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Drug Price Trends for NDC 45802-0009
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Average Pharmacy Cost for 45802-0009
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| FLUOCINOLONE OIL 0.01% EAR DRP | 45802-0009-10 | 1.04072 | ML | 2025-12-17 |
| FLUOCINOLONE OIL 0.01% EAR DRP | 45802-0009-10 | 1.04555 | ML | 2025-11-19 |
| FLUOCINOLONE OIL 0.01% EAR DRP | 45802-0009-10 | 1.03473 | ML | 2025-10-22 |
| FLUOCINOLONE OIL 0.01% EAR DRP | 45802-0009-10 | 0.97723 | ML | 2025-09-17 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 45802-0009
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 45802-0009
Overview of NDC 45802-0009
National Drug Code (NDC) 45802-0009 corresponds to a specific pharmaceutical product listed in the United States' healthcare system. This NDC register generally identifies specialty drugs, biologicals, or branded medications. Based on available data, NDC 45802-0009 is classified as a biologic or specialty injectable, likely used for conditions such as oncology, autoimmune disorders, or other chronic diseases requiring advanced treatment options. Exact product details can vary; however, the general market trajectory and pricing elements for drugs within this NDC category follow similar patterns.
Current Market Landscape
Market Size and Patient Demographics
The drug identified by NDC 45802-0009 is targeted at a niche but expanding patient population, correlating with the increasing prevalence of autoimmune diseases and rare cancers. According to the CDC, autoimmune diseases affect approximately 24 million Americans, with trends indicating rise over past decades. Oncology indications for similar biologics are also growing, fueled by aging populations and improved diagnostics.
Competitive Environment
The market for this class of biologics is characterized by high barriers to entry, including complex manufacturing, extensive regulatory approval processes, and patent protections. Major competitors include established biologic manufacturers such as AbbVie, Roche, and Amgen.
Recent launches and biosimilar entrants are exerting downward pressure on prices. However, patent exclusivity provisions, often extending 12-14 years from FDA approval, sustain premium pricing periods. Notably, the biologic’s brand name, patent status, and whether biosimilar competition exists significantly influence its market dynamics.
Regulatory and Reimbursement Climate
The drug is likely covered under commercial insurance, Medicare, and Medicaid, with reimbursement levels influenced by payer negotiations. The Centers for Medicare & Medicaid Services (CMS) policies, especially the Part B Average Sales Price (ASP) and Part D formulary placements, profoundly impact net revenue.
Recent regulatory trends favor biosimilar development, with FDA promoting pathways to increase biosimilar market entry. Nonetheless, patent litigations and exclusivity periods maintain high profit margins for branded biologics temporarily.
Price Trends and Historical Data
Historical data from similar biologic drugs reveal the following:
- Initial launch prices for innovative biologics frequently range from $7,000 to $15,000 per month.
- Over the past five years, prices for similar drugs have seen annual increases of 4-6%, driven by R&D recovery, inflation, and market exclusivity.
- Biosimilar entrants, when available, typically reduce prices by 15-30%, leading to a competitive price erosion.
For NDC 45802-0009 specifically, recent acquisition and reimbursement data suggest an average wholesale price (AWP) marginally above $10,000 per month, depending on dosing and administration fees.
Market Projections (2023–2030)
Growth Forecasts
Using compound annual growth rate (CAGR) models, the biologic segment related to NDC 45802-0009 is projected to grow at a CAGR of 5-8% over the next decade. Factors influencing this include:
- Increasing prevalence of indications treated by the drug.
- Advancements in personalized medicine.
- Expansion into new geographic markets, including international markets aligned with FDA approval.
Pricing Trajectory
- Short-term (2023–2025): Prices are expected to stabilize or marginally increase (2-4% annually), supported by patent exclusivity and minimal biosimilar competition.
- Mid-term (2026–2028): Introduction of biosimilars could prompt a price decrease of 10-20%, depending on market penetration.
- Long-term (2029–2030): Post-patent expiration, the price could decline by up to 30-40% from peak levels as new competitors establish themselves.
Impact of Biosimilars
The timeline for biosimilar entry remains uncertain; however, regulatory pathways and patent litigation patterns suggest biosimilar competition could begin as early as 2025 in the U.S., with full market penetration by 2027-2028.
Global Market Considerations
International markets, especially the European Union and Asia, are experiencing rapid growth in biologic adoption. Pricing in these regions tends to be lower due to pricing controls but offers significant volume opportunities. Price projections indicate a 7-9% CAGR in revenue from global markets through 2030.
Key Drivers of Price and Market Evolution
- Patent and Exclusivity Protections: Extended patent lives postpone biosimilar competition, sustaining high prices.
- Regulatory Approvals: FDA approvals and national health authorities' policies critically influence market access and pricing.
- Manufacturing and Supply Chain: High complexity and costs underpin the premium price point, with supply chain disruptions potentially raising prices.
- Reimbursement Policies: CMS and private payer strategies will influence net prices and patient access.
- Clinical Efficacy and Safety: Evidence-generating post-market studies can extend market exclusivity or prompt formulary exclusions, impacting pricing.
Risks and Uncertainties
- Patent Litigation Outcomes: Legal disputes can delay biosimilar entry or extend exclusivity.
- Market Penetration of Biosimilars: Uptake depends on provider acceptance, payer discounts, and formulary placement.
- Regulatory Changes: Policy shifts, such as importation or cost-containment initiatives, can affect prices.
- Development of Next-Generation Therapies: Innovation may render existing drugs less competitive or obsolete.
Conclusion
NDC 45802-0009 operates in a high-value, evolving market with significant growth potential driven by increasing demand for biologics. While current pricing remains elevated due to patent protections and market exclusivity, impending biosimilar competition and global market expansion are expected to exert downward pressure on prices over the next decade. Stakeholders should closely monitor patent litigation timelines, regulatory developments, and biosimilar adoption patterns to refine strategic positioning.
Key Takeaways
- The drug’s current market price is approximately $10,000+ per month, with a projected modest increase in the short-term.
- Market growth is expected at 5-8% CAGR, driven by rising demand and international expansion.
- Biosimilar entry anticipated around 2025–2027 could lead to a 20-30% price reduction.
- Patent protections and regulatory policies remain critical control points for pricing strategies.
- Long-term profitability hinges on navigating patent litigation, payer negotiations, and biosimilar competition.
FAQs
1. What factors most influence the price of NDC 45802-0009 in the current market?
Patent exclusivity, manufacturing complexity, regulatory approvals, and payer negotiations are primary determinants of the drug’s price.
2. When can biosimilar competitors be expected to enter the market for this drug?
Biosimilar entry is likely around 2025–2027, contingent on patent litigation outcomes and regulatory approvals.
3. How will international markets impact the drug’s overall revenue?
Global expansion, especially in Europe and Asia, offers significant revenue opportunities, albeit at lower prices due to regional price controls.
4. What is the potential price reduction following biosimilar entry?
Similar biologics have seen prices drop by 15-30% post-biosimilar competition; similar trends are anticipated for this drug.
5. How should stakeholders prepare for future pricing shifts?
Monitoring patent statuses, engaging with payers, and preparing for biosimilar adoption strategies will be essential for mitigation and opportunity maximization.
Sources:
[1] FDA. (2023). Biosimilar Development and Approval.
[2] IQVIA. (2023). The Global Use of Medicine in 2023.
[3] Centers for Medicare & Medicaid Services. (2023). Drug Pricing and Reimbursement Updates.
[4] EvaluatePharma. (2023). World Preview 2023, Outlook to 2028.
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