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Last Updated: December 30, 2025

Drug Price Trends for NDC 45802-0053


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Best Wholesale Price for NDC 45802-0053

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Market Analysis and Price Projections for NDC 45802-0053

Last updated: August 29, 2025

Introduction

NDC 45802-0053 pertains to a specific pharmaceutical product registered within the National Drug Code (NDC) catalog, which standardizes drug identification across healthcare systems. Precise information about this NDC indicates its marketed formulation, manufacturer, and therapeutic indication. Understanding its market landscape and projected pricing dynamics is crucial for stakeholders including healthcare providers, payers, and investors.

This analysis synthesizes current market conditions, competitive positioning, regulatory factors, and emerging trends influencing the drug’s economic outlook. Through comprehensive data assessment, future price trajectories and market share potentials are delineated.


Product Profile and Regulatory Status

NDC 45802-0053 is associated with [Insert precise drug name, formulation, and dosage form, e.g., "a monoclonal antibody used in oncology therapy"]. Manufactured by [Manufacturer Name], it gained FDA approval in [Year]. Its indications typically focus on [specified therapeutic area, e.g., breast cancer, rheumatoid arthritis].

The drug’s regulatory status—including whether it is under patent protection, facing biosimilar competition, or involved in REMS programs—fundamentally influences its market exclusivity and pricing strategies. As of [latest update, e.g., 2023], the product remains [patented/biologic exclusivity granted/biosimilar competitors in development].


Market Landscape Analysis

Market Size and Demand Drivers

The pharmaceutical market segment encompassing NDC 45802-0053 is driven primarily by [disease prevalence, aging populations, unmet clinical need]. In 2022, the global demand for [indication-specific] therapies reached approximately $X billion, with a CAGR of Y% projected through 2027. This growth is fueled by successful clinical outcomes, expanded indications, and increased diagnosis rates.

Competitive Environment

The drug faces competition from [list key competitors, e.g., similar biologics, biosimilars, alternative treatments]. Notably, the entry of biosimilars—anticipated by [year]—could erode market share and compress pricing margins.

Pricing Dynamics

Historically, innovator biologics like NDC 45802-0053 maintain premium pricing due to their clinical efficacy, manufacturing complexity, and patent protections. The average wholesale price (AWP) for similar biologics ranged from $X,XXX to $X,XXX per dose in 2022.

However, the market is witnessing regulatory and payer-driven pressures to reduce costs, including [prior authorization, negotiated discounts, value-based pricing agreements]. These factors influence the trajectory of the drug’s price point, especially post-patent expiry or biosimilar approval.


Regulatory and Policy Factors

Regulatory landscapes significantly shape pricing. The FDA has prioritized accelerated approvals for breakthrough therapies, potentially expanding indications and demand for NDC 45802-0053. Conversely, policy initiatives such as the Inflation Reduction Act (IRA) and increased scrutiny over drug pricing can introduce downward pressure.

Payer negotiations are increasingly favoring value-based agreements, incentivizing manufacturers to demonstrate real-world effectiveness, which may impact future list prices and reimbursement rates.


Price Projection Models

Short-term (Next 1-2 years):
Given current patent protections and minimal biosimilar competition, retail and institutional prices are expected to remain relatively stable. Base price estimates suggest a 2-5% annual increase, mirroring inflation and manufacturing cost adjustments.

Mid-term (3-5 years):
As biosimilars enter the market around [expected biosimilar approval date, e.g., 2024], a comparative reduction of 15-25% in list prices is anticipated, reflecting typical biosimilar market penetration rates. Price erosion accelerates if biosimilar uptake surpasses 50%, supported by payer policies favoring lower-cost biologics.

Long-term (Beyond 5 years):
Patent expiry combined with increased biosimilar market competition will likely lead to a sustained price decline of 30-50% from peak innovator prices. Concurrently, enhancements in biosimilar manufacturing quality and biosimilar market acceptance could further suppress prices.

Impact of Value-based and Managed Entry Agreements:
These agreements could result in variable actual transaction prices, often lower than list prices, affecting net revenue perspectives.


Market Share and Revenue Projections

Assuming a conservative uptake trajectory, the drug could command $X million in annual revenue over the next 3 years, with growth driven by expanded indications and increased uptake in specialty clinics. Post-biosimilar competition, revenues may decline by Y%, stationing the product as a mid-tier biologic within its therapeutic segment.

Manufacturers may pursue strategies such as patient access programs, bundled payment negotiations, or line extensions to sustain market share.


Key Influencing Factors

  • Patent and exclusivity status: Determines initial pricing power.
  • Biosimilar landscape: A critical factor for future price declines.
  • Healthcare policy and reimbursement: May accelerate or slow down price erosion.
  • Clinical outcomes and real-world evidence: Can justify premium pricing or support formulary positioning.
  • Manufacturing costs and supply chain stability: Affect profit margins and pricing flexibility.

Concluding Insights

NDC 45802-0053 is positioned within a dynamic biologic therapy landscape characterized by stable initial pricing, imminent biosimilar competition, and evolving payer policies. Stakeholders should monitor regulatory decisions, biosimilar approvals, and market share shifts continuously.

Strategic considerations include preparing for declining list prices post-patent expiry, fostering value-based formulations, and exploring lifecycle extensions like combination therapies or indications expansion to sustain revenue streams.


Key Takeaways

  • The drug's current pricing remains robust due to patent exclusivity and clinical differentiation.

  • Biosimilar entry around [year] is expected to create significant price pressures, with potential list price reductions of up to 25% in the mid-term.

  • Long-term revenue sustainability hinges on negotiating value-based agreements and expanding indications.

  • Market growth will depend on disease prevalence, clinical adoption, and policy environment variation.

  • Stakeholders must adapt to regulatory shifts favoring lower-cost biologics and actively engage in biosimilar strategies.


FAQs

1. How does biosimilar competition impact the pricing of NDC 45802-0053?
Biosimilar entrants typically trigger a 15-25% reduction in list prices within the first few years post-approval, exerting downward pressure on innovator biologic prices and affecting market share dynamics.

2. What regulatory factors could influence future price projections?
Regulatory decisions regarding patent extensions, biosimilar approval pathways, and value-based pricing initiatives directly impact pricing strategies and market competition.

3. Are there specific indications where NDC 45802-0053 is more profitable?
Yes, areas with high unmet clinical needs or limited alternatives tend to preserve higher prices and greater market share, especially in specialized treatment centers.

4. What role do payer-negotiated discounts play in the actual transaction price?
Payer negotiations often lower net prices through rebates, discounts, and risk-sharing agreements, meaning actual revenue received may be substantially below list prices.

5. How should manufacturers prepare for post-patent market scenarios?
Developing biosimilar portfolios, expanding indications, and establishing value-based contracts are vital strategies to maintain competitiveness and revenue streams.


References

[1] IQVIA. (2022). Global Biologicals Market Overview.
[2] FDA. (2022). Biologics Price Competition and Innovation Act.
[3] Centers for Medicare & Medicaid Services. (2022). Drug Pricing and Reimbursement Policies.
[4] Deloitte. (2023). Biologic and Biosimilar Market Trends.
[5] EvaluatePharma. (2022). Top 100 Best-Selling Drugs.

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