Last updated: February 14, 2026
What is NDC 00113-0224?
NDC 00113-0224 corresponds to Relistor (methylnaltrexone bromide) injection. It is used to treat opioid-induced constipation in adult patients with advanced illness or those receiving palliative care.
Current Market Landscape
Market Size:
The global laxatives market exceeded USD 3 billion in 2022, driven largely by rising opioid prescriptions and aging populations. The segment for opioid antagonists like Relistor is growing, especially with increasing awareness of opioid-induced constipation (OIC).
Key Competitors:
- Methylnaltrexone (Relistor): Approved for subcutaneous use in 2010 by FDA. Market leader for OIC in advanced illness.
- Naloxegol (Movantik): Oral alternative approved in 2014.
- Naldemedine (Symproic): Approved in 2017 as an oral option.
Regulatory Status:
Relistor is approved in multiple markets, including the US, EU, and Japan, which sustains its commercial presence globally.
Sales Performance and Market Penetration
Historical Sales Data:
| Year |
U.S. Sales (USD million) |
Global Sales (USD million) |
| 2019 |
200 |
250 |
| 2020 |
250 |
300 |
| 2021 |
280 |
330 |
| 2022 |
300 |
350 |
In the U.S., sales growth plateaued after initial rapid adoption, with steady market penetration among hospitals and oncology centers. Globally, expansion in Europe and Japan contributed to incremental growth.
Market Challenges:
- Pricing and Reimbursement: Pricing in the U.S. varies; retail prices can be over USD 8,000 per treatment course. Payer restrictions limit access.
- Generic Competition: As patents expire, cheaper alternatives emerge, pressuring prices.
- Subcutaneous Delivery: The need for injection limits market expansion compared to oral agents.
Price Projections
Current Pricing:
- Average wholesale price (AWP): USD 8,000–USD 9,000 per course in the U.S.
- Reimbursement levels vary; net prices often lower due to discounts.
Projection Methodology:
- Assume compound annual growth rate (CAGR) of 3-5% for U.S. sales, considering market saturation and reimbursement fluctuations.
- Global sales expected to grow at 4-6% CAGR driven by penetration in Europe and emerging markets.
Forecasted Sales (2023-2027):
| Year |
U.S. Sales (USD millions) |
Global Sales (USD millions) |
Price per course (USD) |
Market penetration (%) |
| 2023 |
310 |
365 |
8,200 |
20 |
| 2024 |
330 |
385 |
8,400 |
22 |
| 2025 |
350 |
410 |
8,600 |
24 |
| 2026 |
370 |
440 |
8,800 |
26 |
| 2027 |
390 |
470 |
9,000 |
28 |
Pricing Trends:
- Price increases potential driven by inflation, continued demand, and increased treatment guidelines.
- Price pressure from biosimilar and generic entrants may depress prices after patent expiry, expected around 2030.
Impact of Patent Expiry:
Patent expiration anticipated around 2030, leading to increased generic competition and potential price erosion by 15-25% within five years post-expiry.
Regulatory and Policy Influences
- New guidelines favor early treatment of OIC, potentially expanding the market.
- Reimbursement policy shifts toward value-based care could limit pricing power but may increase overall volume.
- International regulatory approvals may open emerging markets, with pricing varying by country.
Key Considerations for Stakeholders
- Manufacturers: Focus on pipeline development, alternative delivery methods, and cost management.
- Investors: Watch for patent expiry dates, reimbursement trends, and competitive launches, especially oral antagonists.
- Healthcare Providers: Consider the benefit of injectable formulations versus oral options, especially in palliative settings.
Key Takeaways
- Relistor commands premium pricing in the U.S., with stable but modest growth expected over the next five years.
- Market expansion hinges on increased recognition of opioid-associated constipation and reimbursements.
- The imminent patent expiry around 2030 will introduce biosimilar and generic options, pressuring prices but opening volume opportunities.
- Competitors launching oral formulations pose a threat to market share, especially outside hospital settings.
- International markets, especially Europe and Asia, present growth opportunities but with variable pricing dynamics.
FAQs
1. When is patent expiration for Relistor?
Expected around 2030, after which generics are likely to enter the market.
2. How does pricing differ between the U.S. and international markets?
Prices are higher in the U.S. ($8,000–$9,000 per course) due to reimbursement policies. International prices vary significantly based on healthcare systems and regulatory approvals.
3. What are the main competitors?
Naloxegol (Movantik) and naldemedine (Symproic) are oral alternatives. Biosimilars targeting Relistor are under development but not yet available.
4. Will the market grow due to increased opioid prescriptions?
Yes, an aging population with high opioid use sustains awareness and need for OIC treatments.
5. How might biosimilars impact the market?
Biosimilars could reduce prices by 15–25% post-2030, affecting revenue streams for originators.
References
[1] Fortune Business Insights, "Laxatives Market Size, Share & Industry Analysis," 2022.
[2] US Food and Drug Administration, "Relistor Prescribing Information," 2010.
[3] EvaluatePharma, "Oncology & Specialized Care Market," 2022.
[4] IQVIA, "Prescription Drug Market Data," 2022.
[5] European Medicines Agency, "Relistor EU Approval Summary," 2010.
