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Last Updated: January 1, 2026

Drug Price Trends for NDC 00245-5316


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Best Wholesale Price for NDC 00245-5316

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions
Drug Name Vendor NDC Count Price ($) Price/Unit ($) Dates Price Type
>Drug Name >Vendor >NDC >Count >Price ($) >Price/Unit ($) >Dates >Price Type
Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Last updated: July 28, 2025

rket Analysis and Price Projections for NDC 00245-5316

Introduction
The National Drug Code (NDC) 00245-5316 corresponds to a specific pharmaceutical product listed in the U.S. Food and Drug Administration’s (FDA) database. Precise details, such as drug name, formulation, and approved indications, are essential for comprehensive market evaluation. While specific product details are not provided here, this analysis synthesizes generic factors shaping market dynamics and future pricing trajectories for similar branded or generic drugs cataloged under this NDC.

Product Overview and Regulatory Context
NDC 00245-5316 is associated with a US-approved medication. Typically, NDCs beginning with ‘00245’ are registered to pharmaceutical companies focused on branded or generic formulations. The drug's therapeutic class, patent status, and exclusivity rights significantly influence market competitiveness and pricing strategies. An understanding of current approval status, patent expirations, and any recent regulatory changes is vital for accurate market forecasting.

Market Landscape Analysis

Demand Drivers
The market demand for drugs like NDC 00245-5316 hinges on several factors:

  • Prevalence of Indication and Disease Burden: If the medication addresses a widespread condition—such as hypertension, diabetes, or chronic pain—the demand remains high. Epidemiological data indicates continued growth in chronic disease management, underpinning consistent need.
  • Regulatory Approvals and Off-Label Uses: FDA approvals for new indications or expanded patient populations can elevate utilization. Conversely, regulatory restrictions or safety concerns could suppress demand.
  • Line of Therapy and Formulation Adoption: If the drug occupies a first-line position or offers advantages like fewer side effects or convenient dosing, market penetration is more robust.

Competitive Landscape
The presence of generic equivalents, biosimilars, or competing branded drugs shapes the competitive environment. Patent protections or exclusivity periods provide temporary pricing power, but the landscape shifts rapidly once patents expire. Notably:

  • Generics Penetration: Once patents expire, generic competitors typically reduce prices by 60-80%, pressuring the originator’s pricing strategies.
  • Market Share Dynamics: Brand loyalty, formulary placements, and physician prescribing habits influence market share. Payer negotiations and formulary tier placements critically impact revenues.

Market Size and Revenue Potential
Based on epidemiological trends and market penetration data, the potential revenue for NDC 00245-5316 depends on:

  • Patient Population: Estimated by disease prevalence and diagnosed demographic segments.
  • Pricing Strategies: Prices are adapted based on competition, payer negotiations, and value proposition assessments.
  • Market Access and Reimbursement Environment: Payer coverage policies and prior authorization requirements are pivotal.

Price Projections

Current Price Benchmarks
For drugs with similar profiles, wholesale acquisition costs (WAC), average selling prices (ASP), and retail prices have recently trended as follows:

  • Brand-Name Drugs: Typically retail between $200 and $600 per unit/dose, influenced by patent protections and manufacturer pricing strategies.
  • Generic Drugs: Once patents expire, prices can decline by 60-80%, often settling between $50 and $150 per unit, depending on manufacturing costs and competition.

Short-Term (1-2 Years)
Given the typical patent cycle timeline, if NDC 00245-5316 remains under patent protection, prices are likely to stay relatively stable, with minor adjustments driven by inflation, supply chain costs, and payer negotiations.

Medium to Long-Term (3-5 Years)
As patent protections lapse or exclusivity periods end, expect prices to decline sharply. Generic entry could reduce the drug’s cost structure substantially, enhancing affordability but diminishing profit margins for originators. Conversely, if the product adopts a biosimilar or innovator-proof pathway, price reductions could be mitigated.

Influencing Factors

  • Regulatory Changes: Potential patent extensions or new indications can extend exclusivity, maintaining higher prices.
  • Market Penetration of Generics and Biosimilars: Entry of new competitors generally results in price erosion.
  • Pharmacoeconomic Evaluations: Payers increasingly base pricing on value assessments; drugs demonstrating superior efficacy or reduced overall healthcare costs can command premium pricing for longer durations.

Emerging Trends and Their Impact

  • Value-Based Pricing: As healthcare shifts toward value-based models, pricing increasingly aligns with demonstrated clinical benefits. Drugs with clear advantages tend to retain higher prices longer.
  • Digital and Precision Medicine Integration: Enhanced targeting and personalized approaches may allow for premium pricing justified by tailored efficacy.
  • Global Markets: International price referencing and market penetration can influence U.S. pricing strategies, especially in countries with high demand for the drug.

Conclusion
The outlook for NDC 00245-5316 hinges on patent status, competitive dynamics, and healthcare policy trajectories. Short-term stability is anticipated if patent protections are maintained. However, imminent patent expirations or regulatory developments could lead to significant price reductions within the next 3-5 years. Companies should monitor market entry of generics, biosimilars, and evolving reimbursement models to formulate strategic pricing and market access plans.


Key Takeaways

  • The drug's current pricing is influenced predominantly by patent status, market demand, and competitive landscape.
  • Price erosion is expected post-patent expiry, with generic competition potentially reducing prices by up to 80%.
  • Value-based pricing models may sustain higher prices if the drug demonstrates superior efficacy or cost savings.
  • Market expansion hinges on disease prevalence, regulatory approvals, and payer acceptance.
  • Strategic planning must consider upcoming patent cliffs, biosimilar entries, and evolving healthcare policies to optimize revenue.

FAQs

1. How does patent expiration impact the price of NDC 00245-5316?
Patent expiration typically opens the market for generic competitors, leading to intensified price competition and significant reductions—often by 60-80%. This shift can substantially decrease revenues for originator manufacturers but improve access for patients.

2. What factors can extend the market exclusivity of this drug?
Additional FDA approvals for new indications, patent extensions, and successful development of biosimilars or combination therapies can prolong the period during which the drug maintains premium pricing.

3. How are healthcare policies influencing drug pricing projections?
Payers are increasingly adopting value-based approaches, favoring drugs with demonstrable clinical or economic advantages. Such policies may support sustained higher pricing for value-optimized therapies while pressuring prices for less comparative-effective options.

4. Can manufacturing costs significantly influence future prices?
Yes. Production cost reductions, driven by manufacturing efficiencies or supply chain improvements, can enable price reductions post-competition. Conversely, increases in raw material costs can pressure prices upward unless offset by market dynamics.

5. What role does international pricing play in U.S. market projections?
International reference pricing and global market competitiveness influence U.S. pricing strategies, especially as global markets often serve as benchmarks for setting or negotiating prices domestically.


Sources:

  1. FDA National Drug Code Directory.
  2. IQVIA Institute for Human Data Science. Market Trends Reports.
  3. U.S. Patent and Trademark Office. Patent Expiry Data.
  4. PhRMA: Prescription Drug Trends and Pricing Policies.
  5. Government and payor policy updates on drug reimbursement.

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