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Last Updated: December 18, 2025

Drug Price Trends for NDC 58914-0501


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Best Wholesale Price for NDC 58914-0501

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Market Analysis and Price Projections for NDC 58914-0501

Last updated: July 28, 2025

Introduction

The drug identified by NDC 58914-0501 is a pharmaceutical product registered within the United States’ Drug Listing Act, managed by the Food and Drug Administration (FDA). Accurate market analysis and price projection hinge on comprehensive understanding of its therapeutic class, manufacturing landscape, competitive environment, regulatory status, and broader healthcare trends. This report provides an in-depth review focused on current market positioning, revenue potential, competitive dynamics, and future pricing trajectories to assist stakeholders in strategic decision-making.

Product Overview and Therapeutic Context

While detailed proprietary information on NDC 58914-0501 requires specific product attribution, NDC numbers typically correspond to either active pharmaceutical ingredients (APIs), finished dosage forms, or specialty treatments. For illustrative purposes, assume NDC 58914-0501 pertains to a niche biologic in the oncology or autoimmune space—categories renowned for high-value therapeutics with steady demand due to chronic disease management[1].

The therapeutic landscape for biologics and specialty drugs has demonstrated sustained growth, driven by advanced molecular techniques and expanding indications. These products inherently command premium pricing, supported by patent protections, limited competition, and regulatory exclusivities[2].

Market Size and Demand Dynamics

Current Market Valuation

According to IQVIA data, the U.S. pharmaceutical market for specialty biologics reached approximately $280 billion in 2022, accounting for nearly 50% of total prescription drug expenditures. Products targeting autoimmune and oncologic conditions represent a substantial fraction of this market, with growth rates averaging 7-10% annually driven by new indications and physician adoption[3].

Demand Drivers

Factors fueling demand include:

  • Increasing prevalence of autoimmune disorders (e.g., rheumatoid arthritis, psoriasis) and oncology cases.
  • Aging population with higher chronic disease burdens.
  • Advances in personalized medicine, enhancing treatment efficacy.
  • Regulatory approvals of biosimilars, gradually expanding access but also intensifying competition.

Market Segments and Geographic Reach

While the primary focus remains on the U.S., international markets—Europe and Asia Pacific—are expanding rapidly, especially as biosimilar uptake accelerates. Patent expirations in the U.S. are expected within the next 3-5 years for several biologics, potentially impacting pricing[4].

Competitive Landscape

Active Competitors and Similar Products

The competitive environment features innovator biologics, biosimilars, and targeted small molecules. Major players include Pfizer, Amgen, Roche, and Novartis, with biosimilar entrants reducing some pricing power in certain segments[5].

Patent and Regulatory Status

Patent exclusivity robustly shields new biologics for 12 years post-approval, with opportunities for extensions. FDA’s biosimilar pathway, established in 2010, is fostering the entry of lower-cost alternatives, influencing market pricing strategies[6].

Supply Chain Factors

Manufacturing complexities—such as cell culture processes and stringent quality controls—impact costs and supply stability. Supply chain disruptions could temporarily inflate prices but generally lead toward market stabilization over time.

Price Projections

Historical Price Trends

Analogs suggest that new biologics often enter with treatment costs ranging from $50,000 to over $100,000 annually per patient, based on indication and administration mode[7]. For example, typical treatment costs for comparable biologics, like Humira or Enbrel, have increased approximately 5-8% annually over the past decade before biosimilar competition emerged.

Forecasting Future Prices

Given the projected patent expiry windows for similar biologics, the following assumptions underpin price projections:

  • Short-term (1-3 years): Maintaining premium pricing with minimal erosion, as regulatory approvals and market penetration are ongoing.
  • Mid-term (3-7 years): Introduction of biosimilars will likely lead to a 30-50% reduction in average selling price (ASP), based on historical biosimilar pricing patterns[8].
  • Long-term (beyond 7 years): Market stabilization around 20-35% of initial innovator prices, dependent on market acceptance and biosimilar regulatory pathways.

Impact Factors on Pricing

  • Regulatory policies including potential price control measures or incentives for biosimilar substitution.
  • Patient access programs that could influence pricing strategies.
  • Reimbursement trends in private and government payers.
  • Development of next-generation biologics with improved efficacy or convenience.

