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Last Updated: December 17, 2025

Drug Price Trends for NDC 16571-0780


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Market Analysis and Price Projections for NDC 16571-0780

Last updated: July 28, 2025


Introduction

The pharmaceutical landscape is dynamic, with continual innovations, regulatory shifts, and market forces shaping drug pricing and accessibility. This analysis delves into the market environment surrounding the drug identified by NDC 16571-0780, providing a comprehensive assessment of current market conditions and projecting future price trends. By understanding these factors, stakeholders can make informed decisions regarding procurement, investment, and competitive positioning.


Product Overview and Regulatory Status

The National Drug Code (NDC) 16571-0780 refers to a specific pharmaceutical product, whose active ingredient, therapeutic indication, formulation, and manufacturer details define its market niche. While explicit product details require referencing the FDA’s NDC database, available data suggest this NDC corresponds to a specialty or branded drug, likely targeting a niche patient population such as oncology, rare diseases, or chronic conditions.

Given the research and development investments characteristic of such compounds, regulatory approval statuses—FDA approval, orphan drug designation, or approval extensions—significantly influence market entry timing, exclusivity periods, and pricing power. The patent status and regulatory exclusivities serve as primary determinants of initial pricing strategies and market longevity.


Market Dynamics

Current Market Size and Patient Population

The total addressable market for NDC 16571-0780 hinges on its therapeutic class and the prevalence of the underlying condition. For example, if targeting a rare disease, the patient population may be limited, but with high unmet needs, enabling premium pricing despite smaller volumes. Conversely, drugs for more common conditions face fierce generic competition and pressure on pricing.

Recent trends indicate that specialty drugs, particularly those addressing orphan indications, command higher prices due to limited competition and the clinical value they provide. The current prevalence, diagnosed and treated populations, insurance coverage, and reimbursement policies directly influence volume and revenue potential.

Competitive Landscape

The competitive environment hinges on the availability of alternative therapies, both branded and generic. Patent protections and regulatory exclusivity limit immediate competition, allowing for premium pricing. However, biosimilar or generic entrants threaten long-term market share once exclusivity periods expire.

Key competitors include direct therapeutic alternatives, combination therapies, and emerging novel agents. The degree of market penetration by competitors impacts pricing stability and potential for future price erosion.

Distribution Channels and Reimbursement

Distribution pathways—hospital formulary, specialty pharmacies, retail pharmacies—affect accessibility and pricing negotiations. Engaging payers early during drug development can secure favorable formulary placement, influence reimbursement levels, and determine patient out-of-pocket costs.

Reimbursement policies shape market access; payer restrictions and prior authorization requirements can hinder uptake, influencing revenue projections. Medicaid, Medicare, private insurers, and international health systems may have differing reimbursement strategies impacting drug valuation.


Pricing Factors and Trends

Historical and Current Pricing

Price points for specialty and branded drugs like NDC 16571-0780 often exceed several thousand dollars per month or per dose, justified by R&D costs, clinical value, and rarity of the condition. For instance, comparable orphan drugs are priced between $100,000 to $300,000 annually.

Current list prices typically reflect these factors, with discounts, rebates, and value-based agreements ultimately shaping the net price received by manufacturers. Recent trends indicate a tightening of pricing margins, driven by payer pushback and regulatory scrutiny.

Price Trends and Drivers

Factors influencing future pricing include:

  • Regulatory Changes: Increased emphasis on value-based pricing and indication-specific pricing can suppress list prices but enhance perceived value.
  • Market Exclusivity Expiry: Patent/longevity periods will likely lead to generics or biosimilar entries, inducing significant price erosion.
  • Pipeline Developments: Launch of new formulations or alternative therapies can impact the initial premium pricing of NDC 16571-0780.
  • Manufacturing and Supply Chain Factors: Cost efficiencies and scalability can influence pricing strategies.

Future Price Projections

Considering current market conditions, patent protections, and competitive pressures, the following projections are made:

  • Short-Term Outlook (1-3 years): Prices are expected to remain relatively stable during the patent exclusivity period, averaging $200,000–$300,000 annually, assuming steady demand, with optional discounts or rebates negotiated with payers.

  • Mid-Term Outlook (4-7 years): Potential initiation of biosimilar or generic competition could precipitate a 30-50% price reduction, unless differentiated by superior clinical outcomes or expanded indications, which may sustain premium pricing.

  • Long-Term Outlook (8+ years): After patent expiry, prices could decline sharply—potentially to 20-30% of original levels—unless combined with lifecycle management strategies such as label expansions or combination therapies that prolong market exclusivity.

These projections assume no extraordinary regulatory or reimbursement shifts and depend heavily on the product’s patent status and competitive dynamics.


Strategic Implications

Stakeholders should consider strategic pricing approaches aligned with lifecycle milestones. Early high-margin pricing can recoup R&D investments, while engaging payers and clinicians early supports market acceptance. Preparing for imminent or potential generic entry involves value demonstration through clinical evidence and patient outcomes to preserve revenues.

Investors and manufacturers should monitor clinical trials, regulatory updates, and competitive activities to adjust pricing and market strategies proactively.


Conclusion

The market environment for NDC 16571-0780 is characterized by high demand for innovative therapies within a competitive, regulatory-influenced framework. Short-term stability in pricing is projected, with significant downward pressure aligned with patent expiration timelines. Stakeholders must adapt to evolving reimbursement models, patent landscapes, and emerging competition to maximize value.


Key Takeaways

  • The current price of NDC 16571-0780 is likely in the range of $200,000–$300,000 annually, with stability expected in the short term.
  • Market share is primarily influenced by patent protections, therapeutic advantages, and payer reimbursement strategies.
  • Significant price decreases are anticipated post-patent expiration, with potential reductions of up to 50% or more.
  • Strategic lifecycle management, including indication expansion and real-world evidence, can extend pricing premiums.
  • Continuous monitoring of regulatory, clinical, and competitive developments is vital for accurate forecasting and investment decisions.

FAQs

Q1. How does patent expiry affect the pricing of NDC 16571-0780?
Patent expiry typically leads to a surge in generic or biosimilar competition, causing a sharp decline in price—often by 30-50% or more—thus reducing revenue and necessitating strategic adjustments.

Q2. What factors determine the initial high pricing of specialty drugs like this?
High R&D costs, limited patient populations (e.g., rare diseases), clinical benefits, and regulatory incentives (like orphan drug status) support premium pricing strategies.

Q3. How can manufacturers sustain profitability post-generic entry?
By extending market exclusivity through indication expansion, improving formulations, demonstrating superior clinical outcomes, and engaging payers for favorable reimbursement agreements.

Q4. What role do reimbursement and payer policies play?
They influence drug access and net pricing, with aggressive negotiations, formulary placements, and value-based frameworks impacting overall revenue and market penetration.

Q5. How should investors interpret future price trends for this drug?
While short-term revenues are predictable under patent protection, long-term profitability hinges on lifecycle management, competitive dynamics, and regulatory developments influencing future pricing.


References

[1] U.S. Food and Drug Administration (FDA) NDC Database.
[2] IQVIA Institute for Human Data Science. "The Future of Drug Pricing and Market Access," 2022.
[3] EvaluatePharma. "Pharmaceutical Pricing Trends," 2022.
[4] Centers for Medicare & Medicaid Services (CMS). "Reimbursement Policies and Impact," 2022.
[5] Market Research Report on Specialty Pharmaceuticals, 2023.

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