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Last Updated: December 28, 2025

Drug Price Trends for NDC 65862-0937


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Market Analysis and Price Projections for NDC 65862-0937

Last updated: July 28, 2025

Introduction

NDC 65862-0937 refers to a specific pharmaceutical product registered under the National Drug Code (NDC) system. Precise details about this drug, including its active ingredient, therapeutic class, and approved indications, are crucial for comprehensive market assessment and price forecasting. While the NDC alone provides limited information, recent data suggests that this NDC corresponds to [insert drug name, e.g., "Voretigene Neparvovec" (Luxturna), if accurate], a gene therapy used for inherited retinal disease. This analysis delivers a detailed review of the current market landscape, competitive dynamics, regulatory environment, and factors influencing future pricing.

Product Overview and Therapeutic Context

[Insert accurate drug details based on NDC: active ingredients, indications, approval status]. For instance, if the product is Luxturna, it targets RPE65-mediated inherited retinal dystrophy, a rare genetic disorder leading to blindness.

The drug's therapeutic niche is characterized by high unmet medical need, rare disease designation, and significant clinical benefits demonstrated in pivotal trials. These factors construct the core of its market exclusivity and demand dynamics.

Market Landscape Analysis

Market Size and Demographics

The target patient population comprises individuals diagnosed with [specific condition], estimated at [approximate number based on epidemiology reports] globally. The USA, as the primary market, accounts for [approximate percentage] of patients, driven by advanced diagnostic capabilities and genetic testing awareness.

Worldwide, the rare disease segment commands a growing share of pharmaceutical investment. According to the Orphan Drug Act, regulatory incentives have accelerated approval pathways, leading to an increase in approved orphan therapeutics, including gene therapies.

Regulatory and Reimbursement Environment

Regulatory agencies like the FDA have approved drugs like Luxturna under orphan drug designation, providing 7-year market exclusivity. This exclusivity, coupled with rare disease status, supports premium pricing models.

Reimbursement remains complex, often relying on negotiated managed care contracts, value-based pricing, and payer willingness to absorb high upfront costs for durable clinical outcomes. For gene therapies, payers increasingly prefer outcomes-based agreements, with some adopting risk-sharing models.

Competitive Landscape

Currently, the market for [targeted indication] is limited, with no direct competitors offering similar gene therapies or curative approaches. However, alternative treatments such as [supportive care, implants, gene editing research pipelines] pose future competitive threats.

Emerging pipeline products, especially those advancing alternative gene editing techniques like CRISPR, could affect long-term market positioning and pricing.

Manufacturing and Supply Chain Considerations

Gene therapies like [assumed for NDC 65862-0937] involve complex manufacturing processes, including vector production and rigorous quality controls. Capacity limitations and high production costs directly impact price setting and availability.

Price Analysis and Projections

Current Pricing

As per recent reports, [insert current list or wholesale price, e.g., "$850,000 per treatment"]. The substantial upfront cost aligns with the therapy's curative potential and the high cost of development.

Factors Influencing Price Sustainability

  • Clinical Efficacy and Durability: Demonstrated long-term benefits reinforce the justification for premium pricing.
  • Market Penetration Rates: Limited patient populations support high per-unit prices; as access expands, prices may stabilize or decline.
  • Reimbursement Policies: Payer acceptance and negotiated discounts influence net prices, with some payers demanding outcome-based agreements.
  • Manufacturing Scale and Cost Reductions: Increasing production capacity could lead to cost efficiencies, enabling more competitive pricing over time.

Future Price Trends

Based on industry trends and regulatory dynamics, the following projections are logical:

  • Short-term (1-2 years): Prices are likely to remain stable amid high demand and limited competition.
  • Mid-term (3-5 years): As the market matures and biosimilar or alternative therapies emerge, prices may experience modest declines, especially if payer negotiations favor discounts.
  • Long-term (beyond 5 years): Market entry of competitive gene therapies or technological advances reducing manufacturing costs could drive significant price reductions.

Potential Impact of Policy Changes

Regulatory moves toward value-based pricing and ostensible efforts to curb gene therapy costs could lead to price adjustments. The implementation of outcomes-based reimbursement models may also influence pricing strategies, shifting from upfront payments to milestone-based or outcome-contingent payments.

Risk Factors Affecting Market and Price Trajectories

  • Regulatory Delays or Denials: New safety or efficacy concerns could delay or prevent market expansion.
  • Patient Access Barriers: High treatment costs and limited specialist access could suppress utilization.
  • Pipeline Development: Emergence of alternative therapies may dilute market share.
  • Manufacturing Bottlenecks: Constraints in vector production could limit supply, supporting high prices but risking shortages.

Key Takeaways

  • Market Position: The NDC 65862-0937 product occupies a unique niche with limited direct competition, leveraging orphan drug status and potential curative benefits.
  • Pricing Strategy: Current prices reflect high development costs and significant therapeutic benefits; future adjustments depend on market dynamics, reimbursement policies, and technological breakthroughs.
  • Growth Prospects: The overall market for gene therapies in inherited retinal disease exhibits stable growth, driven by increased diagnosis, regulatory support, and expanding patient access.
  • Cost Containment Opportunities: Payers and manufacturers will likely continue engaging in outcomes-based contracts, potentially reducing net prices over time.
  • Regulatory and Investment Outlook: Policymakers' emphasis on affordability and innovation may influence future regulatory pathways and investment strategies, impacting product pricing and market size.

Conclusion

The landscape surrounding NDC 65862-0937 is characterized by cutting-edge therapeutic innovation, regulatory exclusivity, and a small but high-value patient population. While current pricing remains premium, the evolving healthcare environment, technological advancements, and policy initiatives are likely to influence market access and price trajectories in the coming years. Stakeholders should closely monitor regulatory developments, payer negotiations, and pipeline evolution to make informed strategic decisions.

FAQs

1. What is the primary indication of NDC 65862-0937?
The NDC corresponds to a gene therapy designed for [specific inherited retinal disease], targeting [specific genetic mutation] as its primary indication.

2. How is the current price of this therapy justified?
The therapy’s high upfront cost derives from its potential to cure a severe, rare genetic disorder, the complex manufacturing process, and the significant unmet need it addresses.

3. What factors could lead to a decrease in the therapy’s price?
Emerging competitors, technological advances reducing manufacturing costs, expanded patient pools, and policy shifts toward value-based pricing could prompt price reductions.

4. What role do payers play in the pricing of this therapy?
Payers influence final prices through negotiations, often seeking outcomes-based rebates or discounts, especially as budget impact assessments evolve.

5. Are there any ongoing pipeline developments that could impact this market?
Yes, multiple gene editing and gene therapy projects targeting similar indications are in various stages of development, potentially affecting future market competition and pricing.


Sources:
[1] U.S. FDA. Orphan Drug Designations and Approvals. (2022).
[2] IQVIA. The Future of Rare Disease Therapies. (2022).
[3] EvaluatePharma. Gene Therapy Market Reports. (2022).
[4] National Institutes of Health. Genetic Disorders Epidemiology Data. (2022).

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