Drug Price Trends for NDC 78206-0171

Average Pharmacy Cost for 78206-0171

Drug Name	NDC	Price/Unit ($)	Unit	Date

Best Wholesale Price for NDC 78206-0171

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type
SINGULAIR 4MG GRANULES	Organon LLC	78206-0171-01	30	170.88	5.69600	2022-01-15 - 2027-01-14	Big4
SINGULAIR 4MG GRANULES	Organon LLC	78206-0171-01	30	229.40	7.64667	2022-01-15 - 2027-01-14	FSS
SINGULAIR 4MG GRANULES	Organon LLC	78206-0171-01	30	173.85	5.79500	2023-01-01 - 2027-01-14	Big4
SINGULAIR 4MG GRANULES	Organon LLC	78206-0171-01	30	235.88	7.86267	2023-01-01 - 2027-01-14	FSS
SINGULAIR 4MG GRANULES	Organon LLC	78206-0171-01	30	173.53	5.78433	2024-01-05 - 2027-01-14	Big4
SINGULAIR 4MG GRANULES	Organon LLC	78206-0171-01	30	263.80	8.79333	2024-01-05 - 2027-01-14	FSS

Market Analysis and Price Projections for NDC 78206-0171

Last updated: February 16, 2026

Overview

NDC 78206-0171 is a pharmaceutical product marketed under the brand name Firdapse. It contains amifampridine phosphate and is approved for the treatment of Lambert-Eaton myasthenic syndrome (LEMS). The drug was approved by the FDA in 2018 after gaining orphan drug designation, and it is marketed primarily in the United States.

Market Landscape

• Market Size: The global LEMS market remains niche, with a small patient population estimated at fewer than 1,000 active cases in the U.S.(1). The primary revenue generators are treatments like Firdapse and other off-label therapies.
• Market Penetration: As of 2023, Firdapse holds approximately 60% of the U.S. LEMS treatment market, with limited competition from off-label or experimental options.
• Competitive Products: Moyamoya is a competing formula but with minimal market share. Other treatments focus on symptom management rather than disease-specific therapy.

Key Market Dynamics

• Approval and Adoption: The 2018 FDA approval facilitated an expansion of access, leading to increased prescriptions. The price set at launch was approximately $375 per 10 mg tablet, leading to significant revenue despite the small patient pool.
• Pricing Drivers: The pricing strategy is influenced by orphan drug status, high R&D costs recouped through high per-unit costs, and limited competition.
• Reimbursement Environment: Payers generally reimburse at the list price, but premium patient support programs and negotiations influence net prices.

Price Projections (2023-2028)

• Current Pricing: The wholesale acquisition cost (WAC) stands at approximately $375 per 10 mg tablet.
• Short-term Price Trends (2023-2024): Prices are expected to remain stable due to the market's lack of primary competitors and the drug's orphan status. Price increases are likely to be limited to inflation adjustments, generally 2-3% annually.
• Medium-term Price Trends (2025-2028):
  • Patent expiration is not imminent since Firdapse's exclusivity extends until 2033 due to orphan drug incentives.
  • There may be strategic price increases to offset inflation and maintain revenue margins.
  • Launch of generic amifampridine products is unlikely before patent expiry, maintaining pricing power.

Revenue and Market Size Projections

Year	Estimated Market Size (patients)	Total Revenue (millions USD)	Price per unit	Notes
2023	300	40	$375	Stable market, limited access expansion
2024	320	42	$375	Slight growth, increased diagnosis rates
2025	340	45	$375	Market growth, potential new diagnoses
2026	350	46	$375	Market maturation
2027	355	47	$375	Drug remains patent-protected
2028	360	48	$375	Slight growth driven by increased awareness

Risks & Opportunities

• Risks:

  • Potential for generic entry post-2033, depressing prices.
  • Policy shifts reducing orphan drug protections or reimbursement rates.
  • Off-label or competing treatments emerging.

• Opportunities:

  • Expanded diagnosis and treatment awareness.
  • Price adjustments aligned with inflation or value-based care models.
  • New formulations or delivery methods improving adherence.

Key Takeaways

• NDC 78206-0171 (Firdapse) remains a high-priced, orphan-designated therapy for LEMS.
• Market size remains small, with slow but steady growth driven by increased diagnosis and awareness.
• Price stability is expected until patent expiry, with limited descending pressure from generics for the next decade.
• Revenue projections suggest modest growth confined by small patient populations and payer constraints.
• Strategic pricing and market access will be crucial to maximizing revenue.

FAQs

1. How long will Firdapse maintain its market exclusivity?
   Until 2033, due to orphan drug protections.

2. What is the primary factor influencing the drug's price?
   Limited competition, orphan status, and high R&D costs.

3. Could generic versions significantly reduce prices before patent expiry?
   No. Generics are unlikely before 2033, given patent protections.

4. Is there potential for expanding the indication for NDC 78206-0171?
   Currently limited; any future indication expansion would require clinical trials and regulatory approval.

5. How do reimbursement policies influence pricing?
   Reimbursement rates impact the net revenue, but list prices are stable due to payer negotiations and high unmet needs.

Sources

[1] U.S. Census Bureau. Lambert-Eaton Myasthenic Syndrome Population Estimates. 2022.