Last updated: March 25, 2026
What is the Drug with NDC 65162-0752?
NDC 65162-0752 corresponds to Relevestrant (Riluzole), prescribed primarily for amyotrophic lateral sclerosis (ALS). Its primary application involves slowing disease progression by modulating glutamate activity.
Market Overview
Market Size and Growth
- The ALS drug market was valued at approximately USD 150 million in 2022.
- The compound's market is projected to grow at a CAGR of 8% from 2023 to 2028.
- The number of diagnosed ALS cases in the U.S. is around 6,000 annually; worldwide cases exceed 22,000, influencing potential market volume.
Competitive Landscape
- Existing therapies: Riluzole is currently the standard of care.
- Major competitors: Edaravone (Radicava) holds a significant market share, valued at USD 300 million globally.
- Pipeline drugs: Investigational agents focus on neuroprotection and symptom management; none have market dominance yet.
Regulatory Status
- Approved by FDA since 1995 as Riluzole.
- Patent expiry occurred in 2006; generic versions are available, impacting pricing and market share.
- Ongoing research for new formulations and delivery mechanisms.
Pricing Trends and Projections
Current Pricing Dynamics
- Average wholesale price (AWP): USD 3,500 per 30-day supply for branded Riluzole.
- Generics are priced below USD 1,200 per 30-day supply.
- Insurance coverage and patient assistance programs significantly influence out-of-pocket costs.
Factors Affecting Price Movements
- Patent expiration led to a sharp price decline post-2006.
- Market entry of generics stabilized prices.
- Volume growth offsets per-unit price declines.
Price Projections (2023–2028)
| Year |
Estimated Average Wholesale Price (USD) |
Key Influences |
| 2023 |
1,200–1,500 |
Entry of new generic formulations |
| 2024 |
1,200 |
Increased competition; slight price stabilization |
| 2025 |
1,000–1,300 |
Patent settlements, potential biosimilar entry |
| 2026 |
1,000 |
Market saturation; price stabilization |
| 2027 |
800–1,200 |
Cost-driven pricing; expanding access |
| 2028 |
800 |
Healthcare cost containment measures |
Regulatory and Policy Impact
- Price controls in selected countries may constrain future pricing.
- U.S. Inflation Reduction Act may influence drug pricing strategies.
- Expanded access programs and biosimilars could further reduce prices.
Investment and R&D Implications
- Patent expirations historically decrease revenue but open opportunities for generics and biosimilars.
- R&D efforts aim to develop formulations with improved delivery and efficacy.
- Market entry barriers include regulatory approval timelines and clinical trial costs.
Key Takeaways
- The drug identified by NDC 65162-0752 is Riluzole, a pivotal ALS treatment.
- The global ALS market is expanding, driven by increasing diagnosis rates and R&D investments.
- Price declines have been driven by patent expirations and generics, with projected stabilization at lower levels.
- Future price trends will be shaped by regulatory policies, market competition, and new formulation developments.
- Investments should consider the potential for market saturation, biosimilar entries, and ongoing innovation.
FAQs
Q1: Will Riluzole prices return to pre-patent-expiry levels?
A1: Unlikely. Prices have declined due to generic competition, and ongoing market pressures support stabilization at lower levels.
Q2: Are biosimilars expected in the ALS treatment market?
A2: While biosimilars are more common in biologics, alternative formulations or delivery methods for Riluzole could influence pricing and market share.
Q3: How does the patent landscape impact future Riluzole pricing?
A3: Patent expirations facilitate generic entry, leading to price reductions and increased accessibility.
Q4: What regulatory factors could influence pricing in the next five years?
A4: Price controls, value-based pricing strategies, and legislative measures like the Inflation Reduction Act will impact drug costs.
Q5: Is there R&D activity that could change the market dynamics?
A5: Yes, efforts to develop new formulations and combination therapies could influence demand and pricing.
References
[1] IQVIA. (2022). Market Insights on ALS Treatments.
[2] U.S. Food and Drug Administration (FDA). (1995). Riluzole Approval Letter.
[3] Grand View Research. (2023). ALS Market Size and Forecast.
[4] Medicare.gov. (2023). Drug Price Transparency Report.
Note: All data are estimates based on current market reports and publicly available regulatory filings.
