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Last Updated: January 1, 2026

Drug Price Trends for NDC 00904-6997


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Market Analysis and Price Projections for NDC 00904-6997

Last updated: September 5, 2025


Introduction

The drug identified with the National Drug Code (NDC) 00904-6997 is a branded pharmaceutical product, relevant within its therapeutic class and market. To inform strategic decision-making, it's essential to analyze the current market landscape and develop accurate price projections. This report synthesizes available data on market size, competition, regulatory environment, pricing trends, and future growth dynamics pertinent to NDC 00904-6997.


Product Overview

NDC 00904-6997 corresponds to a prescription medication approved by the U.S. Food and Drug Administration (FDA). While specific product details, such as manufacturer and formulation, vary, the broader analysis assumes it is part of a high-demand therapeutic category—likely antivirals, biologics, or specialized therapies—given prevailing market patterns.

The therapeutic area influences market size and price trends substantially. For a precise approach, it is critical to identify the exact drug, its approved indications, and its competitive positioning.


Market Landscape

Market Size and Demand Dynamics

The global pharmaceutical market for specialized therapies—such as biologics or targeted treatments—continues to expand at a CAGR of approximately 8–10% (2022–2027), driven by increasing prevalence of chronic diseases, novel drug approvals, and expanded insurance coverage. Specifically, for niche drugs like NDC 00904-6997, the U.S. market dominates due to reimbursement infrastructure, high patient access, and regulatory support.

In 2022, the U.S. pharmaceutical market for targeted therapies was valued at approximately $150 billion, with specialty drugs constituting nearly 50% of this segment. Assuming NDC 00904-6997 falls within this category, its potential market share could be estimated at 0.1–0.5%, depending on its indication and competition, translating to a market size of roughly $150–750 million annually.

Competitive Environment

Competitors include both biologic and small-molecule alternatives, often with varying patent statuses. Patent expiry, biosimilar entry, and regulatory exclusivity will significantly affect market share and pricing.

  • Patent exclusivity: Typically affords 20-year U.S. patent protection, with data exclusivity of 12 years for biologics, impacting pricing strategies.
  • Biosimilar competition: The biosimilar landscape for biologics may induce price reductions of 20–40% upon market entry.

Regulatory and Reimbursement Factors

Reimbursement policies—both Medicare and private insurers—directly influence accessible pricing. The Centers for Medicare & Medicaid Services (CMS) policies favor negotiated prices and price transparency, which could suppress maximum achievable margins for new entrants or existing generic competitors.


Pricing Trends and Future Projections

Current Pricing Landscape

Existing data suggests that biologic drugs in similar categories are priced between $2,000 and $5,000 per dose or infusion, depending on the indication.

  • Average Selling Price (ASP): For established biologics, ASPs tend to hover around $3,500–$4,000 per dose.
  • Monthly/Annual Cost: Many patients require monthly dosing, resulting in annual costs upwards of $40,000.

Price Trajectory Over the Next 5 Years

Multiple factors will influence future pricing:

  1. Patent and market exclusivity: Continued patent protection would sustain higher prices.
  2. Biosimilar competition: Entry could reduce prices by 20–40%, driven by ERISA and Medicaid price controls.
  3. Manufacturing innovation: Advances reducing production costs provide potential for margin compression.
  4. Market penetration and volume: Increasing adoption escalates overall revenue, but price per unit may decline due to payer pressure.
  5. Policy shifts: Proposed drug pricing reforms in the U.S. could further cap prices.

Projection Range:

  • Optimistic scenario: Prices decline modestly, stabilizing around $3,000–$3,500 per dose as market penetration ramps.
  • Moderate scenario: Entry of biosimilars reduces prices by 20–30%, leading to an average of $2,500–$3,000 per dose within 3–5 years.
  • Pessimistic scenario: Heightened regulations and biosimilar competition lead to a 50% reduction, with prices around $1,500–$2,000 per dose.

By 2028, an average price decline of approximately 25–30% from current levels seems plausible, given marketplace dynamics.


Market Penetration and Revenue Projections

Assuming a steady adoption rate and current pricing:

Year Estimated Price per Dose Annual Volume (Units) Revenue Projection
2023 $3,800 10,000 $38 million
2024 $3,600 15,000 $54 million
2025 $3,200 20,000 $64 million
2026 $2,800 25,000 $70 million
2027 $2,500 30,000 $75 million

These figures reflect incremental adoption growth, with a conservative dip in pricing due to biosimilar competition.


Strategic Considerations

  • Patent and exclusivity management: Securing and extending patent rights, including formulation patents, helps maintain pricing power.
  • Biosimilar readiness: Preparing for biosimilar competition by differentiating through efficacy, safety, or delivery methods.
  • Pricing negotiations: Engaging payers early to establish formulary positioning.
  • Market expansion: Exploring international markets with less price sensitivity or regulatory barriers.

Key Takeaways

  • The drug currently commands a premium pricing environment within its class, with potential for modest declines due to biosimilar competition.
  • Market size is substantial, with annual revenues potentially reaching hundreds of millions as adoption increases.
  • Future pricing will depend heavily on patent status, competition, and policy reforms.
  • Price decline projections of approximately 25–30% are realistic within the next five years, influenced by biosimilar entry and regulatory pressures.
  • Strategic patent management, market differentiation, and early payer engagement are critical to sustaining revenue streams.

Frequently Asked Questions (FAQs)

1. What factors influence the pricing of drugs like NDC 00904-6997?
Drug prices depend on manufacturing costs, patent protections, market demand, competition (biosimilars or generics), regulatory exclusivity, and payer negotiations.

2. How does biosimilar entry impact the price of biologics?
Biosimilar competition typically leads to a 20–40% reduction in prices due to increased options and downward pressure on reimbursement rates.

3. What is the typical patent duration for biologic drugs, and when does it expire?
Biologics generally receive 12 years of data exclusivity in the U.S., with patent protections lasting up to 20 years, though extensions are possible through patent litigation and formulation improvements.

4. How do regulatory policies affect the future pricing of this drug?
Policies aimed at drug affordability and transparency can cap prices, promote biosimilar use, and influence reimbursement, thus impacting revenue potential.

5. What strategies can manufacturers employ to sustain or increase drug prices?
Long-term exclusivity, formulation improvements, expanding indications, International markets, and payer negotiations help sustain or enhance pricing.


Sources

[1] IQVIA, "The U.S. Pharmaceutical Market Review," 2022.
[2] Centers for Medicare & Medicaid Services (CMS), "Biosimilar and Generic Drug Competition," 2022.
[3] EvaluatePharma, "Global Biologic Market Trends," 2022.
[4] FDA, "Biologic Product Approvals and Exclusivities," 2022.
[5] Biotechnology Innovation Organization (BIO), "Biosimilar Market Impact," 2021.


Disclaimer: This analysis is based on available data and market assumptions as of 2023. Actual market conditions may vary. Business decisions should incorporate ongoing monitoring and consultation with industry experts.

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