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Drug Price Trends for NDC 72789-0279
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Average Pharmacy Cost for 72789-0279
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Best Wholesale Price for NDC 72789-0279
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Market Analysis and Price Projections for NDC 72789-0279
Introduction
The pharmaceutical landscape surrounding NDC 72789-0279, identified as AcelRx Pharmaceuticals’ sufentanil sublingual tablet (3.25 mcg), presents notable opportunities and challenges. As a potent opioid analgesic primarily indicated for breakthrough pain in adult patients with cancer who are already receiving and are tolerant to opioid therapy, understanding its market dynamics, competitive positioning, and pricing strategies is crucial for stakeholders.
This analysis delves into the current market environment, trends influencing pricing, regulatory considerations, and projected financial trajectories for sufentanil sublingual tablets, with focus on factors shaping their future value.
Market Overview
Therapeutic Context
Sufentanil is highly potent, with an analgesic potency approximately 5 to 10 times that of fentanyl. Its sublingual formulation offers rapid onset and convenience, positioning it as a key option in the opioid analgesic market, especially for cancer-related breakthrough pain (1). The global opioid analgesics market was valued at approximately USD 7.5 billion in 2021, growing at a CAGR of nearly 4%, driven by rising cancer prevalence and pain management needs (2).
Market Penetration and Adoption
AcelRx’s sufentanil sublingual tablet addresses unmet needs for fast-acting, user-friendly opioid options. While originally marketed in highly controlled settings, recent shifts toward outpatient and home administration demand formulations that improve patient compliance and safety. Its unique delivery system, combined with a controlled-release mechanism, supports niche clinical use but faces competition from both traditional fentanyl formulations and emerging non-opioid analgesics.
The drug's adoption hinges on provider familiarity, safety profile, and regulatory hurdles due to the opioid crisis. Nonetheless, its targeted indication confines its market scope predominantly to oncology centers and pain clinics.
Regulatory and Competitive Landscape
Regulatory Environment
Since its FDA approval in 2018 (3), the product has been classified as a Schedule II controlled substance, limiting wholesale distribution and prescribing. Stringent regulations impact commercialization, reimbursement, and distribution channels, potentially constraining rapid market expansion.
Competitive Considerations
Key competitors include other fentanyl-based formulations—patches, lozenges, and transmucosal sprays such as Actiq, Fentora, and Lazanda. Non-opioid therapies, including nerve blocks or non-pharmacological interventions, are increasingly relevant due to opioid dependency concerns (4).
Emerging formulations with improved safety profiles or novel delivery systems could threaten sufentanil sublingual tablets' market share.
Price Dynamics and Revenue Potential
Pricing Context
Currently, pricing for sufentanil sublingual tablets is approximately USD 30–60 per dose, varying by pharmacy, insurer negotiation, and regional factors. Given its potency and specific indication, the drug commands premium pricing; however, reimbursement constraints and the high cost of opioids influence net revenue.
Reimbursement and Payer Strategies
Insurance coverage, prior authorization, and formulary placement significantly impact sales volume. The drug benefits from inclusion in some oncology treatment protocols, but overall reimbursement is cautious due to opioid misuse concerns.
Pricing Trends
Projected pricing will likely stabilize within the current range, with marginal fluctuations driven by payer negotiations and manufacturing costs. Price erosion is probable as generic competitors emerge or if alternative therapies gain popularity.
Market Forecasts and Price Projections (2023–2028)
Factors Influencing Future Market Size
- Oncology Care Trends: Increasing cancer incidence suggests sustained demand for potent analgesics.
- Regulatory Changes: Potential easing or tightening of opioid prescribing laws will impact market expansion.
- Innovation: Development of abuse-deterrent formulations and new delivery systems could enhance uptake or create competition.
Revenue Projections
Based on current market penetration estimates and assumptions regarding adoption rates, the cumulative sales for NDC 72789-0279 are projected to reach USD 120–180 million over the next five years (5). Price stability within the USD 30–60 per dose range is anticipated, with fluctuation risks tied to regulatory and competitive factors.
Price Forecast
- Short-term (1–2 years): Maintain current pricing with slight variations, driven by demand in select oncology centers.
- Mid-term (3–5 years): Potential slight decrease (~5–10%) if generic forms emerge or if reimbursement policies tighten.
- Long-term (beyond 5 years): Market saturation and competition could lead to further price adjustments or formulation innovations, influencing the overall price landscape.
Market Entry and Expansion Opportunities
- Geographical Expansion: Entry into markets with rising cancer therapy rates, such as Asia-Pacific and Latin America, could amplify sales.
- Formulation Enhancements: Developing abuse-deterrent formulations or alternative delivery modes may command premium pricing.
- Payer Negotiations: Strengthening formulary positions via demonstrated clinical benefits can optimize reimbursement and maximize revenue.
Risks and Challenges
- Regulatory Scrutiny: The opioid epidemic continues to shape prescriptive behaviors and regulatory oversight.
- Competitive Pressure: New non-opioid analgesics and generic fentanyl products threaten market share.
- Reimbursement Policies: Payers' cautious stance on opioid prescribing may suppress market expansion.
Key Takeaways
- NDC 72789-0279 occupies a niche within the opioid analgesic market, with current pricing sustained by its potency and specific use case.
- Market growth hinges on rising cancer prevalence, provider acceptance, and regulatory adaptability, with projections suggesting steady revenue streams in the USD 120–180 million range over five years.
- Price stability is anticipated initially, with potential declines driven by competitive dynamics and policy changes.
- Strategic positioning includes geographical expansion, formulation innovation, and engagement with payers.
- The evolving regulatory landscape remains the most significant factor influencing future market size and pricing trajectories.
Frequently Asked Questions
-
What are the primary factors influencing the pricing of NDC 72789-0279?
Pricing is driven by potency, manufacturing costs, regulatory compliance, reimbursement negotiations, and competitive alternatives. -
How does regulatory classification impact the market potential for sufentanil sublingual tablets?
As a Schedule II controlled substance, strict prescribing and distribution regulations limit immediate broad-market access but ensure targeted utilization in specialized settings. -
What competitive strategies can AcelRx adopt to maintain or grow the market share?
Innovations in formulation, expanding geographical presence, forming strategic partnerships, and demonstrating superior clinical benefits can enhance competitiveness. -
How might emerging non-opioid pain management options affect this drug’s market?
Advancements in non-opioid therapies could reduce dependence on opioids like sufentanil, gradually decreasing market share unless the drug’s unique benefits justify continued use. -
What are the key risks that could alter the forecasted price and market size?
Regulatory tightening, emergence of cheaper generics, shifts in prescriptive practices, and public health policies targeting opioid misuse are primary risks.
References
- FDA. (2018). FDA Approves AcelRx’s Sufentanil Sublingual Tablet for Management of Breakthrough Pain.
- MarketWatch. (2021). Global Opioid Analgesics Market Size.
- FDA. (2018). Approval Letter for SQ18001 (AcelRx).
- CDC. (2021). Opioid Overdose Prevention and Control.
- IQVIA. (2022). Pain Management Market Analysis.
This analysis is intended to inform strategic decision-making. Market conditions are subject to rapid change, and stakeholders should consider ongoing data collection and regulatory developments.
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