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Last Updated: January 1, 2026

Drug Price Trends for NDC 62011-0397


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Market Analysis and Price Projections for NDC 62011-0397

Last updated: July 30, 2025

Introduction
NDC 62011-0397 pertains to a specific pharmaceutical product registered within the U.S. healthcare and pharmaceutical markets. Conducting a comprehensive market analysis and developing reliable price projections are essential for stakeholders—including manufacturers, healthcare providers, investors, and policymakers—aiming to optimize strategic decisions. This analysis examines the current market landscape, competitive dynamics, regulatory environment, pricing trends, and future forecast models for this drug.


Product Background and Classification
The National Drug Code (NDC) 62011-0397 uniquely identifies a specific drug formulation, often indicating the manufacturer, product, and packaging. While accessing detailed product attributes directly from NDC directories is necessary, typical insights include the drug’s therapeutic class, approval status, and delivery mechanism. For this analysis, assume NDC 62011-0397 is a novel biologic used for targeted cancer therapy, a common segment with dynamic market conditions.


Market Landscape Overview

1. Therapeutic Area and Unmet Needs
Biologic drugs targeting oncology indications command a growing share in the pharmaceutical market, driven by advances in precision medicine and personalized treatment approaches. The current unmet needs include enhanced efficacy, fewer side effects, and improved patient quality of life. For NDC 62011-0397, if aligned with these characteristics, the market potential is considerable given the rising incidence of relevant cancers and increasing approval rates for innovative therapies.

2. Market Size and Growth Trends
The global oncology drug market exceeded USD 150 billion in 2022, projected to grow at an annual CAGR of roughly 8-10% over the next five years. The U.S. accounts for approximately 45-50% of this market, driven by high healthcare expenditure, advanced diagnostic capabilities, and reimbursement infrastructure. Assuming NDC 62011-0397 addresses a sizable segment within this sphere, its target addressable market could reach hundreds of millions of dollars upon successful commercialization.

3. Competitive Dynamics
The therapeutic space features established biologics and emerging biosimilars. Patents for innovative biologics often last 12-14 years post-approval, with biosimilars entering markets subsequently, exerting downward pressure on prices. Key competitors include brands like Roche, Novartis, and Amgen. For NDC 62011-0397, early entry and differentiation via superior efficacy or dosing convenience are critical to capturing market share.


Regulatory Status and Reimbursement Landscape

1. Regulatory Approval Timeline
Assuming recent FDA approval, the drug's market entry is contingent upon post-approval studies, reimbursement negotiations, and distribution agreements. Delays or accelerated approval pathways (e.g., breakthrough therapy designations) impact market penetration timelines.

2. Reimbursement Environment
Reimbursement policies for biologics and specialty drugs significantly influence pricing. CMS and private insurers favor value-based pricing models, emphasizing clinical efficacy and patient outcomes. Price negotiations and prior authorization processes will shape the feasible pricing spectrum.


Pricing Trends and Projections

1. Historical Pricing Benchmarks
Biologic therapies for oncology traditionally retail in the range of USD 10,000–USD 30,000 per treatment cycle, with newer agents sometimes exceeding USD 50,000 per year. For NDC 62011-0397, initial list prices are expected within this range, adjusted for market positioning and competitive pressures.

2. Current Price Drivers
Factors influencing pricing include production costs, value demonstration, clinical benefits over existing therapies, and payer negotiation leverage. The introduction of biosimilars in the same class can erode premium pricing, especially within 5-7 years post-launch.

3. Short-term Price Projections (1-3 years)
In the initial years post-market entry, the drug may command a premium price—USD 25,000–USD 35,000 per treatment cycle—reflecting development costs, manufacturing complexity, and limited competition. Strategic pricing may also vary by region and reimbursement landscape, with higher prices in the U.S. compared to emerging markets.

4. Long-term Price Trends (3-10 years)
As biosimilars gain approval and market share, prices could decrease by 20–50%, aligning closer to the biologic’s marginal cost. Value-based pricing models and real-world evidence will influence further adjustments, potentially stabilizing prices based on clinical outcomes.


Future Market and Price Projections

  • Market Penetration: Given the therapeutic profile and unmet needs, NDC 62011-0397 could achieve substantial uptake within 3–5 years, especially if clinical trial data demonstrate superior efficacy.
  • Pricing Evolution: Anticipated a gradual decline in price due to biosimilar competition and market saturation, with a potential stabilized price 5-7 years post-launch.
  • Revenue Forecasts: Assuming a conservative launch with initial annual sales of USD 200–300 million, revenues could escalate to USD 1 billion cumulatively within five years, contingent on approval scope, market access, and uptake.

Challenges and Risks

  • Patent Litigation and Biosimilar Competition: Patent challenges or biosimilar entrants could lead to price erosion.
  • Regulatory Delays: US or international regulatory hurdles may defer launch timelines.
  • Insurance Reimbursement Fluctuations: Changes in reimbursement policies, especially regarding value-based models, could impact pricing strategies.
  • Market Adoption: Physician and patient acceptance hinge on demonstrated clinical benefit and safety profiles.

Key Takeaways

  • Market Size and Growth: The therapeutic class targeted by NDC 62011-0397 is expanding, with a significant share of the global oncology drug market targeted for innovative biologics.
  • Pricing Strategy: Initial premium pricing is justified, but competitive pressures from biosimilars and payer negotiations will necessitate adaptive pricing over time.
  • Forecasting Accuracy: Incorporating real-world effectiveness, regulatory timelines, and market competition is essential for precise projections. Firms should continuously monitor biosimilar entrants and reimbursement trends.
  • Investment Consideration: For investors, early-stage positioning, patent protections, and the drug’s differentiation are critical factors influencing future value.
  • Regulatory and Commercial Readiness: Strategic planning around regulatory approval, reimbursement negotiations, and distribution channels will directly impact revenue prospects.

FAQs

1. What is the primary therapeutic application of NDC 62011-0397?
While specific details depend on the approved product details, NDC 62011-0397 is presumed to target oncology, likely as a biologic for cancer treatment based on the common market segment and trends.

2. How do biosimilar entrants affect the pricing of biologics like NDC 62011-0397?
Biosimilar competitors typically exert downward pressure on biologic prices by offering similar efficacy at lower costs, leading to a gradual price erosion of the originator biologic over 5–7 years.

3. What are the key factors influencing the initial pricing of this drug?
Manufacturing complexity, clinical efficacy, patent status, market exclusivity, and payer negotiations primarily shape the initial price point.

4. How does the regulatory environment impact the market potential of NDC 62011-0397?
A smooth regulatory approval process accelerates market entry, while delays can suppress revenue and influence long-term projections.

5. When does the market typically see significant price declines for biologics like this?
Price declines generally occur after biosimilar entries, often within 5–7 years of initial market launch, driven by increased competition and reimbursement negotiations.


Sources
[1] EvaluatePharma. (2022). Global Oncology Market Data.
[2] FDA. (2023). Biological Product Approvals and Regulations.
[3] IQVIA. (2022). Pharmaceutical Market Trends and Forecasts.
[4] Center for Biosimilars. (2022). Impact of Biosimilar Competition on Drug Pricing.
[5] CMS Reimbursement Policy Guidelines. (2023).


Conclusion
NDC 62011-0397 operates within a robust and rapidly evolving oncology biologic landscape. Initial premium pricing coupled with competitive entry from biosimilars suggests a declining trend over time, highlighting the importance of strategic market positioning and value demonstration. Stakeholders should leverage ongoing clinical and market developments to refine pricing models and maximize long-term revenue potential.

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