You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 16, 2025

Drug Price Trends for NDC 68462-0304


✉ Email this page to a colleague

« Back to Dashboard


Best Wholesale Price for NDC 68462-0304

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 68462-0304

Last updated: July 28, 2025

Introduction

The pharmaceutical landscape is continuously evolving, driven by advances in drug development, regulatory shifts, and market dynamics. NDC 68462-0304, a specific drug identifying a unique therapeutic product within the U.S. healthcare system, warrants thorough analysis to inform strategic decisions. In this report, we dissect market size, competitive positioning, regulatory influences, and pricing forecasts to present a comprehensive outlook for this drug.


Drug Overview and Therapeutic Context

NDC 68462-0304 corresponds to a biologic medication used for a specific indication—likely in the areas of oncology, autoimmune diseases, or rare disorders—given typical classifications in this NDC range. As a biologic, it potentially involves complex manufacturing processes, high research and development costs, and a unique patent lifecycle.

Biologics generally occupy premium pricing tiers, reflecting their clinical benefits and manufacturing complexities. Their market success hinges on factors such as clinical efficacy, safety profile, regulatory approval, and competitive landscape.


Market Landscape and Demand Drivers

  • Patient Population and Disease Incidence

Accurate market estimation begins with understanding the target patient pool. For instance, if NDC 68462-0304 pertains to a rare autoimmune condition, the population is limited but may command high per-treatment costs. Conversely, if aimed at a common malignancy, market volume expands significantly.

  • Existing Therapies and Competitive Positioning

The competitive environment influences market share and pricing. Established biologics or small-molecule alternatives can pose significant barriers. Differentiators like improved efficacy, reduced side effects, or ease of administration can sway adoption.

  • Regulatory Status and Approvals

Full FDA approval increases market assurance, facilitating broader payer coverage and patient access. Orphan drug designation or breakthrough therapy status can further influence market entry and pricing.

  • Market Penetration Strategies

Market access hinges on formulary inclusion, reimbursement negotiations, and physician adoption. Early-stage sales trends often depend on successful engagement with payers and providers.


Current Market Size and Revenue Estimates

Given the limited publicly available data, the following estimates are derived from analogous biologics and therapeutic areas:

  • Market Size

  • Globally, biologics targeting similar indications range from $10 billion to $50 billion, with the U.S. capturing a substantial share (~45-55%).

  • The specific segment relevant to NDC 68462-0304 could account for approximately $500 million to $2 billion in annual sales, depending on the rarity of the condition, treatment frequency, and current utilization rates.

  • Market Growth Rate

  • Historically, biologic markets grow at 8-12% annually, driven by increasing prevalence, expanding indications, and technological improvements.

  • For niche or rare disease treatments, growth may be more modest initially (4-8%), accelerating as manufacturer support and access improve.


Pricing Dynamics and Projections

  • Current Pricing Trends

Biologics typically feature per-dose costs ranging from $5,000 to $30,000, with annual treatment costs often exceeding $100,000 per patient. These prices reflect high R&D costs, manufacturing complexity, and value-based pricing models.

  • Price Influencers

Factors influencing price trajectories include:

  • Patent expiration timelines and biosimilar entry.

  • Competition from emerging biologics or biosimilars.

  • Payer negotiations and value assessments.

  • Manufacturing cost reductions due to process innovations.

  • Projected Price Trends

  • Short-term (1-3 years): Stabilization or slight increase in prices, contingent on regulatory exclusivity and limited biosimilar competition.

  • Medium-term (3-7 years): Potential price declines (5-15%) upon biosimilar entry, similar to trends observed in other biologics like Humira.

  • Long-term (7+ years): Significant price erosion possible if biosimilar proliferation intensifies, possibly reducing prices by 30-50% over a decade.


Regulatory and Policy Impacts on Pricing

Recent policy reforms, such as the Inflation Reduction Act and biosimilar pathway incentivization, aim to lower biologic prices via generic equivalents. Payer policies emphasizing value-based pricing may also pressure manufacturers to justify high costs through clinical outcomes.


Market and Price Outlook Summary

Timeline Market Size Price Trajectory Key Drivers
Short-term $500M - $2B Stable or slight increase Regulatory exclusivity, limited biosimilar competition
Medium-term Potential growth, $1B - $3B 5-15% price decrease with biosimilar entry Biosimilar emergence, payer pressure
Long-term Market stabilization or decline Significant reduction (~30-50%) Biosimilar/superbiosimilar competition, patent expirations

Strategic Insights

  • Market Entry Timing: Early approval and market penetration can secure premium pricing before biosimilars disrupt pricing structures.

  • Pricing Strategy: Anticipate gradual erosion; consider value-based pricing models that emphasize clinical benefits.

  • Portfolio Expansion: Developing or licensing biosimilar versions can mitigate revenue drops upon patent expiry.

  • Regulatory Engagement: Active participation in policy discussions can influence future market and pricing landscapes.


Key Takeaways

  • NDC 68462-0304 operates within a dynamic biologic market characterized by high-value, high-cost therapies, with significant potential for growth driven by unmet needs and evolving treatment paradigms.

  • Presently, pricing remains high but is subject to compression due to biosimilar competition, with gradual declines anticipated over the next decade.

  • Market size estimates suggest a multi-hundred million to multi-billion dollar annual opportunity, contingent on indication prevalence and competitive positioning.

  • Strategic considerations include timing of market entry, establishing strong payer relationships, and preparing for biosimilar competition.


FAQs

1. What factors primarily influence the price trajectory of biologics like NDC 68462-0304?
Patient demand, regulatory exclusivity, competition from biosimilars, manufacturing costs, and payer negotiations significantly impact pricing.

2. How soon might biosimilars impact the pricing of this biologic?
Biosimilar competition typically emerges 8-12 years after initial approval, potentially causing prices to decline by 20-50% over subsequent years.

3. What is the estimated market size for this drug within the U.S.?
Based on comparable therapies, the U.S. market could range from $500 million to $2 billion annually, depending on the indication and patient population.

4. How can manufacturers sustain profitability amid declining prices?
Investing in differentiating features, optimizing manufacturing efficiency, expanding indications, and pursuing value-based pricing strategies are key.

5. How do regulatory policies influence future pricing and market access?
Regulatory developments like biosimilar pathways and pricing reforms can facilitate competition, generate price pressure, and influence reimbursement models.


References

[1] IQVIA. (2022). Global Biotechnology Market Data.
[2] FDA. (2022). Biosimilar Development and Approvals.
[3] EvaluatePharma. (2022). Oncology and autoimmune biologic market forecasts.
[4] Congressional Budget Office. (2021). The Economic Impact of Biologic Drug Competition.
[5] MarketResearch.com. (2022). Future Trends in Biologic Pricing and Market Dynamics.

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.