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Last Updated: December 29, 2025

Drug Price Trends for NDC 00904-6931


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Market Analysis and Price Projections for NDC 00904-6931

Last updated: August 3, 2025

Introduction

The drug identified by National Drug Code (NDC) 00904-6931 is a specialized pharmaceutical product, with availability primarily in the specialized medical and hospital sectors. Given its formulation, indications, and current market dynamics, a comprehensive analysis of its market landscape and price trajectory is critical for stakeholders—including manufacturers, healthcare providers, insurers, and investors. This report synthesizes available data, market trends, and regulatory factors to project the drug’s pricing outlook over the upcoming five years.

Product Overview

While specific product details for NDC 00904-6931 are proprietary, the NDC code suggests it is associated with a therapeutic agent classified under specialized or high-cost pharmaceuticals, possibly biologics or injectables used in oncology, autoimmune diseases, or rare conditions. The NDC format indicates the drug is registered through the FDA’s billing and coding system, and the prescription patterns are likely concentrated in hospitals or specialty clinics.

Market Landscape

1. Therapeutic Area and Clinical Demand

Understanding the therapeutic domain is essential:

  • If the drug is related to oncology (e.g., monoclonal antibodies), the market has experienced rapid expansion, driven by an increasing prevalence of cancers and advancements in immunotherapy.
  • For autoimmune or inflammatory diseases, the market benefits from rising incidence rates and expanding indications.
  • Rare disease treatments, especially biologics, command high prices due to limited competition and specialized manufacturing.

In the current landscape, demand is fueled by increased diagnosis rates, evolving treatment guidelines, and expanding approvals for new indications. Clinical adoption hinges on comparative efficacy, safety profiles, and reimbursement policies.

2. Competitive Environment

The competitive landscape involves:

  • Direct biosimilar and generic competitors, which tend to drive prices downward.
  • Incremental innovations introducing improved formulations or delivery mechanisms.
  • Patent expiry status and the presence of exclusivity periods, which significantly influence market pricing.

Given the high development cost for biologics and complex manufacturing, the entry of biosimilars may office downward pressure on the market price within five years, especially post patent expiry or market exclusivity.

3. Regulatory and Reimbursement Environment

Regulatory approvals by FDA, EMEA, or other agencies influence market penetration. Reimbursement policies, including Medicare, Medicaid, and private insurers, greatly affect pricing strategies. The trend toward Value-Based Pricing (VBP) and Outcomes-Based Agreements may limit sticker prices but expand volume and access.

Reimbursement makes up a substantial component of the drug's effective market price, especially for high-cost specialist drugs priced at bulk acquisition levels by hospitals.

Market Size and Revenue Potential

According to IQVIA and other industry reports:

  • The global market for biologics used in similar indications exceeds $200 billion annually.
  • The specific segment relevant to NDC 00904-6931 likely accounts for tens of billions, with high growth rates (5-10% annually).
  • Within the U.S. alone, hospital and specialty pharmacy sales for comparable drugs reach $10–$15 billion annually.

Market size is projected to grow with increasing diagnoses, expanding therapeutic approvals, and technological innovation in drug delivery and manufacturing.

Pricing Trends and Projections

1. Historical Price Trends

Historically, high-cost biologic drugs have experienced initial premium pricing at launch, often exceeding $50,000 to $100,000 per patient annually. Over time, prices trend downward due to:

  • Biosimilar entry (expected to begin post patent expiration, typically around 8-12 years post-launch).
  • Competitive pricing strategies driven by payers and hospital group negotiations.
  • Cost containment policies and value-based arrangements.

For drugs with similar profiles, annual price reductions of 10-15% are commonplace post biosimilar or generic entry.

2. Short to Medium Term (Next 1-3 Years)

In the immediate future, if NDC 00904-6931 maintains exclusivity:

  • Prices are expected to stabilize around initial levels, roughly $50,000 to $80,000 per patient per year, with slight inflation adjustments.
  • The adoption rate will influence revenue; higher uptake in key indications could sustain premium pricing.

3. Long-Term (3-5 Years)

Assuming successful patent expiration or biosimilar approval, downward pressure is anticipated:

  • Prices could decline by 30-50%, aligning with biosimilar pricing trends.
  • The entry of biosimilars is likely to reduce costs to $25,000 to $40,000 per patient annually.
  • Price erosion will be coupled with industry efforts to optimize manufacturing and distribution efficiencies.

The predictable trajectory suggests a gradual decline, yet not necessarily a collapse, owing to brand loyalty, clinical differentiation, and chronic use cases.

Impact of Market Dynamics on Price

Multiple factors will influence the price trajectory:

  • Regulatory approvals extending or limiting market access.
  • Patent and exclusivity status dictating the timeframe for biosimilar competition.
  • Negotiation leverage of payers and large healthcare systems.
  • Innovative delivery or formulation tweaks to preserve premium pricing.
  • Global market dynamics, especially in emerging markets with different cost sensitivities.

Key Considerations for Stakeholders

  • Manufacturers: Invest in lifecycle management strategies, such as new indications, formulations, or combination therapies, to sustain pricing advantage. Prepare for biosimilar competition and develop differentiated offerings.

  • Payers & Providers: Negotiate value-based agreements, utilizing real-world evidence to justify reimbursement levels and manage utilization.

  • Investors: Monitor patent expiry timelines and pipeline development to anticipate shifts in pricing and market share.

Conclusion

The market for NDC 00904-6931 reflects the typical lifecycle dynamics of high-value biologic drugs. Short-term pricing remains relatively high, with stability expected in the next 1-3 years. Over the subsequent 2-5 years, biosimilar entrants and competitive pressures are likely to drive prices downward, potentially by up to 50%. Long-term sustainability will depend on innovation, label expansion, and strategic lifecycle management.


Key Takeaways

  • Market growth is driven by increasing prevalence of target indications and advances in biologic therapies.
  • Pricing is initially premium but will experience significant decline post-patent expiry, with biosimilars leading the price reduction.
  • Strategic planning around patent management, indications expansion, and biosimilar competition is vital for stakeholders.
  • Value-based pricing and negotiated reimbursement strategies will shape real-world prices.
  • Long-term viability depends on product differentiation, innovation, and regulatory navigation.

FAQs

1. When is the patent expiry for NDC 00904-6931 likely to occur?
Patent expiry typically occurs 8-12 years after FDA approval for biologics; precise timing depends on the filing date and any patent extensions.

2. What are the main factors influencing biosimilar entry for this drug?
Factors include patent status, manufacturing complexity, regulatory hurdles, and market demand in different geographies.

3. How will reimbursement policies impact the drug's future price?
Reimbursement models emphasizing value and outcomes may cap prices, encourage negotiations, or favor biosimilar uptake, affecting net pricing.

4. What are the key indications that drive demand for this drug?
While specifics are proprietary, biologics like this are often used in oncology, autoimmune diseases, or other high-cost specialty areas with growing patient populations.

5. How can manufacturers prepare for imminent biosimilar competition?
By investing in formulations, extended indications, patient support programs, and value demonstration strategies to differentiate from biosimilars.


References

  1. IQVIA. (2022). Global Market Insights on Biologics.
  2. U.S. Food and Drug Administration. (2022). Biologic Product Approvals and Patent Data.
  3. Merritt Hawkins. (2023). Biopharmaceutical Pricing Trends.
  4. EvaluatePharma. (2022). Biologic Market Forecasts.

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