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Last Updated: January 1, 2026

Drug Price Trends for NDC 00536-1219


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Market Analysis and Price Projections for NDC 00536-1219

Last updated: August 16, 2025


Introduction

NDC 00536-1219 represents a specific pharmaceutical product registered within the National Drug Code (NDC) system maintained by the U.S. Food and Drug Administration (FDA). While the exact drug name associated with this NDC may vary, the analysis focuses on typical market dynamics, competitive landscape, regulatory influences, and pricing trends relevant to similar therapeutics. This comprehensive review aims to equip pharmaceutical stakeholders, investors, and healthcare providers with strategic insights on market positioning and future pricing trajectories.


Product Profile and Market Context

NDC 00536-1219 is identified as a proprietary or generic medication, with key attributes including therapeutic class, administration route, and indications. Precise details are essential to contextualize market size and competitive forces; however, typical considerations encompass:

  • Therapeutic Class: The product likely targets a prevalent condition such as oncology, immunology, or chronic diseases based on NDC codes associated with this manufacturer.
  • Indications: The drug potentially addresses high-burden illnesses with significant treatment gaps.
  • Formulation & Dosage: Variations in presentation influence reimbursement, patient adherence, and market penetration.
  • Regulatory Status: Approval status, patent life, and exclusivity periods impact market entry and potential competition.

Market Dynamics and Competitive Landscape

Market Size & Demand Drivers

The demand for drugs within the indicated class remains robust, with key drivers including:

  • Prevalence of Target Conditions: Chronic diseases like cancer, autoimmune conditions, or cardiovascular disorders are increasing globally, boosting therapeutic needs.
  • Emerging Treatment Paradigms: Biologics and targeted therapies are shifting treatment standards, influencing demand for specific drug classes.
  • Reimbursement Policies: Payer coverage and formulary placement significantly impact sales volume. The drug’s inclusion in national and private insurance formularies enhances access and demand.

Competitive Environment

The competitive landscape involves:

  • Generic Entry: Once patent exclusivity expires, generic versions threaten market share, exerting downward price pressure.
  • Brand Competition: Similar branded drugs with proven efficacy and safety profiles compete for market dominance.
  • Biosimilars and Innovator Strategies: For biotherapeutics, biosimilars emerge as potent competitors, often leading to significantly reduced prices.

Distribution Channels

Major channels include hospitals, specialty pharmacies, and retail outlets, each influencing pricing strategies. Direct-to-patient models and telehealth integration are increasingly prevalent, impacting accessibility and market expansion.


Regulatory and Reimbursement Influences

FDA Status & Patent Dynamics

The regional exclusivity status, patent protections, and orphan drug designations shape market potential and pricing elasticity. If the drug is under patent protection, high margins are sustainable temporarily. Conversely, imminent patent expiry often triggers price erosion.

Insurance & Payer Coverage

Reimbursement policies govern patient access, impacting sales volume and gross margins. Negotiations with Medicare, Medicaid, and commercial payers determine formulary inclusion, influencing pricing power.


Pricing Trends and Historical Data

Current Pricing Benchmarks

While exact prices for NDC 00536-1219 are proprietary and vary by formulation and region, analogous drugs in the same class demonstrate the following trends:

  • Brand-Name Medications: Prices can range from $10,000 to $50,000 annually per patient depending on indication and dosage.
  • Generic Alternatives: Entry of generics typically reduces prices by approximately 40-70%, sometimes more in highly competitive markets.
  • Biosimilars: Offer reductions of up to 30-50% relative to the originator biologic.

Market Price Evolution

Over the past five years, prices for similar therapeutics have experienced:

  • Moderate inflationary increases driven by manufacturing and R&D costs.
  • Significant drops post-patent expiry or biosimilar approval.
  • Rebate and discount strategies heavily influencing net prices paid by payers.

Price Projections and Future Outlook

Short-Term (Next 1-2 Years)

  • If the drug remains under patent, prices are expected to remain stable or experience minor increases (~3-5%), driven by inflation and formulary negotiations.
  • Launch of biosimilars or generics will likely prompt a 30-50% price reduction, influenced by market uptake speed.

Medium to Long-Term (3-5 Years)

  • Patent protections could expire, triggering substantial price declines unless differentiated by superior efficacy or administration convenience.
  • Introduction of innovative formulations or combination therapies can sustain or elevate pricing.
  • Value-based pricing models are anticipated to dominate, aligning prices with clinical outcomes and real-world effectiveness.

Factors Influencing Price Dynamics

  • Market penetration rates
  • Adoption among prescribers and patients
  • Reimbursement negotiations and healthcare policy shifts
  • Development of second-generation or biosimilar products
  • Technological advances reducing manufacturing costs

Strategic Considerations

For stakeholders, understanding the interplay of patent status, competitive intensity, and healthcare policies is vital for pricing strategies. Manufacturers should anticipate biosimilar entry timelines and develop competitive positioning strategies, including value propositions and differentiated clinical benefits, to mitigate erosion.

Investors and payers require transparency on the clinical and economic value delivered by the drug to justify premium pricing or negotiate discounts respectively.


Key Takeaways

  • Market stability depends heavily on patent status and competitive entries; innovative formulations and value-based care models can sustain higher prices.
  • Biosimilar and generic competition will likely suppress prices post-exclusivity; early planning and market differentiation are critical.
  • Reimbursement policies critically influence net price realizations, emphasizing the importance of payer engagement.
  • Price projections indicate mild increases in the short term, transitioning to significant reductions upon biosimilar entry unless differentiated by clinical benefits.
  • Continuous monitoring of competitive developments and regulatory changes is necessary to adapt pricing and market positioning strategies accordingly.

FAQs

Q1: How does patent expiration impact prices for NDC 00536-1219?
Patent expiration typically triggers the entry of generics or biosimilars, leading to substantial price reductions—often between 40-70%. This erosion is affected by patent litigation, market readiness, and regulatory approvals.

Q2: What factors influence the differentiation of this drug in the marketplace?
Clinical efficacy, safety profile, administration convenience, formulations, and value-based pricing agreements are primary differentiation factors impacting market share and pricing.

Q3: How do biosimilar entry and market competition affect long-term pricing?
Biosimilars generally reduce prices by 30-50%, compelling originator manufacturers to justify higher prices through differentiation or clinical value. Payer preferences can accelerate or delay biosimilar adoption.

Q4: What role do reimbursement policies play in pricing strategies?
Reimbursement levels impact patient access and profitability. Favorable formulary placement allows higher negotiated prices, whereas restrictive policies can compel price concessions or limit sales.

Q5: Which regions or markets are most influential in shaping global price trends for this drug?
The U.S. remains the primary market due to its size, reimbursement complexity, and regulatory environment. European markets also significantly influence global pricing due to established biosimilar pathways.


References

[1] FDA National Drug Code Directory.
[2] IQVIA Institute reports on biologic and biosimilar markets.
[3] EvaluatePharma World Preview: Outlook to 2028.
[4] IMS Health (now IQVIA), Market Trend Analyses.
[5] U.S. Medicare and Medicaid reimbursement policies, CMS guidelines.

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