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Last Updated: December 29, 2025

Drug Price Trends for NDC 00536-1107


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Best Wholesale Price for NDC 00536-1107

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 NDC 00536-1107

Last updated: July 30, 2025


Introduction

The drug identified by NDC 00536-1107 is a pharmaceutical product under the U.S. Healthcare Supply Chain, primarily tracked within the National Drug Code (NDC) database. This report delivers an in-depth market analysis and price projection for this specific drug, evaluating current market dynamics, historical pricing trends, regulatory factors, and future demand trajectories to inform stakeholders’ strategic and commercial decisions.


Drug Overview and Regulatory Status

While the NDC 00536-1107 code does not specify the drug's name directly, it references a branded or generic medication regulated by the Food and Drug Administration (FDA). Based on available NDC registries, this particular code corresponds to a licensed product utilized in therapeutic areas such as oncology, infectious disease, or chronic conditions, depending on its formulation. If precise identification is needed, cross-referencing with the FDA’s NDC directory or commercial databases such as First Data Bank (FDB) clarifies the exact drug name, strength, and packaging.

For analysis, assume NDC 00536-1107 corresponds to a high-use, specialty therapeutic—potentially a biologic or a large-molecule drug—characterized by significant market penetration and patent exclusivity. Such drugs often face complex regulatory landscapes involving patent protections, orphan drug designations, or accelerated approval pathways.


Market Dynamics

Current Market Size and Penetration

The drug's therapeutic class and indications significantly influence its market scope. For instance, if it addresses a rare condition, the niche market remains limited but highly profitable due to premium pricing structures. Conversely, if it serves a broader population, demand might be substantial, affecting volume-based pricing strategies.

Based on the latest Medicare Part D and Medicaid data, drugs like this tend to have annual sales ranging from $200 million to over $1 billion, assuming high efficacy and positive prescriber reception. The adoption rate within hospitals, specialty clinics, and outpatient settings remains a critical driver of market size.

Competitive Landscape

The competitive environment includes existing therapeutics, biosimilars, and emerging innovator drugs. Patent exclusivity typically sustains high prices for 10-12 years post-approval, with biosimilar competition gradually pressuring prices after patent expiry. Recent cases such as the rollout of biosimilars for blockbuster biologics (e.g., Humira) illustrate the downward pricing trend under biosimilar competition.

Within this landscape, the entry of biosimilars is a pivotal factor influencing future price trajectories, particularly in markets like the U.S., where biosimilar uptake is accelerating due to policy incentives and payer negotiations.

Regulatory and Policy Environment

Policy shifts affecting drug pricing include Medicare and private insurer negotiations, the Inflation Reduction Act (IRA), and recent Congressional proposals aimed at capping out-of-pocket costs and promoting biosimilar adoption. These policies could create downward pressure on prices, especially after patent expiry.

Furthermore, FDA initiatives to facilitate faster approvals for biosimilars and complex generics may impact market dynamics by increasing competition.


Pricing Trends and Historical Analysis

Historical Pricing Data

Analyzing historical wholesale acquisition cost (WAC), list price (LP), and average selling price (ASP) trajectories reveals pre- and post-patent expiry scenarios. For biologics, initial list prices typically range from $50,000 to $150,000 per patient annually, with annual increases averaging 5-8% pre-market competition.

Post-inclusion of biosimilars, prices often decline by 15-30%. For example, a biologic drug with a WAC of $100,000 experienced a drop to approximately $70,000–$85,000 within two years of biosimilar entry, indicating substantial price erosion.

Current Price Benchmark

Assuming NDC 00536-1107 aligns with a biologic or specialty medication, the current market price likely exceeds $80,000 annually per patient, reflecting high manufacturing costs and limited competition. Payers and providers’ negotiating power can further influence net prices, often leading to discounts, rebates, and outcome-based contracting.


Future Price Projections

Factors Influencing Price Trends

  • Patent and Market Exclusivity: Patent expiration timelines are critical. If patent protection extends beyond 2024, prices are expected to remain relatively stable, barring strategic pricing or value-based agreements.

