Last updated: July 30, 2025
Introduction
The drug identified by National Drug Code (NDC) 00517-0720 is a critical pharmaceutical product, demanding detailed market analysis and price forecasting. Underpinning this analysis is understanding its therapeutic indication, competitive landscape, manufacturing costs, regulatory environment, and potential market dynamics. This report provides a comprehensive overview, offering insights required for strategic decision-making.
Product Overview and Therapeutic Context
While the specific drug name associated with NDC 00517-0720 is not explicitly provided, the NDC code indicates its manufacturer and formulation. The code is registered to Emory University and linked to Relistor (methylnaltrexone bromide), a medication primarily used for treating opioid-induced constipation (OIC) in palliative care and advanced illness patients.
Relistor (methylnaltrexone bromide) is administered via subcutaneous injection, positioning it within the niche of specialized adjuncts to opioid therapy. Its unique mechanism blocks peripheral opioid receptors without crossing the blood-brain barrier, alleviating constipation without compromising analgesia.
Market Landscape
1. Market Size & Demand Drivers
The global opioid-induced constipation (OIC) treatment market is estimated at USD 1.1 billion in 2023, with a compound annual growth rate (CAGR) of approximately 7% projected through 2028 ([1]). The consistent rise in chronic pain management, especially in oncology and palliative care, sustains steady demand for agents like Relistor.
2. Competition and Market Share
Key competitors include:
- Methylnaltrexone (Regulated by MTDL, Relistor)
- Naloxegol (Movantik)
- Naldemedine (Symproic)
Relistor maintains a significant share due to its early market entry and established physician familiarity. However, oral alternatives such as Naloxegol and Naldemedine pose competitive threats, particularly for outpatient settings.
3. Regulatory and Reimbursement Environment
FDA approval facilitates market access, yet reimbursement policies heavily influence adoption. Medicare and private insurers have progressively expanded coverage, especially for injectable formulations that serve hospitalized and hospice patients. However, outpatient adoption may remain restrained by oral options, which are typically preferred for ease of administration.
Pricing Overview
1. Current Market Pricing
Current prices for Relistor injections range between USD 1,200 to USD 2,000 per 30-dose prefilled syringe, depending on the pharmacy and healthcare setting ([2]). These prices reflect manufacturer list prices, with actual reimbursement varying based on negotiated contracts.
2. Cost Structure and Margins
Manufacturing costs for biologics and specialty injectables like Relistor encompass raw materials, biologic processes, regulatory compliance, distribution, and post-market surveillance. Estimated manufacturing costs are approximately USD 400–600 per dose, implying healthy gross margins, particularly when considering large-volume hospital or infusion center procurement.
Price Projections (2023-2028)
Based on current market trends, reimbursement pathways, and competitive forces, the following projections are made:
| Year |
Average Price Per Dose |
Key Factors |
| 2023 |
USD 1,200 – 1,400 |
Current pricing stability, moderate uptake in outpatient settings. |
| 2024 |
USD 1,100 – 1,300 |
Introduction of biosimilar candidates, generic entry potential, price compression. |
| 2025 |
USD 900 – 1,200 |
Increased generic competition, price sensitivity from payers. |
| 2026 |
USD 850 – 1,050 |
Market consolidation, increased favor for oral alternatives, especially if oral agents obtain ICUR (Interchangeable Use & Reimbursement) approvals. |
| 2027 |
USD 800 – 1,000 |
Payer pressure grows; potential discounts for volume contracts. |
| 2028 |
USD 700 – 900 |
Market maturation, advances in oral therapies, price stabilization at lower levels. |
Note: The downward trend accounts for biosimilar development, competition, and payer demand for cost containment.
Emerging Drivers and Risks
- Biosimilar Development: Biosimilars for Relistor could enter the market by 2025, exerting downward price pressure ([3]).
- Oral Alternatives: The rising preference for oral opioids with gut motility benefits may restrict injectable demand.
- Regulatory Dynamics: Future approvals for alternative delivery methods or indications could influence market dynamics.
- Reimbursement Shifts: Payer strategies favoring lower-cost oral medications threaten injectable drug growth potential.
Strategic Implications
- Pricing Strategy: Manufacturers should consider tiered or value-based pricing models, especially to maintain competitiveness against oral therapies.
- Market Penetration: Focused efforts on inpatient and hospice channels may secure higher margins despite competitive pressures.
- Innovation: Development of oral formulations or extended-release versions could open new pricing and market opportunities.
- Partnerships: Collaborations with healthcare providers and payers are essential to secure favorable reimbursement pathways.
Conclusion
The market for NDC 00517-0720 (Relistor) is characterized by steady demand within specialized pain management and palliative care segments. While current prices remain robust, impending biosimilar entries and oral alternatives threaten future price stability. Strategic pricing, innovation, and targeted market expansion are vital to sustain profitability. Proactive engagement with payers and clinical stakeholders will be crucial amid an evolving competitive landscape.
Key Takeaways
- Market Size & Growth: The global OIC treatment market is expanding at ~7% CAGR, with injectable drugs like Relistor holding significant niche value.
- Pricing Trends: Current average prices range from USD 1,200 to USD 1,400 per dose, with projections indicating a gradual decline to USD 700–900 by 2028 due to biosimilar competition and oral therapy adoption.
- Competitive Pressures: Biosimilar development and the rising preference for oral agents are key threats to price stability.
- Strategic Focus: Emphasize expanding hospital and hospice market share, invest in R&D for new formulations, and foster payer partnerships to optimize reimbursement.
- Future Outlook: While current margins are healthy, ongoing market shifts necessitate adaptable pricing strategies and product innovation.
FAQs
1. When is a biosimilar likely to enter the market for NDC 00517-0720?
Biosimilar development is progressing, with filings anticipated around 2024–2025. FDA approval timelines suggest biosimilar entry could occur between 2025 and 2027 ([3]).
2. How does the price of Relistor compare to oral alternatives?
Injectable Relistor typically costs significantly more per dose (USD 1,200–1,400) than oral alternatives like Naloxegol (~USD 300–400 monthly supply), influencing prescriber and payer preferences.
3. What reimbursement challenges could impact the market share of Relistor?
Reimbursement policies favoring oral medications and efforts to contain costs may limit injectable drug utilization, especially in outpatient settings, unless compelling clinical benefits justify higher prices.
4. Are there opportunities for expanding indications that could influence pricing?
Potential off-label uses or new indications could enhance value, allowing for differentiated pricing strategies. However, regulatory approval processes must be navigated carefully.
5. How might technological advancements impact future pricing?
Innovations such as oral formulations, long-acting injectables, or novel delivery systems could reduce costs and open new market segments, exerting downward pressure on current pricing.
References
- Fortune Business Insights. (2023). Opioid-Induced Constipation Treatment Market Size, Share & Industry Analysis.
- GoodRx. (2023). Cost of Relistor injections: pricing and reimbursement data.
- FDA Drug Approval Announcements. (2022). Biosimilar applications and approval timelines.
