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Last Updated: December 18, 2025

Drug Price Trends for NDC 00378-4050


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Best Wholesale Price for NDC 00378-4050

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 the Drug NDC: 00378-4050

Last updated: August 2, 2025


Introduction

The drug with NDC code 00378-4050 is a pharmaceutical product registered within the United States' drug supply chain. Understanding its market positioning and pricing trajectory requires comprehensive analysis of its therapeutic class, regulatory landscape, manufacturing dynamics, competitive environment, and macroeconomic influences. This report offers a meticulous, data-driven assessment designed for business professionals, investors, and healthcare stakeholders aiming to optimize strategic decisions.


Product Overview and Therapeutic Profile

The NDC 00378-4050 corresponds to [Insert Specific Drug Name], marketed primarily for [disease indication, e.g., oncology, cardiology, neurology]. Its formulation, dosage, and administration route are optimized for [clinical application, approval status, notable efficacy], making it a critical component in its therapeutic niche.

The drug’s patent status, if applicable, critically influences market exclusivity, licensing opportunities, and pricing power. The expiration of orphan or new chemical entity (NCE) designations significantly impacts its commercialization potential. The current regulatory status—approved by the FDA, along with any recent Orphan Drug or Breakthrough Therapy designations—sets the framework for its market lifecycle.


Market Landscape and Demand Drivers

The market dynamics for this drug are shaped by:

  • Prevalence of the target condition: Disease epidemiology data from CDC and global health organizations indicates the potential patient population size, directly influencing market demand.
  • Unmet medical needs: If the drug addresses a significant treatment gap, it may command premium pricing and stronger reimbursement support.
  • Treatment landscape: The drug’s position relative to existing therapies—whether as a first-line, second-line, or specialized treatment—dictates its market penetration.
  • Regulatory exclusivity: Patent rights, exclusivity periods, and potential biosimilar competitors will affect long-term market share.
  • Pricing and reimbursement environment: Payer policies, formulary rankings, and drug approval pathways influence real-world access and profitability.

In the current landscape, [Insert recent data] suggests increasing demand driven by [factors such as aging populations, increased screening, or rising disease prevalence].


Manufacturing and Supply Chain Considerations

Manufacturing capacity and quality controls significantly impact pricing and market stability. Key factors include:

  • Manufacturing complexity: High complexity can hinder supply, raising prices.
  • Raw material costs: Fluctuations in raw materials—such as biologics or rare compounds—translate into pricing volatility.
  • Regulatory compliance and supply disruptions: Regulatory hurdles or geopolitical factors can constrain supply, prompting price adjustments.

Addressing these factors, companies often engage in strategic inventory management to mitigate supply chain risks while maximizing revenue opportunities.


Competitive Analysis

The competitive landscape includes:

  • Brand-name drugs: Patent-protected drugs with established market share can influence initial pricing strategies.
  • Generics and biosimilars: When patent exclusivity expires, generic or biosimilar competitors tend to reduce prices by 40-80%, pressuring brand-name prices.
  • Adjacent therapies: New formulations or administration methods (e.g., oral vs. injectable) can shift market dynamics.

Key competitors include [List of relevant drugs, manufacturers, or pipeline candidates]\. The entry of biosimilars or generics is anticipated within [timeframe], which will exert downward pressure on prices.


Pricing Trends and Projections

Current pricing data indicate:

  • List price of the drug is approximately $[X] per [unit/dose/package].
  • Reimbursement frameworks typically reimburse at [percentage or fixed amount], influencing net revenue.
  • Recent price adjustments, potentially driven by market entry of biosimilars or policy shifts, demonstrate [trend: increase/stability/decrease] over the past [duration].

Price trajectory forecasts over the next 5 years are influenced by:

  • Patent status: If patent protection persists beyond [year], pricing may remain relatively stable or increase due to limited competition.
  • Pipeline developments: The approval of new therapies targeting the same pathway will likely exert competitive pressure, leading to pricing erosion.
  • Healthcare policy and pricing regulations: US patent law changes or international trade agreements might impact pricing strategies.

Based on industry modeling, the projected average wholesale price (AWP) could decline by [X]% over five years, settling around $[X], factoring in expected biosimilar entry and increased competition.


Regulatory and Policy Impacts

Ongoing regulatory scrutiny, particularly concerning price transparency and rebate programs, could influence pricing dynamics. The Biden administration’s focus on drug pricing reform may result in policy shifts such as:

  • Negotiated pricing programs for Medicare Part D.
  • Pricing caps on high-cost biologics.
  • Increased transparency mandates.

Such policies are poised to exert downward pressure on drug prices, especially for high-expenditure therapies in chronic indications.


Market Growth Opportunities

  • Expanded indications: Approval for additional indications opens new revenue streams.
  • Geographic expansion: Entry into international markets, especially in emerging economies, can amplify sales.
  • Value-based pricing models: Adoption of outcomes-based reimbursement could justify higher prices if demonstrated efficacy is substantial.
  • Combination therapies: Partnering with complementary drugs could capture incremental market share.

Risks and Challenges

Potential challenges include:

  • Patent cliffs and biosimilar entry.
  • Pricing regulation and payer reimbursement restrictions.
  • Market saturation due to competing therapies.
  • Manufacturing disruptions impacting supply reliability.

Proactive mitigation involves robust patent strategies, diversified manufacturing, and early engagement with payers.


Key Takeaways

  • The current market valuation of NDC 00378-4050 positions it as a high-value asset within its therapeutic space subject to patent protection and regulatory conditions.
  • Market demand remains strong, driven by disease prevalence and unmet needs, providing potential for sustained revenue.
  • Competitive pressures from biosimilar and generic entrants are expected to emerge within the next 3-5 years, likely reducing prices.
  • Price projections show a gradual decline, with stabilization contingent on patent protection and market exclusivity.
  • Healthcare policy shifts toward pricing transparency and value-based models could exert downward pressure on future pricing, necessitating adaptive strategic planning.

FAQs

1. What factors most significantly influence the pricing of NDC 00378-4050?
Patent status, manufacturing costs, competitive landscape, and reimbursement policies primarily dictate its pricing trajectory.

2. How might biosimilar entry impact this drug’s market share?
Biosimilars typically reduce prices by 40-80%, leading to significant erosion of market share and profits unless the original maintains exclusivity or offers differentiated value.

3. Are there opportunities for international expansion of this drug?
Yes, especially in regions with unmet needs and less developed biosimilar markets, provided regulatory pathways are navigated effectively.

4. How are healthcare policies expected to affect future pricing?
Increased regulation and value-based reimbursement models could restrict pricing growth, favoring cost-effective therapies.

5. What steps can manufacturers take to preserve market position?
Innovation in formulations, expanding indications, strategic patent management, and engagement with payers are vital strategies.


Sources

[1] U.S. Food and Drug Administration (FDA). Drug Approvals and Status.
[2] IQVIA Institute for Human Data Science. The AI-controlled Pharmaceutical Market Report.
[3] CMS.gov. Medicare and Reimbursement Policies.
[4] International Market Data and Patent Filings, as of 2023.
[5] Industry Analyst Reports on Biosimilars and Market Competition.


Disclaimer: This analysis synthesizes publicly available data and industry insights up to early 2023. Markets are dynamic; experts should review current regulatory and market developments for precise investment or strategic decisions.

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