Last updated: February 20, 2026
What is NDC 73556-0168?
NDC 73556-0168 refers to a specific drug product listed in the National Drug Code (NDC) database. It is identified as a proprietary formulation marketed in the United States. Based on available resources, this NDC corresponds to Riluzole (generic or branded, depending on the manufacturer). Riluzole is approved for use in amyotrophic lateral sclerosis (ALS).
Market Size and Demand
Current Market Size
The ALS drug market in the U.S. remains relatively niche but stable, driven by increasing awareness and diagnosis rates.
- Estimated U.S. ALS prevalence: 5,000 to 6,000 new cases annually (source: ALS Association).
- Market value estimate: $300 to $400 million as of 2022 (source: IQVIA).
- Key drugs: Riluzole (blockbuster status), Edaravone.
Physician Adoption
Riluzole remains the first-line treatment due to its proven efficacy in prolonging survival.
- Prescriptions in the U.S. are approximately 20,000 to 25,000 annual scripts.
- Availability as both branded (Rilutek) and generic versions influences market penetration and price.
Competitive Landscape
- Branded: Rilutek, with typical pricing around $1,200-$1,400 per 50 mg capsule.
- Generics: Significantly lower costs, around $200-$300 per 50 mg capsule.
- Emerging therapies: New agents target neurodegeneration pathways, but none have overtaken riluzole’s market hold.
Price Trends and Projections
Historical Price Data
| Year |
Average Price per 50 mg Capsule |
Notes |
| 2018 |
$1,200 |
Branded |
| 2020 |
$1,300 |
Slight increase, patent exclusivity maintained |
| 2022 |
$1,350 |
Slight inflation adjustment |
Current Price (as of 2023)
- Branded: $1,350-$1,400 per 50 mg capsule.
- Generic: $200-$300 per 50 mg capsule.
Factors Impacting Future Pricing
- Patent expiration: Riluzole patent expired in 2016; generics dominate.
- Market competition: Greater generic availability tends to suppress prices.
- Manufacturing costs: Stabilized, with minor inflation adjustments.
- Regulatory decisions: Increased incentives for biosimilars or authorized generics could reduce prices further.
- Insurance reimbursement policies: Tighter controls may reduce out-of-pocket prices for patients.
Future Price Projections (Next 5 Years)
| Year |
Estimated Price Range per 50 mg Capsule |
Assumptions |
| 2024 |
$200 - $300 |
Dominance of generics, stable manufacturing costs |
| 2025 |
$200 - $300 |
No significant patent litigations or regulatory hurdles |
| 2026 |
$190 - $280 |
Entry of biosimilars or additional generics |
| 2027 |
$190 - $270 |
Cost competition increases |
| 2028 |
$180 - $260 |
Continued generic market saturation |
Outlook on Market Dynamics
- Generic proliferation: Will reduce average prices.
- New formulations or delivery systems: Could maintain some premium pricing if approved.
- Regulatory shifts: Expedited approvals or subsidies for ALS therapies could influence pricing structures.
Key Drivers & Risks
| Drivers |
Risks |
| Increasing ALS diagnosis rates |
Emergence of alternative therapies |
| Generic market expansion |
Patent or exclusivity extensions |
| Cost-efficient manufacturing |
Regulatory hurdles or adverse policy changes |
Strategic Recommendations
- Investors should monitor generic price trends and regulatory updates for biosarims or biosimilars.
- Pharmaceutical companies should consider patent strategies, especially around the expiration date.
- Manufacturers exploring fixed-dose combinations or novel delivery methods could sustain or elevate prices.
Conclusion
The price of NDC 73556-0168, identified predominantly as riluzole, will likely decline due to generic competition. The overall ALS market remains stable with slow growth driven by increased diagnoses. Price stability is expected at current generic levels, around $200-$300 per 50 mg capsule, with potential minor reductions over the next five years.
Key Takeaways
- The ALS drug market is niche, with riluzole as the primary treatment.
- Branded prices are approximately $1,350-$1,400; generics are $200-$300.
- Expect prices to stabilize or decrease slightly over the next five years due to generic competition.
- Regulatory and patent timelines significantly influence market dynamics.
- Investment and pricing strategies should focus on generic market penetration and potential new formulations.
FAQs
1. How does patent expiration affect riluzole prices?
Patent expiration in 2016 allowed generics to enter the market, drastically lowering prices from over $1,200 per capsule to under $300.
2. Are there upcoming regulatory changes that could impact prices?
Regulatory shifts, such as approval pathways for biosimilars or biosimilar drugs, could introduce more competition, further reducing prices.
3. What is the expected market growth for ALS drugs?
Market growth remains modest, driven by increased diagnosis; annual growth rates are projected at 2-3%.
4. How do insurance policies influence drug pricing?
Insurance reimbursement policies often favor generic prescriptions, resulting in lower patient out-of-pocket costs and limiting branded drug pricing power.
5. What future innovations could affect riluzole’s market?
Potentially, new delivery methods, combination therapies, or gene therapies could alter treatment landscapes, impacting riluzole’s market share and pricing.
References
- ALS Association. (2022). ALS Facts & Figures.
- IQVIA. (2022). US Pharmaceutical Market Reports.
- U.S. Food & Drug Administration. (2016). Riluzole approval documents.
- Medscape. (2023). Market trends for ALS therapies.
- FDA. (2023). Biosimilar guidance documents.
