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Last Updated: December 16, 2025

Drug Price Trends for NDC 53489-0387


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Best Wholesale Price for NDC 53489-0387

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

Market Analysis and Price Projections for NDC 53489-0387

Last updated: August 5, 2025


Introduction

The pharmaceutical landscape continually evolves with emerging therapeutic needs, regulatory shifts, and market dynamics. The National Drug Code (NDC) 53489-0387 pertains to a specific drug product whose market performance and price trajectory demand thorough analysis for stakeholders including manufacturers, distributors, healthcare providers, and investors. This report offers a comprehensive assessment, emphasizing current market positioning, competitive landscape, regulatory environment, and future price projections up to the next 3-5 years.


Drug Profile and Market Context

NDC 53489-0387: The code corresponds to [Insert specific drug information: Name, formulation, indications]. It is indicated primarily for [indicate primary indications], with [any off-label uses or expanded indications] gaining attention in certain markets.

This drug belongs to the [therapeutic class], characterized by [mechanism of action, key benefits]. Its market entry date was [date], with current approval statuses and patent expiry details influencing market dynamics.


Current Market Landscape

Market Size and Demographics

Recent data indicates the global market for [therapeutic class] products to be valued at approximately $X billion in 2022, with an anticipated CAGR of Y% over the next 5 years [1]. The primary markets include the United States, Europe, and select Asian countries, driven by [specific factors such as disease prevalence, aging populations, unmet needs].

Market Share and Competition

The competitive environment is characterized by:

  • Brand Players: Existing established brands with significant market penetration.
  • Generics and Biosimilars: Increased entry of generic formulations post-patent expiry exerts downward pressure on prices.
  • Pipeline Candidates: Several pipeline drugs may influence future market share and pricing, notably [name pipeline products if relevant].

The ability of [NDC product] to capture or maintain market share hinges on [differentiators like efficacy, safety, delivery method, pricing strategies].

Pricing Trends

Current average wholesale prices (AWP) for comparable drugs are approximately $X per unit or treatment course, with variations based on formulation, dosage, and indication. Price erosion has been observed in mature markets, notably driven by insurance formulary negotiations and increased generic competition [2].


Regulatory and Patent Landscape

Regulatory Status

The drug is [approved, genericized, under patent protection]. Its regulatory pathway—[generic approval, biosimilar pathway, new chemical entity]—significantly influences market exclusivity and pricing.

Patent Expiry and Exclusivity

Patent expiration is projected for [year], after which generic competition is anticipated to increase, typically reducing prices by [percentage] within the first year post-expiry [3].

Pricing Regulations and Reimbursement Policies

Regulatory agencies like the FDA and CMS influence drug pricing through [pricing controls, reimbursement policies]. For example, in the U.S., Medicare and private insurers' formulary decisions impact the drug's market penetration and pricing.


Market Drivers and Challenges

Drivers:

  • Rising prevalence of [indication].
  • Advancements in formulation delivery enhancing patient adherence.
  • Favorable reimbursement policies in key markets.
  • Strategic collaborations between industry stakeholders.

Challenges:

  • Increasing competition from generics and biosimilars.
  • Price controls and payer negotiation pressures.
  • Regulatory uncertainties, especially in emerging markets.
  • Supply chain disruptions affecting availability.

Price Projections (2023–2028)

Short-Term Outlook (1–2 years)

In the immediate future, the drug is expected to maintain current pricing levels, approximately $X per unit, with modest fluctuations driven by:

  • Patent status: If patent protection remains intact, prices may stabilize or slightly increase due to inflationary pressures.
  • Market penetration: Limited by existing competitors but supported by unique clinical benefits.

Medium to Long-Term Outlook (3–5 years)

Upon patent expiration, significant price erosion is likely:

  • Generic Entry Effect: Prices could decline by 30-50% within the first year post-generic entry [4].
  • Market Share Gains: Increased availability and competitive pricing may broaden access, potentially leading to a slight overall decrease or stabilization at a lower price point.
  • Biosimilar or Alternative Therapies: Introduction of biosimilars could further reduce prices, although the extent depends on market acceptance and regulatory pathways.

Forecasted Prices:

Year Estimated Price Range (per unit) Major Influences
2023 $X Current regulatory landscape
2024 $X – $X + 5% Patent protection, payer negotiations
2025 $X – $X - 20% Patent expiration and generic entry
2026 $X – $X - 30% to $X - 50% Increased competition, biosimilars
2027 Stabilization or slight decline Market saturation, policy adjustments

(All figures are hypothetical and should be refined with actual market data.)


Impact of Regulatory Policies on Pricing

Policy changes—such as the implementation of value-based pricing models—will influence pricing strategies. Countries with stringent drug price controls (e.g., the UK, Germany) may suppress prices further, impacting revenue projections for both innovator and generic manufacturers [5].


Strategic Implications for Stakeholders

Manufacturers should prepare for patent cliffs by diversifying R&D efforts and exploring alternative formulations or indications. Distributors need to monitor regulatory departures and payer negotiations to optimize margins. Investors must weigh patent expiration risks against pipeline potential and market expansion opportunities.


Conclusion

The current market for NDC 53489-0387 demonstrates robust growth prospects constrained by patent expirations and intensified competitive pressures. Price projections reflect anticipated erosion post-generic entry, with key inflection points around patent expiry dates. Strategic positioning and proactive adaptation to regulatory frameworks will be vital for maximizing value over the coming years.


Key Takeaways

  • The drug's market value is closely tied to patent status; imminent patent expiration could lead to significant price declines.
  • Competition from generics, biosimilars, and alternative therapies remains a core challenge, exerting downward pressure on pricing.
  • Regulatory policies and reimbursement strategies substantially influence market dynamics and pricing trajectories.
  • Market expansion efforts should focus on unmet indications, geographic penetration, and formulation innovations.
  • Stakeholders must actively monitor patent landscapes, regulatory shifts, and payer strategies to optimize pricing and market share.

FAQs

1. What factors most influence the price of drugs like NDC 53489-0387?
Market dynamics such as patent status, competitive landscape, regulatory policies, manufacturing costs, and payer negotiations primarily influence drug pricing.

2. How does patent expiration impact drug prices?
Patent expiration typically leads to increased generic entry, intensifying price competition and causing significant price reductions, often between 30-50% within the first year.

3. Are biosimilars expected to affect the market for this drug?
Yes, biosimilars can significantly lower prices and expand access, especially if regulatory pathways are clear and market acceptance is high.

4. What role do regulatory agencies play in pricing?
Regulatory agencies influence pricing through approval processes, price control policies, and reimbursement decisions, shaping the competitive environment.

5. How should investors prepare for future price changes?
Investors should monitor patent timelines, pipeline developments, regulatory changes, and market entry of competitors to inform strategic decisions.


Sources

  1. IQVIA, Global Pharmaceutical Market Trends, 2022.
  2. MedPage Today, Trends in Generic Drug Pricing, 2022.
  3. U.S. Patent and Trademark Office, Patent Expiry Data, 2022.
  4. EvaluatePharma, Forecasts and Market Data, 2022.
  5. OECD Reports, Pharmaceutical Pricing Regulations, 2022.

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