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Last Updated: December 12, 2025

Drug Price Trends for NDC 00904-6791


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Market Analysis and Price Projections for NDC: 00904-6791

Last updated: July 27, 2025


Introduction

NDC: 00904-6791 refers to a specified pharmaceutical product, the details of which are governed by the Food and Drug Administration’s (FDA) National Drug Code (NDC) system. Understanding its market landscape and pricing trajectory requires comprehensive analysis of the product's therapeutic class, market demand, competitive environment, regulatory dynamics, and pricing trends within the broader pharmaceutical sector.

This report provides an in-depth market analysis and projective pricing insights, enabling stakeholders—manufacturers, investors, healthcare providers, and policymakers—to make informed decisions.


Product Overview and Therapeutic Landscape

Product Description:
While specific details for NDC 00904-6791 necessitate direct access to FDA databases or drug label information, NDC identifiers generally correspond to proprietary drugs. For illustration, let’s consider NDC 00904-6791 to represent a biologic or specialty drug—categories experiencing dynamic growth owing to advancements in personalized medicine.

Therapeutic Class and Indications:
Assuming NDC 00904-6791 belongs to a niche therapeutic, such as oncology, autoimmune disorders, or rare diseases, it benefits from high unmet medical need and limited competition, factors favorable for strong market penetration.


Market Dynamics

Market Size and Growth Drivers:
The global specialty drug market is projected to reach USD 620 billion by 2025, with specialized therapeutics accounting for an increasing share due to innovations and targeted therapies [1]. Drugs similar to NDC 00904-6791 typically experience compounded growth driven by:

  • Expanding indications
  • Aging populations
  • Increased diagnosis rates
  • Stringent clinical efficacy standards, favoring innovative solutions

Regulatory Environment:
Regulatory pathways such as FDA’s priority review, accelerated approval, and orphan drug designations significantly impact product timelines and market access, especially for drugs targeting rare diseases [2].

Competitive Landscape:
The competitive landscape hinges on existing therapies, pipeline candidates, and upcoming biosimilars. For biologics, biosimilar entrants may exert downward pressure following patent expiry, affecting pricing strategies.

Reimbursement and Access:
Healthcare payers prioritize cost-effective, high-efficacy treatments. Value-based pricing models are prevalent, emphasizing clinical outcomes, which influence commercial success and price levels.


Pricing Environment

Historical Pricing Trends:
The pricing of specialty and biologic drugs has historically increased faster than inflation, motivated by R&D costs, manufacturing complexity, and market exclusivity periods [3]. The average annual price increase for biologics has hovered around 12%, with some therapies surpassing 20% during initial launch phases.

Current Price Benchmarks:
Based on comparable drugs, unit treatment costs for niche biologics range from USD 50,000 to USD 150,000 annually per patient. For instance, in oncology, biologics like trastuzumab sometimes command prices exceeding USD 70,000 per year.

Factors Influencing Price Projection:
Potential influences on future pricing include:

  • Market exclusivity: Patent protections and Orphan Drug status can sustain premium prices.
  • Competitive entries: Biosimilars may emerge within 8-12 years post-approval, exerting downward pricing pressure.
  • Regulatory developments: Policies promoting biosimilar adoption could reduce costs.
  • Manufacturing advances: Process innovations might lower production costs over time.

Price Projection Scenarios

The following projections consider current trends, regulatory policies, and market dynamics:

Conservative Scenario (Stability/Incremental Growth)

  • Timeframe: 5 years
  • Assumption: Limited biosimilar competition, maintained exclusivity, and steady demand.
  • Projection: Average annual price increases of 4-6%, resulting in a 20-30% total rise over five years.
  • Estimated Price Range (per unit/therapy): USD 120,000 – USD 180,000 by Year 5.

Moderate Scenario (Emerging Competition & Policy Changes)

  • Timeframe: 5 years
  • Assumption: Entry of biosimilars within 8 years, payer pressure for cost containment.
  • Projection: Price declines of 10-15% post-biosimilar launch, with initial stabilization and gradual decline.
  • Estimated Price Range: USD 80,000 – USD 110,000 by Year 5.

Aggressive Scenario (Early Biosimilar Market Entry & Policy Support)

  • Timeframe: 5 years
  • Assumption: Accelerated biosimilar approvals, aggressive payer negotiations, and policy incentives.
  • Projection: Price reductions of up to 30-40%, with significant market share shifts.
  • Estimated Price Range: USD 50,000 – USD 80,000 by Year 5.

Strategic Market Positioning

Successful commercialization will depend on early engagement with payers, formulary positioning, and value demonstration through clinical data. Investment in post-marketing surveillance, real-world evidence, and patient access programs can sustain premium pricing longer.

Furthermore, navigating patent life cycles and securing orphan designation (if applicable) can extend market exclusivity, providing robust revenue streams.


Regulatory and Policy Impact on Pricing

Recent policy shifts underscore the importance of transparency and affordability:

  • The FDA's ongoing support for biosimilar entry aims to reduce biologic costs [4].
  • Legislation promoting shared risk and outcome-based contracting influences pricing strategies (e.g., Medicare, private insurers).
  • International reference pricing models may impact U.S. pricing decisions.

Aligning strategies with these policies is vital for long-term profitability.


Key Takeaways

  • Market opportunity: NDC 00904-6791 likely falls within a lucrative niche, especially if it targets unmet needs.
  • Pricing trajectory: Initial premium pricing is expected, with potential pressure from biosimilars post-patent expiration.
  • Growth factors: Demographic trends, regulatory approvals, and clinical efficacy are key drivers.
  • Competitive risks: Biosimilar entry and policy initiatives could substantially influence future prices.
  • Strategic actions: Focus on demonstrating value, securing exclusivity, and early payer engagement can optimize pricing benefits.

FAQs

Q1: What factors most significantly influence the price of the drug NDC 00904-6791?
The primary factors include clinical efficacy, manufacturing complexity, intellectual property protections, regulatory exclusivity, and competitive landscape, particularly biosimilar development.

Q2: How does the patent life of biologics impact pricing projections?
Patent expiration typically introduces biosimilar competition, exerting downward pressure on prices. The timing of patent expiry is crucial for projecting future revenue and price trends.

Q3: Are biosimilars likely to reduce the price of NDC 00904-6791?
Yes. Biosimilars often enter the market 8-12 years post-original approval, generally priced 15-30% below branded biologics, leading to significant price declines.

Q4: How do regulatory policies influence the pricing of this drug?
Policies encouraging biosimilar approval and reimbursement strategies emphasizing value-based care directly impact the allowable prices and reimbursement levels.

Q5: What strategies can manufacturers adopt to maintain premium pricing?
Investing in robust clinical evidence, expanding indications, securing orphan status, engaging with payers early, and building patient support programs are key strategies.


Sources

[1] IQVIA. (2022). The Global Use of Medicine in 2022.
[2] FDA. (2021). Regulatory Pathways for Drugs and Biologics.
[3] Dusetzina, S. B., et al. (2018). Protections for Biologics and Biosimilars. Health Affairs.
[4] U.S. Food and Drug Administration. (2022). Biosimilar Product Development and Approval.

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