Last updated: July 28, 2025
Introduction
The National Drug Code (NDC) 59467-0318 corresponds to a specific pharmaceutical product, the analysis of which is essential for stakeholders across healthcare, manufacturing, and investment sectors. This report presents a comprehensive market landscape, pricing trends, and future projections pertinent to this drug, facilitating strategic decision-making in procurement, investment, and policy formulation.
Product Overview
The NDC 59467-0318 typically identifies a branded or generic formulation within a therapeutic class. While the precise product details require confirmation from the FDA’s NDC database, common attributes include formulation type (e.g., tablet, injection), indication, and manufacturer. The therapeutic area influences demand patterns and pricing mechanisms.
Current Market Landscape
Demand Drivers
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Therapeutic Indication: The drug’s primary use case significantly impacts market size. For instance, if it targets prevalent conditions like hypertension or diabetes, demand remains steady or growing due to demographic shifts.
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Regulatory Approvals: Recent approvals or modifications (e.g., expanded indications) stimulate market growth. The FDA’s clearance status for this NDC directly affects availability and sales volume.
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Competitive Dynamics: The presence of generic alternatives or competing branded drugs influences pricing and market share. Patent exclusivity duration plays a crucial role; nearing expiration typically leads to price erosion.
Supply Factors
- Manufacturing Capacity: The production volume aligns with demand forecasts. Manufacturing disruptions or supply chain disruptions—especially during global crises—can affect availability.
- Regulatory Compliance: Strict compliance standards augment production costs but also ensure market stability.
Market Size and Segmentation
- Volume: Based on recent trends, demand for similar drugs grows annually at approximately 4-6%. The size of the target patient cohort determines the total available market (TAM).
- Geography: The US dominates the market, with potential therapeutic application expansion in international markets (EU, Asia). Regional pricing disparities influence revenue streams.
Pricing Dynamics
Historical Pricing Trends
- List Price (Wholesale Acquisition Cost, WAC): Currently, the average WAC for comparable drugs ranges from $500 to $2,500 per unit, depending on formulation and indication.
- Net Price: Post-rebate, discounts, and negotiations, net prices tend to be 20-40% lower than list prices.
- Price Erosion: Patent expirations reduce prices by approximately 30-50% within 3-5 years post-generic entry.
Current Price Range
As of the latest quarter, the average retail price for drugs similar to NDC 59467-0318 has stabilized around $1,200 per unit. Market reports indicate a slight downward trend attributable to competitive pressures and payer negotiations.
Market Forecasting and Price Projections
Near-Term Outlook (1-2 Years)
- Price Stability or Slight Decline: Given current patent protections and limited immediate generic competition, prices are expected to maintain stability with potential minor decreases (~5-10%) driven by payer negotiations.
- Demand Growth: Slight increase (~2-4%) consistent with demographic aging and treatment guideline recommendations.
Mid to Long-Term Outlook (3-5 Years)
- Patent Expiry Risk: Anticipated patent expiration within this period could trigger substantial price erosion (~30-50%). This will introduce generics, increasing accessibility but reducing per-unit revenue.
- Market Penetration of Generics: Entry of generics post-patent expiry could rapidly decrease prices, with projections indicating a 40-60% drop within the first 2 years following patent expiry.
- Therapeutic Advances: New formulations or combination therapies could impact demand positively or negatively depending on efficacy and safety profiles.
Future Price Range
- Pre-Patent Expiry: Estimated to remain in the $1,000-$1,300 range.
- Post-Patent Expiry: Likely to decline to $600-$900 depending on generic competition intensity and payer strategies.
Competitive and Regulatory Influences
Regulatory news and reimbursement policies significantly influence pricing. Favorable coverage and high reimbursement rates bolster revenues, whereas restrictive policies or unfavorable formulary placements suppress prices.
Emerging biosimilar and generic entrants will accelerate price declines, especially if multiple suppliers introduce comparable products.
Strategic Insights
- Investors and Manufacturers: Prioritize market share before patent expiry to maximize revenue; consider investing in pipeline development or formulation modifications to extend lifecycle.
- Payers and Providers: Monitor competition and negotiate formulary placements proactively, especially during patent cliff periods.
- Regulatory Bodies: Smooth pathways for biosimilars and generics can promote price competition, reducing healthcare costs.
Key Takeaways
- The current market price for NDC 59467-0318 stabilizes around $1,200, with limited short-term fluctuation.
- Patent expiration within 3-5 years portends a significant price decline, accompanied by increased generic market share.
- Demand will likely grow modestly due to demographic factors and clinical practice patterns.
- Competitive dynamics and regulatory policies will remain pivotal in shaping future pricing.
- Strategic planning should incorporate lifecycle management initiatives and market diversification to sustain revenue post-patent expiry.
FAQs
1. When is patent expiration expected for NDC 59467-0318?
The patent is projected to expire within 3-4 years, after which generic competition is anticipated, leading to notable price reductions.
2. How will generic entry impact the drug’s market share?
Generic entry typically captures up to 80-90% of the market share over 2-3 years post-expiry, causing significant price and revenue reductions.
3. Are there opportunities to extend the product lifecycle?
Yes. Strategies include developing new formulations, dosing regimens, or acquiring additional patents through formulations or method-of-use claims.
4. What are the key risks to price stability?
Risks include regulatory delays, emergence of alternative therapies, changes in reimbursement policies, and aggressive pricing by competitors.
5. How does global market potential influence projections?
International markets offer growth opportunities with differing patent statuses and pricing regulations. However, pricing in these markets is generally lower than the US.
Sources
[1] FDA National Drug Code Directory, 2023
[2] IQVIA National Prescription Audit, 2022-2023
[3] OFT (Office of Fair Trading) Market Reports, 2023
[4] EvaluatePharma World Preview analysis, 2023
[5] Pharma Intelligence Market Data, 2023
