Last updated: February 22, 2026
What is the Drug Corresponding to NDC 00168-0277?
NDC 00168-0277 refers to Riluzole Extended-Release (ER), marketed under the brand name Riluzole ER. Approved by the FDA in 2017 for amyotrophic lateral sclerosis (ALS) treatment, Riluzole ER is designed to improve long-term tolerability while maintaining efficacy comparable to the immediate-release formulation.
Market Overview
Indications and Patient Demographics
The primary indication for Riluzole ER is ALS, a rare neurodegenerative disease affecting approximately 6,000 new cases annually in the U.S. (ALS Association, 2022). The drug targets both early-stage and progressive cases, with an estimated US patient population of approximately 16,000-20,000.
Market Size and Growth
The global ALS drug market was valued at $440 million in 2020 and is projected to grow at a CAGR of 4.3% through 2027 (Research and Markets, 2021). The U.S. medication share accounts for roughly 60% of the market, with Riluzole historically constituting approximately 70%-80% of therapeutic sales.
Competitive Landscape
Main competitors include:
- Edaravone (Radicava) — Approved in 2017 for ALS; accounts for about 20-25% of sales.
- Other experimental therapies — Gene therapies and monoclonal antibodies under development.
No direct generic version of Riluzole ER currently exists; the immediate-release formulation is available as a generic, but Pfizer's ER variant maintains patent exclusivity until approximately 2030.
Pricing History and Projections
Current Market Price
As of Q1 2023, the wholesale acquisition cost (WAC) for Riluzole ER in the U.S. is approximately $32,000 to $36,000 annually per patient. This figure is based on publicly available drug databases and pharmacy claims data. In comparison, the generic immediate-release version costs approximately $2,000 to $3,000 annually.
| Parameter |
Price Range (2023) |
Notes |
| Riluzole ER (Annual Cost) |
$32,000 - $36,000 |
Brand name, proprietary, patent-protected |
| Generic Riluzole (Immediate Release) |
$2,000 - $3,000 |
As per pharmacy and wholesaler data |
| Forecasted Price Adjustment |
2-3% increase annually |
Based on inflation and market dynamics |
Price Drivers
- Patent exclusivity until 2030 preserves high pricing.
- Limited competition due to the drug's orphan status and regulatory exclusivity.
- Potential biosimilar or generic entries could substantially reduce prices in the mid to long term.
Price Projections (2023-2027)
| Year |
Estimated Price Range |
Key Factors |
| 2023 |
$32,000 - $36,000 |
Current patent protection, steady demand |
| 2024 |
$32,640 - $36,720 |
Slight inflation adjustment |
| 2025 |
$33,283 - $37,477 |
No generic competition, steady market growth |
| 2026 |
$33,949 - $38,226 |
Patent litigation or potential biosimilar entry delayed |
| 2027 |
$34,627 - $39,111 |
Patent expiry approaches, biosimilar development begins |
Competitive Pricing Outlook
The entry of biosimilars or generics closer to 2029-2030 could reduce prices by 40-60%. A sharp decline would influence healthcare budgets and insurance reimbursement policies.
Regulatory and Market Dynamics
Patent and Exclusivity Status
- Patent protection until 2030.
- No current biosimilar or generic filings for ER formulation.
- Market exclusivity supports sustained premium pricing.
Reimbursement Landscape
- Medicare and private insurers typically reimburse based on negotiated prices.
- Out-of-pocket costs can vary significantly due to tiered formulary placement.
R&D and Pipeline Considerations
- Companies developing next-generation ALS therapies could introduce competition.
- Potential shift toward combination therapies or personalized approaches may alter market size.
Risks and Opportunities
Risks
- Patent challenges or legal disputes.
- Regulatory hurdles for biosimilar approvals.
- Development of more effective or targeted therapies.
Opportunities
- Increased demand with expanding ALS diagnostics.
- Potential for negotiated price reductions through value-based agreements.
- Expansion into other neurodegenerative indications remains uncertain.
Key Takeaways
- Riluzole ER holds a dominant, patent-protected market position with current annual prices around $32,000-$36,000 per patient.
- The market is constrained by limited competition, with anticipated pressure from biosimilars or generics only after 2029.
- Long-term price declines could reach 40-60% post-patent expiry, aligning with biosimilar adoption trends observed in other neurodegenerative drugs.
FAQs
1. When will generic versions of Riluzole ER likely enter the market?
Not before patent expiry around 2030. Existing generics are immediate-release formulations, which do not directly compete with ER variants.
2. How will biosimilar entries impact Riluzole ER pricing?
Biosimilars could reduce prices by 40-60%, depending on market acceptance and pricing strategies. Entry could erode high margin sales and influence reimbursement policies.
3. Are there emerging alternative therapies that could affect Riluzole ER's market?
Yes. Several experimental therapies and gene treatments for ALS are in clinical trials. Their success could shift market share away from riluzole-based treatments.
4. What factors could accelerate pricing reductions?
Patent disputes or regulatory delays may delay biosimilar entry. Policy changes promoting biosimilar adoption and payer negotiations could also expedite price declines.
5. How significant is the impact of the orphan drug designation on pricing?
It confers patent exclusivity and market protection until 2030, maintaining high prices but limiting competition.
References
[1] ALS Association. (2022). ALS Facts and Figures. Retrieved from https://www.als.org
[2] Research and Markets. (2021). Global ALS Treatment Market Report. Retrieved from https://www.researchandmarkets.com
[3] U.S. Food and Drug Administration. (2017). Riluzole Extended-Release Approval. Retrieved from https://www.fda.gov
