Last updated: February 27, 2026
What Is the Drug Identified by NDC 45802-0128?
NDC 45802-0128 corresponds to Riluzole in a 50 mg oral capsule. Riluzole is approved for the treatment of amyotrophic lateral sclerosis (ALS). It is marketed under the brand name Rilutek, with generics available since patent expiration.
Market Position and Sales Dynamics
Current Market Size
The global ALS drug market was valued at approximately $250 million in 2022. Riluzole accounts for around 70% of the U.S. ALS treatment market, reflecting its status as the only FDA-approved drug for this indication since 1995.
Sales Trends
- Estimated 2022 U.S. sales: $170 million
- Growth rate (2018-2022): 2% annually, driven by increased diagnosis rates and adoption of generic versions.
- Market share: Riluzole holds about 65-75% of the ALS drug market, with the rest split among experimental treatments.
Competitive Landscape
| Competitors |
Entry Year |
Market Share (approx.) |
Notes |
| Riluzole (generic) |
2016 |
70% |
Dominates due to early patent expiration |
| Edaravone (Radicava) |
2017 |
25% |
Used in specific cases or as adjunct therapy |
| Experimental treatments |
N/A |
5% |
Clinical trials ongoing for neuroprotective agents |
Licensing and Patent Outlook
- The original patent for Riluzole expired in 2016.
- Patent challenges led to multiple generics entering the market.
- Pending or potential patents for formulation improvements or delivery methods could influence future market exclusivity.
Price Trajectory Analysis
Baseline Pricing
- Brand-name Rilutek (pre-2016): Approximately $1,200 per month.
- Generic Riluzole (2016 onwards): Coordinates around $300-400 per month, reflecting increased competition.
Current Pricing
- Retail prices for generics hover around $300–$350 per month.
- Prices vary depending on payer type, pharmacy, and regional factors.
Factors Influencing Price Trends
- Market competition: Entry of multiple generics has kept prices stable or declining.
- Reimbursement policies: CMS, private insurers, and pharmacy benefit managers impact net prices.
- Supply chain issues: Manufacturing disruptions could temporarily impact supply and pricing.
- Formulation innovations: New delivery methods (e.g., liquid formulations) could command premium pricing if approved.
Projections for 2023–2027
| Year |
Estimated Price Range |
Key Factors |
| 2023 |
$300–$350 |
Continued generic competition |
| 2024 |
$290–$340 |
Potential market entry of biosimilars or reformulations, slight downward pressure |
| 2025 |
$280–$330 |
Increasing adoption of biosimilars globally, patent challenges for formulations |
| 2026 |
$270–$320 |
Market saturation, standardization of generic pricing |
| 2027 |
$260–$310 |
Potential regulatory incentives for improved formulations |
Strategic Market Considerations
- Pipeline drugs: Limited pipeline, with few ALS-specific drugs approved; thus, Riluzole retains a dominant position.
- Off-label uses: No significant off-label indications affecting the market.
- Pricing pressure: Fierce competition among generics suppresses price upward movement.
- Global markets: Emerging markets may see higher prices due to limited local manufacturing, while high-income countries experience stable or declining prices due to generic competition.
Regulatory and Policy Impact
- No current patent protections or exclusivities protect Riluzole beyond generics.
- Expected to remain off-patent through 2026, influencing pricing declines.
- Future modifications (e.g., delivery method patents) could temporarily alter the price landscape.
Key Takeaways
- NDC 45802-0128 corresponds to generic Riluzole, used primarily for ALS.
- The global ALS market is stable, with generics capturing about 70% of sales in the U.S.
- Prices have declined from approximately $1,200 for brand Rilutek to about $300–$350 for generics.
- Future prices are expected to stay flat or decline slightly, influenced by generic competition and market saturation.
- Limited pipeline and off-label use suggest Riluzole’s market will remain primarily driven by existing generics.
FAQs
1. How has the market for Riluzole evolved since patent expiration?
Generic entry in 2016 caused prices to halve and increased accessibility, consolidating market share among several competitors.
2. Are there emerging therapies that threaten Riluzole’s dominance?
Limited pipeline and a lack of new disease-modifying therapies suggest Riluzole will maintain a leading position for the foreseeable future.
3. What factors could lead to a price rebound for Riluzole?
Introduction of reformulations, delivery innovations, or regulatory exclusivities could temporarily increase prices.
4. How do regional differences impact Riluzole prices?
Pricing varies with healthcare policies; high-income countries tend to have lower generic prices due to purchasing power and regulation.
5. What are the main risks affecting Riluzole’s market share?
Patent challenges, safety concerns, or new approved drugs for ALS could reduce Riluzole’s dominance.
Sources:
[1] EvaluatePharma. (2022). Global ALS drug market data.
[2] IQVIA. (2022). U.S. prescription drug sales data.
[3] FDA. (2022). Approved drugs for ALS.
[4] FDA. (2020). Patent and exclusivity data.
