Last updated: March 18, 2026
What Is NDC 69097-0859?
NDC 69097-0859 is a drug product identified by the National Drug Code (NDC) as a specific formulation. According to the FDA database, this code corresponds to Fentanyl Citrate Sublingual Tablets, 100 mcg.
Product Overview
- Active Ingredient: Fentanyl citrate
- Dosage Strength: 100 mcg
- Formulation: Sublingual tablets
- Indications: Managed pain in opioid-tolerant patients (primarily for acute or chronic pain).
Market Landscape
Market Size
The fentanyl sublingual tablet market targets primarily pain management for opioid-tolerant patients. The global fentanyl market was valued at approximately $3.2 billion in 2021, with a Compound Annual Growth Rate (CAGR) of around 7% from 2022 to 2027. The sublingual segment accounted for estimated 20% of this market, driven by preferences for rapid-onset formulations.
Competition and Key Players
Major competitors include:
- Aliq (Alkermes)
- Abstral (Insys)
- Sublimaze (Mallinckrodt)
- Generic manufacturers (multiple firms producing fentanyl sublingual tablets)
Market entry barriers include strict regulatory requirements, high R&D costs, and safety concerns surrounding fentanyl.
Regulatory Environment
The FDA classifies fentanyl under controlled substances (Schedule II). Deployment of restrictions such as REMS (Risk Evaluation and Mitigation Strategies) limits distribution. Recent policy changes focus on combating illicit fentanyl, adding complexity for legal market expansion.
Distribution Channels
- Hospital pharmacies
- Specialty pharmacies
- Pain clinics
- Import/export channels (where regulatory allowances exist)
Pricing Considerations
- Current List Price: The listed retail price for equivalent branded fentanyl sublingual products ranges between $43 and $72 per 30-tablet blister pack (per 100 mcg strength).
- Generic Price Point: Generics typically retail at 20-40% lower prices.
- Reimbursement: Coverage varies under Medicaid, Medicare, and private insurers; prior authorization is common.
Price Projection Analysis
Base Case Assumptions
- Market Penetration: 5–10% of designated pain management market within 5 years.
- Pricing Strategy: Slightly below leading competitors for market entry.
- Channel Distribution: Primarily through specialty pharmacies and hospitals.
- Regulatory Stability: No significant regulatory changes, but increased monitoring expected.
5-Year Price Trend (2023–2028)
| Year |
Estimated Average Price per 100 mcg Tablet |
Rationale |
| 2023 |
$1.20 |
Initial launch, competitive positioning, regulation limits |
| 2024 |
$1.10 |
Slight reduction due to generics, competitive pressure |
| 2025 |
$1.05 |
Market expansion, pricing stabilization |
| 2026 |
$1.00 |
Increased generics dilute price, volume offsets |
| 2027 |
$0.95 |
Price compression continues, reimbursement pressures |
Note: These estimates are based on comparable trends observed in similar fentanyl formulations (e.g., Abstral). The influence of potential shortages or regulatory restrictions could alter these projections.
Risks to Price Stability
- Regulatory Actions: Stricter controls could tighten supply.
- Generic Entry: May lead to significant price erosion.
- Market Demand: Dependence on opioid-tolerant patient populations limits volume growth.
- Insurance Coverage Changes: Could restrict patient access, impacting revenue.
Revenue Implications
Assuming a conservative market share of 5%, the revenue from the product could reach:
- Year 1: ~$12 million (assuming volume of 10 million tablets at ~$1.20 per tablet)
- Year 5: ~$25 million (assuming increased market share, lower prices, and higher volumes)
Key Takeaways
- NDC 69097-0859 corresponds to a fentanyl sublingual tablet used in pain management.
- The market is dominated by branded and generic players, constrained by regulatory restrictions.
- Pricing is expected to decline incrementally over five years, with an initial retail price around $1.20 per tablet.
- Market growth hinges on penetration into opioid-tolerant patient populations and regulatory stability.
- Revenue projections suggest modest gains constrained by high competition and regulatory challenges.
FAQs
1. How does regulatory policy impact fentanyl product pricing?
Restrictions under REMS and tighter controls reduce supply flexibility, potentially increasing costs for manufacturers but often leading to lower retail prices due to limited distribution channels.
2. Are generics likely to significantly affect the market for NDC 69097-0859?
Yes. As patents expire, generic competition typically leads to a 20-40% price reduction, pressuring branded product margins.
3. What are key barriers to market entry for new fentanyl-based products?
Regulatory approval costs, safety concerns, and restricted distribution channels create substantial barriers.
4. How does insurance reimbursement influence pricing strategies?
Reimbursement policies often restrict access, compelling manufacturers to set competitive prices while managing payer negotiations.
5. What factors could cause the market to grow faster than projections?
Increased opioid-tolerant patient populations, new formulations offering advantages, or reduced regulatory restrictions could accelerate growth.
References
- Food and Drug Administration. (2022). NDC directory. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases
- Grand View Research. (2022). Fentanyl market size, share & trends. https://www.grandviewresearch.com/industry-analysis/fentanyl-market
- IQVIA. (2022). Drug pricing and reimbursement insights.
- U.S. Drug Enforcement Administration. (2022). Fentanyl regulations. https://www.deadiversion.usdoj.gov/Notice/list1_4/index.html
