Last updated: February 13, 2026
What is NDC 00641-6195?
NDC 00641-6195 is the National Drug Code for Ruzurgi (amifampridine), a medication approved by the FDA for the treatment of Lambert-Eaton myasthenic syndrome (LEMS). It is produced by Jacobus Pharmaceuticals.
Current Market Context
- Indication: LEMS is a rare autoimmune neuromuscular disorder characterized by muscle weakness.
- FDA Approval: Approved in 2019, with a relatively recent market entry.
- Market Size: LEMS affects approximately 3,000–4,000 patients in the U.S. [1]. The small patient population limits total demand.
Pricing Data
Wholesale Acquisition Cost (WAC):
As of Q1 2023, Ruzurgi's WAC is approximately $66,500 per year per patient. This is based on publicly available pricing databases such as First Databank and IQVIA [2].
| Parameter |
Value |
| WAC per year |
$66,500 |
| Estimated annual treatment cost |
$66,500 (assuming full adherence and no discounts) |
Average Selling Price (ASP):
Typically 10-15% below WAC; estimated at $56,700–$58,000 annually.
Reimbursement & Insurance Coverage:
Reimbursement varies; insurers may negotiate discounts or formulary placements yielding net prices of approximately 20-30% lower than ASP.
Market Dynamics
- Monopoly Status: Jacobus Pharma is the sole manufacturer, giving it pricing power.
- Pricing Trends: Drugs for rare diseases often command high prices due to limited competition.
- Market Entry Barriers: Development challenges for rare conditions, small patient populations, and regulatory hurdles sustain high price points.
Price Projections (2023–2028)
Assumptions:
- Steady demand driven by confirmed diagnoses of LEMS.
- No significant price reductions due to external factors (e.g., policy reforms, biosimilar or generic entry).
- Cost inflation at approximately 3% annually, aligned with healthcare inflation rates.
| Year |
Projected WAC |
Estimated ASP |
Notes |
| 2023 |
$66,500 |
$58,000 |
Current baseline |
| 2024 |
$68,500 |
$59,700 |
Slight price increase, potential volume growth |
| 2025 |
$70,600 |
$61,400 |
Expected continued demand growth |
| 2026 |
$72,800 |
$63,200 |
Presumed stable competition remains low |
| 2027 |
$75,100 |
$65,100 |
Market maturity, demand plateau |
| 2028 |
$77,400 |
$67,100 |
Potential impact of policy or competition shifts |
Key Factors Influencing Future Prices
- Market Exclusivity: Patents and market exclusivity protect current pricing for at least several more years.
- Regulatory Landscape: Any changes affecting orphan drugs or rare disease pricing could pressure prices.
- Manufacturing Costs: Supply chain disruptions or increased costs could influence pricing.
- Competitive Entry: The emergence of generic or biosimilar products would heavily impact pricing.
- Reimbursement Policies: CMS and private payers' reimbursement strategies can influence net prices.
Risk Factors
- Market Size Variability: Underdiagnosis or misdiagnosis of LEMS could limit actual sales volume.
- Policy & Pricing Reforms: Legislation aimed at drug pricing transparency or capping could reduce profitability.
- Manufacturing Challenges: Disruptions or failures could constrain supply, influencing prices.
Key Takeaways
- Ruzurgi's current WAC is roughly $66,500 annually per patient, with net prices likely lower.
- Demand is limited by the rarity of LEMS, constraining the overall market size.
- Price projections indicate modest increases aligned with inflation and demand growth, assuming no major competitive threats.
- Market exclusivity and regulatory protections reinforce high pricing for the foreseeable future.
- External factors, including policy reforms and competition, could significantly alter these projections.
FAQs
1. How does the rarity of LEMS affect drug pricing?
Rare disease status enables high prices due to limited competition and high unmet medical needs.
2. Are biosimilars or generics likely for Ruzurgi?
Generic entry is unlikely in the near term due to patent protections and market exclusivity. Biosimilars are less relevant for small molecules like amifampridine.
3. What are typical reimbursement rates for Ruzurgi?
Private insurers reimburse at rates 20-30% lower than ASP; Medicaid and Medicare align reimbursements with MS-DRG or ASP standards.
4. How have recent policy changes impacted similar orphan drugs?
Some legislative steps aim to cap prices for certain high-cost drugs, but effects on drugs like Ruzurgi remain limited thus far.
5. What potential exists for price reduction?
Price reductions are possible with market entry of competitors or regulatory actions, but current protections limit this risk.
References
[1] National Organization for Rare Disorders (NORD). Lambert-Eaton Myasthenic Syndrome. Accessed 2023.
[2] First Databank, IQVIA pricing insights, 2023.
