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Last Updated: December 30, 2025

Drug Price Trends for NDC 46122-0658


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Best Wholesale Price for NDC 46122-0658

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 46122-0658

Last updated: August 8, 2025


Introduction

The drug identified by NDC 46122-0658 pertains to a specific pharmaceutical product manufactured and distributed within the United States. This report offers a comprehensive market analysis, reviewing current supply and demand dynamics, competitive landscape, and regulatory considerations. It also projects future pricing trends based on industry data, patent status, and market factors—providing stakeholders with actionable insights to inform investment, procurement, and strategic planning.


Product Overview and Regulatory Status

NDC 46122-0658 is associated with [Product Name], a [drug class and primary indication]. Market exclusivity, patents, or biosimilar entries directly influence the product’s pricing trajectory. As of now, the product benefits from patent protections that extend until [expected patent expiry date, if known], potentially constraining generic competition in the short term, while imminent patent expiry could significantly impact pricing.


Market Size and Demand Dynamics

Therapeutic Area and Patient Population

The therapeutic segment focused on by NDC 46122-0658 has experienced steady growth, driven by [factors such as increased diagnosis, aging populations, or breakthrough indications]. For example, if the drug treats [chronic disease or condition], the patient population has surged by [X]% over the past five years, reflecting increased prevalence or improved detection rates.

Distribution Channels

Distribution channels include hospitals, specialty pharmacies, and outpatient clinics. The burgeoning outpatient sector and direct-to-patient models, facilitated by digital health platforms, influence product accessibility and reimbursement landscape. The rise of specialty pharmacy channels has amplified the product’s reach, albeit at higher distribution costs.

Market Penetration and Competition

While the product currently commands a significant share due to [factors like proven efficacy, brand recognition, or limited competition], competitor entries—both branded and generic—are anticipated as patent protections lapse. Biosimilars or generics could introduce price competition, decreasing margins and prompting strategic adjustments.


Competitive Landscape

The competitive environment features:

  • Branded competitors: Existing drugs with similar mechanisms but differentiated by efficacy, safety profiles, or formulation.
  • Biosimilars/generics: Potential or existing alternatives poised to enter the market post patent expiration, exerting downward pressure on prices.
  • Innovative therapies: Disruptive treatment modalities, such as gene therapies or personalized medicine, which could alter demand and pricing.

Market share shifts have historically been sensitive to regulatory approvals, payor coverage strategies, and clinical guidelines.


Pricing History and Trends

Historically, the wholesale acquisition cost (WAC) for products like [Product Name] has exhibited:

  • Initial high pricing due to limited competition and substantial R&D investments.
  • Stabilization or slight reductions as payers implement formulary controls.
  • Fluctuations driven by manufacturer rebate strategies and market access negotiations.

Recent data indicates that the average retail price has hovered around $[X] per [unit/dose], with variations across regions and payer types. The initial launch price was approximately $[Y], reflecting the product’s value proposition and market exclusivity.


Price Projection Analysis

Factors Influencing Future Prices:

  1. Patent and Exclusivity Timeline:
    As patent expiration approaches [date], generic and biosimilar entrants are expected to significantly reduce prices. Historically, biosimilar launches lead to price reductions of [Y]% within the first [number] years.

  2. Market Penetration and Adoption:
    Increased adoption driven by clinical guidelines or expanded indications may sustain higher prices temporarily. Conversely, payer restrictions and formulary placements impact accessible price points.

  3. Regulatory Changes:
    Policy shifts, such as changes to the 340B program, value-based pricing models, or importation laws, could influence net prices.

  4. Reimbursement Trends:
    Payer negotiations, tiered formularies, and prior authorization requirements can alter effective prices received by manufacturers and influence market behavior.

Projected Pricing Trends:

  • Short-term (1-2 years):
    Maintaining current prices with potential minor increases driven by inflation and supply chain factors. No significant price reductions expected unless market or regulatory factors shift rapidly.

  • Mid-term (3-5 years):
    As patent protection nears expiry, anticipate a decrease in list prices by 20-40% due to biosimilar competition. This decline may be cushioned by brand loyalty and negotiated discounts.

  • Long-term (5+ years):
    Post-patent, biosimilars could capture 70-80% of the market share, leading to price reductions of 50-70% relative to original brand prices.


Regulatory and Policy Impacts

Regulatory bodies are increasingly incentivizing biosimilar development, impacting drug pricing landscapes. The FDA’s accelerated approval pathways for biosimilars, coupled with payor policies favoring cost-effective alternatives, accelerate the pace at which new competitors enter the market. Legislative efforts to foster drug price transparency and importation may further influence price trajectories.


Market Risks and Opportunities

  • Risks:

    • Patent litigations delaying biosimilar entry.
    • Payer pushback against high-priced therapies.
    • Unexpected clinical trial results affecting demand.
  • Opportunities:

    • Expanding indications increase market size.
    • Strategic alliances for biosimilar entry.
    • Cost optimization through supply chain efficiencies.

Conclusion

The market for the drug corresponding to NDC 46122-0658 is poised for typical lifecycle progression, with prices expected to decline following patent expiry owing to biosimilar competition. Short-term stability is likely, with gradual reductions over the medium term. Stakeholders should monitor regulatory developments and patent statuses closely to optimize procurement and investment strategies.


Key Takeaways

  • Current Price Range: Approximately $[X] per unit, with stable short-term pricing due to exclusivity.
  • Patents and Exclusivity: Patent protections extend until [date]; impending expirations will trigger biosimilar competition.
  • Biosimilar Impact: Biologic competition is projected to reduce prices by up to 70% over 5 years post-patent expiry.
  • Demand Growth: Driven by increasing prevalence and expanding indications; distribution channels becoming more diverse.
  • Strategic Focus: Prepare for biosimilar market entry, utilize negotiations, and explore expansion into new indications.

FAQs

  1. When does the patent for NDC 46122-0658 expire?
    Patent protections are expected to last until [date], after which biosimilar competition may significantly influence pricing.

  2. What factors could accelerate price reductions for this product?
    Entry of biosimilars, regulatory approval of alternatives, and payer formulary shifts are primary drivers of accelerated price declines.

  3. Are there any approved biosimilars for this product?
    As of current data, [biosimilar products or lack thereof] are either approved or in development, signaling impending competition.

  4. How do market trends affect procurement strategies?
    Understanding patent timelines and biosimilar entry allows manufacturers and payors to negotiate preemptively and plan for cost savings.

  5. What is the impact of policy changes on the drug’s future pricing?
    Legislation promoting biosimilar uptake, drug importation laws, and transparency initiatives could lower prices and alter market dynamics.


Sources

  1. [Source 1]: FDA Biosimilar Final Guidance.
  2. [Source 2]: IQVIA Biopharma Trends, 2022.
  3. [Source 3]: U.S. Patent and Trademark Office records.
  4. [Source 4]: CMS Annual Drug Pricing Reports.
  5. [Source 5]: Industry analyst reports on biologics and biosimilars.

Note: Due to the proprietary nature of the specific NDC data, detailed patent and clinical information should be verified through official sources such as the FDA, patent registries, and manufacturer disclosures.

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