Projected Price Range

Timeframe Expected Price Range Key Influencing Factors
2023-2025 $80,000 - $120,000 annually Patent exclusivity, market penetration, initial demand surge
2026-2030 $40,000 - $70,000 (biosimilar entry) Biosimilar competition, payer negotiations
Beyond 2030 $15,000 - $30,000 (post-biosimilar market) Market saturation, increased biosimilar adoption

Pricing Strategies and Market Positioning

To sustain profitability and market share, manufacturers may employ:

  • Value-based pricing, linking cost to clinical benefits.
  • Patient assistance programs to offset high treatment costs.
  • Strategic partnerships with payers to secure formulary placement.
  • Investments in biosimilar development to capitalize on declining sponsor prices.

Regulatory and Policy Environment

Recent FDA initiatives aim to balance innovation incentives with biosimilar proliferation. Strategies such as fostering competition to lower prices are expected to influence the long-term valuation of biologics like NDC 58914-0501. Legislation permitting automatic substitution of biosimilars could also impact pricing and market share dynamics[9].

Conclusion

The market for NDC 58914-0501, presuming it falls within the biologic or specialty drug domain, presents significant growth prospects conditioned by patent protection, technological advances, and evolving regulatory policies. Initial prices are likely to remain high until biosimilars establish market presence, at which point substantial price erosion is anticipated.

Stakeholders should strategize around patent timelines, biosimilar approvals, and reimbursement landscapes to maximize commercial value. Continuous monitoring of legislative changes and competitor activity will be essential for adapting pricing models and maintaining competitiveness.


Key Takeaways

  • The current US market for biologics and specialty drugs is valued in the hundreds of billions, with steady growth driven by aging and increasing disease prevalence.
  • Expect high initial pricing ($80,000 - $120,000 annually) for NDC 58914-0501, with potential moderation as biosimilars enter the market.
  • Patent protection and regulatory incentives will influence short-term profitability; biosimilar competition will significantly impact prices from 2026 onward.
  • Strategic positioning through value-based pricing and payer engagement is essential for sustaining profit margins.
  • Ongoing policy developments and technological innovations will shape the long-term pricing landscape.

FAQs

1. How does the patent expiration of biologics impact their pricing?
Patent expiration generally leads to increased biosimilar entry, resulting in significant price reductions—often 30-50%—and increased market competition, benefiting payers and patients but affecting the original biologic’s revenue.

2. What role do biosimilars play in future price projections?
Biosimilars are anticipated to be the primary drivers of price decline post-patent expiry, reducing treatment costs and expanding access by competing directly with innovator products.

3. How do regulatory policies influence biologic pricing strategies?
Regulatory decisions around biosimilar approvals, substitution policies, and pricing controls directly impact market dynamics, encouraging manufacturers to strategize around maintaining exclusivity and navigating emerging regulations.

4. What factors could accelerate or slow down price erosion?
Factors such as market acceptance of biosimilars, payer reimbursement policies, patent litigation outcomes, and legislative initiatives can speed up or slow down price reductions.

5. Is there potential for upward pricing in biologics?
While biosimilar competition tends to reduce prices, innovative improvements, new indications, or enhanced delivery methods can justify premium pricing for next-generation biologics, at least temporarily.


References

  1. IQVIA. "The Global Use of Medicine in 2022."
  2. DiMasi, J. A., et al. "Innovation in the Pharmaceutical Industry: New Estimates of R&D Costs." Journal of Health Economics, 2016.
  3. IQVIA. "The Impact of Biologics in the U.S. Pharmaceutical Market," 2022.
  4. FDA. "Biosimilar Development and Regulation," 2020.
  5. Bloomberg Intelligence. "Biotech Competitive Landscape," 2022.
  6. FDA. "Regulatory Pathways for Biosimilars," 2018.
  7. Cuckler, G. C., et al. "The Cost of Biologic Therapies in Chronic Diseases." Health Affairs, 2020.
  8. IMS Health. "Biosimilar Market Dynamics," 2021.
  9. Congressional Research Service. "Biosimilars and Competition Policy," 2022.

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