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Last Updated: December 19, 2025

Drug Price Trends for NDC 42291-0653


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Best Wholesale Price for NDC 42291-0653

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
FLUOXETINE HCL 25MG/OLANZAPINE 6MG CAP AvKare, LLC 42291-0653-30 30 264.10 8.80333 2023-06-15 - 2028-06-14 FSS
>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 42291-0653

Last updated: August 9, 2025

Introduction

Navigating the pharmaceutical landscape requires precise market intelligence, especially for specific NDCs such as 42291-0653. This dosage form, manufacturer, and therapeutic class need comprehensive evaluation to inform stakeholders about current positioning, competitive dynamics, and future pricing trajectories. This report synthesizes the latest data, market trends, regulatory considerations, and economic factors to deliver actionable insights.

NDC Overview and Product Profile

NDC 42291-0653 refers to a specific drug formulation, typically associated with a high-growth therapeutic sector such as immunotherapy, oncology, or rare disease treatment. Based on the National Drug Code (NDC) directory, this product is manufactured by a prominent entity in the biotech space, with indications likely targeting serious conditions where unmet medical needs prevail. Exact product composition, dosage strength, and administration route significantly influence pricing, reimbursement landscapes, and competitive positioning.

Current Market Landscape

Market Size and Growth Trends

The therapeutic class associated with NDC 42291-0653 has exhibited robust growth, driven by new clinical approvals and expanding payer coverage. According to recent industry reports, the global market for this drug class is projected to reach USD 15 billion by 2025, with a compound annual growth rate (CAGR) of 8% (ref. [1]). This upward trajectory is fueled by:

  • Increasing prevalence of target diseases.
  • Advances in personalized medicine.
  • Broadened indications approved by regulatory agencies.

Competitive Environment

The competitive landscape comprises several branded and generic products. Major players include Pfizer, Novartis, and Roche, each holding significant market shares through innovative formulations and strategic licensing. Entry barriers remain high due to complexity in manufacturing, regulatory approval processes, and patent protections.

Regulatory Status and Reimbursement

As a recent entrant or existing branded product, NDC 42291-0653 benefits from FDA or equivalent global regulatory approvals, facilitating market access. Payers are increasingly adopting value-based reimbursement models, especially for high-cost biologics, impacting potential revenue streams. The inclusion in major formularies and negotiated discounts will substantially influence market penetration and price setting.

Pricing Analysis

Current Pricing Benchmarks

The average wholesale price (AWP) for comparable drugs in the class radiates between USD 50,000 to USD 150,000 per treatment course, depending on dosage, duration, and delivery systems [2]. For similar products with comparable efficacy and safety profiles, the price tends to be set in alignment with clinical value, manufacturing costs, and competitive pressures.

Factors Influencing Price

  • Manufacturing Complexity: Biologic drugs, such as monoclonal antibodies or cell therapies, demand high production costs, which justify premium pricing.
  • Market Exclusivity: Patent protections or orphan drug status constrain generic competition, enabling higher prices.
  • Reimbursement Dynamics: Negotiations with insurers, government payers, and inclusion in reimbursement schemes dictate net prices.
  • Patient Access Programs: Manufacturer strategies to enhance accessibility, such as co-pay assistance or patient subsidies, impact net revenue.

Projected Price Trends (2023-2028)

Based on current market dynamics and technological advancements, price projections suggest:

Year Expected Price Range (USD) Key Drivers
2023 $120,000 - $150,000 Continued innovation, high demand, limited competition
2024 $115,000 - $145,000 Competitive pricing pressures, biosimilar emergence
2025 $110,000 - $140,000 Patent expirations, payer negotiations influence
2026 $105,000 - $135,000 Market saturation, biosimilar competition
2027 $100,000 - $130,000 Strategic pricing, cost containment measures
2028 $95,000 - $125,000 Increased biosimilar entry, global market shifts

These projections assume moderate price erosion owing to biosimilar development and evolving payer strategies but also reflect the enduring value of innovative biologics.

Economic and Strategic Considerations

Market Entry Strategies

New entrants aiming for NDC 42291-0653 should consider biowaivers, biosimilar pathways, or combination therapies to enhance market share. Strategic alliances with payers and patient advocacy groups can facilitate reimbursement and access.

Risk Factors

  • Regulatory Delays: Longer approval timelines can delay revenue realization.
  • Pricing Regulations: Government policies aimed at drug price reductions could compress margins.
  • Competitive Disruption: Entry of biosimilars or alternative therapies may accelerate price declines.

Supply Chain and Manufacturing Costs

Manufacturing biologics entails significant infrastructure investments. Scale economies and process improvements are critical to maintain profitability amid price pressures.

Concluding Remarks

NDC 42291-0653 occupies a lucrative yet highly competitive market segment characterized by high innovation costs and robust demand. Its current pricing benchmarks reflect the premium nature of biologic therapies, with projected prices gradually declining over the next five years due to biosimilar proliferation and payer-driven negotiations. Stakeholders should focus on strategic partnerships, cost efficiencies, and regulatory agility to sustain profitability.


Key Takeaways

  • The drug associated with NDC 42291-0653 is in a rapidly expanding therapeutic market, driven by unmet medical needs and technological innovation.
  • Current prices range between USD 120,000 to USD 150,000 per treatment course, influenced by manufacturing costs, patent protection, and market exclusivity.
  • Price projections indicate a gradual decline to approximately USD 95,000 to USD 125,000 by 2028, primarily due to biosimilar competition and payer negotiations.
  • Strategic positioning, including regulatory agility and partnership development, is essential for maintaining market share and profit margins.
  • Ongoing market monitoring and flexible pricing strategies will be paramount in navigating evolving reimbursement and competitive landscapes.

FAQs

1. What is the target indication for NDC 42291-0653?
The specific therapeutic indication depends on the product formulation. Typically, drugs in this NDC range target oncology, autoimmune, or rare diseases; confirming the precise indication requires product-specific documentation.

2. How does patent protection influence the price of NDC 42291-0653?
Patent protection grants exclusivity, enabling manufacturers to set higher prices without generic competition. As patents expire, biosimilar or generic entrants exert downward pressure on prices.

3. What are the key regulatory hurdles for this drug?
Regulatory challenges include demonstrating biosimilarity (if applicable), securing reimbursement approvals, and maintaining compliance with changing pharmacovigilance requirements.

4. How can manufacturers optimize pricing strategies for NDC 42291-0653?
Manufacturers should balance maximizing revenues with payer negotiations, implement value-based pricing models, and explore patient assistance programs to enhance access and sustain profitability.

5. What future market trends could impact the price of this drug?
Emerging biosimilars, policy reforms targeting drug costs, and technological innovations like personalized medicine are poised to influence future pricing dynamics for NDC 42291-0653.


Sources

  1. MarketWatch. “Global Biologic Drug Market Size & Growth Forecast,” 2022.
  2. IQVIA. “Pharmaceutical Pricing & Market Access Report,” 2023.

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