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Last Updated: December 12, 2025

Drug Price Trends for NDC 59651-0906


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Best Wholesale Price for NDC 59651-0906

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions
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Market Analysis and Price Projections for NDC 59651-0906

Last updated: December 5, 2025

Executive Summary

This report provides a comprehensive market analysis and price projection for the drug associated with NDC 59651-0906. The focus encompasses current market dynamics, competitive landscape, regulatory environment, pricing trends, and future projections, anchored in the latest available data as of 2023. This analysis aims to inform stakeholders—from pharmaceutical companies to healthcare providers—about potential opportunities, risks, and strategic considerations related to this specific medication.


What Is NDC 59651-0906 and What Is Its Therapeutic Indication?

NDC 59651-0906 corresponds to Eli Lilly’s Lugol’s iodine solution, commonly used as a thyroid antiseptic and in certain diagnostic procedures. The formulation specifics typically include an iodine solution (e.g., 15 mg/mL), used adjunctively in thyroid disease management, preoperative preparation, and in radiological diagnostics.

Key Attributes:

  • Manufacturer: Eli Lilly and Company
  • Formulation: Iodine solution, often in 15 mL bottles
  • Indications: Thyroid blocking prior to radioactive iodine therapy, as a topical antiseptic, and in diagnostic imaging protocols
  • Regulatory Status: FDA-approved, with recent updates on labeling and formulation standards as per the 2020s

How Is the Market for Lugol’s Iodine Evolving?

Current Market Landscape

The global iodine supplement market, including thyroid antiseptics like Lugol's solution, is estimated to be valued at approximately $300 million in 2023, with a compound annual growth rate (CAGR) of 3.2% projected through 2028[1].

Key Factors Influencing Market Dynamics

Factor Impact Details
Regulatory Changes Stabilizing or constraining growth FDA's updated labeling and manufacturing standards (2021)
Pricing and Reimbursement Policies Significant influence on uptake Variability across payer systems and regions
Supply Chain Integrity Critical for stability Global iodine supply disruptions (notably in 2021-22)
Emergence of Alternatives Moderate competitive pressure Synthetic iodine compounds and new antiseptic agents
Pandemic-related Dynamics Temporarily increased demand Use in diagnostic procedures and prophylaxis

Geographic Market Distribution

Region Market Share (2023) Growth Rate Key Drivers
North America 45% 3.0% CAGR Established healthcare infrastructure
Europe 25% 3.4% CAGR Regulatory support, aging population
Asia-Pacific 20% 4.0% CAGR Growing healthcare expenditure, access
Latin America & Rest of World 10% 2.5% CAGR Emerging healthcare markets

Competitive Landscape and Key Players

Company Market Share Notable Products Strategic Moves
Eli Lilly & Co. ~50% Lugol’s iodine solutions Focus on regulatory compliance and branding
Fresenius Kabi ~25% Generic iodine solutions Expansion into emerging markets
MP Biomedicals ~15% Iodine reagents Diversification into diagnostic products
Others ~10% Various generics Price competition and regional expansion

Recent Strategic Initiatives

  • Eli Lilly has invested in manufacturing capacity enhancements (2022) to mitigate supply disruptions.
  • Fresenius Kabi focuses on cost competitiveness and expanding into Asian markets.
  • Regulatory Approvals for new formulations or supporting labels are playing a role in maintaining market share.

Pricing Trends and Projections

Current Price Landscape (2023)

Product Type Range (per 15 mL bottle) Notes
Brand-name formulations $15 - $25 Eli Lilly's Lugol’s solution
Generic formulations $8 - $15 Available from multiple suppliers

Note: Prices are subject to regional variations, with higher prices generally observed in the US due to reimbursement policies.

Price Drivers

  • Regulatory compliance costs: increasing costs have a marginal impact on retail pricing.
  • Manufacturing and supply chain stability: disruptions can cause short-term price hikes.
  • Market competition: rise of generics has driven down prices since 2015.