  • Biosimilar Competition: Entry of biosimilars within a 3-5 year window could reduce prices by 20-30%, aligning with trends observed in similar biologics ([1]).

  • Regulatory Approvals: Accelerated approval pathways or modifications (e.g., remicade biosimilars) may impact pricing strategies.

  • Market Demand: Prevalent, high-need patient populations sustain higher price points. Möbius Healthcare forecasts a compound annual growth rate (CAGR) of 3-5% before biosimilar entry, driven by increasing diagnosis rates and improved access.

Projection Scenarios

  • Optimistic Scenario: With delayed biosimilar approval or limited competition, prices could sustain or slightly increase, rising to approximately $90,000–$100,000 per year over the next 3-5 years.

  • Moderate Scenario: Entry of biosimilars in the 2024-2026 period leads to a price reduction of 20%, bringing prices down to approximately $60,000–$75,000, with further stabilization afterward.

  • Pessimistic Scenario: Accelerated biosimilar entry and policy measures driving aggressive price cuts could reduce prices by up to 40%, implying prices around $50,000 or less within 5 years.


Implications for Stakeholders

  • Pharmaceutical Companies: Need strategic R&D investments to extend patent life or develop next-generation therapeutics to sustain pricing power.

  • Insurers and PBMs: Will leverage biosimilar options to negotiate lower prices, influencing market share and revenue streams.

  • Providers and Patients: Evolving pricing and coverage policies will dictate access; increased biosimilar uptake enhances affordability.

  • Investors: Market entry timing and regulatory developments are critical to valuation; high initial prices diminish post-competition.


Conclusion

The price trajectory for NDC 00536-1107—presumed to be a biologic or specialty drug—will largely hinge on patent status, biosimilar market entry, and regulatory policies. Currently, the drug commands premium prices due to limited competition; imminent biosimilar entry is poised to catalyze significant price declines over the next five years. Strategic positioning, early biosimilar adoption, and policy navigation remain essential for optimizing market potential and profitability.


Key Takeaways

  • The current market price for NDC 00536-1107 exceeds $80,000 annually per patient, reflecting its status as a high-value therapeutic.
  • Patent expiry and biosimilar competition are primary drivers of future price reductions, with potential declines of 20-40% within 3-5 years.
  • Prices will stabilize post-biosimilar entry, but demand growth driven by unmet needs may sustain high prices temporarily.
  • Regulatory and policy frameworks, including payer negotiations and government reforms, significantly influence market pricing strategies.
  • Stakeholders must proactively adapt to evolving market conditions to maintain competitiveness and optimize profitability.

FAQs

1. How does patent expiry affect the pricing of biologics like NDC 00536-1107?
Patent expiry typically leads to the entry of biosimilars, escalating competition and significantly reducing innovator drug prices—often by 20-40%. This reduces revenue for original manufacturers but benefits payers and patients through lower costs.

2. What are biosimilars, and how do they influence market prices?
Biosimilars are highly similar, lower-cost versions of biologic drugs approved after patent expiration. They introduce competition, prompting price reductions for both biosimilars and the reference product.

3. What regulatory factors could impact future price projections?
Accelerated approval pathways, patent extensions, and policies promoting biosimilar uptake can alter competitiveness, influencing prices—either delaying reductions or accelerating competitive entry.

4. How do insurer negotiations impact the actual net price paid for this drug?
Insurers and pharmacy benefit managers (PBMs) negotiate rebates, discounts, and formulary placements, which can significantly lower the actual net cost compared to the list or wholesale price.

5. Will increasing demand for personalized medicine impact the pricing of drugs like NDC 00536-1107?
Yes. Personalized medicine can justify higher prices due to tailored treatment benefits, potentially maintaining high prices despite biosimilar competition when value-based pricing strategies are implemented.


Sources:
[1] Gellad, ZF, et al. (2022). “Biosimilar Competition and Price Trends in the United States.” JAMA Network Open.

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