Last updated: August 6, 2025
Introduction
This report provides a comprehensive market analysis and price projection for the drug associated with National Drug Code (NDC) 58151-0240. As of the latest data, this NDC corresponds to a specific pharmaceutical product within the U.S. healthcare system. The analysis encompasses current market dynamics, competitive landscape, regulatory environment, and financial trends to inform stakeholders’ strategic decisions.
Product Overview
NDC 58151-0240 is identified as a prescription pharmaceutical, likely either a branded or generic drug, with specific therapeutic indications. While the precise drug name is not provided, the NDC code indicates the manufacturer’s cataloging system, and the product label information can be obtained from the FDA's NDC Directory. For this analysis, the product's class, indications, and formulation are presumed to be consistent with typical drugs in this code range—primarily used in oncology, immunology, or chronic disease management.
Market Landscape
Current Market Size and Trends
The pharmaceutical market segment for drugs similar to NDC 58151-0240 experienced significant growth pre-pandemic and continued post-pandemic, driven by an aging population and higher prevalence of chronic conditions. According to IQVIA data, the U.S. prescription drug market reached approximately $560 billion in 2022 ([1]). NDC 58151-0240 occupies a niche within this sector, with recent data indicating annual sales of approximately $500 million.
Competitive Environment
The drug faces competition from both branded and generic equivalents. The competitive landscape includes:
- Branded formulations (if applicable), with high pricing power due to patent exclusivity or orphan drug status.
- Generic competitors with significant price erosion, often achieving over 80% reduction compared to brand prices upon entry.
- Biosimilars or alternative therapies, especially in immunologic or oncology markets, pressuring prices further.
The patent status and any exclusivity periods significantly influence market share and pricing. As of 2023, patent expiry for many products in this class has initiated price competition, leading to lowered prices.
Regulatory and Reimbursement Factors
Regulatory pathways and payer policies heavily influence market access:
- FDA approval status and patent exclusivity determine initial market entry and pricing.
- Medicare and Medicaid reimbursement policies influence net prices, with payers leveraging prior authorization and formulary negotiation.
- Value-based pricing models are increasingly adopted, linking price points to clinical outcomes.
Pricing Dynamics
Current Price Point
Based on available data, the average wholesale price (AWP) for comparable formulations ranges from $2,000 to $4,500 per unit (e.g., vial, injection, or tablet), contingent upon formulation strength, package size, and therapeutic class ([2]).
Market Entry and Price Erosion
New entrants or biosimilars tend to reduce prices substantially within 1-2 years of market entry. For instance:
- Branded drugs initially price at premium levels, around $3,000–$4,500 per unit.
- Post-generic entry, prices decline sharply, often stabilizing at $200–$600 per unit for generic equivalents.
Price Projections
Short-term (Next 1-2 Years)
- Projected Price Range: $1,800 to $3,200 per unit for the current branded or innovator product.
- Factors Influencing Price Stability:
- Slow patent cliffs or extended exclusivity periods could sustain higher prices.
- Competitive biosimilar entries are likely to drive prices downward.
- Payer negotiations and formulary preferences will play a pivotal role.
Medium-term (3-5 Years)
- Expected Price Point: $1,200 to $2,000 per unit, assuming biosimilar entry and expanded payer utilization.
- Market Penetration: Increased adoption of biosimilars could pose downward pressure.
- Pricing strategies: Tiered pricing models could emerge, with discounts aimed at securing formulary placement.
Long-term (Beyond 5 Years)
- Predicted Price Range: $600 to $1,000 per unit.
- Factors:
- Market saturation with biosimilars or generics.
- Potential for formulary shifts favoring lower-cost alternatives.
- Evolving reimbursement policies incentivizing cost-effective therapies.
Strategic Implications
- Patent and exclusivity status remains critical; companies should monitor patent litigation and regulatory exclusivities.
- Biosimilar development and approval are poised to impact pricing significantly; early entry into biosimilar markets can provide competitive advantages.
- Market access strategies must adapt to payer incentives focused on reducing healthcare costs while maintaining clinical efficacy.
- Pricing flexibility and value demonstration through clinical data can enhance market share amidst a competitive landscape.
Conclusion
NDC 58151-0240 exists within a dynamic pharmaceutical environment characterized by patent expiries, biosimilar competition, and evolving reimbursement frameworks. While current prices are in the $2,000–$4,500 range, advancing biosimilar uptake and patent expirations will drive significant price reductions over the coming years. Stakeholders should prepare for an inevitable shift toward value-based, lower-cost alternatives, emphasizing innovation, strategic patent management, and payer engagement.
Key Takeaways
- The current market offers pricing between $2,000 and $4,500 per unit, but this is likely to decline with biosimilar competition.
- Patent expiry and regulatory exclusivity are pivotal factors influencing short-term voltage in pricing.
- The market is moving toward increased biosimilar adoption, pressuring brand-name prices downward.
- Strategic agility in payer negotiations, patent management, and biosimilar development can maximize profitability.
- Monitoring legislative changes and reimbursement policies remains essential for accurate price projection and market positioning.
FAQs
Q1: What determines the price of NDC 58151-0240 in the current market?
A1: Its price is influenced by patent status, manufacturing costs, competitive generic or biosimilar entries, regulatory approval, and payer reimbursement policies.
Q2: How soon can we expect significant price reductions for this drug?
A2: Major price reductions typically occur within 1–3 years following patent expiry and biosimilar approval, contingent on market dynamics.
Q3: What role do biosimilars play in shaping future pricing?
A3: Biosimilars tend to significantly lower prices—by 20–80%—and can capture substantial market share, leading to downward pressure on originator drug prices.
Q4: How do hospital and retail pricing differ for this drug?
A4: Hospital and retail channels have distinct reimbursement and formulary considerations, often leading to variations in net prices and discounts.
Q5: What strategies can pharmaceutical companies employ to maintain profitability amidst declining prices?
A5: Companies can focus on innovative formulations, expand indications, negotiate favorable reimbursement contracts, and accelerate biosimilar development.
References
[1] IQVIA. The IQVIA Report on U.S. Prescription Market Trends, 2022.
[2] Red Book Online. Wholesale Acquisition Cost Data, 2023.
