Last updated: July 28, 2025
Introduction
The National Drug Code (NDC) 00115-1554 represents a specific pharmaceutical product registered within the U.S. healthcare system. To comprehensively analyze this drug's market and project its future pricing trends, we must examine its therapeutic class, current market dynamics, regulatory status, manufacturing factors, and competitive landscape. This report synthesizes publicly available data, recent industry trends, and economic factors influencing drug pricing.
Drug Profile and Therapeutic Context
NDC 00115-1554 corresponds to Votrient (pazopanib), an anti-cancer agent approved for advanced renal cell carcinoma and soft tissue sarcoma. It belongs to the protein kinase inhibitor class, targeting vascular endothelial growth factor receptors (VEGFR), platelet-derived growth factor receptors (PDGFR), and other kinases involved in tumor angiogenesis.
Votrient entered the oncology market post-approval in 2009, with a well-established placement as a second-line therapy. Its clinical efficacy and safety profile have secured its position, but the therapeutic landscape's evolution is influencing its market dynamics.
Market Size and Demand Analysis
Current Market Landscape
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Prevalence and Incidence: Renal cell carcinoma (RCC) accounts for approximately 2-3% of adult cancers, with an estimated 76,000 new cases annually in the U.S. [1]. Soft tissue sarcomas are rarer, with around 12,000 new cases yearly [2].
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Treatment Paradigm: Votrient is utilized primarily in metastatic cases refractory to other therapies. The presence of multiple competitors affects its market share.
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Market Penetration: Based on IQVIA data, the US sales of Votrient hovered around $200 million annually over recent years, indicating moderate market penetration relative to other targeted cancer therapies [3].
Competitive Landscape
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Alternative Therapies: Other TKIs like sunitinib, cabozantinib, and newer immunotherapies are integral competitors. The advent of immune checkpoint inhibitors is altering treatment sequences, impacting demand for Votrient.
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Emerging Biosimilars & Generics: While no biosimilars for Votrient currently exist, patent expirations and manufacturing efficiencies could introduce price pressures.
Regulatory and Pricing Factors
Regulatory Status
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Patent and Exclusivity: Votrient’s primary patents expired in 2018, opening the door for biosimilar development, though none are yet marketed.
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Reimbursement Policies: Insurance coverage and formulary placements significantly influence actual market prices and access.
Pricing Trends
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Historical Pricing: The average wholesale price (AWP) for Votrient has been approximately $7,000 - $8,000 per month, translating to about $80,000 - $100,000 annually, depending on dosing.
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Price Adjustments: Manufacturers typically engage in tiered discounts, rebates, and value-based pricing to optimize reimbursement and market penetration.
Price Projection Analysis
Factors Influencing Future Pricing
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Patent Landscape & Biosimilar Entry: Pending patent expirations may foster biosimilar competition, likely reducing list prices by 20-50% over the next 3-5 years.
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Market Dinamics & New Therapies: The growing adoption of immunotherapy combinations could decrease demand, exerting downward pressure on prices.
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Usage Guidelines & Reimbursement: Evolving clinical guidelines may restrict or expand Votrient’s use, impacting revenue.
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Manufacturing & Supply Chain: Cost efficiencies from manufacturing scale-up could reduce costs, enabling competitive pricing.
Projected Pricing Trends
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Short-term (1-2 years): Marginal price stability with potential minor discounts due to payer negotiations and rebates.
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Mid-term (3-5 years): Anticipated 10-30% reduction in average net price, primarily driven by biosimilar competition and market saturation.
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Long-term (5+ years): Possible stabilization at 50-70% of current list prices if biosimilars or alternative therapies dominate the therapeutic landscape.
Revenue Forecasts and Market Opportunities
Based on current demand and potential price reductions, the total U.S. market revenue could decline from approximately $200 million annually to a projected $140-$160 million over the next five years. Geographic expansion into international markets could offset domestic declines, although regulatory hurdles and local pricing controls are concerns.
Conclusion
The outlook for NDC 00115-1554 (Votrient) suggests a mature market facing competitive threats from emerging therapies and generics. While the current price remains relatively high, impending patent expirations and biosimilar developments are poised to drive downward price pressures over the next five years. Strategic positioning—such as expanding indications, optimizing reimbursement, and engaging in value-based pricing—will be essential for stakeholders seeking sustained profitability.
Key Takeaways
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The Votrient market is characterized by moderate current demand, with annual revenues around $200 million in the U.S.
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Patent expirations and biosimilar emergence will likely reduce list prices by up to 50% within five years.
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Increasing competition from immunotherapies and combination treatments is reshaping the treatment landscape.
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Future pricing strategies should focus on cost efficiencies, expanded indications, and value-based models to maximize revenue.
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International markets offer growth potential, but pricing and regulatory barriers must be considered.
FAQs
1. What is the expected impact of biosimilar entry on Votrient's price?
Biosimilar entry is anticipated to cause a significant price reduction, potentially between 20-50%, due to increased competition and market pressures.
2. How does the rising use of immunotherapies affect Votrient's market share?
Immunotherapies are increasingly preferred as first-line treatments, which could reduce Votrient’s utilization, especially in earlier lines of therapy, impacting overall sales.
3. Are there ongoing efforts to extend Votrient's patent or develop next-generation formulations?
There are no current patent extensions or next-generation formulations publicly announced; future developments may influence market dynamics.
4. What are the key factors that can stabilize Votrient’s pricing in the future?
Value-based reimbursement, expanded indications, and strong clinical positioning can help sustain prices amid competitive pressures.
5. How do international markets influence the overall pricing strategy for Votrient?
Pricing varies globally due to differing healthcare systems and patent statuses. International markets can offer growth opportunities but often at lower prices than domestic settings.
References
[1] American Cancer Society. Cancer Facts & Figures 2022.
[2] Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2022. CA Cancer J Clin; 72(1):7-33.
[3] IQVIA. Medicine Use and Spending in the U.S.: A Review of 2021 and Outlook to 2026.
