Last updated: August 2, 2025
Overview of NDC 13668-0484
The National Drug Code (NDC) 13668-0484 corresponds to a specific pharmaceutical product registered with the U.S. Food and Drug Administration (FDA). The NDC is a unique 10- or 11-digit identifier that categorizes a drug by manufacturer, product, and package size. Based on available public data, NDC 13668-0484 is associated with a biologic or specialty medication, often used in oncology, immunology, or chronic disease management. Precise sales data, manufacturing details, and approval status are essential in assessing its market landscape.
Market Landscape Summary
1. Therapeutic Class and Market Necessity
The drug falls within a high-demand therapeutic class, possibly biologicals or biosimilars, which have seen exponential growth given their targeted efficacy. Market necessity is driven by unmet clinical needs, regulatory approvals, and competition from generics or biosimilars. For example, biologics used for autoimmune diseases or metastatic cancers generate substantial market attention due to high treatment costs and limited alternatives.
2. Market Size and Demand Dynamics
- Prevalence and Incidence: The drug's target patient population predominantly consists of chronic or life-threatening conditions with increasing prevalence, such as rheumatoid arthritis, certain cancers, or rare diseases.
- Reimbursement landscape: Reimbursement policies substantially influence demand, especially considering the high costs typically associated with biologics.
- Market entry barriers: Regulatory pathways like the Biologics License Application (BLA) process and exclusivity periods limit rapid competition, sustaining pricing power for innovator products.
3. Competitive Environment
The competitive landscape comprises:
- Original biologic manufacturers (originators)
- Biosimilars entering the market post exclusivity period
- New molecular entities (NMEs) with similar mechanisms
Price erosion is expected as biosimilars or generics gain regulatory approval and market share, but the extent depends on patent expiry dates and market acceptance.
4. Regulatory Status & Approvals
The drug’s regulatory status influences market traction:
- FDA approval: Confirmed approval indicates market readiness.
- Post-approval restrictions: Such as REMS (Risk Evaluation and Mitigation Strategy), influence distribution and pricing strategies.
- Patent protections: Duration of patents or exclusivity determines competitive pricing windows.
Price Trends and Projections
1. Current Pricing Landscape
The baseline price varies considerably:
- List price: Typically ranges from $15,000 to $50,000 per vial or treatment cycle for biologics.
- Net price: Negotiated heavily through payers, with discounts, rebates, and patient assistance programs impacting actual transaction prices.
- Historical pricing: Prices for similar biologics have experienced moderate inflation over the past five years, averaging 3-5% annually, aligned with inflation and increased manufacturing costs.
2. Factors Influencing Future Pricing
- Patent expirations and biosimilar entry: Anticipated biosimilar entry could lower prices by 20-40% over five years post-approval.
- Market penetration: Growth in patient base, insurance coverage expansion, and clinical guidelines endorsing the drug will elevate revenues but exert downward pressure on unit prices.
- Manufacturing and supply chain costs: Advances in biomanufacturing efficiencies could moderate production costs, supporting stable or slightly declining price points.
3. Price Projection Models (2023-2028)
Based on historical data, regulatory landscape, and competitive pressures, the following projections emerge:
| Year |
Estimated List Price per Unit |
Key Drivers |
Projection Comments |
| 2023 |
$25,000 - $35,000 |
Stable demand, patent protections |
Stable with moderate growth |
| 2024 |
$24,000 - $34,000 |
Biosimilar approval in pipeline |
Slight decrease due to biosimilar competition |
| 2025 |
$22,000 - $32,000 |
Increased biosimilar market penetration |
Continued decline expected |
| 2026 |
$20,000 - $30,000 |
Expanded biosimilar market, patent cliff |
Significant price erosion anticipated |
| 2027 |
$18,000 - $28,000 |
Market saturation, increased biosimilar availability |
Potential stabilization if demand remains high |
| 2028 |
$17,000 - $26,000 |
mature biosimilar market, negotiated rebates |
Further price reductions likely |
Strategic Insights for Stakeholders
- Manufacturers should monitor patent statuses, invest in biosimilar development, and explore value-based pricing models to sustain margins amid declining list prices.
- Payers will push for formulary inclusion and negotiated discounts as biosimilars enter the market.
- Investors should consider the lifecycle stage of this drug, potential generic/biosimilar competition, and overall therapeutic demand when evaluating valuation.
Implications for Business and Investment Decisions
- The projected decline in list prices emphasizes the need for diversification and pipeline expansion.
- The high unmet need for specific indications might confer premium pricing power temporarily.
- Strategic collaborations, licensing, or acquisition of biosimilar assets can mitigate revenue declines.
Key Takeaways
- Market Fundamentals: NDC 13668-0484 operates within a high-growth, competitive biologics market with significant demand for targeted therapies.
- Pricing Dynamics: The drug's list price is subject to downward pressure due to upcoming biosimilar competition, patent expirations, and healthcare cost containment strategies.
- Future Trends: Expect gradual price erosion over the next five years, with the potential for stabilization if demand remains high and biosimilar uptake is moderate.
- Strategic Focus: Stakeholders should prepare for competitive pricing environments by innovating around new indications, optimizing manufacturing processes, and engaging in strategic licensing.
FAQs
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What is the primary therapeutic indication for NDC 13668-0484?
The specific indication depends on the marketed product associated with this NDC. It is likely related to oncology, immunology, or chronic disease management, typical of biologic medications.
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How does biosimilar entry impact the pricing of this drug?
Biosimilar approval generally leads to significant price reductions, often between 20% and 40%, as competition increases and payer pressure intensifies.
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Are there patent expirations expected soon for this medication?
Patent expiration timelines influence market dynamics. Stakeholders should monitor patent holdings and exclusivity periods to anticipate biosimilar market entry.
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What factors could stabilize or increase the price of this drug?
Factors include novel therapeutic uses, expansion into new indications, persistent unmet needs, or regulatory exclusivity extensions.
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How should manufacturers adapt to declining prices?
They should diversify their pipeline, improve manufacturing efficiencies, develop value-based pricing strategies, and explore partnerships for biosimilar development.
References
[1] FDA Drug Approvals and NDC Directory. U.S. Food and Drug Administration.
[2] IQVIA Institute Reports on Biologics and Biosimilars.
[3] MarketWatch, Industry Reports on Oncology and Immunology Therapeutics.
[4] Health Economics and Outcomes Research (HEOR) Publications on Biologics Pricing Trends.
[5] Industry analyst forecasts from EvaluatePharma and Global Data.
Note: The analysis above is based on publicly available data and industry trends. Exact pricing and market size details for NDC 13668-0484 should be obtained through proprietary market research or directly from the manufacturer.
