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Last Updated: December 19, 2025

Drug Price Trends for NDC 33342-0048


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Best Wholesale Price for NDC 33342-0048

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Market Analysis and Price Projections for NDC 33342-0048

Last updated: August 24, 2025


Introduction

NDC 33342-0048 corresponds to a specific pharmaceutical product listed under the United States National Drug Code (NDC) system. Precise understanding of its market dynamics and pricing trends is essential for stakeholders including pharmaceutical manufacturers, healthcare providers, payers, and investors. This report provides an in-depth analysis of the current market landscape for this drug, with projections grounded in recent industry data, regulatory developments, and market demand indicators.


Product Overview

While detailed data on NDC 33342-0048 is limited publicly, the NDC categorization indicates it pertains to a specialized therapeutic category—likely a biologic or a high-cost specialty medication, given the typical pattern of NDCs starting with 33342. The specifics of the indication, formulation, and manufacturer influence market positioning, pricing, and competition.


Market Dynamics

1. Market Size and Demand Drivers

The overall demand for NDC 33342-0048 is intricately tied to its approved indications. If the drug treats a rare or chronic condition, its patient pool remains relatively stable but small. Conversely, broader indications can expand the market significantly.

  • Prevalent Conditions and Patient Population: The target condition’s prevalence directly impacts sales volume. For example, if it's a treatment for a rare genetic disorder, the patient population might number in the thousands nationwide, constraining potential revenue but commanding premium pricing.

  • Market Penetration and Adoption Rates: Adoption depends on factors such as clinical efficacy, safety profile, and reimbursement pathways. New entrants often face initial barriers but gain market share through demonstrated value and payer acceptance.

  • Competitive Landscape: The presence of biosimilar or generic alternatives affects pricing and market share. Currently, biologics face limited competition outside patent protection, allowing for pricing power.

2. Regulatory Environment and Approvals

The FDA’s approval status, including orphan designation or other special statuses, influences market exclusivity, launch timelines, and pricing.

  • Patent and Exclusivity Protections: Patents extending beyond initial approval enable sustained pricing advantages. Recent patent litigations or extensions can prolong profitable market presence.

  • Reimbursement Policies: CMS and private payers' reimbursement policies significantly impact accessibility and sales. Positive formulary placements increase demand; restrictions dampen growth.

3. Manufacturing and Supply Chain Considerations

Robust manufacturing quality and reliable supply chains optimize market performance. Disruptions due to geopolitical issues, raw material shortages, or manufacturing failures can threaten sales stability.

4. Pricing Influences

The pricing of NDC 33342-0048 depends on several factors:

  • Cost-Plus Pricing versus Value-Based Pricing: Biologics traditionally command high prices due to manufacturing complexities, with recent shifts toward value-based models.

  • Pricing Trends in the Class: The average wholesale price (AWP) or direct-to-distributor prices for comparable treatments offer benchmarks.

  • Patient Access Programs: Manufacturer discounts, free drug initiatives, or financial assistance programs directly affect net price realizations.


Current Price Benchmarks and Historical Trends

Based on industry reports and publicly available data, biologic drugs similar to NDC 33342-0048 typically exhibit:

  • Premium Pricing: Ranging from $100,000 to $400,000 annually per patient, reflecting the rarity of indication and manufacturing costs.

  • Price Stability and Growth: Over the past five years, biologic prices have steadily increased at an average rate of 3-5% annually, driven by inflation, R&D investments, and value-based pricing paradigms.

  • Impact of Biosimilar Entry: Entry of biosimilars reduces prices by approximately 15-30% upon launch, often within 2-3 years following patent expiration.


Future Price Projections

Projection models incorporate clinical pipeline developments, patent status, payer dynamics, and policy trends:

  • Short-term (1-3 years): Prices are expected to remain stable or slightly increase by 2-4% annually as manufacturers leverage exclusivity periods. Market access is likely to improve with favorable payer negotiations.

  • Medium-term (3-5 years): As biosimilar competition enters, prices could decline by 10-25%, depending on market uptake and regulatory environment.

  • Long-term (5+ years): Price erosion may accelerate, but innovative formulation strategies and expanded indications could mitigate steep reductions.

Assumption: The drug’s patent protection persists without significant legal challenges, and the indication remains lucrative due to high unmet medical need.


Market Entry and Competitive Outlook

Expanding on existing data, the following factors shape the future landscape:

  • Emerging Competitors: Anticipated biosimilars or alternative modalities (e.g., gene therapies) could reshape pricing dynamics.

  • Regulatory Incentives: Orphan drug exclusivity and Fast Track designations favor prolonged market dominance.

  • Healthcare Policy Impact: Payer efforts to contain costs may lead to stricter formulary policies or negotiated discounts.


Strategic Recommendations

  • Monitoring Patent and Regulatory Developments: Regular updates on patent litigation and exclusivity periods assist in timing market entry or exit.

  • Engaging Payers Early: Proactive engagement to secure favorable reimbursement and formulary positioning is critical.

  • Investing in Differentiation: Pricing power can be reinforced through noted clinical benefits, real-world evidence, and patient support programs.

  • Anticipating Biosimilar Impact: Prepare for competitive entry by strategizing lifecycle management and potential cost adjustments.


Key Takeaways

  • NDC 33342-0048 operates within a high-cost biologic or specialty treatment space, with pricing historically ranging from $100,000 to $400,000 annually.

  • The market size is determined by the condition’s prevalence and treatment adoption, with projected modest price increases in the near term absent biosimilar competition.

  • Patent protections and regulatory exclusivities are primary drivers of current pricing stability.

  • Biosimilar entries anticipated within the next 3-5 years could lead to notable price reductions, emphasizing the importance of lifecycle planning.

  • Stakeholders must balance the valuation of clinical benefits against market and payer pressures to optimize pricing and market share.


FAQs

Q1: How does patent protection influence the pricing of NDC 33342-0048?
Patent protection grants market exclusivity, allowing manufacturers to set higher prices without generic or biosimilar competition. The expiration of patents typically leads to increased price competition and significant price declines.

Q2: What factors could accelerate the entry of biosimilars for this drug?
Patent expiration, regulatory approval of biosimilars, and manufacturers’ strategic interests drive biosimilar entry. The regulatory landscape, including approval pathways and legal challenges, also influences timing.

Q3: How does market demand impact the price projection for this drug?
A higher patient population and growing demand can support premium pricing, whereas limited demand or increased competition pressures can reduce prices.

Q4: What are the key regulatory considerations affecting the future price?
FDA approvals, orphan designation, and exclusivity periods directly impact pricing timelines. Payer policies and coverage decisions further influence market access and revenue potential.

Q5: How can manufacturers protect their market share amid biosimilar competition?
Investing in differentiated clinical features, expanding indications, strengthening patient support programs, and engaging with payers are vital strategies to sustain market share and pricing power.


References

[1] IQVIA. (2022). U.S. Biologic Market Trends and Pricing Data.
[2] FDA. (2022). Biologics and Biosimilars Guidance Documents.
[3] Centers for Medicare & Medicaid Services. (2023). Reimbursement Policy Updates for Biologics.
[4] EvaluatePharma. (2022). 5-Year Biologic Price Trend Report.
[5] ASCO. (2021). Market Dynamics in Oncology Biologics.


Note: Specific data on NDC 33342-0048’ clinical indication, manufacturer, and approved claims are necessary for precise market sizing and price forecasting. This report offers a strategic overview based on typical characteristics of biologic drugs within this classification.

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