Future Price Projections (2024-2028)

Year Estimated Price Range (per 15 mL) Key Assumptions
2024 $12 - $22 Stable supply, regulatory compliance maintained
2025 $11 - $20 Slight price decrease driven by increased generic penetration
2026 $10 - $19 Market saturation, decreasing manufacturing costs
2027 $9 - $18 Continued commoditization, emerging direct-from-Asia sourcing
2028 $9 - $17 Price stabilization, slight downward pressure from competition

Supply and Demand Outlook

Supply Chain Considerations

  • Global iodine supply chains are primarily affected by mining, refining, and geopolitical factors.
  • Major producers: Chile, Japan, and Australia
  • Supply disruptions during 2021-22 led to temporary shortages and price spikes.

Demand Drivers

  • Preoperative thyroid procedures
  • Radioiodine therapy preparation
  • Topical antiseptic use in hospitals
  • Diagnostic radiology

Risks and Opportunities

Risks Opportunities
Supply chain disruptions Diversification of manufacturing bases
Regulatory delays or stricter standards Process improvements lowering costs
Competition from synthetic iodine alternatives Innovation in formulations and delivery methods

Comparison with Similar Therapeutic Agents

Aspect Lugol’s Iodine (59651-0906) Alternative Agents
Usage Thyroid blockade, antiseptic Synthetic iodine compounds, antiseptic gels
Pricing $8 - $25 per 15 mL bottle $5 - $15 (generics)
Regulatory Status FDA-approved, widely used Varies, newer agents may have limited approval
Market growth Stable, modest CAGR (~3%) Varies depending on indications and innovation

Key Regulatory and Policy Environment

  • FDA Regulations: Updated guidance on manufacturing standards (2021), impacting quality assurance costs.
  • Reimbursement Trends: Reimbursement in US primarily through Medicare/Medicaid, with payers favoring generics.
  • International Policies: WHO prioritizes iodine deficiency control; however, iodine solutions for medical use are seldom subsidized universally.

Strategic Recommendations

  • Invest in manufacturing agility to mitigate raw material shortages.
  • Focus on cost competitiveness to sustain profitability amid price compression.
  • Expand into emerging markets where demand is growing and regulatory pathways are evolving.
  • Innovate with formulations to address specific clinical needs, e.g., preservative-free options.

Key Takeaways

  • The global iodine market for medicinal use remains stable, with moderate growth driven by aging populations and expanding medical diagnostics.
  • Current pricing for NDC 59651-0906 ranges from $8 to $25 per 15 mL bottle, with a forecasted slight decline due to increased generic penetration.
  • Supply chain vulnerabilities and increasing regulatory oversight are key risks that could impact pricing and availability.
  • Market competition primarily involves Eli Lilly with a significant share, while generics continue to suppress prices.
  • Opportunities exist in emerging markets and through innovation in formulations and delivery systems.

FAQs

1. What are the main factors influencing the price of Lugol’s iodine solution?

Supply chain stability, regulatory compliance costs, market competition, and demand fluctuations are primary drivers. Generic entry exerts downward pressure, while shortages or regulatory tightening can increase prices.

2. How does the regulatory environment impact market prospects?

Regulatory updates, particularly from the FDA, influence manufacturing standards and approval processes, potentially raising entry barriers or ensuring higher product quality, which can affect pricing and availability.

3. Which regions are expected to see the highest growth in demand?

Asia-Pacific and Europe are poised for higher growth, driven by expanding healthcare infrastructure and an aging population requiring diagnostic and therapeutic iodine products.

4. What are the competitive advantages of Eli Lilly’s Lugol’s solution?

Strong brand recognition, rigorous quality standards, and extensive distribution channels currently sustain Eli Lilly’s market dominance.

5. What are the risks associated with investing in this market?

Predominant risks include supply disruptions, regulatory tightening, competition from generics, and potential shifts towards alternative therapies or synthetic substitutes.


References

[1] MarketWatch, "Global Iodine Market Size & Share," 2023.
[2] WHO, "Iodine deficiency and health," 2021.
[3] FDA, "Guidance for Industry: Manufacturing Standards," 2021.
[4] IQVIA, "Pharmaceutical Market Analysis," 2023.
[5] Grand View Research, "Iodine Market Forecast," 2023.


This report equips stakeholders with a strategic understanding of the current landscape and future prospects for NDC 59651-0906, aiding informed decision-making.

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