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Last Updated: January 1, 2026

Drug Price Trends for NDC 10370-0347


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Market Analysis and Price Projections for NDC: 10370-0347

Last updated: September 21, 2025


Introduction

The drug identified by National Drug Code (NDC) 10370-0347 pertains to a specific pharmaceutical product, crucial for stakeholders in healthcare, pharmaceuticals, and investment sectors. Accurate market analysis and price projection analyses are vital for strategic planning, regulatory positioning, and investment decisions. This report synthesizes current market dynamics, competitive landscape, regulatory trends, and pricing models to forecast the product's price trajectory.


Product Overview and Therapeutic Indication

NDC 10370-0347 corresponds to a [Insert drug name], developed by [Manufacturer], primarily indicated for [indication, e.g., oncology, cardiovascular, neurology]. The drug’s mechanism involves [brief description], and it holds [approval status, e.g., FDA-approved, accelerated approval]. The therapeutic area exhibits significant unmet needs, high treatment costs, and considerable market potential, influencing pricing strategies.


Market Landscape Analysis

Market Size and Growth Dynamics

The global market for [therapeutic area] is projected to reach approximately [$X billion] by 2025, expanding at a compound annual growth rate (CAGR) of [%] ([source]). In the U.S., this niche is characterized by rapid expansion driven by increased disease prevalence, favorable reimbursement policies, and innovative treatment modalities.

Specifically, the indications targeted by NDC 10370-0347 are experiencing a surge in prevalence; for example, [disease prevalence] in the U.S. increased by [%] over the past five years ([source]). This trend underpins elevated demand, subsequently influencing pricing and market entry strategies.

Competitive Landscape

The competitive environment features a mix of branded and biosimilar products. Key competitors include:

  • Product A: Price point around [$], marketed by [Company], with mechanisms similar or alternative to NDC 10370-0347.

  • Product B: Biosimilar versions priced significantly lower, prompting price erosion pressures.

Market differentiation hinges on efficacy, safety profile, dosing convenience, and reimbursement access. The ongoing patent protections for the product prolong exclusivity, delaying biosimilar entry until at least [year], potentially safeguarding initial pricing advantages.

Regulatory Status and Market Access

The drug holds [regulatory designation, e.g., orphan drug, breakthrough therapy], which offers benefits such as market exclusivity and expedited review processes. Such status enhances pricing power and market penetration prospects. Reimbursement policies from CMS and private payers further influence net price realizations.


Price Development Factors

Manufacturing and R&D Costs

The development of NDC 10370-0347 involved substantial R&D investment estimated at [$X million] ([source]). Manufacturing complexities, including [e.g., biologics, cold chain requirements], elevate production costs, supporting higher price points.

Market Demand and Patient Access

Demand remains robust within the targeted indication, particularly in regions with high prevalence. Price sensitivity among payers and patients varies; payers tend to negotiate discounts, while high-cost products often rely on value-based pricing models that reward clinical efficacy.

Pricing Strategies and Stakeholder Influence

The manufacturer’s initial launch price typically reflects the value proposition, competitive posture, and payer negotiations. For instance, similar biologics are priced between [$X and $Y], with premium positioning for drugs demonstrating superior efficacy.

Pricing pressures from biosimilars and generics can erode margins, prompting a strategic shift toward value-based contracts, outcome-based pricing, and tiered formulary placements.


Price Projections

Short-Term (1–3 Years)

In the immediate future, prices are expected to remain relatively stable, with minimal downward pressure owing to patent protection and regulatory exclusivity. Launch prices are anticipated to be in the range of [$X–Y], aligning with comparable products. Payer negotiations may permit modest discounts, averaging around [%].

Mid-to-Long Term (4–10 Years)

As patent exclusivity lapses, biosimilar competition will increase, intensifying price competition. By year 5, projected biosimilar entry could reduce prices by [%–%], leading to an adjusted range of [$A–B].

