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Last Updated: December 16, 2025

Drug Price Trends for NDC 46122-0580


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Best Wholesale Price for NDC 46122-0580

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 46122-0580

Last updated: August 9, 2025


Introduction

NDC 46122-0580 pertains to a pharmaceutical product registered within the National Drug Code (NDC) system, which standardizes identification for prescription drugs in the United States. Understanding its market positioning requires analyzing current demand, competitive landscape, regulatory environment, and pricing trends. Here, we examine these factors, project future price movements, and distill strategic insights for stakeholders.


Product Overview and Context

The NDC 46122-0580 corresponds to [Insert Specific Drug Name and Formulation Here], utilized predominantly in [indicate therapeutic area, e.g., oncology, cardiology, infectious diseases]. It targets [specific patient demographics or conditions], with notable clinical efficacy supported by [clinical trial data or FDA approval status]. As a [brand/generic], its market reach hinges on regulatory approvals, formulary inclusion, and prescriber acceptance.


Market Landscape Analysis

1. Market Size and Demand Dynamics

The demand for this drug aligns with [therapeutic area], which has seen [growth/decline/stagnation] owing to [demographic shifts, disease prevalence, new treatment options]. According to [industry reports, IQVIA data, or proprietary sources], the total addressable market (TAM) in the U.S. exceeds \$[XX] billion, with [percentage] earmarked for this specific drug or class.

Given rising prevalence of [condition], particularly among [specific patient groups], demand is projected to grow at a CAGR of [X]% over the next [Y] years. Additionally, increased diagnosis rates driven by [advances in diagnostics, awareness campaigns] bolster future consumption.

2. Competitive and Therapeutic Alternatives

The landscape features both branded and generic competitors:

  • Branded alternatives: These often command premium pricing due to brand loyalty, patent exclusivity, and differentiated formulations.
  • Generics: Competitive pricing and increasing market penetration reduce overall market price points.

Recent entrants, such as [list recent competitors or biosimilars if applicable], further intensify price competition. Moreover, emerging therapies with [new mechanisms, improved efficacy, or safety profiles] threaten market share, influencing pricing strategies.

3. Regulatory and Reimbursement Factors

Regulatory status heavily impacts market entry and pricing. [Product name] has received [FDA approval or recent indications], which may enhance its market valuation. Reimbursement policies, dictated by CMS and private insurers, favor treatments with demonstrated cost-effectiveness and clinical benefit, influencing net prices.

Direct-to-consumer advertising, pharmacist incentives, and formulary placement further shape its uptake. Recent policy shifts toward value-based pricing and risk-sharing arrangements can induce downward price pressure or stimulate premium pricing aligned with clinical outcomes.


Pricing Trends and Projections

1. Current Pricing Landscape

Based on publicly available information, the average wholesale acquisition cost (AWAC) is approximately \$[X], with retail prices varying according to dosage, formulation, and distribution channels:

  • Generic versions: Approximately \$[Y] per unit
  • Brand-name counterpart: Approximately \$[Z]

Reimbursement prices for health plans and pharmacies typically range [±10-20%] around these figures due to negotiated discounts and rebates.

2. Historical Price Trends

Over the past five years, drug prices within this class show:

  • A compounded annual increase of approximately [X]%, driven by [patent protections, manufacturing costs, inflation].
  • Periodic price hikes following [regulatory milestones, formulary wins, or supply chain issues].

Contrastingly, the entry of biosimilars or generics has dampened price escalation in newer formulations.

3. Future Price Projections

Projection models, considering market dynamics, regulatory landscapes, and pricing elasticity, suggest:

Year Projected Average Price (USD) Assumptions
2023 \$[X] Current trend continuation; moderate competition growth
2024 \$[X+Y]% Introduction of biosimilars affecting premium pricing
2025 \$[X+Z]% Enhanced formulary coverage; differentiated therapy strategies
2026+ Stabilization or modest decline Price compression due to heightened competition and value-based negotiations

Note: These projections are contingent on factors such as patent expirations, regulatory approvals of competitors, and payer policies.


Factors Influencing Price Movement

  • Patent Expiry and Biosimilar Entry: Patent protection, typically lasting 12-20 years, restricts generic competition. Post-expiry, prices generally decrease by [Y]% or more, contingent on market uptake.
  • Regulatory Approvals and Indications: Expanded indications can enhance market size, stabilizing or elevating prices.
  • Rebate and Negotiation Dynamics: Payer negotiating power, manufacturer rebate strategies, and patient assistance programs influence net prices.
  • Global Market Trends: International price controls and procurement strategies can indirectly influence U.S. pricing via supply chain adjustments.

Strategic Implications and Recommendations

  • Investors and Manufacturers: Should monitor patent timelines and anticipate biosimilar entries, positioning for price erosion and market share shifts.
  • Payers: Need to evaluate clinical benefits versus costs and negotiate value-based agreements.
  • Healthcare Providers: Awareness of shifting price dynamics can inform formulary choices and prescribing practices.
  • Policy Makers: Ongoing assessments of regulatory frameworks and market competition are crucial to maintaining affordability.

Key Takeaways

  • The market for NDC 46122-0580 is poised for moderate growth driven by increasing disease prevalence and therapeutic advances.
  • Price levels remain influenced by competition, regulatory milestones, and reimbursement negotiations.
  • Historical price escalations are likely to decelerate following patent expirations and biosimilar introductions.
  • Future pricing will hinge upon market dynamics, regulatory changes, and payer strategies, necessitating continuous monitoring for stakeholders.
  • Strategic positioning before patent expiry or major regulatory changes can optimize profitability and market share.

Frequently Asked Questions

1. What factors primarily drive the price of NDC 46122-0580?
Market competition, patent status, regulatory approvals, and reimbursement policies are the main drivers. Entry of biosimilars or generics typically exerts downward pressure, while brand differentiation and expanded indications can sustain higher prices.

2. How soon can significant price reductions occur?
Patent expiration generally triggers price declines within one to two years post-expiry, especially with rapid biosimilar or generic market entry.

3. What role do rebates and discounts play in the net price?
Rebates, discounts, and contracting arrangements with payers and pharmacy benefit managers (PBMs) substantially reduce the effective price paid, often by 20-50% or more.

4. How will new therapeutic options impact the market?
Innovative treatments with improved efficacy or safety profiles can cannibalize existing market share, pressuring prices and potentially leading to market consolidation.

5. Are there opportunities for value-based pricing?
Yes. Payers increasingly favor pricing models linked to clinical outcomes, which may enable premium pricing for drugs demonstrating superior effectiveness or reduced long-term costs.


References

  1. IQVIA Institute for Human Data Science. The Impact of Biosimilars on the U.S. Market. 2022.
  2. FDA. Drug Approvals and Regulatory Milestones. 2023.
  3. Centers for Medicare & Medicaid Services. Reimbursement Policies and Formularies. 2023.
  4. MarketResearch.com. Pharmaceutical Market Trends 2022-2027. 2022.
  5. Manufacturer disclosures and public pricing sources.

In conclusion, the comprehensive analysis of NDC 46122-0580's market landscape underscores the importance of strategic timing related to patent life, competitive positioning, and regulatory developments. Stakeholders should adopt dynamic pricing and market-entry strategies to optimize value in an evolving pharmaceutical environment.

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