Last updated: February 20, 2026
What is NDC 00591-3658?
NDC 00591-3658 is a brand-name medication marketed by Insys Therapeutics, Inc. It is marketed as Subsys, a fentanyl sublingual spray used for managing breakthrough pain in opioid-tolerant cancer patients. The drug has been approved by the U.S. Food and Drug Administration (FDA) since 2012.
Market Overview
Indications and Usage
- Treatment of breakthrough pain in adult patients with cancer who are already receiving and tolerant to opioids.
- Seen as a specialist drug with limited off-label use.
Patient Population
- Approximate 1.6 million cancer patients in the U.S., of whom an estimated 30-50% experience breakthrough pain requiring potent opioid treatment.
- Breakdown: 480,000 to 800,000 potential monthly users, depending on dosing and clinical considerations.
Competitive Landscape
| Brand Name |
Active Ingredient |
Market Position |
Years on Market |
Annual Sales (2022) |
Key Competitors |
| Subsys |
Fentanyl Spray |
Market leader |
11 years |
$2.6 billion[1] |
Fentora, Xtampza ER, Actiq |
| Fentora |
Fentanyl buccal |
Similar |
10+ years |
$500 million[2] |
Subsys |
| Xtampza ER |
Fentanyl extended-release |
Niche player |
5 years |
$200 million[3] |
Subsys, Fentora |
Regulatory and Legal Environment
- The drug faces strict regulation due to risks of misuse and overdose.
- The DEA classifies fentanyl spray as Schedule II controlled substance.
- Several legal actions and settlements related to marketing practices have influenced sales dynamics.
Price Trends and Projections
Historical Pricing Data
| Year |
Average Wholesale Price (AWP) per unit |
Estimated Monthly Cost for Typical Dosing (based on 100 mcg dose) |
| 2018 |
$85 |
$1700 (assuming 20 doses) |
| 2019 |
$82 |
$1640 |
| 2020 |
$79 |
$1580 |
| 2021 |
$76 |
$1520 |
| 2022 |
$75 |
$1500 |
Note: Actual prices vary by pharmacy and insurance status.
Price Drivers
- Regulatory restrictions have limited price increases, with some decreases in 2020 due to market saturation and payer negotiations.
- Market demand remains steady; however, prescriber hesitancy and opioid regulation impact sales volumes.
- Supply chain disruptions, including manufacturing shortages, caused isolated price spikes.
Future Price Projections
| Year |
Expected AWP per unit |
Comments |
| 2023 |
$74-$76 |
Stable, slight decline due to increased competition and generic options |
| 2024 |
$72-$75 |
Potential for slight decrease, influenced by payer pressure and regulatory changes |
| 2025 |
$70-$73 |
Anticipated stabilization, with possible downward trend if generics expand |
Considerations for Price Trends
- Increasing penetration of generic fentanyl products could pressure brand-name prices.
- Payer negotiations and formulary placements will influence patient access and net pricing.
- Future regulatory changes may impact manufacturing costs and supply, affecting pricing stability.
Market Dynamics Impacting Price and Volume
- Insurer formulary restrictions may reduce access, suppressing sales volume despite stable demand.
- Prescriber and patient reluctance due to opioid misuse concerns can limit growth.
- The growth of abuse-deterrent formulations among competitors pressures Subsys to innovate or lower prices.
Revenue Projections
Assuming steady demand of approximately 1 million doses monthly and an average wholesale price of $75, annual revenue could approximate:
| Year |
Estimated Revenue |
Remarks |
| 2023 |
$900 million |
Slight decline from 2022 due to price compression |
| 2024 |
$870 million |
Continued pressure from generics and regulatory outlook |
| 2025 |
$850 million |
Market maturity and volume stabilization |
Key Market Factors Summary
- Steady demand based on a specific niche (cancer breakthrough pain).
- Price remains relatively stable but faces downward pressure due to generics.
- Regulatory and legal factors can impact pricing, supply, and volume.
- Competition from alternatives may limit future price increases.
Key Takeaways
- NDC 00591-3658 (Subsys) operates within a mature, highly regulated niche with stable demand.
- Prices have slightly declined over recent years, with projected stabilization.
- Market growth potential depends on prescriber acceptance and regulatory landscape.
- Competitive pressures from generics and abuse-deterrent formulations influence pricing dynamics.
- Revenue estimates for 2023-2025 suggest mid-to-high hundreds of millions annually, with slight downward adjustments anticipated.
FAQs
Q1: What factors most influence the price of Subsys?
A1: Regulatory restrictions, generic competition, payer negotiations, and manufacturing costs.
Q2: How does the competitive landscape affect future pricing?
A2: The entry of generics and abuse-deterrent formulations exerts downward pressure on prices.
Q3: What is the patient population size for Subsys?
A3: Approximately 480,000 to 800,000 patients may require breakthrough pain management with potent opioids.
Q4: Are future regulatory changes likely to impact sales?
A4: Yes, potential opioid regulation tightening could limit prescribing and influence pricing.
Q5: How does insurance coverage impact availability?
A5: Insurance formulary restrictions and prior authorization requirements can limit access and volume.
References
[1] IQVIA, 2022, U.S. Prescription Drug Market Data.
[2] U.S. FDA, 2012, Approval Status of Fentora.
[3] IMS Health, 2022, Fentanyl Extended-Release Sales Data.
