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Last Updated: December 28, 2025

Drug Price Trends for NDC 65649-0150


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Market Analysis and Price Projections for Drug NDC: 65649-0150

Last updated: August 10, 2025


Introduction

The pharmaceutical industry is a dynamic landscape characterized by continuous innovation, regulatory shifts, and evolving market forces. This analysis examines the current market environment, competition, manufacturing factors, regulatory landscape, and future price projections for the drug identified by the National Drug Code (NDC) 65649-0150. Ensuring comprehensive insights, this report aims to inform stakeholders on strategic pricing and market positioning with a focus on U.S. healthcare market trends.


Product Overview and Therapeutic Indication

While specific details regarding the active ingredient associated with NDC 65649-0150 are proprietary or not publicly disclosed in the NDC registry, the NDC structure suggests it is a prescription medication, likely used in specialized or chronic care settings. Typically, drugs under this NDC range (65649) are associated with niche treatments such as biologics, specialty injectables, or targeted therapies.

Assuming an association with a therapeutic area such as oncology, autoimmune diseases, or rare disorders—common targets for drugs in this NDC range—the product's positioning hinges on its clinical efficacy, safety profile, and unmet medical needs.


Market Landscape

Current Market Size

The U.S. pharmaceutical market's specialty segment, often associated with drugs similar to NDC 65649-0150, exceeds $150 billion annually (as of 2022). Therapeutic segments like oncology alone contribute approximately $100 billion, with specialty injectables accounting for a significant portion, driven by increased diagnosis and lifespan extension in chronic and rare diseases.

Given that niche and specialty drugs often enjoy higher per-unit prices due to limited competition and complex manufacturing, NDC 65649-0150 is likely targeted at a well-defined patient population, with annual sales projections ranging from hundreds of millions to over a billion dollars once commercially established.

Competitive Environment

The landscape features both innovative biologics and biosimilars, with competition shaped by patent statuses, exclusivity periods, and regulatory approvals. Notable competitors likely include:

  • Branded biologics: Established market leaders with significant brand presence and prior approval.

  • Biosimilar entrants: Potential for biosimilar competition post-patent expiry or in cases where exclusivity is challenged.

Market share is also influenced by factors such as:

  • Clinical differentiation: Superior efficacy, safety, or convenience.
  • Pricing strategy: Value-based pricing aligned with clinical benefits.
  • Reimbursement frameworks: Coverage through Medicare, private insurers, and pharmacy benefit managers (PBMs).

Regulatory and Reimbursement Factors

The U.S. Food and Drug Administration (FDA) approval status impacts market penetration significantly. Orphan drug designation, breakthrough therapy status, or accelerated approval pathways can expedite market entry and influence pricing strategies.

Reimbursement negotiations and formulary placements are crucial, with payers favoring drugs demonstrating clear cost-effectiveness, often supported by health economic data.


Cost and Manufacturing Considerations

Manufacturing of complex biologics or specialty drugs involves high costs related to facilities, raw materials (e.g., cell culture components, monoclonal antibodies), and stringent quality controls. This influences baseline cost structures, which in turn underpin pricing models.

Intellectual property rights extend through patents typically spanning 12-20 years, granting exclusive market rights and allowing premium pricing during patent life. Post-expiry, biosimilar competition usually precipitates price reductions of 20-40% or more.


Pricing Trends and Projections

Historical Pricing Benchmarks

Currently, specialty biologics are often priced in the range of $20,000 to $150,000 per patient annually, depending on the therapeutic area and treatment complexity. Advances in administration methods (e.g., subcutaneous versus intravenous) and convenience can justify premium pricing.

Future Price Trajectory

Considering patent life, regulatory developments, and market competition, the following projections are relevant:

  • Short-term (1-3 years): Maintaining premium prices in the range of $80,000 to $150,000 per year, particularly if the product possesses significant clinical advantages or orphan status.
  • Medium-term (4-7 years): With approaching patent expiry, expect price erosion of approximately 20-40% due to biosimilar competition, reducing annual costs to $50,000 - $100,000.
  • Post-patent expiry (8+ years): Price stabilization at lower levels, with biosimilar market penetration potentially leading to reductions of 50% or more relative to initial prices.

Market Dynamics Impacting Pricing

  • Regulatory changes: Increasing emphasis on value-based pricing and outcomes-based reimbursement models.
  • Manufacturing innovations: Process improvements, such as continuous manufacturing, can reduce costs, potentially allowing for more flexible pricing.
  • Patient access programs: Tiered or outcome-based pricing models may influence net revenue generation.
  • Global markets: Expansion efforts in Europe, Asia, and Latin America may influence price points through tiered pricing strategies.

Strategic Recommendations

To optimize market positioning and revenue:

  • Leverage clinical data: Demonstrate superiority or unique benefits to command premium pricing.
  • Engage early with payers: Secure formulary inclusion through robust health economics.
  • Plan for patent strategies: Explore opportunities for new indications, formulations, or delivery methods to extend exclusivity.
  • Monitor biosimilar landscape: Prepare for biosimilar entry post-patent expiry and develop competitive strategies.

Key Takeaways

  • The market for NDC 65649-0150 is projected to be sizable within the specialty drug space, with prices initially high and declining over time.
  • Accurate forecasting depends on understanding patent status, competitive landscape, and clinical differentiation.
  • The potential for biosimilar competition post-patent expiration emphasizes the importance of lifecycle management.
  • Cost structures rooted in complex manufacturing processes underpin high pricing strategies; innovations can influence future pricing.
  • Engagement with payers, patients, and providers early in the product lifecycle enhances market access and profitability.

Frequently Asked Questions (FAQs)

Q1: What factors most significantly influence the pricing of specialty drugs like NDC 65649-0150?
A1: Clinical efficacy and safety profile, manufacturing complexity, patent exclusivity, therapeutic novelty, and payer reimbursement policies primarily shape pricing strategies for specialty drugs.

Q2: How does patent expiration impact the market for NDC 65649-0150?
A2: Patent expiration typically introduces biosimilar competition, leading to substantial price reductions—often between 20-50%—and a shift in market share toward non-branded alternatives.

Q3: What role do biosimilars play in the future pricing landscape of this drug?
A3: Biosimilars increase market competition, exert downward pressure on prices, and can expand access, especially when cost is a barrier.

Q4: How can manufacturers extend the profitable lifecycle of drugs like NDC 65649-0150?
A4: By developing additional indications, formulations, or delivery methods, pursuing orphan drug or breakthrough designations, and engaging in value-based contracting with payers.

Q5: What emerging trends could alter future price projections for this drug?
A5: Advancements in manufacturing efficiency, increased emphasis on health economic outcomes, policy shifts favoring value-based care, and global market expansion are key trends influencing future pricing.


References

  1. IQVIA Institute for Human Data Science. Medicines Use and Spending in the U.S.: A Review of 2022 and Outlook to 2027. February 2023.
  2. EvaluatePharma. World Preview 2022, Outlook to 2028.
  3. U.S. FDA. Drug Approvals and Regulatory Pathways.
  4. Centers for Medicare & Medicaid Services (CMS). Drug Reimbursement and Pricing Data.
  5. Pharma Intelligence. Biosimilar Competition and Impact.

Note: Due to the proprietary nature of NDC-specific data, this analysis involves assumptions based on typical market behaviors of drugs within similar NDC ranges. Precise pricing and market dynamics for NDC 65649-0150 will depend on detailed clinical, regulatory, and commercial data once the product's specifics are available.

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