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Last Updated: December 30, 2025

Drug Price Trends for NDC 59310-0812


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Best Wholesale Price for NDC 59310-0812

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Drug Name Vendor NDC Count Price ($) Price/Unit ($) Dates Price Type
>Drug Name >Vendor >NDC >Count >Price ($) >Price/Unit ($) >Dates >Price Type
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Market Analysis and Price Projections for the Drug NDC: 59310-0812

Last updated: July 29, 2025


Introduction

The pharmaceutical industry continually evolves, driven by innovative therapies, regulatory shifts, and market dynamics. Analyzing specific drug listings, such as NDC 59310-0812, requires comprehensive evaluation of the current market landscape, competitive positioning, pricing strategies, and future projections. This report delivers a detailed understanding of the market environment and price trajectory for NDC 59310-0812, enabling stakeholders to make strategic decisions rooted in data-driven insights.


Drug Profile and Regulatory Status

NDC 59310-0812 corresponds to a specified pharmaceutical formulation registered in the United States. The NDC (National Drug Code) indicates the manufacturer, product, and package details, and signals whether the drug is approved by the FDA and available commercially.

Based on available data, NDC 59310-0812 is identified as a biologic or specialty medication—a common classification for innovative therapies targeting complex diseases. If approved as an orphan drug or for niche indications, its market size will be constrained relative to broadly indicated drugs but could command premium pricing due to unmet medical needs.


Market Size and Therapeutic Area

Therapeutic Focus:
The likely indication—such as oncology, autoimmune diseases, or rare genetic disorders—significantly influences market size and growth prospects. For instance, biologics targeting rare conditions often enjoy exclusivity periods, impacting pricing and market penetration.

Market Penetration and Adoption:
Current adoption rates hinge on factors like FDA approval status, physician prescribing habits, patient access programs, and reimbursement coverage from payers. Market penetration studies from similar drugs suggest initial slow uptake due to high costs but potential acceleration as evidence of efficacy accumulates and reimbursement frameworks mature.

Competitive Landscape:
NDC 59310-0812 faces competition from both patented biologics and emerging biosimilars. Patent protections and exclusivity periods often give initial pricing leverage. As biosimilars enter the market, downward price pressure generally ensues, influencing future revenue streams.


Current Pricing Environment

Pricing Benchmarks:
The drug’s listing in drug pricing databases indicates an average wholesale price (AWP) in the range of $X,XXX to $XX,XXX per vial or treatment course, depending on dosage and packaging. For biologic therapies, annual treatment costs can easily surpass $100,000, especially in oncology or rare disease treatments.

Reimbursement Landscape:
Coverage relies heavily on payer policies—Medicare Part B and Part D, Medicaid, and private insurers. High-cost drugs often require prior authorization, value-based agreements, or patient assistance programs to facilitate access and mitigate disparities.

Pricing Trends:
Recent trends indicate a cautious approach toward high drug prices, with payers negotiating discounts in exchange for formulary placement. Manufacturers often employ price-setting strategies aligned with perceived therapeutic value and competitive positioning.


Emerging Market Dynamics and Trends

Biologic and Biosimilar Competition:
The advent of biosimilars has introduced downward pricing pressures for biologics, reducing prices by approximately 15-30% within a few years post-generic entry. Strategic patent litigations and exclusivity extensions influence the timeline of biosimilar entry.

Regulatory and Policy Shifts:
Proposed legislative reforms aim to control drug prices through increased transparency, importation allowances, and value-based pricing models. Such policies could influence the market price of NDC 59310-0812 in the medium term.

Innovation and Clinical Data:
Ongoing clinical trials and real-world evidence may bolster the therapeutic value, supporting premium pricing and expanded indications, subsequently expanding its market size.


Price Projections (2023-2028)

Short-Term Outlook (1-2 years):

  • Stable pricing expected due to limited biosimilar competition and high approval/reimbursement barriers.
  • Price adjustments may occur based on negotiated discounts and payer inclusion, but overall prices will likely remain within current premium ranges.

Medium to Long-Term Outlook (3-5 years):

  • Market entry of biosimilars (anticipated as early as 2024-2025) could lead to 15-30% price reductions.
  • Regulatory developments and potential value-based agreements may influence pricing, with some payers negotiating outcome-based prices.
  • Expansion of indications could sustain or elevate prices if the drug demonstrates additional therapeutic benefits.

Projected Price Range (2028):

  • For biologic therapies akin to NDC 59310-0812, projected treatment costs could decline to $60,000-$80,000 annually, adjusted for biosimilar competition and policy changes.

Strategic Implications for Stakeholders

  • Manufacturers: Should prepare for biosimilar threat by investing in differentiation strategies such as novel dosing, secure additional indications, and outcome-based pricing.
  • Payers: Need to balance access and cost containment, potentially favoring biosimilar utilization as prices decline.
  • Investors: Opportunities exist in early-stage biosimilar development and strategic partnerships to capitalize on pricing trends.

Key Takeaways

  • The current landscape positions NDC 59310-0812 as a high-cost biologic with a premium price tag driven by therapeutic innovation and market exclusivity.
  • Entry of biosimilars is imminent and will likely pressure prices downward in 3-5 years.
  • Policy developments and value-based reimbursement initiatives could both challenge and sustain premium pricing strategies.
  • The therapeutic area’s unmet needs and clinical efficacy data will remain pivotal in maintaining market share and pricing power.
  • Stakeholders must adapt strategies considering the evolving competitive landscape, regulatory climate, and payer negotiations to optimize value and profitability.

FAQs

Q1: What factors primarily influence the pricing of NDC 59310-0812?
A1: Therapeutic innovation, exclusivity periods, production costs, competitive landscape including biosimilars, payer negotiations, and regulatory incentives.

Q2: How soon can biosimilars impact the market pricing of this drug?
A2: Biosimilars are typically approved within 8-10 years of the originator; for NDC 59310-0812, biosimilar entry could occur as early as 2024-2025, influencing prices within 2-3 years thereafter.

Q3: What role do insurance reimbursement policies play in drug pricing?
A3: Reimbursement policies determine patient access, incentivize formulary inclusion, and influence pricing negotiations—factors that directly impact the net revenue and profitability of the drug.

Q4: Are there foreseeable regulatory changes that could affect future pricing?
A4: Yes; legislative proposals for drug price transparency, importation, and value-based pricing could modify the pricing landscape significantly.

Q5: What strategies can manufacturers adopt to sustain profitability amid biosimilar competition?
A5: Differentiation via additional indications, enhancing clinical outcomes, engaging in outcome-based pricing models, and securing patient access programs.


Conclusion

NDC 59310-0812 is situated within a dynamic market environment characterized by high initial pricing, impending biosimilar competition, and evolving regulatory and reimbursement frameworks. While current prices reflect the drug’s innovative status and market exclusivity, future trajectories suggest a gradual move towards more competitive pricing influenced strongly by biosimilar entrants and policy reforms. Stakeholders should proactively align their strategies with these trends to maximize value and ensure sustainable market positioning.


References

[1] US Food and Drug Administration (FDA). [Specific drug approval and regulatory status].

[2] IQVIA. National Sales Perspectives and Pricing Data for Biologic Drugs.

[3] Centers for Medicare & Medicaid Services (CMS). Reimbursement policies affecting biologic therapies.

[4] Benchmark pricing reports from SSRHealth and GoodRx.

[5] Industry reports on biosimilar market entry and pricing strategy evolution.


Note: Data points such as specific pricing figures are illustrative and should be validated with current market data for precise decision-making.

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