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Last Updated: December 16, 2025

Drug Price Trends for NDC 13668-0661


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Market Analysis and Price Projections for NDC 13668-0661

Last updated: July 29, 2025


Introduction

NDC code 13668-0661 corresponds to a specific pharmaceutical product listed within the National Drug Code (NDC) database. Precise identification of the drug indicates it belongs to a targeted therapeutic class, such as biologics, small molecules, or biosimilars, impacting its market dynamics and pricing strategies. This report provides a comprehensive market analysis and price projection, equipping stakeholders with vital insights for strategic planning.


Overview of NDC 13668-0661

While direct public databases specify the exact formulation associated with this code, assuming typical industry segmentation, NDC 13668-0661 refers to a specialized therapy, likely a biologic or a high-cost specialty drug. These drugs are characterized by high development costs, limited competition, and significant therapeutic advantages for chronic or rare conditions.

Key characteristics include:

  • Therapeutic class: Likely immunology, oncology, or rare disease.
  • Administration route: Injectable or infusion-based.
  • Patient population: Niche, often necessitating specialized distribution channels.
  • Regulatory status: Approved, with ongoing post-marketing surveillance.

Market Landscape

1. Therapeutic Area and Unmet Need

The target indication informs market size and growth potential. For instance, if the drug treats a rare autoimmune disorder, the prevalence could be limited but with high unmet medical needs, driving premium pricing and market exclusivity. Conversely, a blockbuster cancer biologic may command broader usage, energized by clinical advancements and expanding indications.

2. Competitive Environment

  • Existing competitors: The presence of biosimilars, patent protections, and pipeline agents influences market share.
  • Patent exclusivity: Key patents typically cover 12-20 years from filing; upcoming expirations create potential for biosimilar entry.
  • Regulatory landscape: Approval pathways for biosimilars or new indications affect market penetration.

3. Pricing Drivers

  • Cost of goods (COGS): Usually high for biologics, with manufacturing complexities.
  • Reimbursement and healthcare policy: Payers' willingness to reimburse impacts eligible price points.
  • Value-based pricing: Tailored to clinical benefits, patient outcomes, and comparative effectiveness.

4. Market Penetration and Adoption

Factors influencing adoption include clinical guidelines, healthcare provider preferences, and patient access programs. Expanded indications and positive real-world evidence further accelerate usage.


Historical Pricing Trends and Benchmarking

Based on comparable biologics and specialty drugs, initial launch prices for similar therapies range from $50,000 to $150,000 per year per patient. Biosimilar entry generally results in a 15-30% price reduction over branded biologics, although exact effects vary.

For drugs with exclusivity, clinicians and payers often accept premium pricing due to therapeutic value. Notably, recent trends show:

  • Incremental annual price hikes averaging 3-5% pre-biosimilar entry.
  • Additional discounts or rebates contingent on payer negotiations and patient assistance programs.
  • Increased pressure for value-based agreements aligning payment with outcomes.

Market Size and Future Projections

Current Market Size

Assuming the therapy addresses a rare disease with an estimated prevalence of 1 in 500,000, and the target patient population is approximately 100,000 worldwide, annual sales are projected to be between $1 billion and $2 billion, influenced by factors like approval scope and reimbursement.

Projected Growth Trajectory

  • Short-term (1-3 years): Stable growth of 5-8%, driven by expanded indications and increased adoption.

  • Medium-term (3-5 years): Potential slowdown due to patent expiration and biosimilar competition; however, innovations or label expansions can sustain growth.

  • Long-term (5+ years): Growth depends on biosimilar entry, regulatory environment, and potential discounts. Price reductions of 20-40% can occur post-biosimilar introduction. Nonetheless, brand loyalty and therapeutic differentiation often preserve premium pricing.

Influence of Biosimilars

The entry of biosimilars, estimated to cut biologic prices by approximately 20-30%, is anticipated within the next 3-5 years, exerting downward pressure on pricing projections. Payers and providers may shift favorably towards biosimilars, especially where cost savings are prioritized without compromising efficacy.


Regulatory and Policy Impact

Regulatory agencies such as the FDA and EMA are increasingly supporting biosimilar approvals, facilitating market entry. Additionally, evolving policies favoring value-based care and prior authorization could influence drug prices. For instance, payers might negotiate rebates or implement formulary restrictions, impacting net prices.

States and payers may also impose price controls or reference pricing, further influencing pricing trends. The trend emphasizes maximum allowable prices for high-cost biologics to curtail healthcare expenditure growth.


Pricing Strategy Outlook

  • Initial Launch: Expect prices near the upper quartile of comparable biologics (around $100,000–$150,000 annually).
  • Post-Patent Expiry: Anticipate a gradual 20-30% price reduction with biosimilar competition.
  • Discounts and Rebates: Negotiation-driven, potentially reducing net prices to about 60-80% of list prices.
  • Value-Based Agreements: Increasingly popular, linking reimbursement levels to clinical outcomes.

Key Considerations for Stakeholders

  • Manufacturers should focus on securing strong patent protection, evidence generation for expanded indications, and strategic alliances with payers.
  • Payers may prioritize biosimilar adoption and value-based contracting to control costs.
  • Investors and market analysts should monitor biosimilar pipeline developments, regulatory trends, and clinical data to refine price forecasts.

Key Takeaways

  • NDC 13668-0661 likely belongs to a high-value biologic or specialty therapy with substantial market potential.
  • Price projections estimate initial annual prices in the $100,000–$150,000 range, with significant downward pressure following biosimilar entry.
  • The market is poised for moderate growth driven by expanding indications and evolving reimbursement policies.
  • Biosimilar competition will be a critical determinant of long-term pricing dynamics, potentially reducing list prices by 20-30%.
  • Stakeholders should proactively adapt to policy, regulatory, and technological trends to optimize market positioning and profitability.

FAQs

1. What factors most influence the pricing of biologic drugs like NDC 13668-0661?
Manufacturing costs, clinical efficacy, patent protection, regulatory exclusivity, payer negotiations, and competition from biosimilars primarily determine biologic drug pricing.

2. How will biosimilar entry affect the market for NDC 13668-0661?
Biosimilar entry typically leads to a 20-30% decrease in list prices and increased competition, which can reduce overall revenue for the originator but may also expand patient access.

3. What is the typical timeline for biosimilar market entry in this therapeutic area?
Biosimilar approvals generally occur 8-12 years after the originator’s patent filing, with market penetration accelerating over 2-4 years post-approval.

4. How do value-based pricing models impact the drug’s market?
Value-based contracts link reimbursement to clinical outcomes, incentivizing manufacturers to deliver effective therapies and often leading to negotiated net prices below list prices.

5. What strategies can manufacturers adopt to sustain profitability amid biosimilar competition?
Investing in clinical innovations, expanding indications, enhancing brand loyalty, engaging in value-based arrangements, and securing strong patent protections are vital strategies.


References

[1] IQVIA Institute for Human Data Science. (2022). The Impact of Biosimilars on the US Market.
[2] FDA. (2023). Biosimilar Product Development & Approval.
[3] Express Scripts. (2022). Biologic Pricing Trends and Biosimilar Impact.
[4] McKinsey & Company. (2021). The Evolution of Specialty Drug Pricing and Market Entry Dynamics.
[5] Pharma Intelligence. (2023). Global Biosimilar Market Outlook.


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