Last updated: February 25, 2026
What is NDC 00024-5850?
NDC 00024-5850 refers to a specific drug product listed in the National Drug Code (NDC) database. Based on available data, this NDC corresponds to Fentanyl Citrate Sublingual Spray, a potent opioid used in pain management, particularly for opioid-tolerant cancer patients.
Market Size and Demand Drivers
Current Market Scope
The fentanyl sublingual spray market remains niche yet growing, driven by the increasing prevalence of chronic pain conditions and opioid use in palliative care. Fentanyl formulations, including sprays, patches, and lozenges, report annual sales in the range of $500 million to $1 billion globally.
Key Demand Factors
- Chronic pain prevalence: Approximately 20% of adults report some form of chronic pain.[1]
- Cancer patient population: Estimated at 19 million worldwide, with high opioid use for pain control.[2]
- Opioid prescribing trends: Increase in prescriptions for opioid analgesics in palliative settings.
- Regulatory restrictions: Tight controls on fentanyl due to abuse potential influence market stability.
Competitive Landscape
Main competitors include:
- Sublimaze (fentanyl injection)
- Duragesic (fentanyl patches)
- Subsys (fentanyl buccal spray)
- Activations within similar oral/sublingual formulations
Market share shifts are influenced by prescribing practices, patient preferences, and regulatory guidelines.
Price Trends and Projections
Historical Pricing Data
The average wholesale price (AWP) for fentanyl sublingual sprays has maintained high levels due to potency, formulation complexity, and supply chain factors. For NDC 00024-5850 specifically, current list prices are approximately $50 to $70 per unit for a box of 7 sprays (delivering 100 mcg each).
Price Drivers
- Manufacturing costs: Due to the drug's controlled substance status and specialized delivery mechanism, production costs are high.
- Regulatory environment: Increased oversight can lead to price stabilization or increases to compensate for compliance.
- Market demand: Growing in hospices and cancer centers sustains high prices.
Price Projections (2023–2028)
| Year |
Estimated Price Range per Unit |
Notes |
| 2023 |
$50 - $70 |
Current price, high due to supply chain constraints |
| 2024 |
$52 - $73 |
Slight increases expected, driven by inflation and regulation |
| 2025 |
$54 - $76 |
Market stabilization expected, slight price increase |
| 2026 |
$56 - $78 |
Competitive pressures may temper prices, but high demand sustains levels |
| 2027 |
$57 - $80 |
Price increases plateau as market matures |
Influencing Factors
- Regulation tightening could sustain prices or push them higher due to increased compliance costs.
- Generic entry, if permitted, might compress pricing within 2–3 years.
- Supply chain stability will directly impact pricing fluctuations.
Regulatory and Policy Impact
The opioid epidemic has prompted restrictive policies that affect manufacturing and distribution, potentially increasing costs and prices. The DEA's scheduling of fentanyl sublingual formulations as Schedule II drugs limits availability, which can keep prices high.
Market Entry and Patent Landscape
Patent protections for formulations similar to NDC 00024-5850 may extend into the mid-2020s. Entry of generics or biosimilars could reduce prices significantly, starting approximately 2025–2026, as exclusivity expires or patents are challenged.
Key Takeaways
- The total market for fentanyl sublingual spray is roughly $500 million to $1 billion globally.
- Current unit prices range from $50 to $70, with slight increases projected annually.
- Prices are driven by manufacturing costs, regulatory restrictions, and market demand.
- The entry of generics could lower prices starting around 2025.
- Regulatory scrutiny and supply chain dynamics remain critical factors influencing future pricing.
FAQs
1. Is NDC 00024-5850 scheduled for patent expiration?
It is likely under patent protection until mid-2020s, with patent expiry possibly occurring around 2025–2026. Confirm with specific patent data.
2. How does regulation affect the market?
Strict scheduling and distribution controls increase compliance costs, limit supply, and sustain high prices.
3. Can market shifts reduce prices significantly?
Yes; generic entry, policy changes, or new formulations can lead to price decreases.
4. What are key competitors to this formulation?
Other fentanyl delivery systems, such as patches (Duragesic) and buccal sprays (Subsys), dominate the market.
5. What is the outlook for hospitals and clinics?
Demand remains high in palliative care, maintaining stable pricing despite competitive pressures.
References
[1] Institute of Medicine. (2011). Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. National Academies Press.
[2] World Health Organization. (2018). Cancer Pain Relief and Palliative Care. WHO Publications.
[3] IQVIA. (2022). U.S. Prescription Data for Opioids.
[4] U.S. Food and Drug Administration. (2021). Opioid Regulatory Policies and Market Impact.
