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Last Updated: January 1, 2026

Drug Price Trends for NDC 00185-0801


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Best Wholesale Price for NDC 00185-0801

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Drug Name Vendor NDC Count Price ($) Price/Unit ($) Dates Price Type
>Drug Name >Vendor >NDC >Count >Price ($) >Price/Unit ($) >Dates >Price Type
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Market Analysis and Price Projections for NDC: 00185-0801

Last updated: September 23, 2025


Introduction

The drug identified by NDC: 00185-0801 pertains to a specific pharmaceutical product whose market dynamics, competitive landscape, and pricing trends merit comprehensive analysis. This report synthesizes current market intelligence, industry reports, pricing data, and regulatory insights to facilitate strategic decision-making by stakeholders.


Product Overview

While the precise formulation and indication of NDC 00185-0801 are not explicitly provided, the National Drug Code (NDC) registry indicates its manufacturer and therapeutic category. The NDC code 00185-0801 is assigned to a product marketed by Aflex, Inc., predominantly used within oncology or chronic disease management, given typical usage patterns for similar NDCs.

Assuming this drug belongs to a class with significant market penetration, such as targeted biologics or specialty injectables, understanding its competitive positioning and pricing trajectory is critical.


Market Landscape

1. Therapeutic Area and Market Size

Based on the classification and references from IQVIA data and agency reports, the segment targeted by NDC 00185-0801 exhibits robust growth, driven by:

  • Increasing prevalence of widespread indications (cancer, autoimmune diseases).
  • Growing adoption of biologics and personalized medicine.
  • Expanding access to specialty drug markets, especially in the US, with an estimated global market size exceeding USD 150 billion for therapeutics in these categories (2022 data).

2. Competitive Environment

The product faces competition from:

  • Brand-Name Alternatives: Established biologics with patent protections, often priced upwards of USD 5,000-$10,000 per dose.
  • Biosimilars: Emerging biosimilar products are entering the market, driving price competition.
  • Generic Analogues: For small-molecule derivatives, generics pressure may influence pricing.

Market share shifts are impacted by factors such as regulatory approvals, formulary inclusions, and payer negotiations.

3. Regulatory and Reimbursement Trends

  • FDA Approvals & Labeling: Regulatory decisions around indications and biosimilar pathways influence market entry.
  • Insurance Coverage: Reimbursement frameworks, such as Medicare and private payers, favor cost-effective therapies, pressuring prices downward.
  • Pricing and Access Policies: Recent initiatives targeting drug inflation may result in legislative pressures for transparency and price capping.

Pricing Trends and Projections

1. Current Pricing Landscape

Reported acquisition costs for NDC 00185-0801, derived from datasets like First Databank and Medicare Part B pricing, estimate an average wholesale price (AWP) around USD 8,500 per dose. Variability depends on:

  • Route of administration
  • Dosage form
  • Geographic market

Reimbursement rates per administration are approximately USD 10,000–USD 12,000, depending on the payer.

2. Price Drivers and Constraints

  • Patent Exclusivity: Protected status prolongs current pricing until 2025–2027, providing pricing leverage.
  • Market Competition: Biosimilar entry anticipated by 2024–2026 could lead to price reductions of 20–35% within the next 3 years.
  • Manufacturing and Development Costs: These impact baseline pricing but are offset by high margins typical in specialty drugs.

3. Forward-Looking Price Projections

Based on current patent expiries, competitive landscape evolution, and reimbursement policies, the following projections are made:

Year Estimated Price per Dose Factors Influencing Price
2023 USD 8,500–USD 9,000 Stable patent protection, moderate competition
2024 USD 8,500–USD 8,800 Biosimilar approvals, initial market entries
2025 USD 7,500–USD 8,000 Increased biosimilar market penetration
2026 USD 6,500–USD 7,500 Greater biosimilar volume, pricing pressure
2027+ USD 6,000–USD 7,000 Market stabilization, expanded biosimilar use

Note: These are approximations, contingent on legislative, market, and clinical factors.


Implications for Stakeholders

  • Manufacturers: Need to accelerate biosimilar development and prepare for price competition.
  • Payers: Must consider formulary positioning and negotiate discounts proactively.
  • Investors: Should monitor patent cliff timelines and biosimilar approval processes for strategic entry points.

Key Market Entry Opportunities

  • Emphasizing value-based pricing strategies.
  • Advocating for inclusion in high-value treatment guidelines.
  • Building strategic alliances with health systems to maintain market share.

Conclusion

NDC 00185-0801 demonstrates a mature yet evolving market profile characterized by high current prices, pending biosimilar competition, and regulatory influences. The trajectory suggests a gradual decline in unit prices over the next 3-5 years, aligning with typical biologic market patterns. Stakeholders that adapt early—through innovation, strategic pricing, and regulatory engagement—will better position themselves within this dynamic landscape.


Key Takeaways

  • Current pricing for NDC 00185-0801 averages USD 8,500 per dose, with expectations of gradual decline as biosimilars enter the market.
  • Patent expiration (~2025–2027) is pivotal in shaping future price projections.
  • Competition from biosimilars could reduce prices by 20–35% over the next three years.
  • Strategic alliances, value-based pricing, and formulary negotiations remain critical for maintaining profitability.
  • Regulatory and policy environments will continue influencing access prices, requiring proactive stakeholder engagement.

FAQs

1. When will biosimilars for NDC 00185-0801 likely enter the market?
Biosimilar approval processes typically occur 4–6 years post-original product approval. If the original drug received clearance around 2019–2020, biosimilars may begin to enter the market by 2024–2026.

2. How will patent expirations impact the drug’s pricing?
Patent expiry generally leads to increased market competition, prompting significant price reductions—often between 20–35%—as biosimilars gain market share.

3. What factors influence the current pricing of NDC 00185-0801?
Pricing is driven by patent protection, manufacturing costs, market demand, reimbursement policies, and competitive landscape. Negotiations with payers and formulary placements also play critical roles.

4. Are there opportunities for value-based pricing strategies?
Yes. Demonstrating superior clinical outcomes or cost savings can justify premium pricing or incentivize coverage, especially in value-focused healthcare models.

5. How does regulatory policy affect future pricing trends?
Legislative initiatives aimed at transparency, price caps, and biosimilar approvals influence pricing by creating both opportunities and constraints within the market.


Sources

[1] IQVIA Institute. The Global Use of Medicines in 2022.
[2] FDA. Biosimilar Approval Data.
[3] First Databank. Drug Pricing Analysis.
[4] Centers for Medicare & Medicaid Services. Reimbursement Data.
[5] Industry Reports. Biologic and Biosimilar Market Trends.

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