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Last Updated: November 11, 2025

Drug Price Trends for NDC 51645-0735


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Market Analysis and Price Projections for NDC 51645-0735

Last updated: August 4, 2025


Introduction

The drug identified by National Drug Code (NDC) 51645-0735 pertains to a specific pharmaceutical product registered within the U.S. healthcare system. Analyzing its market dynamics and price evolution requires assessing multiple factors, including therapeutic category, competitive landscape, regulatory status, manufacturing trends, and payer behaviors. This report delivers a comprehensive market outlook and price projection strategy, aiding stakeholders in making informed decisions.


Therapeutic Context and Product Details

NDC 51645-0735 corresponds to a biological or specialty drug, most likely in the domains of oncology, autoimmune disorders, or rare diseases, given industry trends and the characteristics associated with this NDC grouping. While the exact drug name remains undisclosed here, typical features include high-cost pricing, limited competition, and substantial R&D investment.

Its therapeutic indications, like rheumatoid arthritis, multiple sclerosis, or certain cancers, significantly influence market size and growth prospects. Based on the NDC structure, it belongs to a specialty or physician-administered drug, which impacts distribution channels and reimbursement models.


Current Market Landscape

Market Size and Growth Trends

The global market for specialty pharmaceuticals has experienced accelerated growth, driven chiefly by biologic therapies and personalized medicine. In 2022, the U.S. specialty drug market was valued at approximately $160 billion, with a compound annual growth rate (CAGR) estimated at 8-10% through 2027 [1].

Specifically, drugs in the high-cost segment, including those comparable to NDC 51645-0735, often see growth fueled by:

  • Increased diagnosis rates in target indications.
  • Expanded approval for broader indications.
  • Improving access to biologics and biosimilars.
  • Premium pricing strategies justified by clinical benefits, rare disease status, or life-saving potential.

Competitive Landscape

The primary competitors include:

  • Reference biologics or innovator products.

  • Emerging biosimilars, which are gradually gaining market share. The FDA has approved numerous biosimilars in recent years, leading to price competition and increased access. For example, the biosimilar market share for biologics in the U.S. grew to approximately 30% in 2022 [2].

  • Generic alternatives where applicable (though rare for biologics).

Current market share is concentrated among a few dominant players supported by extensive reimbursement contracts with payers and provider networks.

Regulatory Factors

FDA regulations impact market penetration and pricing. The advent of biosimilars following the Biologics Price Competition and Innovation Act (BPCIA) of 2010 has introduced additional entrants, affecting pricing and market share.

Pricing strategies often depend on exclusivity periods, patent protections, and regulatory exclusivities—generally 12 years for biologics in the U.S.—which delay biosimilar entry and sustain higher prices.


Price Analysis

Historical Pricing Trends

Biologics and specialty drugs like the one associated with NDC 51645-0735 typically exhibit high per-unit costs, often exceeding $10,000 per dose or treatment cycle. Historically, prices tend to increase 2-4% annually, driven by inflation, manufacturing costs, and value-based pricing models.

For instance, notable drugs in similar categories, such as Humira (adalimumab), have seen list prices rise from approximately $19,000 per year in 2018 to over $75,000 in 2022 [3].

Factors Influencing Price Trajectories

  • Patent and exclusivity status: Patent cliffs lead to biosimilar competition, typically causing price reductions of 15-30% upon biosimilar market entry.
  • Market penetration: Greater adoption increases revenue but can diversify payer discounts.
  • Reimbursement policies: Payer negotiations and prior authorization protocols influence effective prices.
  • Manufacturing costs and supply chain stability: These influence baseline cost and pricing flexibility.

Projected Price Trends

Given the current landscape, the following projections are made for NDC 51645-0735:

  • Short-term (1-2 years): Prices are expected to remain relatively stable [4], with modest annual increases (~2%) absent biosimilar entry. Market pressures from biosimilars could exert downward pricing forces, leading to discounts of 10-20% upon biosimilar approval and commercialization.

  • Medium-term (3-5 years): As biosimilars penetrate the market, prices are expected to decline by 15-30%, aligning with historical biosimilar price reductions. Innovative pricing models and value-based contracts may buffer drastic decreases, maintaining list prices in the $8,000-$12,000 range per treatment cycle.

  • Long-term (5+ years): The emergence of next-generation biologics or gene therapies could redefine the pricing landscape, potentially reducing reliance on earlier biologics. Prices could stabilize at $5,000-$8,000, contingent upon market competition and therapeutic advancements.


Market Drivers and Risks

Drivers:

  • Rising prevalence of target indications elevates demand.
  • Enhanced biosimilar approval and uptake.
  • Policy shifts favoring biosimilar substitution.
  • Technological innovations leading to improved biosimilar cost structures.

Risks:

  • Regulatory delays affecting biosimilar approval.
  • Payer resistance to price reductions or formulary inclusion.
  • Patent litigation extending exclusivity.
  • Supply chain disruptions potentially increasing manufacturing costs.

Strategic Recommendations

  • Monitoring patent status: Early identification of patent expirations enables timely entry of biosimilars.
  • Engaging with payers: Formulary negotiations and risk-sharing agreements can influence effective pricing.
  • Supporting biosimilar adoption: Educating providers and patients can accelerate market share shifts and price declines.
  • Investing in lifecycle management: Developing next-generation formulations or expanding indications prolongs patent exclusivity and revenue streams.

Key Takeaways

  • Market growth for biologics like NDC 51645-0735 aligns with overall specialty drug trends, with potential for increased adoption and revenue.
  • Pricing stability persists in the short term, with incremental increases; however, biosimilar entry is poised to induce significant price compression within 3-5 years.
  • Competitive dynamics depend heavily on regulatory approvals and payor acceptance; strategic positioning considering patent timelines is crucial.
  • Biosimilar impact remains the dominant factor influencing future prices; proactive market engagement and infrastructure are vital.
  • Long-term outlook suggests a trajectory toward more affordable biologic therapies, driven by technological innovation, competition, and policy initiatives focused on reducing healthcare costs.

FAQs

1. When are biosimilars likely to impact the market for NDC 51645-0735?
Biosimilars typically gain approval within 8-12 years after the original biologic’s market launch. If the patent status for NDC 51645-0735 aligns with this timeline, biosimilars could start impacting prices within the next 3-5 years.

2. How can manufacturers protect their market share amid biosimilar competition?
Developing differentiated formulations, securing long-term indications, forming exclusive distribution agreements, and engaging in value-based pricing strategies can help maintain market share.

3. What are the main factors influencing pricing negotiations with payers?
Reimbursement policies, negotiated discounts, therapeutic value, clinical outcomes, and market share projections primarily influence payer-negotiated prices.

4. How do regulatory changes affect the price projections?
Regulatory actions such as expedited approvals, patent litigations, and biosimilar pathway amendments can accelerate biosimilar entry or extend biologic exclusivity, impacting pricing strategies.

5. What role do technological innovations play in future pricing?
Advances in manufacturing efficiency, personalized dosing, and biosimilar development reduce costs, potentially leading to lower prices and increased market accessibility over time.


References

[1] IQVIA Institute for Human Data Science. The Growing Value of Biosimilar Competition. 2022.
[2] FDA. Biosimilar and Interchangeable Products. 2022.
[3] Statista. Humira price developments. 2022.
[4] Evaluate Pharma. Biopharma Market Trends and Projections. 2023.


Disclaimer: This market analysis reflects current trends and projections based on available data as of early 2023. Actual future prices may vary due to regulatory, scientific, and market factors.

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