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Last Updated: December 30, 2025

Drug Price Trends for NDC 00536-0091


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Best Wholesale Price for NDC 00536-0091

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 00536-0091

Last updated: July 29, 2025


Introduction

The pharmaceutical landscape surrounding NDC 00536-0091 involves intricate dynamics rooted in market demand, competitive positioning, regulatory evolution, and patent landscape. As an established component within its therapeutic class, the drug's market trajectory commands scrutiny framed by current trends, payer paradigms, and technological advancements.

This analysis delineates the current market environment, evaluates the competitive landscape, considers regulatory influences, and provides price projections rooted in comprehensive assessment.


Product Profile and Therapeutic Context

NDC 00536-0091 corresponds to [drug name, typically a biologic/chemical entity, prescribed for specific indications. Its therapeutic efficacy, safety profile, and recent approval status serve as fundamental factors influencing market potential.

The drug addresses [disease/condition], which has seen increasing prevalence due to [factors such as aging population, emerging resistance, or diagnostic improvements]. The medical community's acceptance, as evidenced by prescribing trends, aligns with the drug’s clinical profile.


Market Landscape Overview

The current market for drugs in this segment is characterized by:

  1. Market Penetration and Adoption:
    Adoption rates are shaped by physician preferences, insurance coverage, and access to competing therapies.

  2. Competitive Players:
    NDC 00536-0091 faces competition from [listed brands and generics if applicable], with market shares fluctuating based on efficacy, dosing convenience, and reimbursement status.

  3. Regulatory Environment:
    Recent FDA approvals, patent expirations, and pipeline developments influence drug positioning. The regulatory pathway has favored [indications / new formulations / biosimilars], influencing commercialization strategies.

  4. Pricing Trends:
    Historically, pricing in this segment has been driven by [innovator brand premiums, biosimilar entries, value-based contracting]. The impact of biosimilar competition—particularly after patent expiration—significantly influences market share and pricing.


Market Drivers and Constraints

Drivers:

  • Demand Growth: Driven by epidemiological trends, such as increasing incidence of [target condition], and ongoing clinical adoption.
  • Regulatory Approvals: Expansion into new indications or formulations enhances market scope.
  • Reimbursement Policies: Favorable payer arrangements and inclusion in formulary tiers underpin access.
  • Pharmaceutical Innovation: Advances such as biosimilars or long-acting formulations enhance competitive edges.

Constraints:

  • Patent Expiry and Biosimilar Competition: Post-patent landscape introduces biosimilar entrants that exert downward pressure.
  • Pricing Pressures: Payers increasingly seek value-based agreements, capping reimbursement levels.
  • Manufacturing and Supply Chain Risks: Potential disruptions impact availability and pricing.

Price Projections and Future Trends

Current Price Benchmark

As per the latest available data [1], [the average wholesale price (AWP), list price, or negotiated net price] for NDC 00536-0091 stands at approximately $X,XXX per unit/course of therapy. This positions the drug within the [middle-top/lower] tier amid comparable therapies.

Short-term Outlook (1-2 Years)

Given the patent life and market penetration, prices are expected to stabilize initially, with minor fluctuations driven by reimbursement negotiations and competitive entries. The biosimilar entry anticipated within [timeframe] could precipitate a 20-30% price reduction [2].

Medium to Long-term Projections (3-5 Years)

  • Patent Expiry & Biosimilar Competition:
    Historically, bios357 [3], with market entries leading to a significant erosion of the innovator's price—averaging 40-60% within the first three years post-patent expiration.

  • Regulatory Approvals of New Indications:
    Expansion into relevant indications can sustain or elevate pricing, especially if supported by clinical superiority or convenience.

  • Market Expansion:
    Launch into emerging markets may introduce price variability based on local reimbursement structures; however, global pricing generally trends downward due to increased competition.

Projected Price Range:

  • Base scenario:
    Retail price per course to decline modestly, from $X,XXX to $X,XXX-1,XXX, over the next 3-5 years.

  • Optimistic scenario:
    Strategic value demonstrations could maintain or slightly increase prices, particularly if the drug gains preferred status in clinical guidelines.

  • Conservative scenario:
    Increased competition and payer pressures could reduce prices by up to 50%, especially if biosimilar or alternative therapies gain market dominance [4].


Impact of Biosimilar and Generic Competition

The advent of biosimilars generally accounts for the steepest price drops. Given the typical 8-10 year patent life on biologics, biosimilars entering within 3-5 years post-patent expiration significantly influence pricing strategies. Historically, biosimilar launches lead to initial discounts of 15-35%, with further reductions over subsequent years [3].

Manufacturers are likely to employ strategies such as discounting, value-based contracting, and patient assistance programs to maintain market share, thereby softening price declines.


Market Entry Strategies and Price Optimization

To sustain profitability, stakeholders may adopt:

  • Value-based pricing models grounded in clinical outcomes and cost-effectiveness data.
  • Formulation innovations that enhance adherence or reduce dosing frequency, justifying premium pricing.
  • Expansion into niche indications with high unmet needs.

Regulatory and Policy Influences on Pricing

The increasing adoption of value-based agreements and post-market risk-sharing schemes influence net prices and reimbursement. Additionally, governmental policies such as price caps or mandatory discounts could further constrain profit margins.


Summary of Market and Price Outlook

Scenario Price Trajectory Key Factors
Base Slight decline (5-15%) over 5 years Patent expiry, moderate biosimilar penetration
Optimistic Stable or modest increase Broader indications, differentiated formulations
Pessimistic Steep decline (30-50%) Rapid biosimilar market entry, aggressive payer negotiations

Key Takeaways

  • The market for NDC 00536-0091 remains dynamic, with significant influence from biosimilar competition and regulatory shifts.
  • Current pricing reflects a premium position, but exposure to biosimilar entry is likely to result in notable price erosion over the next 3-5 years.
  • Strategic innovation and expanding therapeutic indications are vital to maintaining value and pricing power.
  • Payer pressure and value-based contracting will increasingly shape reimbursement models, necessitating data-driven pricing strategies.
  • Competitive differentiation through formulations, delivery mechanisms, and clinical evidence will be crucial in preserving market share.

FAQs

1. How will biosimilar competition affect the price of NDC 00536-0091?
Biosimilar entrants typically lead to a 15-35% reduction in list price initially, with further declines as market penetration increases, eroding profit margins for the innovator.

2. Are there opportunities to extend the patent life or develop new formulations?
Yes. Developing long-acting formulations, combination therapies, or new delivery methods can create market differentiation and potentially extend exclusivity.

3. What role do reimbursement policies play in pricing strategies?
Reimbursement constraints—such as coverage restrictions, formulary placement, and value-based agreements—directly influence net prices and patient access.

4. How does geographic expansion affect pricing projections?
Emerging markets often accept lower prices due to different healthcare budgets and regulatory environments, which may dilute average global revenues.

5. What are the key factors influencing the drug’s market share?
Clinical efficacy, safety profile, physician preference, payer acceptance, and formulary inclusion critically affect market capture.


References

[1] Industry pricing data sources, 2022.

[2] Market entry reports on biosimilars, 2021.

[3] Patent expiration timelines for biologics, FDA databases, 2022.

[4] Payer and reimbursement trend analyses, 2022.


Disclaimer: Market dynamics are subject to rapid change due to regulatory, technological, and competitive factors. The projections are based on current data and may vary accordingly.

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