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Last Updated: January 1, 2026

Drug Price Trends for NDC 64380-0797


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Market Analysis and Price Projections for NDC 64380-0797

Last updated: September 11, 2025


Introduction

The National Drug Code (NDC) 64380-0797 represents a specific pharmaceutical product within the U.S. healthcare market. Its proprietary identity implies a distinct formulation, manufacturer, and therapeutic indication. Analyzing its market landscape and projecting future pricing dynamics involve evaluating industry trends, competitive positioning, regulatory factors, and economic influences. This report synthesizes current market intelligence to assist stakeholders—manufacturers, payers, and investors—in strategic decision-making.


Product Overview

NDC 64380-0797 corresponds to a specific formulation, likely biologic or small-molecule drug, designed for targeted therapy. While precise details depend on proprietary databases, typical attributes influencing market success include therapeutic efficacy, safety profile, administration route, and patent status.

Assuming the drug advances as a specialized treatment in areas such as oncology, immunology, or rare diseases, these fields currently exhibit robust growth driven by unmet needs and innovative therapies. The product's lifecycle stage—whether launching or established—profoundly impacts market and pricing dynamics.


Market Landscape

Therapeutic Indication and Patient Demographics

The market size hinges on the disease prevalence and demographic factors. For instance, if the drug treats a rare disease (orphan indication), market size remains constrained but commands premium pricing due to limited competition and high unmet needs.

Conversely, if it provides a broader indication—such as autoimmune diseases or cancers—the potential patient population expands, influencing revenue expectations and price benchmarks.

Competitive Environment

Competitive analysis requires identifying existing therapies, biosimilars, and pipeline products targeting similar indications:

  • Brand Name and Biosimilar Competition: Patent expiry schedules dictate the pace of biosimilar entries, exerting downward pressure on prices.
  • Market Share Dynamics: Established players with entrenched clinical workflows may slow adoption of new entrants, impacting revenue projections.
  • Exclusivity Periods and Patent Life: Intellectual property protections sustain pricing power; however, impending patent cliffs often precipitate price erosion.

Regulatory Factors

Regulatory approval status, including FDA labeling, indications, and post-marketing commitments, impacts market penetration timing. Accelerated approvals or breakthrough designations can compress time-to-market, influencing early revenue potential.


Pricing Analysis

Current Pricing Strategies

Prices are influenced by:

  • Therapeutic Value: Drugs with superior efficacy or reduced side effects command premium prices.
  • Market Positioning: Premium pricing often aligns with orphan drug status or innovative biologics.
  • Reimbursement Landscape: Payer policies, coverage restrictions, and prior authorization requirements shape achievable prices.
  • Manufacturing and Supply Chain Costs: Impact profitability margins.

If the product is currently on the market, its pricing can vary widely—from several thousand to hundreds of thousands of dollars per treatment course—typically reflecting therapy complexity and market exclusivity.

Price Trends and Historical Precedent

Examining comparable drugs over recent years reveals that:

  • Initial Launch Prices: Frequently set at premium levels, especially for orphan drugs, often exceeding $100,000 annually.
  • Post-Patent Expiry: Prices tend to decline by 20-50% following biosimilar or generic competition.
  • Market Penetration Impact: As market share stabilizes, prices may gradually decrease unless new indications or formulations extend exclusivity.

Future Price Projections

Factors Influencing Price Trajectory

  1. Patent Expirations: Expected within 8-12 years, after which biosimilars or generics could reduce prices substantially.
  2. Market Demand and Competition: Introduction of biosimilar competitors can push prices downward, with observed declines of up to 30-50% within 2-3 years post-launch.
  3. Regulatory Changes: Policy shifts favoring biosimilar use may accelerate price erosion.
  4. Pricing Reforms: Healthcare payers' cost-containment efforts, value-based pricing models, and drug price negotiation (e.g., under the Inflation Reduction Act) could further influence prices.
  5. Innovation and Line Extensions: New indications or formulations might sustain or increase prices temporarily.

Projections Over the Next Decade

  • Short-term (1-3 years): Price stability or slight increase; depending on launch success and initial reimbursement negotiations.
  • Mid-term (4-7 years): Potential price decline of 20-40% driven by biosimilar competition.
  • Long-term (>8 years): Likely significant reductions, especially following patent expirations, with prices potentially halved or more.

Market Demand Forecast

Demand projections hinge on disease prevalence, treatment guidelines, payer acceptance, and clinical adoption rates. For niche indications with high unmet needs, demand may increase steadily, sustaining higher prices. However, broader indications with widespread use face pricing pressures despite rising volumes.

Estimated annual sales growth for innovative biologics or specialty drugs in this space typically range from 5-12%, tempered by biosimilar entry and policy reforms.


Conclusion

The market outlook for NDC 64380-0797 is characterized by high initial revenue potential, buoyed by specialty positioning, but subject to attrition due to biosimilar competition and policy-driven price controls. Strategic patent management, pipeline development, and engagement with payers will be essential to maximize profitability. Price projections suggest a gradual decline aligned with competitive and regulatory trends, emphasizing the importance of early market share capture and value demonstration.


Key Takeaways

  • High-value niche: Positioning within an unmet medical need assures premium pricing early but faces eventual competition.
  • Patent lifecycle influence: Protects pricing power for 8-12 years; post-expiry, expect significant price reductions.
  • Competitive pressures: Biosimilars are primary drivers of future price erosion.
  • Regulatory environment: Policies favoring biosimilar adoption and value-based pricing will accelerate price declines.
  • Strategic focus: Continuous innovation, expanding indications, and engagement with payers are critical for sustaining revenue.

Frequently Asked Questions (FAQs)

  1. What are the primary drivers behind the pricing of biologic drugs like the one represented by NDC 64380-0797?
    The key factors include therapeutic effectiveness, market exclusivity, manufacturing costs, competitive landscape, reimbursement policies, and regulatory designations.

  2. How does biosimilar entry influence the price of biologics?
    Biosimilars introduce competitive pressure, often leading to substantial price reductions—typically 20-50%—within a few years of their market entry.

  3. What role do regulatory decisions play in the market success of this drug?
    Clear FDA approval, favorable label expansions, and timely access to reimbursement pathways enhance market penetration and pricing stability.

  4. What are the typical revenue impact timelines post-approval and patent expiry?
    Revenue peaks during exclusivity (initial 8-12 years), followed by gradual declines correlated with biosimilar competition, generally over 2-5 years after patent expiry.

  5. How can manufacturers mitigate the impact of impending biosimilar competition?
    Strategies include developing next-generation formulations, expanding indications, demonstrating superior clinical value, and establishing long-term patient engagement programs.


References

  1. U.S. Food and Drug Administration (FDA). Biologics License Application (BLA) data and approval trends.
  2. IQVIA Institute for Human Data Science. The Global Use of Medicine in 2022.
  3. EvaluatePharma. World Preview 2023: Outlook to 2028.
  4. Congressional Budget Office. Budgets and Price Trends for Biopharmaceuticals.
  5. Centers for Medicare & Medicaid Services (CMS). Policies Impacting Biologic Drug Pricing and Reimbursement.

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