies.
Summary of Data
| Data Point |
Value / Status |
| U.S. patient population |
1,000 – 1,500 |
| Current list/WAC price |
$15,000 – $20,000 per 30-day supply |
| Patent status |
Valid until 2028 |
| Competition |
Limited; mainly off-label or experimental |
Key Takeaways
- NDC 42794-0080 (Firdapse) holds a near-monopoly in the U.S. for LEMS treatment, with stable pricing driven by limited competition and patent protection.
- Price projections suggest gradual increases aligned with inflation, barring market entry of generics or alternative treatments.
- Market size remains constrained by disease prevalence, but demand remains steady due to the absence of approved competitors.
- Pricing strategies depend heavily on reimbursement policies and patent protections.
FAQs
1. How long is Firdapse’s patent protected in the U.S.?
Patent protection extends until 2028, providing exclusivity and pricing power.
2. Are there any approved generic versions?
As of now, no approved generics exist; patent exclusivity prevents generic entry until 2028.
3. What factors could influence price reduction?
Patent challenges, regulatory changes, or new therapies entering the market could pressure prices downward.
4. How does off-label use impact the market?
Limited off-label use exists but does not significantly affect the overall market size or pricing due to the lack of approved alternatives.
5. What is the anticipated impact of new therapies on Firdapse?
Emerging drugs targeting LEMS or related conditions could erode market share and reduce prices if they gain approval and market acceptance.
References
[1] U.S. Food and Drug Administration. (2018). Firdapse (amifampridine) approval.
[2] Catalyst Pharmaceuticals. (2022). Market overview and financial reports.
[3] IQVIA. (2022). U.S. prescription drug market analysis.
[4] Court, A. (2021). Patent landscape of neuroactive drugs. Journal of Patent & Trademark Office.
