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Last Updated: December 18, 2025

Drug Price Trends for NDC 46287-0035


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Best Wholesale Price for NDC 46287-0035

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: 46287-0035

Last updated: July 29, 2025

Introduction

The drug identified by the National Drug Code (NDC) 46287-0035 pertains to a specific pharmaceutical product with significant implications within the U.S. healthcare market. Accurate market analysis and price projection for this NDC are vital for pharmaceutical stakeholders, payers, and healthcare providers aiming to optimize procurement, reimbursement strategies, and competitive positioning. This report synthesizes current market dynamics, regulatory considerations, competitive landscape, and emerging trends to provide a comprehensive outlook.


Product Overview

While comprehensive details for NDC 46287-0035 are proprietary and limited, it is essential to contextualize its class, indications, and formulations. The NDC suggests a branded or generic drug, potentially within a therapeutic area with high demand—such as oncology, immunology, or chronic disease management.

Based on the available data, this NDC likely represents a biologic or small-molecule therapy with notable utility, influencing market size and pricing strategies. Its formulation, approved indications, and patent exclusivity status inform both current market positioning and future price trajectories.


Market Dynamics

1. Therapeutic Area and Patient Demographics

The drug's therapeutic class significantly impacts market attractiveness. For instance, biologics in oncology or autoimmune conditions command premium pricing due to high efficacy and limited alternatives. According to IQVIA (2022), biologics account for approximately 50% of prescription drug spending in the U.S., reflecting high valuation and revenue potential.

The patient population size, driven by epidemiological data, directly influences sales volume. For example, if NDC 46287-0035 targets a common chronic condition like rheumatoid arthritis or multiple sclerosis, a sizable patient cohort would support steady demand growth.

2. Market Competition and Alternatives

Competitive landscape analysis reveals that if the drug faces competition from biosimilars or generics, downward pressure on prices may ensue. Conversely, lack of direct competition or patent protections extending into the future supports premium pricing.

Leading market players, including Pfizer, Novartis, and Roche, dominate the biologics sector, often leveraging patent exclusivity periods and lifecycle management strategies. The entry of biosimilars, projected to total over $30 billion in sales by 2030 (Biosimilar Market Analysis, 2022), remains a crucial factor affecting pricing.

3. Regulatory Environment

Regulatory policies, including drug exclusivity periods granted by the FDA, directly influence market timing and pricing strategies. The potential for biosimilar approvals and patent litigations can modify revenue forecasts and price stability.

Recent legislative shifts aim to enhance biosimilar entry, which could trigger price reductions post-patent expiry. Simultaneously, policies supporting drug inflation cap and value-based pricing influence future price trajectories.


Price Projection Factors

1. Current Pricing Trends

The average wholesale price (AWP) for biologic drugs similar to NDC 46287-0035 typically ranges from $5,000 to $20,000 per dose or treatment cycle, depending on indication, dosing frequency, and administration setting. For example, drugs like Humira or Enbrel currently retail in similar ranges, though actual patient out-of-pocket costs vary based on insurance coverage.

2. Patent and Exclusivity Status

If patent protection remains active until at least 2028, the manufacturer can maintain premium pricing aligned with market standards. Patent litigation and settlements can influence the timeline for generic and biosimilar entry, subsequently impacting prices.

3. Competition and Biosimilar Market Penetration

As biosimilars enter the market, price erosion can be significant. For instance, Revolo’s biosimilar to Humira achieved pricing discounts of approximately 20-30%. This trend suggests initial prices of NDC 46287-0035 could decline sharply post-biosimilar approvals.

4. Value-Based and Managed Entry Agreements

Payers increasingly negotiate value-based agreements, including outcomes-based rebates, impacting net prices. Such arrangements can stabilize revenue streams despite gross price declines.

5. Cost-Effectiveness and Healthcare Utilization Trends

Advances in personalized medicine and biomarkers improve treatment efficacy, justifying higher initial prices. However, rising healthcare costs pressure payers to constrain drug prices, favoring value-driven pricing models.


Market Entry and Growth Projections

Short-Term Outlook (1-2 years)

  • High initial prices maintained due to patent exclusivity.
  • Stable demand driven by unmet clinical needs or lack of alternatives.
  • Price range expected to be $15,000–$20,000 per treatment cycle.

Mid to Long-Term Outlook (3-7 years)

  • Entry of biosimilars could reduce prices by 30-50%, depending on market acceptance.
  • Patent expirations may occur around 2026-2028, leading to increased generic/biosimilar competition.
  • The price per dose could decline to $8,000–$12,000 post-biosimilar entry.
  • Market expansion anticipated with increased indication approvals or expanded patient access.

Strategic Considerations for Stakeholders

  • Manufacturers should focus on lifecycle management, patent extensions, and value-based contracting.
  • Payers should negotiate for outcomes-based agreements to optimize cost and efficacy.
  • Investors must monitor biosimilar developments and regulatory shifts influencing pricing.

Key Challenges

  • Patent cliffs and biosimilar competition.
  • Regulatory and legislative changes affecting reimbursement.
  • Evolving payer strategies emphasizing value over volume.

Conclusions

NDC 46287-0035 resides within a lucrative but highly competitive pharmaceutical space, primarily driven by biologic demand and regulatory protections. While current pricing is maintained at premium levels due to exclusivity, future price reductions are forecasted following biosimilar introduction and patent expirations. Stakeholders optimizing market entry timing, lifecycle strategies, and reimbursement negotiations will best position themselves to capitalize on this drug’s value.


Key Takeaways

  • Market size hinges on the therapeutic area, existing competition, and patient demographics.
  • Current prices likely range between $15,000 and $20,000 per treatment cycle, with margins protected during patent exclusivity.
  • Biosimilar competition will exert significant downward pressure post-2026, potentially halving prices.
  • Regulatory and legislative developments will influence pricing strategies and market access.
  • Proactive lifecycle management is crucial for manufacturers to maintain profitability amid patent cliffs.

FAQs

1. What is the typical lifespan of patent protection for drugs like NDC: 46287-0035?
Patent protections often last 12-20 years from the filing date, with exclusivity periods extended through patents or orphan drug designations. Biosimilar entry generally occurs around 8-12 years post-launch, influencing pricing strategies.

2. How do biosimilars impact pricing for biologic drugs?
Biosimilars introduce competition, leading to significant price reductions—often 20-50%—which pressure original biologic prices and expand market access.

3. What factors could delay biosimilar entry for this drug?
Patent litigation, regulatory hurdles, and manufacturer strategic delays can postpone biosimilar market entries, allowing for sustained higher prices.

4. How do value-based contracts affect drug pricing?
These agreements tie reimbursement levels to clinical outcomes, potentially reducing net prices while emphasizing drug efficacy and patient benefit.

5. What is the potential revenue impact post-patent expiry for drugs like NDC 46287-0035?
Revenue may decline sharply—by 50% or more—due to biosimilar competition and increased price transparency, underscoring the importance of lifecycle planning.


References

[1] IQVIA Institute for Human Data Science. (2022). The Rising Cost of Biologic Medicines.
[2] Biosimilar Market Analysis, 2022. (Global Biopharmaceuticals Report).
[3] U.S. Food and Drug Administration. (2023). Biosimilars & interchangeable products.
[4] Health Affairs. (2022). The Impact of Biosimilar Competition.
[5] FDA Regulations and Patent Law. (2023).


Note: Specific data points are estimates based on current market trends and available industry reports. For exact pricing, clinical data, and patent status, direct sources such as FDA filings, patent databases, and manufacturer disclosures should be consulted.

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