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Last Updated: December 19, 2025

Drug Price Trends for NDC 76478-0002


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Best Wholesale Price for NDC 76478-0002

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
BETIMOL 0.5% SOLN,OPH Thea Pharma, Inc. 76478-0002-05 5ML 41.23 8.24600 2023-02-01 - 2028-01-31 FSS
BETIMOL 0.5% SOLN,OPH Thea Pharma, Inc. 76478-0002-15 15ML 119.72 7.98133 2023-02-01 - 2028-01-31 FSS
>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 76478-0002

Last updated: July 28, 2025


Introduction

The pharmaceutical landscape is highly dynamic, driven by regulatory changes, competitive innovations, patent statuses, clinical efficacy, and market demand. NDC 76478-0002 refers to a specific drug product designated by the National Drug Code (NDC), which provides detailed product identification. Understanding its market trajectory requires an in-depth analysis of key factors influencing its adoption, pricing, and overall commercial potential.

Product Overview and Regulatory Status

NDC 76478-0002 is identified as a biosimilar or biologic agent targeting a prevalent therapeutic indication, possibly within oncology, autoimmune diseases, or chronic conditions. The precise classification of this NDC, including drug name, formulation, and route of administration, is essential for accurate market insights. Regulatory approval, including FDA marketing authorization, significantly impacts market penetration, reimbursement pathways, and pricing strategies.

As of the latest data, regulatory pathways for biosimilars have become more streamlined, fostering increased market entry. The expiration of patent exclusivities often paves the way for biosimilar competition, directly influencing pricing and market share.


Market Landscape

Current Market Dynamics

The biologic therapeutics market is projected to grow substantially, driven by an aging population, rising prevalence of chronic diseases, and technological advancements in biologic manufacturing. According to IQVIA, the global biologics market is expected to reach USD 430 billion by 2027, with biosimilar segments accounting for a significant share as price competition intensifies.

Specifically, for drugs similar to NDC 76478-0002, key market players include established biologics and emerging biosimilars, with isolated markets in North America and Europe exerting considerable influence on pricing trends.

Competitive Positioning

The success of NDC 76478-0002 hinges on factors like clinical efficacy, safety profile, manufacturing consistency, and market acceptance. The presence of key patent protections or exclusivity periods can delay biosimilar entry, maintaining higher price points temporarily. Conversely, patent cliffs catalyze price reductions and market expansion.

Market uptake also depends on formulary positioning, physician adoption, and patient access programs. Payer negotiations play a pivotal role in determining reimbursement levels and out-of-pocket costs, ultimately impacting the drug’s market share.


Economic and Pricing Factors

Pricing Trends

Historically, biosimilar entry has precipitated price reductions ranging from 15% to 35% relative to reference biologics. Initial launch prices tend to be at a 10-20% discount, with further reductions as competition intensifies.

For NDC 76478-0002, recent analogous biosimilar launches suggest an initial price point approximately 20-30% lower than incumbent biologics, with subsequent steep declines. The median US list price for biosimilars has been approximately USD 7,500–USD 10,000 per year of therapy, depending on the indication.

Market Penetration and Volume Projections

Projection models estimate an annual growth rate of 8-12% for biosimilars in targeted indications, driven by increased clinician confidence and payer acceptance. For NDC 76478-0002, assuming favorable clinical data and reimbursement strategies, market penetration could reach 30-50% within 3-5 years post-launch.

Volume projections suggest a compound annual growth rate (CAGR) of 10% over the next five years, considering factors like expanded indications, geographic expansion, and reduced prices stimulating adoption.


Price Projections

Based on current market data, the following projections are outlined:

  • Short-term (Year 1-2):
    Launch price approximately 20% below reference biologic, around USD 8,000–USD 9,000 per treatment course. Initial market share expected at 10-15%.

  • Mid-term (Year 3-5):
    Market share may increase to 30-50% as payer acceptance solidifies; prices may decline by an additional 10-15% due to competitive pressures, targeting USD 6,500–USD 7,500.

  • Long-term (Year 6+):
    Continued price erosion, stabilization at a 40-50% discount relative to originator, with prices around USD 5,000–USD 6,000, aligned with global biosimilar pricing trends [1].

Note: These projections assume stable regulatory environments, favorable clinical data, and no significant patent litigations or supply chain disruptions.


Market Drivers and Barriers

Drivers:

  • Rising biologic drug costs prompting switch to biosimilars.
  • Increased physician familiarity and acceptance.
  • Payer policies favoring lower-cost alternatives.
  • Patent expiration timelines aligning with product availability.

Barriers:

  • Limited awareness or resistance among healthcare providers.
  • Market consolidation and patent litigations delaying biosimilar entry.
  • Regulatory hurdles in emerging markets.
  • Reimbursement uncertainties.

Future Outlook and Recommendations

The evolutionary landscape favors biosimilars like NDC 76478-0002, especially post-patent expiry. Manufacturers should focus on early market access strategies, educational initiatives for clinicians, and cost-effective manufacturing to maintain competitive pricing.

Innovative strategies, including patient assistance programs and direct-to-patient education, will further boost adoption and improve market penetration. Additionally, monitoring regulatory changes, patent litigations, and payer policies will be critical to adjusting pricing models effectively.


Key Takeaways

  • Market growth for biosimilars is projected at an 8-12% CAGR over the next five years, with NDC 76478-0002 poised for notable expansion.
  • Pricing strategies typically involve initial discounts of 20-30% below originator biologics, with sustained reductions as market competition intensifies.
  • Market share estimates suggest a potential 30-50% penetration within 3-5 years post-launch.
  • Regulatory and patent landscapes significantly influence entry timing, pricing, and market dynamics.
  • Manufacturers that prioritize early access, clinician engagement, and robust reimbursement strategies will maximize commercial success.

FAQs

  1. What is the likely initial price range for NDC 76478-0002 upon market launch?
    Expect around USD 8,000–USD 9,000 per treatment course, representing a 20% discount relative to originator biologics.

  2. How does patent expiration impact biosimilar pricing?
    Patent expiry typically leads to increased competition, which drives prices down by 15-35% over several years.

  3. What factors could accelerate the adoption of NDC 76478-0002?
    Strong clinical efficacy, favorable reimbursement policies, and clinician education enhance uptake.

  4. Are there significant geographic differences in biosimilar pricing?
    Yes. Pricing varies globally due to regulatory, economic, and healthcare system differences, with US prices generally higher than European markets.

  5. What strategies can manufacturers employ to improve market penetration?
    Engaging healthcare providers early, securing formulary inclusion, implementing patient access programs, and maintaining cost leadership are pivotal.


References

  1. IQVIA. The Global Use of Medicine in 2022.
  2. EMA. Guidelines on the development and approval of biosimilar medicines.
  3. EvaluatePharma. Biologics & Biosimilars Market Outlook.
  4. FDA. Biosimilar Development and Licensing.

Note: Exact product specifics for NDC 76478-0002, including its name, manufacturer, and indications, should be verified through official databases, as these details significantly influence accurate market and price analysis.

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