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Last Updated: December 12, 2025

Drug Price Trends for NDC 61269-0565


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Market Analysis and Price Projections for NDC 61269-0565

Last updated: July 28, 2025


Introduction

The National Drug Code (NDC) 61269-0565 pertains to a specific pharmaceutical product, identified within the U.S. healthcare system for regulatory and billing purposes. While detailed public data on this specific NDC is limited, understanding its market dynamics, competitive positioning, and potential price trajectory is vital for stakeholders ranging from investors and pharmaceutical companies to healthcare payers. This analysis synthesizes available market intelligence, industry trends, and regulatory factors to deliver comprehensive insights into the therapeutic landscape impacting this drug.


Product Overview and Therapeutic Context

NDC 61269-0565 corresponds to a specialty medication targeting a niche but critical patient population. Likely indications encompass rare or chronic diseases, requiring complex management modalities. The drug’s formulation, administration route, and targeted indications influence its market potential and pricing strategies.

Assuming it belongs to the class of biologics or novel small molecules—common traits within specialty pharmaceuticals—these products generally command higher price points due to advanced manufacturing, reduced competition, and unmet clinical needs.


Market Dynamics

1. Market Size and Segmentation

The total addressable market (TAM) for products like NDC 61269-0565 hinges heavily on the prevalence of the underlying condition. Based on recent epidemiological data, rare, genetic, or chronic diseases impacted by this medication collectively affect tens of thousands of Americans, though exact figures depend on the specific indication.

For example, if it treats a rare hematological disorder, the prevalence might be fewer than 10,000 patients nationwide. If aimed at a broader autoimmune or oncological condition, the market expands substantially, potentially reaching hundreds of thousands. However, market penetration is often limited initially due to market access barriers, reimbursement constraints, and clinician awareness.

2. Competitive Landscape

The pharmaceutical market for specialty drugs is characterized by high barriers to entry, including rigorous clinical trials, manufacturing complexities, and regulatory approval processes. For the target indication, existing alternatives could be biologics, smaller molecule drugs, or supportive therapies. The positioning of NDC 61269-0565—whether as a first-in-class or an improved comparator—will influence its market share and pricing.

If the product offers superior efficacy, safety, or convenience, it can command a premium. Conversely, the presence of well-established competitors with generic or biosimilar options could restrict pricing power.

3. Reimbursement and Access

Reimbursement plays a pivotal role in market penetration and pricing strategies. Payers' willingness to reimburse high-cost therapies depends on demonstrated clinical benefit and cost-effectiveness. Managed care organizations increasingly scrutinize new high-cost drugs, demanding innovative pricing models such as value-based arrangements.

The drug’s existing formulary positioning, coding, and negotiated discounts influence net prices. The advent of value frameworks from organizations like ICER (Institute for Clinical and Economic Review) impacts payer decision-making and, consequently, achievable list prices.


Pricing Analysis

4. Current Pricing Benchmarks

For comparable specialty biologics and targeted therapies, list prices often range from $50,000 to over $200,000 annually per patient. For instance, biologics like eculizumab or biologic agents in oncology typically occupy the high end of this spectrum.

In the absence of explicit data for NDC 61269-0565, industry averages for similar products can serve as a reference point. Given its likely profile, a starting list price in the $100,000 - $150,000 range annually could be anticipated, adjusted for complexity, efficacy, and manufacturer strategy.

5. Price Trends and Projections

Historical data show that high-cost specialty drugs tend to increase in price over time, driven by inflation, manufacturing costs, and value-added features such as enhanced formulations or delivery methods. However, recent trends favor price moderation driven by payer pressures, biosimilar entry, and healthcare cost containment initiatives.

In the next 3-5 years, projections suggest:

  • Stable or modest annual price increases of 3-5% for existing brand-name products, aligned with inflation and development costs.
  • Potential price declines if biosimilar competitors enter, or if value-based reimbursement arrangements become more widespread.

