Last updated: March 9, 2026
What is NDC 46122-0788?
NDC 46122-0788 is a unique identifier assigned by the FDA for a specific drug product. The product is AcelRX’s sufentanil sublingual tablet (Brand Name: Dsuvia). Approved in 2018, Dsuvia addresses severe acute pain, typically in hospital settings. It is a high-potency opioid, classified as Schedule II, with significant regulatory and misuse considerations.
Market Landscape
Current Market Size
The demand for opioids like Dsuvia depends on surgical procedures, inpatient pain management, and opioid prescription trends. The current opioid market in the U.S. was valued at approximately $22 billion in 2022, with a declining trend due to regulation, opioid stewardship programs, and alternatives (IQVIA, 2022).
Market Drivers
- Hospital Use: Limited to inpatient settings with controlled administration.
- Opioid Crisis Response: Regulatory scrutiny impacts prescribing practices but maintains demand for specific pain management alternatives.
- Innovation in Analgesics: There is competitive pressure from non-opioid analgesics and abuse-deterrent formulations.
Market Barriers
- Regulatory Restrictions: Dsuvia’s approval came with strict controls; its use is limited to hospitals with a REMS (Risk Evaluation and Mitigation Strategy).
- Reputation and Safety Concerns: Increased focus on opioid misuse limits prescriber enthusiasm.
- Pricing Pressure: Payors and hospitals seek cost-effective alternatives.
Competitive Landscape
- Other Opioids: Morphine, fentanyl patches, intranasal sprays.
- Non-Opioids: NSAIDs, acetaminophen, nerve blocks.
- Abuse-Deterrent Formulations: Designed to mitigate misuse, affecting market share.
Key competitors in analgesic market segments include:
- Fentanyl transdermal patches
- Hydromorphone injections
- Non-opioid alternatives like ketamine infusions
Price Projections
Current Pricing
As of 2023, the approximate wholesale acquisition cost (WAC) for Dsuvia is:
| Metric |
Price ($) |
| Per 30-count box |
$3,000 - $3,500 |
This translates to approximately $100-$117 per tablet, considering typical dosing.
Price Trends (2023-2027)
- Short-term (2023-2024): Prices are expected to remain stable due to limited supply chain variability and regulatory controls.
- Mid-term (2025-2026): Prices could decline slightly (5-10%) if generic formulations or alternative medications gain market share or if hospital procurement strategies tighten.
- Long-term (2027): Depending on usage restrictions and market acceptance, prices may decline further, potentially stabilizing around $80-$100 per tablet.
Factors Influencing Price Changes
- Regulatory Landscape: Stricter controls could limit distribution, reducing volume but maintaining high prices for authorized use.
- Market Penetration: Limited hospital adoption may keep prices high and volume low.
- Insurance and Reimbursement: Changes in coverage policies could pressure hospitals to lower acquisition costs.
- Generic Development: No current generics exist; approval of alternatives may suppress prices.
Policy and Regulatory Impact
The FDA’s REMS for Dsuvia restricts distribution to certified providers and enforces safety protocols. This maintains a controlled market with limited volume and high prices but limits growth potential.
Conclusions
- The current market for NDC 46122-0788 (Dsuvia) is restricted to specific institutional settings, with limited patient population access.
- The price in 2023 remains high, reflecting its controlled status and high potency.
- Future price declines are likely but gradual, contingent on regulatory changes, market acceptance, and emergence of alternatives.
Key Takeaways
- The drug faces a constrained market due to regulatory restrictions and safety concerns.
- Prices are currently high, around $100-$117 per tablet.
- Market growth is limited; prices could decline modestly over the next four years.
- Competition from other opioids and non-opioid painkillers remains influential.
- Long-term prospects depend heavily on regulatory trends and societal perspectives on opioid use.
FAQs
Q1: What factors most influence Dsuvia’s pricing?
Regulatory restrictions, hospital adoption rates, and competition from alternative analgesics.
Q2: How does regulatory oversight impact Dsuvia’s market?
It restricts distribution and limits volume, maintaining high prices but reducing market size.
Q3: Are there generic versions of Dsuvia available?
No, as of 2023, generic formulations are not approved, but competitors may develop alternatives.
Q4: What regions outside the U.S. could be interested in Dsuvia?
Limited international markets due to regulatory hurdles and safety concerns, mainly high-income countries with established opioid markets.
Q5: How will the opioid epidemic influence Dsuvia’s future?
It will likely constrain usage growth and keep prices high, with increased oversight and potential shifts toward non-opioid therapies.
References
- IQVIA. (2022). Opioid Market Analysis. IQVIA Reports.
- FDA. (2018). Approval of Dsuvia (sufentanil sublingual tablet). Federal Register.
- Medtrack. (2023). Drug pricing and market trends for opioids.
- Healthcare Data & Analytics. (2023). Opioid product market projections.
