Last updated: March 4, 2026
What is NDC 00904-6371?
NDC 00904-6371 corresponds to a formulation of Riluzole, a drug indicated for the treatment of amyotrophic lateral sclerosis (ALS). It is marketed primarily as Rilutek or Riluzole in the United States.
Market Overview
Market Size and Demand
- The ALS market is estimated at approximately $150 million annually in the U.S. (IQVIA, 2022).
- Riluzole accounts for around 65% of this market, with the remainder split among generic options.
- The stock of ALS diagnosed cases in the U.S. is roughly 20,000 (Harvard ALS Clinic, 2021).
- Riluzole's sales depend on disease prevalence, diagnosis rate, and treatment penetration.
Competitive Landscape
- Brand Name: Rilutek (Sanofi)
- Generics: Multiple suppliers offering bio-similar formulations.
- Market share shifts have favored generics since patent expiration in 2017.
- Several pipeline candidates are under development, but none have achieved regulatory approval yet.
Regulatory Status
- Approved in the U.S. since 1995.
- Orphan drug designation has been maintained.
- Pricing is influenced by FDA approvals, competitive generics, and insurance reimbursement policies.
Price Analysis
Current Pricing
- Wholesale acquisition cost (WAC) for Riluzole ranges from $10 to $15 per tablet.
- The average monthly cost for patients, based on typical dosage (50 mg twice daily), is approximately $600–$900.
Impact of Generic Competition
- Patent expiry in 2017 led to a marked decrease in prices.
- Current generic tablets are priced at roughly 15-25% lower than the brand.
- Equivalence of bio-similar generics leads to price stabilization in the low $10s per tablet.
Price Projections
| Year |
Projected WAC per Tablet |
Rationale |
| 2023 |
$11 |
Existing competition stabilizes pricing |
| 2024 |
$11.50 |
Slight increase due to inflation or manufacturing cost rise |
| 2025 |
$12 |
Potential new biosimilar or reformulation entry may influence prices |
Factors Influencing Future Prices
- Patent litigation or new patent protections could sustain higher prices temporarily.
- Introduction of authorized generics or biosimilars could further reduce prices.
- Policy changes favoring biosimilar substitution in healthcare will pressure price declines.
- Reimbursement models may incentivize higher or lower pricing depending on coverage.
Revenue Projections
Based on current demand and pricing:
| Year |
Estimated Annual Revenue (millions) |
Key Assumptions |
| 2023 |
$25–30 |
Market penetration of 75–85%, stable pricing |
| 2024 |
$26–32 |
Slight pricing increase and increased diagnosis rates |
| 2025 |
$27–35 |
Steady demand with potential biosimilar discounts |
Key Market Risks
- Emergence of new ALS treatments (e.g., edaravone, gene therapies) could reduce Riluzole's market share.
- Price erosion from biosimilar competition.
- Changes in insurance policies potentially limiting reimbursement.
Summary
The U.S. ALS drug market remains relatively stable due to the small patient population, but prices for NDC 00904-6371 are trending downward due to generic competition. The annual market size hovers around $150 million, with Riluzole dominating roughly 65% of sales.
Future price levels are expected to stabilize around $11 per tablet, with minor upward adjustments driven by inflation or market factors. Revenue projections for 2023-2025 suggest modest growth barring significant market shifts.
Key Takeaways
- NDC 00904-6371 is a bioequivalent formulation of Riluzole, primarily used for ALS.
- The market is mostly supplied by generics, leading to lower prices.
- Current prices roughly range from $10 to $15 per tablet.
- Price stability is anticipated over the next few years due to existing generic competition.
- Market growth depends on new treatment options, policies, and biosimilar entry.
FAQs
1. How does patent expiration influence Riluzole pricing?
Patent expiration in 2017 allowed generic manufacturers to enter the market, significantly lowering prices through increased competition.
2. Are biosimilars expected to affect Riluzole prices?
While biosimilars are more common in complex biologics, they are unlikely for Riluzole in the near term. However, bio-generated or reformulated generics could influence prices.
3. What is the typical treatment adherence rate for ALS patients on Riluzole?
Adherence rates are approximately 70-80%, influenced by tolerability and disease progression.
4. How are insurance policies impacting Riluzole reimbursement?
Insurance coverage varies; Medicaid and private insurers generally reimburse Riluzole at negotiated rates, influencing market access.
5. What is the potential for price increases due to supply chain factors?
Supply disruptions or manufacturing cost increases could prompt temporary price hikes, but market competition tends to limit sustained inflation.
References
- IQVIA. (2022). Pharmaceutical Market Data.
- Harvard ALS Clinic. (2021). ALS Epidemiology and Diagnostics.
- U.S. Food and Drug Administration (FDA). (2022). ANDA Approvals: Riluzole.
- Sanofi. (2017). Patent and Market Exclusivity Details.
