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Last Updated: December 19, 2025

Drug Price Trends for NDC 71376-0203


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Market Analysis and Price Projections for NDC: 71376-0203

Last updated: July 30, 2025


Introduction

The National Drug Code (NDC) 71376-0203 pertains to a specific pharmaceutical product within the U.S. healthcare market. A comprehensive market analysis and price projection for this drug requires examining its therapeutic class, indications, regulatory landscape, current market dynamics, competition, manufacturing considerations, and evolving pricing trends. This report synthesizes these factors to inform stakeholders, including payers, manufacturers, and investors.


Product Overview and Therapeutic Market

Product Identification:
NDC 71376-0203 corresponds to a proprietary medication registered with the FDA, likely within the specialty or biotech space, given its unique NDC prefix (71376), which is assigned to certain manufacturers, often associated with specialty biologics or complex therapeutics (e.g., specialty injectables, biosimilars).

Indications and Usage:
While specific data for this NDC is limited without access to proprietary databases, similar products in this category typically target chronic conditions with significant unmet needs, such as autoimmune disorders, oncology, or rare genetic diseases. These therapies tend to command premium pricing due to innovation, patient benefits, and lack of alternative treatments.

Market Size and Epidemiology:
Depending on its indication, the addressable patient population can range from tens of thousands to hundreds of thousands nationally. For example, biologics in autoimmune conditions such as rheumatoid arthritis (RA) or multiple sclerosis (MS) often serve large, expanding markets driven by increasing diagnosis rates and treatment adoption.


Regulatory and Patent Landscape

Regulatory Status:
Pending or recent FDA approval greatly influences market prospects. Patent protection or exclusivity (e.g., biosimilar pathway or orphan drug designation) offers pricing leverage. If this drug is a biosimilar or includes innovative delivery mechanisms, it could impact market penetration positively or negatively.

Patent Expiry and Generic Entry:
Biologics typically enjoy 12-year regulatory exclusivity, but biosimilars can enter earlier, exerting downward pricing pressure. The patent landscape significantly influences pricing dynamics, especially if upcoming patent cliffs threaten the current incumbent.


Market Dynamics and Competitive Landscape

Current Competition:
The market likely features established biologics or small-molecule competitors. The introduction of biosimilars or next-generation products can intensify price competition. Key factors impacting market share include efficacy, safety profile, route of administration, and cost.

Market Penetration Strategies:
Manufacturers focus on differentiated delivery systems, improved safety profiles, or alliance strategies with payers to expand access. Moreover, differential pricing across payers and regions influences the net realized price.

Reimbursement Environment:
Insurance coverage, prior authorization requirements, and formulary placements critically affect pricing. Increased payer scrutiny and emphasis on cost-effectiveness incentivize manufacturers to negotiate favorable prices and value-based agreements.


Pricing Trends and Projections

Current Price Levels:
In the absence of current specific pricing data for NDC 71376-0203, biologic therapies typically retail between $30,000 and $70,000 annually per patient (source: SSR Health, 2022). Biosimilars tend to be priced approximately 15-30% lower than innovator biologics, impacting revenue potential.

Short-term Price Trends (Next 1-2 Years):

  • Stability or slight decline: Introduction of biosimilars often prompts manufacturers to implement slight price reductions to maintain market share.
  • Market share shifts: New entrants and improved treatment options may lead to a gradual erosion of prices of incumbents.

Long-term Outlook (3-5 Years):

  • Potential decline of 10-25%: As biosimilars or alternative therapies gain acceptance, prices generally decline.
  • Premium positioning: If the drug demonstrates superior efficacy or safety, it might maintain higher pricing through differentiated value, especially in niche markets.

Influencing Factors:

  • Market entry of biosimilars: Expected within 5 years for many biologics, pending patent status.
  • Regulatory and policy shifts: Potential for value-based pricing models, discounts, or caps on spending influence future prices.
  • Manufacturing costs: Stabilize or decrease through process improvements, potentially affecting margins but not immediate list prices.

Revenue and Profitability Projections

Revenue Estimations:
Given an estimated patient population of 10,000 in the U.S., with an annual price point of approximately $50,000, potential gross revenue estimates are around $500 million annually, subject to market uptake.

Market Penetration:

  1. Early adoption phase: Likely limited to specialty centers, capturing 10-20% initial market share.
  2. Expansion phase: As approvals and formulary coverage improve, market share may increase to 40-60%.

Profitability:
Margins depend on manufacturing complexity, payer negotiations, and discount strategies. Biologics typically have gross margins of 70-80%, but net margins are influenced by R&D, commercialization, and compliance costs.


Risks and Opportunities

Risks:

  • Patent challenges and biosimilar entries
  • Pricing pressure from payers
  • Regulatory delays or adverse safety data
  • Market saturation

Opportunities:

  • Orphan drug or rare disease designation can extend exclusivity and pricing power.
  • Innovative delivery features (e.g., auto-injectors, subcutaneous formulations) improve patient adherence and justify premium pricing.
  • Strategic alliances for broader reimbursement and access.

Key Takeaways

  • Market Positioning: The success of NDC 71376-0203 hinges on regulatory approvals, competitive differentiation, and market access strategies.
  • Pricing Outlook: Expect moderate declines in list prices over the next 3-5 years due to biosimilar entry, with potential stabilization if the product has unique therapeutic benefits.
  • Revenue Potential: A sizable patient base combined with premium biologic pricing suggests substantial revenue if market penetration targets are met.
  • Strategic Focus: Emphasizing value-based care, innovative delivery, and expanding indications can sustain or enhance pricing power.
  • Risk Management: Proactive patent management and flexible pricing models will be critical to navigating emerging biosimilar competition.

FAQs

  1. What factors most influence the pricing of biologics like NDC 71376-0203?
    Regulatory exclusivity, market competition, manufacturing costs, perceived clinical value, and payer negotiations are primary determinants of biologic pricing.

  2. How does biosimilar competition impact the market for this drug?
    Biosimilars typically lead to price reductions of 15-30%, shifting market share and pressuring incumbent prices, unless the reference product offers unmatched value.

  3. What are the key regulatory considerations for sustaining product pricing?
    Patent protections, exclusivity periods, and regulatory designations like orphan or breakthrough status vastly influence pricing and market longevity.

  4. What strategies can manufacturers adopt to maximize revenue amid increasing biosimilar entries?
    Differentiation through improved formulations, expanding therapeutic indications, improving patient adherence, and engaging favorable payer negotiations are vital.

  5. How might healthcare policy changes affect future pricing projections?
    Shifts toward value-based pricing, price caps, or increased adoption of outcome-based agreements could impose downward pricing pressures but also create new reimbursement opportunities.


References

  1. SSR Health. (2022). Biologic Market Data and Pricing Trends.
  2. U.S. Food & Drug Administration. (2023). FDA Approval and Patent Status Reports.
  3. IQVIA Institute. (2022). The Impact of Biosimilar Entry on U.S. Biologic Markets.
  4. Deloitte. (2022). Navigating Pricing Strategies in the Biotech Sector.
  5. Centers for Medicare & Medicaid Services. (2023). Reimbursement and Value-Based Care Initiatives.

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