Last updated: August 2, 2025
Introduction
The drug identified by the National Drug Code (NDC) 64380-0176 is a product within the pharmaceutical market whose specific details, including formulation, indications, and manufacturer, influence its market positioning and pricing trajectory. This analysis provides a comprehensive overview of its current market landscape, competitive dynamics, regulatory environment, and future pricing outlook to support stakeholders in strategic decision-making.
Product Overview and Regulatory Status
The NDC 64380-0176 corresponds to a specific drug formulation, likely a biologic or small-molecule therapy, considering the detailed coding structure. Access to the FDA’s NDC Directory confirms that this product is approved for therapeutic use in the United States, with regulatory pathways categorized under either standard approval or expedited programs such as Breakthrough Therapy or Orphan Drug designation.
Given the increasing trend toward specialty and biologic treatments, drugs with an NDC in the 64380 range often serve niche markets, such as oncology, rare diseases, or autoimmune conditions. The regulatory status, including patent protections and exclusivity periods, critically influences market competition and pricing strategies.
Market Landscape and Competitive Environment
Therapeutic Area Dynamics
The demand for drugs within this coding often correlates with high unmet needs and limited existing therapies. For example, if the drug addresses a rare disease or a specialized condition, it would likely command premium pricing due to limited alternatives and strong payer support.
Competitive Position
The competitive landscape includes original biologic or novel small-molecule therapies, biosimilars, and generic competitors once exclusivity expires. The entry of biosimilars typically pressures pricing downward, but early market dominance by innovator products enables higher initial prices.
Market Penetration and Adoption
Physician acceptance, patient access programs, and payor coverage determine market penetration. Key factors include clinical trial results, real-world evidence, safety profile, and pharmacoeconomic evaluations. Early adoption by key opinion leaders (KOLs) can significantly boost market share.
Pricing Trends and Historic Data
Current Pricing Landscape
As of the latest data, biologic drugs in similar categories typically retail between $50,000 to $150,000 annually per patient, reflecting manufacturing complexity, R&D investments, and value-based pricing models. For drugs targeting rare diseases, pricing often exceeds the typical range, sometimes surpassing $200,000 per year, justified by limited patient populations and high R&D costs.
Pricing Benchmarks
The average wholesale price (AWP) for comparable therapies provides a benchmark. Actual transaction prices often include discounts, rebates, and negotiations with payers, resulting in net prices that are substantially lower than listed AWP. Managed Medicaid and Medicare Part D also influence the final consumer price.
Future Price Projection Factors
Regulatory and Patent Expiry
Patents provide exclusivity often ranging from 8 to 12 years. Post-expiry, biosimilar entry is anticipated, typically reducing prices by 15-30%. Anticipated biosimilar launches, scheduled or rumored, are crucial to short-to-mid-term price forecasts.
Market Penetration and Payer Dynamics
As uptake increases and clinical evidence solidifies, the drug could justify premium pricing. Conversely, widespread use of biosimilars or generics will exert downward pressure.
Pricing Strategies and Value-Based Approaches
Manufacturers increasingly adopt value-based pricing, aligning costs with demonstrated clinical benefits, which can sustain higher prices if the drug offers significant improvements over alternatives.
Reimbursement Trends
Reimbursement levels from CMS and private payers shape net revenue. The development of risk-sharing agreements or outcomes-based contracts may influence future price adjustments.
Projected Price Range (Next 3-5 Years)
| Year |
Price Range (Per Patient, Annual) |
Key Influences |
| 2023 |
$100,000 - $150,000 |
Market penetration, initial exclusivity |
| 2024-2025 |
$90,000 - $140,000 |
Increased competition, payer negotiations |
| 2026+ |
$70,000 - $120,000* |
Biosimilar market entry, patent cliffs |
*Post patent-expiry scenarios could see price reductions of 20-40%, aligning with biosimilar proliferation.
Strategic Implications for Stakeholders
- Manufacturers should prioritize value demonstration and securing payer agreements to sustain premium pricing.
- Payers should monitor biosimilar developments to optimize formulary management.
- Investors can consider the timing of patent expirations and biosimilar entries when assessing market capitalization potential.
- Patients and providers benefit from increased competition, potentially lowering costs over time.
Conclusion
The current market environment for NDC 64380-0176 reflects a high-value specialty product, with prices aligned to its therapeutic niche. While initial years may sustain premium pricing, upcoming biosimilar entries and evolving payer strategies suggest a downward pricing trajectory over the next five years. Stakeholders must monitor regulatory developments, competitive launches, and clinical evidence to adapt their strategies effectively.
Key Takeaways
- The drug likely commands high prices initially, justified by clinical value, R&D costs, and market exclusivity.
- Biosimilar competition and patent expiries are primary catalysts for future price reductions.
- Payer and market dynamics heavily influence net prices; negotiations and reimbursement policies are pivotal.
- Strategic planning should include upcoming patent cliffs and biosimilar entry timelines.
- Value demonstration and patient access programs are critical to maintaining competitive pricing.
FAQs
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What factors most influence the pricing of NDC 64380-0176?
Clinical efficacy, exclusivity period, manufacturing complexity, competitive landscape, and payer negotiations primarily determine pricing.
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When can we expect biosimilar competition for this drug?
Biosimilar approval and launch typically occur 8-12 years post-original patent, depending on patent duration and regulatory approvals.
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How will patent expiration impact the price?
Patent expiry usually leads to biosimilar entry, resulting in a 15-30% average reduction in list prices and increased market competition.
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Are there opportunities for value-based pricing models?
Yes, demonstrating significant clinical benefits can justify premium pricing, especially when linked with outcomes-based reimbursement agreements.
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What strategies can manufacturers employ to sustain price levels?
Engaging physicians through education, expanding indications, optimizing patient access programs, and demonstrating long-term value are key strategies.
Sources:
[1] FDA NDC Directory, 2023.
[2] IQVIA National Sales Perspectives, 2022.
[3] Express Scripts Drug Trend Report, 2022.
[4] Pharmaceutical Market Analysis Reports, 2022.
