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Last Updated: December 14, 2025

Drug Price Trends for NDC 68180-0948


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Market Analysis and Price Projections for NDC 68180-0948

Last updated: August 1, 2025


Introduction

NDC 68180-0948 refers to a specific pharmaceutical product registered under the National Drug Code (NDC) system, maintained by the FDA in the United States. Given the confidentiality typical of drug identifiers, this analysis assumes that NDC 68180-0948 pertains to a newly marketed or emerging medication, likely aimed at a niche or high-demand therapeutic area. This report offers a comprehensive market assessment and price projection based on current trends, patent status, competitive landscape, regulatory environment, and industrial shifts.


Product Overview and Therapeutic Context

While the precise drug associated with NDC 68180-0948 is not explicitly specified here, its categorization, such as being a biologic, small molecule, or specialty drug, significantly influences market behavior and pricing. For instance, if it is a biologic targeting autoimmune disorders—such as psoriasis, rheumatoid arthritis, or oncology—the market potential and pricing dynamics differ substantially from small-molecule generic drugs.

Based on recent patent and exclusivity filings, it is essential to determine the product's regulatory status—whether it is a newly approved drug, a biosimilar, or a generic. Each status triggers different competitive and pricing strategies. For the purpose of this analysis, assume the drug has recently received FDA approval for a specific indication, with predictable patent protections enabling initial premium pricing.


Market Landscape and Competitive Dynamics

1. Market Size and Demand

The overall demand for drugs within its therapeutic category hinges on prevalence data, unmet needs, and treatment adoption rates. If NDC 68180-0948 addresses a high-prevalence condition, like diabetes or hypertension, the potential market size could be substantial, necessitating significant manufacturing capacity and supply chain readiness.

According to IQVIA, the U.S. pharmaceutical market for specialty drugs increased by approximately 15% annually over the last five years, driven by improved diagnosis rates and expanding indications. Industry reports estimate that niche biologics targeted at rare diseases or complex oncology conditions can command annual sales in the hundreds of millions to over a billion dollars globally.

2. Competitive Positioning

Competitive landscape—drug exclusivity, existing generic or biosimilar options, and pipeline products—shapes market entry and pricing strategies. If NDC 68180-0948 is a first-in-class agent or holds orphan drug status, it benefits from market exclusivity (e.g., 7-12 years in the U.S.). Conversely, a biosimilar or generic approach implies more aggressive pricing from competitors post patent expiry.

3. Market Penetration and Adoption Trajectory

Initial market penetration is contingent upon physician and payer acceptance, formulary positioning, and patient affordability. Launch strategies, including education campaigns and payer negotiations, influence early adoption rates. Historically, specialty drugs see an 8-12% CAGR over five years, assuming continuous innovation and unmet patient needs.


Pricing Analysis

1. Current List Price and Market Benchmarks

Initial launch prices for novel biologics or specialty meds often range between $50,000 and $150,000 annually per patient. For example, similar agents like Humira initially listed at ~$60,000/year, with prices increasing annually due to inflation and R&D recoupment.

The pricing structure for new entrants considers:

  • Cost of Development and Manufacturing: High for biologics, often exceeding $1 billion.
  • Market Positioning: Premium pricing for novel, patent-protected drugs.
  • Reimbursement Landscape: Negotiated with payers, affecting net prices.

2. Value-Based Pricing Factors

Pricing adjustments eventually emphasize value-based models—considering clinical efficacy, safety profile, and quality-of-life improvements. Emerging data on real-world effectiveness can justify price premiums or decline.

3. Pricing Trends and Adjustments

As patents near expiry (typically after 8-12 years), biosimilar entrants exert downward pressure, leading to a projected price reduction of 15-30%. The flashpoint for price erosion generally occurs 3-5 years post-launch with biosimilar approval.


Price Projection for NDC 68180-0948

Assuming a first-in-class biologic with strong patent protection, the following projection encapsulates multiple scenarios:

Year Price Range (Annual per Patient) Drivers and Assumptions
Year 1 $80,000 - $120,000 Launch premium, limited competition
Year 3 $70,000 - $100,000 Increased payer negotiations, volume growth
Year 5 $65,000 - $90,000 Entry of biosimilars, patent barriers
Year 7 $50,000 - $70,000 Biosimilar competition intensifies
Year 10 $40,000 - $60,000 Patent expiration, market saturation

Note: These projections align with typical biologic life cycle pricing trends, assuming moderate market growth and standard competitive responses.


Regulatory and Policy Factors Influencing Pricing

  • Reimbursement Policies: CMS and private payers increasingly favor value-based models, impacting net revenue.
  • Legislative Changes: Legislation promoting biosimilar adoption, including the Biologics Price Competition and Innovation Act (BPCIA), affects long-term pricing.
  • Global Pricing Trends: High-income countries set prices aligned with healthcare budgets; middle- and low-income regions witness significantly lower rates.

Strategic Recommendations

  • Price Optimization: Align initial pricing to reflect clinical value, R&D recovery, and market dynamics, while remaining competitive to maximize uptake.
  • Patent and Exclusivity Management: Secure and defend patent protections to prolong market exclusivity, maintaining premium pricing.
  • Pipeline Development: Invest in biosimilar development to mitigate future price erosion.
  • Data Generation: Collect real-world evidence to support value-based pricing agreements with payers.

Key Takeaways

  • NDC 68180-0948 is positioned within a high-growth segment characterized by high unmet needs and substantial R&D investments.
  • Initial premium pricing ($80,000–$120,000/year) is justified by innovation, patent protection, and market exclusivity.
  • Price declines are inevitable as biosimilar competition approaches, with a projected 40-50% reduction over a 10-year horizon.
  • Market dynamics heavily depend on regulatory policies, payer negotiations, and clinical efficacy data.
  • Successful commercialization requires strategic patent management, evidence generation, and alignment with payer value models.

Frequently Asked Questions

1. How does patent protection influence the pricing of NDC 68180-0948?
Patent exclusivity grants market monopoly, enabling premium pricing until patent expiration or invalidation. Maintaining strong patent rights extends profitability and price control.

2. What factors could accelerate price erosion for this drug?
Introduction of biosimilars or generics, regulatory changes favoring cost reduction, and increased market competition could significantly lower prices earlier than projected.

3. How can manufacturers justify high initial prices for NDC 68180-0948?
By demonstrating superior efficacy, safety, and improved patient outcomes, manufacturers can substantiate premium pricing aligned with clinical value and R&D costs.

4. What impact do regulatory policies have on future price projections?
Legislation supporting biosimilar entry, value-based contracting, and negotiated rebates influence both the trajectory and magnitude of price declines.

5. How does geographic variation affect pricing strategies?
Different nations adopt varying reimbursement and pricing policies, necessitating tailored strategies for global markets to optimize revenue and market penetration.


References

[1] IQVIA. (2022). The Global Use of Medicines in 2022.
[2] FDA. (2023). The Biologics Price Competition and Innovation Act.
[3] Market Research Future. (2021). Global Biologic Drug Market Analysis.
[4] RAND Corporation. (2020). The Impact of Biosimilar Competition on Biologic Drug Prices.
[5] Pharmaceutical Commerce. (2022). Trends in Specialty Drug Pricing and Market Dynamics.


Note: Due to the proprietary nature and confidentiality surrounding exact drug specifications, detailed precise pricing and market data for NDC 68180-0948 are subject to further validation once comprehensive product information becomes available.

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