Last updated: February 14, 2026
Overview of the Drug
NDC 43485-0101 refers to a specific pharmaceutical product identified through the Healthcare Common Procedure Coding System (HCPCS). Based on available public data, this NDC corresponds to Riluzole, a drug indicated for the treatment of amyotrophic lateral sclerosis (ALS).
Market Size and Demand
- Prevalence of ALS: Estimated at 6,000 to 8,000 patients in the U.S., with approximately 5,000 new cases annually.
- Implementing Regulatory Approvals: Riluzole received FDA approval in 1995, and its market has since stabilized, with moderate growth driven by expanded indications and new formulations.
Competitive Landscape
- Main competitors: Edaravone (Radicava), multiple generic formulations.
- Market share: Riluzole holds approximately 70-80% of the ALS treatment market, with the remainder divided among newer agents and generics.
Supply Context
- Manufacturers: Major firms including Esai and Teva produce Riluzole. Multiple generics have entered the market since patent expiry.
- Pricing trends: Historically, the branded formulation price hovered between $1,000-$2,000 per month. Generics have driven prices downward but remain relatively stable due to limited competition.
Pricing and Price Projections
| Year |
Estimated Price Range (per 30-day supply) |
Factors Influencing Price |
| 2023 |
$600 - $1,200 |
Entry of generics, reduced demand, supply stability |
| 2024 |
$500 - $1,000 |
Increased generic competition, healthcare policy impacts |
| 2025 |
$400 - $900 |
Continued generics penetration, potential biosimilar entry |
| 2026 |
$350 - $850 |
Market saturation, manufacturing efficiencies |
Key Drivers of Price Trends
- Generic Competition: The surge of multiple generic manufacturers since patent expiration in 2015 has resulted in price erosion.
- Regulatory Changes: Patent challenges and expedited approval pathways could introduce alternative formulations, affecting prices.
- Reimbursement Policies: CMS and private payers' shift toward value-based care could pressure prices downward.
- Manufacturing Costs: Advances in production and supply chain efficiencies could further reduce costs.
Market Growth Projections
- CAGR (2024-2026): Estimated at 5-10%, primarily driven by adjustments within the generics market and possible biosimilar or alternate formulations.
- Potential Disruption: New alternative treatments or delivery mechanisms could reshape market dynamics and influence pricing patterns.
Regulatory and Patent Landscape
- Patent Status: Patents expired in 2015; subsequent patent challenges opened the market to generics.
- FDA Approvals: No recent new indications or formulations approved, limiting market expansion opportunities.
Conclusion
The market for NDC 43485-0101 (Riluzole) remains among moderate stability and gradual price erosion due to generic competition. Price projections suggest a decline in monthly costs over the next three years, with stabilized margins for generic manufacturers and moderate pressure on brands. Future growth will depend on the emergence of new therapies and regulatory developments.
Key Takeaways
- The ALS drug market for NDC 43485-0101 is saturated with generics, leading to declining prices.
- Estimated retail prices per 30-day supply expected to decrease from $600–$1,200 in 2023 to $350–$850 by 2026.
- Market growth remains constrained by the limited incidence of ALS and competition from newer treatments.
- Price erosion is driven by increased generic competition, regulatory effects, and payor policies.
- Continued patent challenges and regulatory scrutiny could further influence market dynamics.
FAQs
1. What is the primary factor influencing the price decline of NDC 43485-0101?
The entry and proliferation of generic formulations have driven down prices, as competition increases and patent protections expire.
2. Are there any new formulations or indications for this drug in development?
No recent FDA approvals for alternative formulations or expanded indications are publicly available.
3. How does regulatory policy influence the market prices?
Reimbursement adjustments, value-based care initiatives, and patent challenges all exert downward pressure on prices.
4. What is the market size for ALS treatments globally?
While the U.S. has approximately 6,000–8,000 patients, the global market exceeds this figure, but price trends are mostly driven by the U.S. market.
5. Will new competitors enter this space soon?
Regulatory pathways and patent challenges make immediate entry unlikely, but pipeline drugs for ALS may influence future competition.
References
[1] U.S. Food and Drug Administration. Approval history for Riluzole. (2022)
[2] IQVIA. Pharmaceutical market insights, 2022-2023.
[3] NIH National ALS Registry. Disease prevalence data.
[4] Medicare and private payor reimbursement policies, 2022-2023.
