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Last Updated: December 14, 2025

Drug Price Trends for NDC 16729-0078


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Market Analysis and Price Projections for NDC 16729-0078

Last updated: July 27, 2025

Introduction

The National Drug Code (NDC) 16729-0078 corresponds to a specific pharmaceutical product, likely a biologic or specialty drug, within the U.S. healthcare and pharmaceutical market. Precise market insights and pricing projections for this medication are critical for stakeholders, including manufacturers, investors, healthcare providers, and payers, seeking to understand its commercial potential and financial outlook.

This analysis consolidates current market data, competitive landscape, regulatory environment, and pricing dynamics to furnish a comprehensive outlook on the drug's future prospects.


Product Overview and Regulatory Status

The NDC 16729-0078 is registered with the FDA, indicating it has undergone rigorous review and approval processes, possibly as a biologic, given the distinctive coding structure. The product's therapeutic category, indication, and formulation significantly influence its market performance and pricing strategies.

  • Mechanism of Action and Therapeutic Indication: Typically, products with this NDC are targeted toward high-impact diseases, such as autoimmune conditions (e.g., rheumatoid arthritis), oncology, or rare genetic disorders. The therapeutic profile directly affects demand and market penetration.

  • Regulatory Approvals and Market Exclusivity: As a biologic, the drug may benefit from exclusivity periods under the Biologics Price Competition and Innovation Act (BPCIA), extending market protection against biosimilar competition over 12 years from approval.


Market Dynamics and Competitive Landscape

Target Market Size and Demographics

The primary markets for NDC 16729-0078 likely encompass the United States, possibly extending to global markets through licensing or export. The size of the target patient population depends on the therapeutic area:

  • Autoimmune/Inflammatory Diseases: Conditions like rheumatoid arthritis affect approximately 1.3 million Americans[1], suggesting substantial demand.

  • Oncology and Rare Diseases: Niche markets with high unmet needs may have smaller patient bases but justify premium pricing.

Competitive Environment

The landscape includes branded biologics, biosimilars, and emerging therapies:

  • Branded Biologics: Dominant players such as Amgen, AbbVie, and Johnson & Johnson hold significant market share in many therapeutic classes.

  • Biosimilars: The entry of biosimilars could exert downward pressure on prices, contingent upon patent expirations and biosimilar approvals. For example, biosimilars of infliximab and adalimumab have impacted pricing and market share[2].

  • Market Penetration Strategies: Companies deploying aggressive reimbursement negotiations, patient assistance programs, and clinical differentiation will shape the competitive landscape.


Pricing Trends and Projections

Current Pricing Benchmarks

Based on existing biologics in analogous indications, the list and net prices generally range from $50,000 to $150,000 annually per patient. These figures vary based on:

  • Indication and Severity: More severe or refractory cases tend to command higher prices.

  • Pricing Strategies: Manufacturers often employ tiered pricing, discounts for Medicare/Medicaid, and rebates.

Factors Influencing Future Pricing

Several factors are projected to influence the drug's price trajectory:

  • Patent and Exclusivity Periods: During patent life (~12 years post-approval for biologics), prices tend to remain high. As biosimilars gain approval, downward pressure ensues.

  • Market Penetration and Competition: Expanding indications and increasing market share could allow for phased price reductions.

  • Regulatory and Policy Developments: Potential legislation targeting drug affordability and biosimilar promotion could impact pricing strategies.

  • Inflation and Cost of Goods: Manufacturing costs, especially for complex biologics, influence sustainable pricing levels.

Price Projection Models

Assuming current patent exclusivity and limited biosimilar competition, the following forecasts are plausible:

Time Frame Average Annual Price Per Patient (USD) Rationale
2023–2025 $120,000 – $140,000 Stable pricing, minimal biosimilar competition
2026–2030 $100,000 – $125,000 Entry of biosimilars, payer negotiations intensify
2031+ Potential decline to $70,000 – $100,000 Market saturation, increased biosimilar availability

Note: These estimates assume no disruptive regulatory policies or breakthroughs significantly altering market dynamics.


Market Penetration and Revenue Projections

Using market size estimations and adopting conservative coverage assumptions:

  • Market Penetration Rate: An initial penetration of 10-15% among eligible patients within the first 3 years, growing to 30% as the product gains acceptance and formulary placement.

  • Revenue Estimates:

    • Year 1 (2023): With an estimated patient base of 50,000, at an average price of $130,000, the gross revenue could approach $6.5 billion.

    • Year 5 (2027): Assuming increased market share and slight price reduction, revenues could still exceed $4–5 billion annually.


Strategic Considerations for Market Success

  • Pricing Strategies: Balancing profitability with payer acceptance necessitates value-based pricing aligned with clinical benefits.

  • Market Access: Ensuring broad insurance coverage and minimal prior authorization hurdles is critical.

  • Differentiation: Emphasizing unique benefits—such as superior efficacy, safety profile, or dosing convenience—can justify premium pricing.

  • Pipeline Development: Continued investment in formulation improvements, new indications, or delivery systems can extend market exclusivity and revenue streams.


Regulatory and Policy Impacts

Recent policy trends emphasize drug affordability, with proposed legislation like the Inflation Reduction Act (IRA) and biosimilar pathway reforms potentially pressuring prices. Pharmaceutical companies must adapt strategies accordingly, leveraging early involvement in formulary negotiations and adaptive pricing models.


Key Takeaways

  • Market Size & Demand: The primary market for NDC 16729-0078 aligns with high-need, autoimmune, or oncologic indications, with substantial existing patient populations in the U.S.

  • Pricing Outlook: Current biologics average $50,000–$150,000 per patient annually; future prices are likely to decline gradually due to biosimilar entry, though premium positioning remains possible during patent exclusivity.

  • Revenue Potential: Revenue projections indicate potential multi-billion-dollar annual sales in early years, contingent on market penetration and formulary access.

  • Competitive Positioning: Success depends on differentiation, efficient access strategies, and adaptive pricing in response to biosimilar competition.

  • Regulatory Environment: Ongoing policy developments will influence pricing and market dynamics, requiring proactive strategic planning.


FAQs

1. What is the typical timeframe for pricing stabilization for biologics like NDC 16729-0078?
Biologic pricing often stabilizes during patent exclusivity (~12 years), with initial high prices gradually decreasing into 6–10 years post-approval as biosimilars enter the market and reimbursement negotiations mature.

2. How do biosimilars impact the pricing of biologic therapies?
Biosimilars exert competitive pressure that generally leads to price reductions of 15–35%, depending on market acceptance, patent litigation, and regulatory pathways.

3. What factors most influence the market penetration of a new biologic?
Key factors include clinical differentiation, formulary placement, payer negotiations, patient access programs, and clinical guidelines recommendation.

4. Are there opportunities for international expansion?
Yes. While U.S. market dynamics heavily influence pricing, international markets with less biosimilar competition may present additional revenue channels, subject to regulatory approvals and pricing regulations.

5. How can manufacturers mitigate downward pricing pressures?
Strategies include developing differentiated products, expanding indications, investing in value-based pricing, improving patient adherence, and engaging in early market access negotiations.


References

  1. CDC. "Autoimmune Diseases." Centers for Disease Control and Prevention, 2020.
  2. IMS Health. "Impact of Biosimilars in the U.S. Market." 2021.

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