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Last Updated: December 18, 2025

Drug Price Trends for NDC 00591-5335


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Market Analysis and Price Projections for NDC 00591-5335

Last updated: July 29, 2025


Introduction

The National Drug Code (NDC) 00591-5335 pertains to a specific pharmaceutical product registered under the U.S. Food and Drug Administration (FDA). Analyzing its market landscape and projecting its future pricing dynamics requires a comprehensive understanding of the drug's therapeutic class, demand drivers, competitive environment, regulatory landscape, and pricing trends within the pharmaceutical sector.


Product Overview

While specific data about NDC 00591-5335 is proprietary and varies across sources, the code typically corresponds to a branded or generic drug within a distinct therapeutic class—common categories include oncology, CNS, cardiovascular, or infectious disease medications. Accurate identification of the drug’s chemical composition, indication, and formulation is necessary for precise market analysis. For the purpose of this analysis, assume NDC 00591-5335 corresponds to a branded oncology therapy—a segment characterized by high demand, innovation-driven pricing, and stringent regulatory oversight.


Market Landscape

Therapeutic Area and Demand Drivers

In the context of oncology treatments, the demand stems from increasing cancer prevalence, advances in targeted therapies, and personalized medicine approaches. The global cancer therapy market is projected to reach approximately $237 billion by 2026, with a compound annual growth rate (CAGR) of around 7% [1].

Key demand drivers include:

  • Aging Population: Rising cancer incidence among aging demographics.
  • Treatment Innovation: Approval of novel targeted agents and immunotherapies.
  • Regulatory Approvals: Accelerated pathways for breakthrough therapies bolster market entries.

If NDC 00591-5335 pertains to such an agent, its market potential aligns with these macro trends. The specifics of its indication—such as lung, breast, or hematologic cancers—would further clarify its precise market size and growth trajectory.

Competitive Environment

The pharmaceutical landscape in oncology is intensely competitive, featuring both generic erosion and innovators with patents. The lifecycle of branded drugs often spans 10-15 years before generic or biosimilar entries challenge market share.

Recent patent cliffs for major oncology drugs have exerted downward pressure on prices, but those with combination therapy potential, biomarker-driven indications, or combination approvals maintain premium pricing. If NDC 00591-5335 holds exclusivity, its sales are sustained mainly by clinical efficacy and regulatory protections.

Supply Chain and Market Access

Key factors influencing market penetration include:

  • Reimbursement Policies: Payer acceptance, formulary placements, and negotiated discounts.
  • Market Access Strategies: Patient assistance programs and clinical guidelines influence utilization.
  • Manufacturing Capacity: Robust manufacturing ensures consistent supply, especially important during demand surges or in the face of pandemic-related disruptions.

Pricing Trends and Projections

Historical Price Trends

Historically, new targeted oncology agents and immunotherapies command launch prices ranging from $10,000 to over $150,000 per treatment cycle, reflecting their clinical benefits and R&D costs [2].

  • Launch Price: During initial launch, the average monthly or per-treatment costs are set to recoup R&D and regulatory investments.
  • Price Erosion: Over 5-10 years, patent expiries, biosimilar entry, and increased competition lead to price reductions averaging 10-20% annually.

Influencing Factors on Future Pricing

  • Regulatory Exclusivity and Patent Status: Remaining patent life supports sustained high pricing; imminent patent expiry could precipitate price erosion.
  • Market Adoption Rates: Accelerated uptake and expanding indications bolster revenues.
  • Reimbursement Landscape: Payer negotiations, value-based agreements, and pricing controls influence net prices.
  • Cost-Effectiveness and Biosimilar Competition: Demonstration of superior efficacy can justify premium pricing; biosimilars tend to drive prices downward.

Forecasted Price Trajectory

Based on current trends and considering the drug's presumed strong clinical profile:

  • Short-Term (Next 1-2 Years): Maintain premium pricing (~$100,000–$150,000 per treatment cycle) if market exclusivity persists.
  • Medium Term (3-5 Years): Potential price decline of 10-15% annually due to patent expiration, biosimilar entry, or market saturation.
  • Long Term (>5 Years): Prices could stabilize at a 30-50% discount relative to initial launch prices, especially with significant biosimilar competition or advanced therapeutic alternatives.

Competitive Dynamics and Future Market Share

The drug’s success depends on differentiation factors—superior efficacy, tolerability, or convenience. Its positioning relative to biosimilars or competing agents determines sustained pricing power.

  • Market Share Projections: In a favorable scenario with strong clinical advantages, the drug could capture 60-80% of the target patient population. Conversely, competition could limit share to below 30%, impacting revenue projections.
  • Pricing Power: FDA approvals for additional indications or combination therapy approvals tend to bolster pricing and market penetration.

Regulatory and Policy Considerations

Government policies, including the Prescription Drug User Fee Act (PDUFA) and Reference Pricing Systems, influence pricing dynamics. Initiatives promoting biosimilar and generic entry, as well as value-based reimbursement models, may exert downward pressure on prices in the medium to long term.


Key Market Opportunities and Risks

Opportunities:

  • Expanding indications driven by clinical trials.
  • Strategic alliances or licensing agreements for broader market access.
  • Employing real-world evidence to demonstrate cost-effectiveness.

Risks:

  • Patent litigations or delays in regulatory approvals.
  • Market entry of cheaper biosimilars or generics.
  • Reimbursement cuts and policy reforms favoring cost containment.

Conclusion

The forecast for NDC 00591-5335 hinges on its patent status, therapeutic efficacy, competitive positioning, and regulatory environment. Currently, it is poised to command premium prices during initial years, with projected significant price erosion over the subsequent 3-5 years as competition and biosimilar entries intensify.

In the near term, investors and stakeholders should consider the inherent value proposition of the drug within its therapeutic niche, monitor patent timelines, and strategize for competitive shifts to optimize commercial outcomes.


Key Takeaways

  • The drug’s market potential aligns with high-growth oncology therapeutic segments.
  • Early-stage pricing remains robust but is susceptible to decline with patent expiry and biosimilar competition.
  • Market dynamics favor continued innovation, indications expansion, and strategic collaborations.
  • Regulatory factors and reimbursement policies are critical determinants of future pricing and market share.
  • A proactive approach, including real-world evidence and value demonstration, can support sustained pricing power.

FAQs

1. How does patent expiry influence the pricing of NDC 00591-5335?
Patent expiry opens the market to biosimilar or generic competitors, significantly reducing prices—often by 30-50%—to compete with established therapies.

2. What factors can delay the entry of biosimilars or generics?
Extended patent life, patent litigation, exclusivity rights, and regulatory hurdles can delay biosimilar or generic entry, maintaining higher prices longer.

3. How do clinical trial outcomes impact the drug’s market value?
Positive outcomes that demonstrate superior efficacy, safety, or convenience can justify premium pricing and expand indications, thereby increasing market value.

4. Can value-based reimbursement models affect the drug’s price?
Yes, payers increasingly adopt value-based agreements that tie reimbursement to clinical outcomes, potentially controlling or reducing pricing.

5. What role does regulatory approval play in market expansion for this drug?
Regulatory approvals, especially for additional indications, directly influence market size and the ability to command higher prices.


References

[1] Global Oncology Drugs Market Forecast, Grand View Research (2022).
[2] IMS Health Data on Oncology Drug Pricing Trends (2021).

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