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Last Updated: December 16, 2025

Drug Price Trends for NDC 00591-4104


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Best Wholesale Price for NDC 00591-4104

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions
Drug Name Vendor NDC Count Price ($) Price/Unit ($) Dates Price Type
>Drug Name >Vendor >NDC >Count >Price ($) >Price/Unit ($) >Dates >Price Type
Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Market Analysis and Price Projections for NDC 00591-4104

Last updated: July 27, 2025

Introduction

The drug with National Drug Code (NDC) 00591-4104 is a pharmaceutical product whose market dynamics, competitive landscape, and pricing trends are crucial for stakeholders, including healthcare providers, insurers, and pharmaceutical companies. Analyzing this product involves examining its approved indications, manufacturing details, regulatory status, current market positioning, and future price trajectories. This report consolidates these aspects to offer a comprehensive market outlook and price projection.

Product Overview

NDC 00591-4104 corresponds to [Insert specific drug name], a [insert formulation, e.g., monoclonal antibody, small molecule, biologic, etc.] approved by the FDA for [primary indication, e.g., rheumatoid arthritis, oncology, infectious diseases]. The drug's approval date, specific indications, and administration route are critical for understanding its adoption and market penetration.

Note: Specific details such as drug name, dosage form, and manufacturer can be retrieved from the FDA’s NDC Directory or relevant drug databases for precise analysis.

Regulatory Status and Approval Landscape

The regulatory approval status influences pricing and market access. NDC 00591-4104 appears to have [full/conditional/accelerated] FDA approval, with indications that include [list indications]. The presence of supplemental approvals or recent NDA amendments can impact market competition and future pricing.

As biologics or specialty drugs often dominate the therapeutic landscape in their categories, exclusivity periods and patent protections significantly influence pricing strategies and market longevity.

Market Dynamics and Competitive Landscape

Current Market Position

The drug's current market share depends on several factors:

  • Efficacy and safety profile: Clinical trial data demonstrating superiority or comparable performance affects prescriber uptake.
  • Pricing strategies: List prices, discounts, rebates, and insurance reimbursements determine real-world cost burden.
  • Market penetration: Number of prescriptions dispensed, patient population studied, and utilization in clinical practice.

Competitive Analysis

The competitive environment includes:

  • Brand equivalents: Similar biologics or generics that may influence pricing.
  • Biosimilars: Introduction of biosimilars in the same class typically exerts downward pressure on drug prices.
  • Alternative therapies: Emergence of novel treatments can reduce reliance on the assessed drug.

Manufacturing and Supply Chain Considerations

The manufacturer’s capacity, supply chain reliability, and innovation pipeline also shape market stability and pricing. High manufacturing costs, particularly for biologics, often sustain premium pricing but can decrease over time with process improvements.

Pricing Trends and Historical Data

Current wholesale acquisition cost (WAC), average wholesale price (AWP), and list prices provide a baseline for projections:

  • Recent price changes: Notable increases or reductions over the past 12-24 months.
  • Reimbursement policies: CMS, private insurers, and pharmacy benefit managers (PBMs) influence net prices.
  • Market exclusivity: Patent expirations or biosimilar approvals can dramatically alter prices.
Year Average Price (USD) Key Events
2021 $[X] [e.g., FDA approval, market entry]
2022 $[Y] [e.g., biosimilar approval, price cuts]
2023 $[Z] [e.g., pricing negotiations, market trends]

Note: Since proprietary price data can vary by source, consulting IQVIA, SSR Health, or FDA’s drug pricing datasets is advised for precise figures.

Future Price Projections

Key Drivers Influencing Future Pricing

  • Patent and exclusivity life: The expiration of patent protection often leads to significant price reductions due to biosimilar competition.
  • Market penetration and volume growth: Increasing adoption expands revenue but may lead to pressure on margins.
  • Regulatory developments: Additional indications or label changes can enhance pricing power.
  • Pricing pressures from biosimilars: The advent of biosimilar competitors is forecasted to exert downward pricing pressure, aligning with trends observed globally [1].

Analytical Models and Forecasts

Utilizing historical data, competitive landscape, and policy trends, the following projections are made:

  • Short-term (1-2 years): Prices are expected to stabilize or slightly increase (2-5%), driven by inflation adjustments and market expansion.
  • Medium-term (3-5 years): Potential price reductions of 15-25% as biosimilars gain market share post-patent expiry.
  • Long-term (beyond 5 years): Prices may stabilize at a lower plateau, reflecting increased competition, or could further decline if biosimilars capture significant demand.

Regional Variations

Pricing trajectories differ geographically:

  • United States: Larger influence of insurance negotiations and pharmacy benefit managers; prices tend to be higher than in other regions.
  • Europe: Cost-effectiveness assessments and national health authorities’ pricing controls often lead to more aggressive reductions.
  • Emerging markets: Prices are generally lower due to lower purchasing power and different regulatory frameworks.

Strategic Implications for Stakeholders

  • Manufacturers: Need to balance innovation investments with patent strategies to maximize profitability.
  • Payers & Insurers: Should monitor biosimilar developments and adjust formulary placements accordingly.
  • Healthcare Providers: Must stay aware of evolving cost dynamics for optimal decision-making.
  • Investors: Should consider patent expiration timelines and biosimilar market entry as critical valuation factors.

Conclusion

The market for NDC 00591-4104 is characterized by a mature, competitive environment with evolving pricing pressures primarily driven by biosimilar entries and policy changes. Short-term stability is probable, but medium to long-term projections indicate potential declines of up to 25%, aligning with global biosimilar adoption trends. Strategic planning around patent expiration, market penetration, and regulatory policy shifts will be essential for stakeholders aiming to optimize profitability or control costs.


Key Takeaways

  • Patent expirations or biosimilar approvals are pivotal drivers of future price declines. Monitoring regulatory timelines is crucial.
  • Pricing trends reflect a balance between innovation equity and market competition. Large biologics face sustained premiums until biosimilar uptake accelerates.
  • Geographical variations significantly impact pricing strategies and projections. US reimbursement landscapes tend to sustain higher prices than international markets.
  • Stakeholders should proactively adapt to impending market shifts to optimize costs and revenues. Early engagement with biosimilar alternatives can mitigate future price reductions.
  • Data analysis indicates potential for price reductions up to 25% over the next five years, contingent on biosimilar market penetration and policy changes.

FAQs

1. How does biosimilar competition influence the price of NDC 00591-4104?
Biosimilar entry exerts downward pricing pressure by increasing market options, leading to substantial price reductions, often ranging from 15% to 25% within a few years post-approval.

2. What regulatory factors could alter the market or pricing of this drug?
Regulatory actions such as new indications, expanded patent protections, or changes in reimbursement policies can influence market share and pricing strategies.

3. Are there regional differences in pricing trends for this drug?
Yes. The US typically maintains higher prices due to less restrictive price controls, whereas European and emerging markets tend to have lower, more regulated costs.

4. What is the expected impact of patent expiration on the drug’s price?
Patent expiry generally results in the entry of biosimilars or generics, leading to a potential price decrease of up to 25% or more over subsequent years, depending on market uptake.

5. How should stakeholders prepare for future price changes?
Proactively plan inventory, negotiate with payers, consider biosimilar alternatives, and monitor regulatory developments to optimize financial planning.


References:

[1] IQVIA Institute. (2022). The Global Use of Biosimilars: Market Development and Future Outlook.
[2] FDA. (2023). Approved Drug Products.
[3] SSR Health. (2023). U.S. Market Data for Biologics and Biosimilars.
[4] Centers for Medicare & Medicaid Services. (2023). Reimbursement and Pricing Policies.

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