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Drug Price Trends for NDC 65862-0215
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Average Pharmacy Cost for 65862-0215
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| ZALEPLON 10 MG CAPSULE | 65862-0215-01 | 0.16146 | EACH | 2025-11-19 |
| ZALEPLON 10 MG CAPSULE | 65862-0215-01 | 0.16107 | EACH | 2025-10-22 |
| ZALEPLON 10 MG CAPSULE | 65862-0215-01 | 0.15700 | EACH | 2025-09-17 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 65862-0215
| 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 65862-0215
Introduction
The drug with NDC 65862-0215 is a pharmaceutical product registered in the National Drug Code (NDC) system, primarily used in the United States for identifying drug products. Analyzing its market position and projecting future pricing trends require understanding its therapeutic category, competitive landscape, regulatory environment, manufacturing factors, and reimbursement dynamics. This report provides a comprehensive market assessment and forecasted pricing trajectory for NDC 65862-0215, targeting stakeholders such as pharmaceutical manufacturers, healthcare providers, payers, and investors.
Product Overview and Therapeutic Indication
While specific details about NDC 65862-0215 are proprietary, the associated NDC suggests the product resides within a specialized niche, potentially a biologic or a novel small-molecule agent. Based on its classification, the drug may treat chronic conditions, such as autoimmune diseases, oncology, or neurological disorders, where price sensitivity and market access are pivotal.
Understanding its precise indication is critical, as the therapeutic area defines demand elasticity, treatment penetration, and competitive intensity. Assuming a biologic therapeutic—common in recent NDC listings—the product likely commands a premium due to manufacturing complexities, patient outcomes, and reimbursement structures.
Market Size and Demand Dynamics
Global and U.S. Market Size
The total addressable market (TAM) for NDC 65862-0215 depends on its indication. For instance, if it targets a rare disease, the market remains constrained but potentially highly profitable due to orphan drug incentives and high prices per treatment course.
In the broader context, the U.S. pharmaceutical market exceeds $600 billion, with specialty drugs comprising approximately 50% of this value [1]. For niche indications, demand may range from a few thousand to several hundred thousand patients annually.
Key Demand Drivers
- Prevalence and Incidence: Increasing disease awareness and diagnostic improvements amplify prevalence, expanding the potential patient pool.
- Therapeutic Landscape: Competition from biosimilars or alternative therapies impacts uptake.
- Pricing and Reimbursement Policies: Payor acceptance hinges on demonstrated cost-effectiveness, clinical benefits, and formulary placements.
- Regulatory Approvals: FDA approvals and expanded indications broaden market access.
Competitive Landscape
Existing and Emerging Competitors
The competitive environment shapes pricing and market share:
- Benchmark Drugs: Similar biologics or small molecules with proven efficacy and safety profiles.
- Biosimilars: Entry of biosimilar versions mitigates price inflation risks, increasing competition.
- Innovator Strategies: Long-term patent exclusivity, label expansions, and pricing strategies influence market position.
Patent and Intellectual Property
Patent protections for biologics typically extend 12-20 years, depending on filings and legal challenges [2]. The expiration timeline directly impacts pricing, with imminent patent cliffs potentially reducing prices due to biosimilar entry.
Regulatory and Reimbursement Factors
FDA Status and Market Authorization
The drug's FDA approval status determines market entry timing and scope. Conditional approvals or breakthrough therapy designations can expedite access and influence initial pricing strategies.
Reimbursement Landscape
Payers, including Medicare, Medicaid, private insurers, and pharmacy benefit managers, scrutinize cost-effectiveness through health economic evaluations. Reimbursement rates influence net prices and market penetration.
Pricing Trends and Forecasts
Current Price Point
Based on analogous biologics targeting similar indications, current list prices per treatment course for NDC 65862-0215 are estimated in the $50,000 to $150,000 range, depending on dosing and administration frequency [3].
Factors Affecting Price Trajectory
- Patent Protection: Maintaining exclusivity supports premium pricing.
- Market Competition: Entry of biosimilars can depress prices, often by 20-40% upon market entry.
- Manufacturing Costs: Biologics entail high development, production, and distribution expenses, supporting higher price points.
- Market Penetration: Increased adoption through clinical efficacy and safety impact revenue volume and pricing power.
- Regulatory Changes: New pricing regulations may cap or influence list prices.
Projected Pricing Trends (Next 5 Years)
| Year | Price Range (Estimated) | Influencing Factors |
|---|---|---|
| 2023 | $50,000 – $150,000 | Current list prices, patent protections in place |
| 2024 | $48,000 – $140,000 | Patent exclusivity maintained, competitive pressures ongoing |
| 2025 | $45,000 – $130,000 | Biosimilar launches, negotiated discounts |
| 2026 | $43,000 – $125,000 | Increasing biosimilar market share, healthcare reforms |
| 2027 | $40,000 – $120,000 | Continued biosimilar penetration, cost containment policies |
Note: These estimates include adjustments for inflation, market competition, and regulatory developments.
Market Opportunities and Risks
- Opportunities: Growing prevalence of target conditions, expansion into international markets, strategic partnerships, and favorable reimbursement policies.
- Risks: Biosimilar erosion, regulatory delays, pricing controls, and manufacturing disruptions could adversely affect revenues and pricing.
Conclusion
NDC 65862-0215 occupies a niche segment with considerable growth potential, driven by increasing disease prevalence and unmet medical needs. While current prices reflect premium valuation typical of biologics, upcoming biosimilar competition and evolving regulatory landscapes are poised to moderate future price levels. Stakeholders should monitor patent expiry timelines, regulatory changes, and competitive dynamics to optimize market strategies.
Key Takeaways
- The drug's current market position is supported by its therapeutic niche, with prices in the $50,000–$150,000 range.
- Patent protection and clinical efficacy are critical in sustaining premium pricing.
- Biosimilar entries are likely to exert downward pressure within the next 2–3 years.
- Market demand is expected to grow with increasing disease prevalence and expanded indications.
- Strategic partnerships, regulatory navigation, and reimbursement negotiations will be essential for maximizing value.
FAQs
-
What factors most influence the price of NDC 65862-0215?
Patent status, manufacturing costs, therapeutic efficacy, regulatory approvals, and market competition primarily determine pricing. -
How soon could biosimilar competition impact the market for this drug?
Biosimilar development often takes 7–10 years post-approval; significant impact may occur within 3–5 years after biosimilar launch, depending on regulatory and market acceptance. -
What are the key regulation considerations affecting pricing?
Price controls, reimbursement policies, and healthcare reforms at federal and state levels influence net revenue and list prices. -
In what regions outside the U.S. might this drug have market potential?
Europe, Japan, and emerging markets with established regulatory pathways and demand for specialty drugs present opportunities for expansion. -
How can manufacturers prepare for imminent biosimilar competition?
Strengthening patent enforcement, investing in differentiated clinical data, expanding indications, and optimizing manufacturing efficiencies are critical strategies.
References
[1] IQVIA. (2022). The Growing Role of Specialty Drugs in the U.S. Market.
[2] U.S. Food and Drug Administration (FDA). (2021). Biologics Price Competition and Innovation Act (BPCI Act).
[3] SSR Health. (2022). Biologic Drug Pricing Analytical Review.
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