Last updated: February 24, 2026
What is NDC 51407-0366?
NDC 51407-0366 refers to a specific drug product. Based on available data, it corresponds to Riluzole (Rilutek), used for the treatment of amyotrophic lateral sclerosis (ALS).
Market Landscape Overview
Market Size and Demand
- Patients: Approximately 6,000-8,000 ALS patients in the U.S. annually (ALS Association, 2022).
- Market Penetration: Riluzole remains the first-line treatment. Estimated that 70-80% of diagnosed patients receive the drug.
- Market Growth Drivers: Increasing diagnosis rates, awareness, and supportive care developments.
Competitive Environment
- Main competitors: Edaravone (Radicava) is approved as an alternative treatment.
- Market share: Riluzole holds approximately 85-90% of the ALS pharmacological treatment market for approved drugs.
- Pipeline Threats: Emerging treatments targeting genetic and cellular mechanisms; however, none currently threaten Riluzole’s predominant position.
Regulatory Status
- FDA approval date: 1995.
- Additional approvals: Orphan drug status maintains exclusivity until 2025, with some extensions possible.
- Biosimilar presence: None currently; patent protections (expired or soon to expire) influence pricing and generics’ entry.
Price Trends and Projections
Current Pricing
- Brand Name (Rilutek): Approximate wholesale acquisition cost (WAC) is about $8,000–$12,000 annually.
- Generic versions: Rounded WAC ranges from $4,000 to $8,000 annually, pending manufacturing and distribution channels.
Historical Pricing Dynamics
| Year |
Average Wholesale Price (AWP) |
Notes |
| 2010 |
~ $10,000 per year |
Patent expiration considerations began |
| 2015 |
~ $9,500 per year |
Entry of generics (limited) |
| 2020 |
~ $8,200 per year |
Increased generics and biosimilar threat |
Short-term Projections (Next 2-3 Years)
- Price trends: Anticipate modest decreases due to increasing generic competition.
- Factors influencing prices:
- Patent status: Patent expires in 2025.
- Manufacturing costs: Slight decrease expected with increased generic competition.
- Market penetration: Slight increase in use as early diagnosis improves.
| Projection |
Price Range (Annual) |
Timeframe |
| Conservative |
$6,000 – $8,000 |
2023-2025 |
| Optimistic |
$4,000 – $6,000 |
Post-2025 (once generics dominate) |
Long-term Price Outlook (Beyond 2025)
- Biosimilar and generic impact: Likely to drive retail price downward by 50%-70%.
- Market entry of new treatments: Little immediate threat but could influence pricing indirectly.
Critical Considerations
- Patent expiration in 2025 will enable multiple generics to enter the U.S. market.
- Authorized generics may be introduced before patent expiry, further pressuring prices.
- Pricing negotiations with payers and formulary inclusion will also influence final patient costs.
- Manufacturing scale-up may reduce costs faster than expected, further lowering prices.
Key Takeaways
- Market size remains small, with stable demand driven by ALS diagnosis rates.
- Pricing is expected to decline significantly post-2025, influenced by patent expiry and generic competition.
- Current prices for branded Rilutek hover around $8,000–$12,000 annually, with generics available below $8,000.
- Future trends: Long-term price reductions are likely to be substantial, potentially bringing annual treatment costs below $5,000.
FAQs
Q1: When does the patent for Riluzole (Rilutek) expire?
A1: The primary patent is set to expire in 2025, opening the market to generics.
Q2: What are the main competitors for NDC 51407-0366?
A2: Edaravone (Radicava) is the main alternative approved for ALS treatment.
Q3: How will generic entry affect pricing?
A3: It is expected to decrease prices by 50% or more over the next 3-5 years, depending on market dynamics.
Q4: Are there any biosimilar options available?
A4: Currently, no biosimilars exist for Riluzole; generics are standard.
Q5: What factors could accelerate price decline?
A5: Increased competition, regulatory policies, and earlier authorized generics could expedite reductions.
References
[1] ALS Association. (2022). ALS Facts & Figures. https://www.als.org/resources/impact-als/facts-figures
[2] MedlinePlus. (2022). Riluzole. https://medlineplus.gov/druginfo/meds/a684026.html
[3] U.S. FDA. (2022). Riluzole patent and exclusivity status. https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm
[4] IQVIA. (2022). National Drug Data File (NDDF).
[5] GoodRx. (2023). Riluzole prices. https://www.goodrx.com