Furthermore, competitive pressure from alternative therapies, combined with potential regulatory changes and market consolidation, could accelerate price declines. However, if the product demonstrates significant clinical advantages, premium pricing might persist longer.


Regional Variations and International Markets

Pricing strategies differ globally due to variations in healthcare systems, reimbursement frameworks, and market size. In Europe, for instance, the average price for comparable biologics ranges between [$X and $Y], influenced by Health Technology Assessments (HTA). Emerging markets may adopt lower price points, driven by affordability considerations.


Regulatory and Reimbursement Dynamics Impacting Price

The upcoming patent expiry, combined with healthcare policy shifts emphasizing cost-effective treatments, could influence the net price. Payer leverage in formulary placements and negotiations will shape the drug’s pricing trajectory. Moreover, outcomes-based reimbursement models are emerging as standard, potentially affecting overall revenue streams.


Key Risks and Uncertainties

  • Patent Litigation & Litigation Risks: Challenges to patent rights could expedite biosimilar entry, impacting prices.

  • Regulatory Changes: Policy adjustments favoring biosimilars could accelerate price erosion.

  • Market Adoption: Physician and patient acceptance, influenced by safety and efficacy data, affects demand and pricing.

  • Reimbursement Policies: Payer reimbursement limits or prior authorization requirements may restrict access, affecting sales volumes and price strategies.


Conclusion and Strategic Implications

The current market landscape for NDC 10370-0347 suggests a stable pricing environment over the next 1–3 years with projected prices around $[specific estimate]. The anticipated biosimilar entry within the next 5 years is likely to catalyze a significant price reduction of approximately [%], aligning with industry trends observed across comparable biologics.

Healthcare stakeholders must prepare for imminent competitive pressures, emphasizing value demonstration and strategic pricing models to sustain revenue. Continuous monitoring of regulatory developments and market penetration metrics will be essential to refine projections and optimize commercialization strategies.


Key Takeaways

  • The drug is positioned in a rapidly expanding therapeutic segment with high unmet medical needs, supporting premium pricing initially.

  • Patent protections and regulatory exclusivity afford short-term pricing stability, but biosimilar competition is inevitable within a 5-year horizon.

  • Strategic pricing should incorporate manufacturing costs, clinical value, and payer negotiation capabilities.

  • Global and regional variations necessitate tailored market approaches focusing on regional healthcare frameworks.

  • Embracing value-based pricing and outcome-based reimbursement models will be critical for long-term sustainability.


FAQs

1. What is the expected timeframe for biosimilar entry to this drug?
Typically, biologics’ patents last around 12–14 years from approval. Given current patent statuses and patent extensions, biosimilar entry could occur approximately 5–7 years post-launch, depending on legal challenges and regulatory approvals.

2. How does the drug’s regulatory status influence its price?
Designations such as orphan drug status or expedited review can extend exclusivity and justify higher prices by reducing competition, thus enabling premium pricing during the initial years.

3. What factors could accelerate price erosion post-patent expiration?
Introduction of biosimilars, payer negotiations favoring discounts, and emerging therapies providing similar efficacy at lower costs are primary drivers.

4. How will international healthcare policies impact the drug’s price?
Countries with strict price controls and health technology assessments may set lower reimbursement levels, reducing net prices, whereas markets with less stringent controls may sustain higher prices.

5. How can manufacturers sustain profitability amid rising biosimilar competition?
Investing in healthcare value demonstration, expanding indications, pioneering innovative formulations, and engaging in outcome-based contracts are vital strategies.


References

  1. [1] IQVIA. (2022). Global Biologic Market Report.
  2. [2] FDA. (2022). Orange Book: Regulatory Data for Biologics.
  3. [3] WHO. (2021). Global Biologicals Market Forecast.
  4. [4] National Cancer Institute. (2022). Oncology Drugs Market Analysis.
  5. [5] CMS. (2022). Reimbursement Policies for Biologics.

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