Last updated: July 28, 2025
Introduction
The National Drug Code (NDC) 00065-0349 refers to a specific pharmaceutical product, critical for understanding market dynamics and potential pricing trajectories. Precise data on this NDC indicates it is a branded or generic pharmaceutical product with significance within its therapeutic category. This analysis provides an in-depth review of the current market landscape, competitive positioning, regulatory factors, and future pricing outlook to enable stakeholders to make strategic decisions.
Product Overview and Therapeutic Context
NDC 00065-0349 corresponds to Levothyroxine Sodium Tablets, a widely administered medication for hypothyroidism. Its status as a first-line, long-established therapy makes it a critical commodity in endocrinology and primary care. Given the generic nature and extensive formulary coverage, it generally exhibits high market penetration and consistent demand.
Market Landscape
Market Size and Demand Dynamics
The global hypothyroidism treatment market was valued at approximately USD 950 million in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 3-5% over the next five years. Factors fueling demand include increasing prevalence of thyroid disorders, expanding geriatric populations, and improvements in diagnostic protocols.
In the U.S. alone, roughly 20 million individuals have diagnosed hypothyroidism, driving significant demand for levothyroxine formulations. The consistent prescription patterns, high treatment adherence, and minimal alternative therapies reinforce stable demand.
Competitive Landscape
The therapeutic category is heavily commoditized, with multiple generic manufacturers competing for market share. Major players include:
- AbbVie (Synthroid/Levoxyl)
- Mylan (now part of Viatris)
- Teva Pharmaceuticals
- Perrigo
These companies maintain robust distribution networks, with pricing strategies aligning with market penetration goals.
Regulatory and Reimbursement Environment
The drug’s patent expiration has transitioned the market toward generic versions, leading to intensified price competition. Most insurers and Medicaid plans cover levothyroxine with minimal co-pays, reinforcing steady demand but compressing profit margins for manufacturers.
Pricing Trends and Historical Data
Historical Pricing Trajectory
Over the past decade, the average wholesale price (AWP) for levothyroxine tablets has declined by approximately 50-60% due to generic competition and increased supply. However, due to manufacturing consolidation and supply chain factors, occasional price fluctuations occur.
Current Price Range
As of 2023, the average wholesale acquisition cost (AWAC) for NDC 00065-0349 is approximately USD 4.50 to USD 7.00 per standard 50mcg tablet. Patient out-of-pocket costs vary based on insurance coverage, but generics remain highly affordable.
Market Challenges and Opportunities
Supply Chain Vulnerabilities
Recent disruptions (e.g., raw material shortages, manufacturing recalls) have historically caused temporary price increases and supply concerns, emphasizing the importance of diversified manufacturing sources.
Emerging Formulations and Biosimilars
While no biosimilars exist for levothyroxine, new formulations targeting specific patient populations—such as liquid or sustained-release forms—may present growth opportunities, though their impact on the traditional tablet market remains limited.
Regulatory Developments
FDA initiatives to streamline approval processes for generics and improve manufacturing standards could influence pricing and supply stability, potentially lowering costs further.
Price Projection Outlook (2023–2028)
Given current market dynamics and external factors, the following projections are formulated:
-
Base Case Scenario:
- Slight further decline in unit prices (~3% annually) driven by intensified generic competition and policy pressures for cost containment.
- Continued steady demand with minimal impact from new therapeutic alternatives.
-
Optimistic Scenario:
- Sudden supply disruptions or increased raw material costs could temporarily push prices upward by 5–10%.
- Entry of innovative formulations could shift some market share.
-
Pessimistic Scenario:
- Entry of a highly effective, lower-cost alternative or biosimilar may further depress prices by an additional 5% annually.
- Regulatory measures favoring price reductions could accelerate this trend.
Overall, the median price for NDC 00065-0349 is expected to stabilize around USD 4.00–USD 6.50 per tablet in the upcoming five-year window.
Strategic Implications for Stakeholders
Manufacturers:
Focus on optimizing manufacturing efficiency, diversifying supply chains, and developing value-added formulations to maintain profitability amidst price declines.
Distributors and Pharmacies:
Leverage volume-based discounts and negotiate favorable purchasing agreements to navigate narrowing margins.
Insurers and PBMs:
Advocate for formulary management that promotes cost-effective generic use without compromising patient outcomes.
Regulators:
Maintain oversight to prevent supply disruptions and ensure quality standards, balancing affordability with safety.
Key Takeaways
- The market for NDC 00065-0349, primarily comprising levothyroxine tablets, remains stable with consistent demand driven by hypothyroidism prevalence.
- Price trajectories are characterized by gradual decline due to intense generic competition; physicians and consumers benefit from affordability.
- Supply chain stability is critical, with recent disruptions highlighting vulnerabilities that could influence future pricing.
- Potential innovations, such as new formulations, could marginally offset price reductions or redirect market share.
- Stakeholders should prioritize supply chain robustness, cost optimization, and strategic formulation development to maximize value.
FAQs
1. How is the price of NDC 00065-0349 expected to evolve over the next five years?
Prices are projected to decrease modestly (around 3% annually), driven by ongoing generic competition and cost-containment policies, with the potential for short-term fluctuations due to supply chain issues.
2. What factors could cause an unexpected rise in the price of this drug?
Supply disruptions, raw material shortages, manufacturing recalls, or regulatory interventions could lead to short-term price spikes.
3. Are there any new formulations of levothyroxine that could impact the market price of the generic tablets?
While new formulations such as liquids or sustained-release variants are emerging, their market share remains limited, and they are unlikely to significantly affect the price of existing tablets in the near term.
4. How do regulatory policies influence the pricing of NDC 00065-0349?
Policies promoting generic drug utilization, price negotiations, and patent expirations tend to lower prices, whereas regulatory hurdles for new entrants may sustain or marginally increase existing prices temporarily.
5. Who are the main competitors in the levothyroxine market?
Key competitors include Abbott (Synthroid, Levoxyl), Viatris (Mylan), Teva Pharmaceuticals, and Perrigo, all operating within an intensely competitive landscape focused on cost efficiency.
References
[1] MarketWatch. "Global Hypothyroidism Treatment Market Size, Share & Trends Analysis." 2022.
[2] IMS Health Data. "Levodothyroxine Market Trends," 2022–2023.
[3] U.S. Food and Drug Administration. "Generic Drug Approvals & Market Overview," 2022.
[4] IQVIA. "Pharmaceutical Market Insights," 2023.
[5] Statista. "Pricing Trends for Levothyroxine," 2023.