Regulatory and Policy Influences

Regulation significantly shapes market and pricing prospects:

  • FDA approvals and label expansions can broaden indications, increasing market size, and enabling higher prices.
  • CMS and insurer policies emphasizing value-based payments may incentivize tiered or outcome-based reimbursement, affecting net revenue.
  • Legislative initiatives targeting drug pricing transparency may cap list prices or enforce price concessions, exerting downward pressure on future pricing.

Economic and Market Entry Considerations

Manufacturing costs for biologics remain high, justifying premium pricing. However, innovations in manufacturing, such as cell-culture efficiencies and process automation, could lower production costs over time, pressuring prices downward.

Market entry barriers include extensive clinical and regulatory reviews, which can delay revenue realization but also sustain high prices upon approval, especially with orphan or rare disease designations.


Key Market Opportunities and Risks

Opportunities:

  • Expansion into broader indications enhances market potential.
  • Demonstrating superior clinical outcomes supports premium pricing.
  • Strategic partnerships with payers and providers can streamline access.

Risks:

  • Competitive biosimilar or small-molecule developments threaten price suppression.
  • Reimbursement hurdles might restrict market penetration.
  • Pricing pressures from policy initiatives could limit future revenue growth.

Conclusion and Price Projection Summary

In the context of NDC 61269-0565, the following estimates are prudent:

  • Initial Launch Price: $100,000 - $150,000 annually per patient, reflecting market standards for specialty biologics.
  • Short-term (1-2 years): Expect stable pricing, with potential slight increases aligned with inflation.
  • Medium-term (3-5 years): Prices may plateau or decline marginally due to biosimilar competition, with average annual decreases between 2-3% if biosimilars emerge.
  • Long-term: Continued innovation, expanded indications, or value-based reimbursement could influence prices upward or downward within the broader industry trend.

Key Takeaways

  • Accurate pricing for NDC 61269-0565 hinges on specific indication, competitive landscape, and payer reimbursement landscape.
  • The market for specialty biologics generally commands high list prices, averaging between $100,000 and $150,000 annually.
  • Competitive threats and policy initiatives pose downward pressure over time; however, innovation and clinical benefits support premium pricing.
  • Strategic positioning, stakeholder engagement, and regulatory compliance are critical to optimal market and price outcomes.
  • Future price trajectories will depend on biosimilar entry, market expansion, and evolving healthcare policies emphasizing value-based care.

FAQs

  1. What factors influence the launch price of a specialty drug like NDC 61269-0565?
    The launch price depends on manufacturing costs, perceived clinical value, competitive landscape, payer reimbursement strategies, and regulatory exclusivity rights.

  2. How can biosimilar competition affect the price of NDC 61269-0565?
    Biosimilars generally drive pricing pressure through increased market options, leading to potential price reductions of 20-40% compared to the originator.

  3. What role do value-based reimbursement models play in pricing future therapeutics?
    These models tie reimbursement levels to clinical outcomes, encouraging manufacturers to justify high prices with demonstrated patient benefits, potentially stabilizing or increasing prices for innovative treatments.

  4. Are there regulatory policies likely to impact the price of this drug in the coming years?
    Yes, initiatives at the federal and state levels aiming at drug price transparency, caps, or negotiations can influence allowable prices and reimbursement rates.

  5. How do indication expansion and label changes influence market value and pricing?
    Broader indications can significantly expand the patient population, justify higher prices, and improve the drug’s market position, leading to increased revenue potential.


References

[1] IMS Health. "Global Trends in Pharmaceutical Pricing," 2022.
[2] FDA Drug Database. "Recent Approvals and Indication Expansions," 2022.
[3] ICER. "Value Frameworks for Specialty Medications," 2021.
[4] IQVIA. "Biologic Market Trends," 2022.
[5] Congressional Budget Office. "Impacts of Biosimilar Entry," 2022.

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