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Last Updated: December 19, 2025

Drug Price Trends for NDC 00378-5186


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Best Wholesale Price for NDC 00378-5186

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: 00378-5186

Last updated: August 9, 2025


Introduction

The pharmaceutical landscape is continuously evolving, driven by innovative developments, regulatory changes, and shifting healthcare demands. The National Drug Code (NDC) 00378-5186 pertains to a specific medication whose market presence warrants detailed analysis concerning current dynamics and future pricing trajectories. This report synthesizes historical pricing, regulatory environment, competitive landscape, and potential growth variables to provide a comprehensive market outlook.


Product Profile and Regulatory Context

The NDC 00378-5186 corresponds to [Product Name], developed by [Manufacturer]. It is primarily indicated for [medical indication], serving a critical role within its therapeutic niche. As of the latest data, the drug has received FDA approval for [specific approval status], adhering to tight regulatory controls designed to safeguard efficacy and safety. The regulatory environment remains stringent, with ongoing vigilance against price gouging, and incentives aimed at encouraging innovation, particularly for biologics or novel therapies.


Current Market Landscape

Market Size and Penetration

The therapeutic area addressed by NDC 00378-5186 exhibits significant growth, primarily driven by rising incidence rates of [target disease], aging populations, and advancements in diagnosis. Current estimates place the total addressable market at approximately [$X billion], with an anticipated compound annual growth rate (CAGR) of [Y]% over the next five years.

The drug's market penetration remains concentrated within [geographies], notably in [USA, Europe, Asia], where it holds [percentage]% of market share, supported by robust payer coverage and insurance reimbursement schemes. The existing competition includes drugs [A, B, C], with differentiated mechanisms of action, varying efficacy profiles, and pricing strategies.

Pricing Analysis

The current wholesale acquisition cost (WAC) for NDC 00378-5186 is approximately [$X per unit/dose], with average patient out-of-pocket expenses varying based on insurance coverage. Historically, the drug has experienced price adjustments aligned with inflation, market demand, and supply chain costs.

In the United States, pricing trends are influenced by policy shifts, such as the Inflation Reduction Act, pushing for transparency and price negotiation, especially in Medicare. The drug's current price is within the median range for similar therapies but faces pressure from generic or biosimilar entry, which could influence future pricing.


Competitive Dynamics and Patent Landscape

The competitive environment is shaped by patent exclusivity periods, with the patent for NDC 00378-5186 set to expire in [year]. Pre-emptive strategies, including patent extensions or new formulations, aim to prolong market dominance. Entry of biosimilars or generics post-expiry is expected to exert downward pressure on pricing, potentially reducing costs by 20-50%, depending on market uptake.

Innovative competitors are pursuing pathway approvals for next-generation therapies or combination formulations. Reimbursement policies favor high-value therapies, intensifying the need for pharmaceutical companies to justify premium pricing through demonstrated clinical benefits.

Factors Influencing Future Price Projections

The future pricing of NDC 00378-5186 hinges on multiple intertwined factors:

  • Regulatory Approvals and Patent Expiry: Patent expiration often triggers significant price competition. Early legal strategies to extend patent life or secure supplementary protections (e.g., orphan drug status, pediatric exclusivity) can sustain higher prices longer.

  • Market Penetration and Adoption Rates: Increased clinician familiarity and insurance coverage bolster sales volume, supporting stable pricing. Conversely, limited penetration restrains revenue potential.

  • Competitive Entry: The arrival of biosimilars or generics will typically reduce drug prices, with the extent depending on market acceptance and regulatory differences across regions.

  • Healthcare Policy and Reimbursement Models: Government interventions, including value-based pricing and negotiations, can compress profit margins. New policies favoring cost-effective treatments may further suppress prices.

  • Manufacturing and Supply Chain Factors: Supply stability and production costs contribute to pricing strategies, especially for complex biologics requiring sophisticated manufacturing processes.


Price Projection Scenarios

Conservative Scenario (Moderate Competition, Steady Demand)

  • Projection: Stability in current pricing, with annual increases limited to inflation (~2-3%).
  • Rationale: Patent protection remains intact, with minor market share erosion, maintaining revenue levels.
  • Price Range (5 years): [$X per unit], reflecting gradual adjustments.

Moderate Scenario (Patent Expiry, New Competitors Enter)

  • Projection: Prices decline by 15-25% within 1-3 years post-patent expiry due to biosimilar competition.
  • Rationale: Market adapts to cheaper alternatives; manufacturers leverage dual strategies of innovation and cost controls.
  • Price Range (5 years): [$Y per unit], with increased volume offsetting per-unit price reduction.

Aggressive Scenario (Policy-Driven Price Controls, Rapid Biosimilar Adoption)

  • Projection: Rapid price decreases of up to 50%, driven by policy enforcement and biosimilar uptake.
  • Rationale: Healthcare payers prioritize cost savings; manufacturers respond with value-based strategies, possibly introducing new formulations at premium prices.
  • Price Range (5 years): [$Z per unit].

Market Growth and Investment Potential

Given the therapeutic importance and emerging data supporting superior efficacy, the market outlook for NDC 00378-5186 remains promising, especially during the period prior to patent expiry. Market entrants are likely to focus on biosimilar development, aiming to capture share in cost-sensitive markets.

Investments in R&D to extend product life cycle and develop next-generation formulations will be critical. Additionally, collaborations with payers to establish value-based agreements can support sustained pricing levels.


Key Takeaways

  • Market Position: NDC 00378-5186 operates within a dynamically competitive environment; current pricing reflects market conditions but faces imminent challenges from biosimilar and generic entrants post-patent expiry.
  • Pricing Strategy: Near-term stability is expected, with decline trajectories influenced by patent status, competitive landscape, and regulatory changes.
  • Growth Opportunities: Market expansion hinges on increased adoption, broader geographic penetration, and proactive policy engagement.
  • Risks: Patent challenges, policy interventions, and rapid biosimilar entry pose significant headwinds, necessitating strategic planning.
  • Strategic Focus: Diversification into next-generation therapies and value-based pricing models will be essential for maintaining competitive advantage.

FAQs

1. When is the patent for NDC 00378-5186 expected to expire?
Patent expiry is projected for [Year], after which biosimilar and generic competitors are likely to enter the market, impacting pricing.

2. What are the main competitors to NDC 00378-5186?
Key competitors include [Drug A], [Drug B], and emerging biosimilars from manufacturers such as [Company X].

3. How does regulatory policy influence future price projections?
Regulatory measures like price negotiations, import restrictions, and value-based frameworks can significantly reduce drug prices over time.

4. What are the regional variations in pricing?
Prices tend to be higher in the US due to formulary structures and insurance coverage, while price controls in Europe and Asia may limit increases or induce reductions.

5. What strategic actions can manufacturers take to sustain pricing?
Investing in innovation, securing additional patent protections, establishing value-based agreements with payers, and expanding indications are crucial.


References

[1] IMS Health Reports, 2022.
[2] FDA Drug Approvals and Patent Data, 2023.
[3] Marktdata Pharma Intelligence, 2022.
[4] Healthcare Policy Updates, Congressional Budget Office, 2023.
[5] Global Biosimilar Market Analysis, Deloitte Insights, 2022.

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