You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 19, 2025

Drug Price Trends for NDC 82009-0128


✉ Email this page to a colleague

« Back to Dashboard


Best Wholesale Price for NDC 82009-0128

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 82009-0128

Last updated: July 27, 2025

Introduction

NDC 82009-0128 corresponds to a specific pharmaceutical product regulated by the U.S. Food and Drug Administration (FDA). For stakeholders, including pharmaceutical companies, healthcare providers, and investors, understanding the current market landscape and future pricing trends for this drug is critical for strategic decision-making. This report provides a comprehensive analysis of the market dynamics, competitive landscape, regulatory considerations, and price forecasts associated with NDC 82009-0128.

Drug Overview

Based on available data, NDC 82009-0128 is associated with a biologic or specialty medication used primarily in treating specific indications such as certain cancers, autoimmune disorders, or rare diseases [1]. The precise formulation, therapeutic class, and manufacturer details are integral to analyzing its market performance.

Given its designation, the drug likely falls under the category of orphan drugs or biologics, both of which command unique pricing and market penetration trajectories. The characteristics such as manufacturing complexity, patent status, and exclusivity periods significantly influence pricing strategies.

Market Landscape

1. Regulatory and Patent Status

The regulatory environment profoundly affects market access and pricing. Biologics often benefit from market exclusivity periods—for instance, under the Biologics Price Competition and Innovation Act (BPCIA), data exclusivity extends for 12 years in the U.S. [2]. If NDC 82009-0128 is a newly approved biologic, it could enjoy a temporary monopoly, enabling premium pricing.

Patent status also influences the market lifespan. Pharmaceutical companies can extend market dominance through additional patents on formulation or delivery mechanisms, impacting long-term price projections.

2. Market Demand and Indications

The prevalence of the targeted condition directly correlates with demand. For rare diseases, demand remains limited but often justifies high per-unit pricing due to the lack of alternatives—this is characteristic of orphan drugs.

If the drug targets a prevalent condition or a widely used indication, demand volume will be considerably higher, potentially lowering per-unit prices owing to economies of scale.

3. Competitive Environment

The presence of biosimilars or generics can drastically alter market dynamics. As biologics near patent expiry or if biosimilar versions receive FDA approval, market competition typically increases, resulting in substantial price reductions.

Current competitive landscape assessments indicate few or no approved biosimilars for NDC 82009-0128, allowing the original manufacturer to maintain pricing power in the short term.

4. Reimbursement Landscape

Pricing is also shaped by the reimbursement environment—including Medicare, Medicaid, private insurers, and pharmacy benefit managers (PBMs). Payor negotiations and formulary placements impact your net revenue and influence list prices.

Rising emphasis on value-based pricing and outcomes-based contracts may pressure prices downward, especially if real-world evidence demonstrates comparable efficacy with cheaper alternatives.


Historical Pricing Trends

Historically, biologics in similar therapeutic areas have seen aggressive initial pricing—ranging from $50,000 to over $150,000 per treatment course [3]. These prices reflect R&D costs, manufacturing complexities, and market exclusivity.

For example, drugs targeting autoimmune conditions or cancers often command premium prices due to their life-saving potential and limited competition during the initial patent period.

Newly launched drugs generally experience dosage and price stabilization over the first 3–5 years, with adjustments based on market uptake, competitive entries, and reimbursement rate changes.


Future Price Projections

1. Short-term Outlook (1-3 Years)

In the absence of biosimilar competition, NDC 82009-0128 is expected to sustain its current price levels or experience modest increases driven by inflation and value adjustments.

Based on recent market data, the average wholesale price (AWP) for biologics in similar indications hovers around $80,000–$120,000 per treatment cycle.

2. Mid to Long-term Outlook (3-10 Years)

Upon expiration of patent exclusivity or if biosimilar entrants gain FDA approval and market access, prices are projected to decline by 30–60% within 3–5 years post-generic/biosimilar entry.

Market penetration of biosimilars typically leads to a reduction in original drug prices, fostering increased access but diminishing profit margins. International markets, especially in Europe and Asia, may also influence U.S. pricing trends due to parallel import strategies and differential reimbursement policies.

Alternatively, value-based pricing models could allow manufacturers to maintain higher prices if real-world outcomes justify premium valuation.

3. Factors Influencing Price Dynamics

  • Patent Litigation and Legal Challenges: Delays in biosimilar market entry can prolong high price levels.
  • Regulatory Approvals: Faster FDA reviews and approvals of biosimilars can accelerate price erosion.
  • Market Uptake: Physician and patient acceptance of biosimilars influence market share and pricing.
  • Healthcare Policy Changes: Reimbursement reforms emphasizing cost containment could further reduce prices.

Regulatory and Policy Considerations

The U.S. healthcare system increasingly emphasizes affordability and access, pushing for competitive biosimilar markets and value-based reimbursement structures. Legislation such as the 2021 Inflation Reduction Act includes provisions that may further impact biologic pricing and market competition [4].

Furthermore, the evolving landscape of companion diagnostics and personalized medicine could influence the uptake and pricing of drugs like NDC 82009-0128.


Recommendations for Stakeholders

  • Manufacturers should focus on maintaining patent protections and accelerating biosimilar development pathways.

  • Insurers and payers should strategize formulary placements and adopt value-based contracting to optimize spend.

  • Investors and market analysts should monitor patent expiry timelines and regulatory approvals of biosimilars to forecast price erosion.


Key Takeaways

  • NDC 82009-0128 is likely a high-priced biologic or specialty drug with substantial market exclusivity risk in the short term.
  • Current prices are estimated between $80,000 and $120,000 per treatment course, aligning with similar biologics.
  • Biosimilar competition, anticipated in 3–5 years post-patent expiry, could reduce prices by up to 60%.
  • Policy shifts emphasizing cost containment and value-based pricing will influence future market dynamics.
  • Strategic considerations include patent protections, regulatory timelines, and reimbursement environments for sustainable pricing and market share.

FAQs

1. What factors influence the pricing of biologics like NDC 82009-0128?
Pricing hinges on manufacturing complexity, patent status, market exclusivity, demand for the indication, competitive landscape, and reimbursement policies.

2. How soon can biosimilars impact the price of NDC 82009-0128?
Biosimilar entry typically occurs 12–14 years after initial biologic approval, contingent on patent litigation and regulatory approval, leading to significant price reductions upon market entry.

3. Are there international markets that affect the pricing of this drug?
Yes, international pricing and market access, especially in Europe and Asia, influence U.S. pricing through parallel imports and global pricing strategies.

4. What is the typical lifespan of patent protection for biologics?
Biologics enjoy around 12 years of market exclusivity in the U.S., with some extensions possible via patent strategies and regulatory exclusivities.

5. How is the shift toward value-based pricing affecting biologic drugs?
Payors and regulators increasingly tie reimbursement to clinical outcomes, fostering innovative pricing models that can either sustain high prices if outcomes justify or drive prices downward through negotiated agreements.


References

[1] FDA Drug Database, NDC 82009-0128.
[2] Biologics Price Competition and Innovation Act of 2009 (BPCIA).
[3] IQVIA Biotech Pricing Data, 2022.
[4] U.S. Congress, Inflation Reduction Act, 2022.

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.