Last updated: July 27, 2025
Introduction
The drug identified by NDC 00187-0653 is Sutent (sunitinib malate), a targeted tyrosine kinase inhibitor primarily used in oncology to treat renal cell carcinoma (RCC) and gastrointestinal stromal tumors (GIST). This market analysis provides a comprehensive review of Sutent's current position, competitive landscape, pricing trends, and future market projections, offering critical insights for stakeholders.
Overview of Sutent (NDC 00187-0653)
Sunitinib malate, marketed as Sutent by Pfizer, was approved by the FDA in 2006. Its mechanism involves inhibiting multiple receptor tyrosine kinases, including vascular endothelial growth factor receptors (VEGFRs), platelet-derived growth factor receptors (PDGFRs), and others, effectively suppressing tumor angiogenesis and proliferation. The drug's indications have expanded to include advanced pancreatic neuroendocrine tumors and certain types of metastatic cancers.
Current Market Landscape
Market Size & Demand
Sutent’s global market size was valued at approximately $1.2 billion in 2022, with continued growth driven by expanding indications and adoption in emerging markets. In the U.S., brand sales accounted for roughly $650 million, reflecting its prominence in oncology treatment regimens.
Competitive Position
Sutent faces competition from several targeted therapies, including:
- Axitinib (Inlyta): Primarily for RCC, with comparable efficacy.
- Lenvatinib (Lenvima): Used in differentiated thyroid carcinoma and RCC.
- Cabozantinib (Cabometyx): Indicated for RCC and GIST after prior therapy.
- Emerging biosimilars and generics: Patent expirations and biosimilar entries threaten Sutent's market share.
Despite this, Sutent maintains a significant foothold due to its well-established efficacy, clinician familiarity, and branded pricing.
Patent & Regulatory Environment
Pfizer’s original patent for Sutent expired in 2018 for certain formulations, opening opportunities for biosimilars and generics, which exert downward pressure on prices. However, patent litigations and exclusivity extensions continue to influence market dynamics.
Pricing Trends and Projections
Historical Pricing Trends
Historically, the wholesale acquisition cost (WAC) for Sutent hovered around $8,000 to $10,000 per month for a standard treatment course. Brand pricing stability was maintained due to its clinical efficacy and lack of direct generic competition until recent years.
Impact of Patent Expiry and Biosimilar Entry
Since patent expiration, the market has seen:
- Introduction of biosimilars and generics in 2019-2020.
- Price erosion of up to 50%-70% for generic formulations.
- A gradual decline in average wholesale prices (AWP), with current references approximately $3,000 to $4,000 per month for bioequivalent formulations.
Future Price Projections (2023-2028)
Based on current market trends and industry analyst reports, the following projections are expected:
- Short-term (1-2 years): Continued price competition, with generics capturing 70-80% of prescriptions. Prices likely to stabilize around $2,500 to $3,500/month for the lowest-cost generics.
- Mid-term (3-5 years): Introduction of biosimilars may further reduce prices by an additional 20%-30%, averaging $2,000 to $2,800/month. Price differences will hinge on formularies and insurance negotiations.
- Long-term (5+ years): Market saturation with generics and biosimilars could result in further price decline, potentially stabilizing around $1,500 to $2,000/month, especially as newer therapies with better safety profiles emerge.
Pricing Drivers
- Regulatory approvals: Faster approval pathways for biosimilars.
- Payer strategies: Rebates, formularies, and tiered pricing affecting final consumer costs.
- Market demand: Growing incidence of RCC and GIST encourages continued use.
- Patent litigation outcomes: Extended exclusivities can temporarily stabilize pricing.
Market Opportunities and Risks
Opportunities
- Expansion into new indications such as combination therapies or novel tumor types.
- Development of biosimilar versions with cost advantages.
- Penetration into emerging markets where high-cost branded drugs are less accessible.
- Innovative delivery methods or formulation improvements to extend patent life.
Risks
- Market erosion due to biosimilar and generic competition.
- Pricing pressures from insurers and pharmacy benefit managers.
- Emergence of newer therapies (e.g., immunotherapies) which may supplant kinase inhibitors.
- Regulatory challenges in launching branded or biosimilar versions.
Regulatory & Patent Outlook
Patent expiry in 2018, coupled with biosimilar approvals in the U.S. and Europe, will likely sustain downward pressure. Those biosimilars gaining market share might achieve pricing as low as $1,000 to $1,500/month within five years, depending on acceptance and reimbursement.
Key Considerations for Stakeholders
- Pharmaceutical companies: Focus on biosimilar development, patent litigation strategies, and portfolio diversification.
- Healthcare providers: Balance efficacy, cost, and emerging treatment options.
- Payers: Emphasize formulary management and cost containment through negotiated rebates.
- Investors: Monitor biosimilar pipeline progress and patent litigation outcomes to assess market risks and growth potential.
Conclusions
The landscape for NDC 00187-0653 (Sutent) is characterized by substantial price erosion driven by patent expiration and biosimilar proliferation. While immediate prospects see significant price declines, opportunities remain in developing next-generation therapies and biosimilars. Long-term market stability for Sutent hinges on maintaining clinical relevance amid evolving oncology treatment paradigms.
Key Takeaways
- Market maturity: Sutent faces intense competition from biosimilars and generics, leading to substantial price reductions.
- Price trajectory: Expect a steady decline from approximately $4,000/month currently to around $1,500-$2,000/month over the next five years.
- Strategic focus: Stakeholders should prioritize biosimilar development, patent litigation, and expanding indications.
- Emerging opportunities: Entry into new markets, formulations, and combination regimens could mitigate declining prices.
- Risk management: Price erosion, regulatory changes, and competitive innovations remain primary risks.
FAQs
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What is the current wholesale price of Sutent (NDC 00187-0653)?
Currently, the average wholesale price (AWP) for generic formulations ranges between $2,500 and $4,000 per month. The branded Sutent maintains higher prices but has experienced significant declines since patent expiration.
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How does patent expiration affect Sutent’s market and pricing?
Patent expiration introduces biosimilars and generics, increasing market competition and exerting downward pressure on prices, potentially reducing costs by 50% or more in the medium term.
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What are the prospects for biosimilar versions of Sutent?
Biosimilars are expected to enter the market within the next 1-3 years, offering competitive pricing possibly as low as $1,000 to $1,500 per month, further decreasing the brand’s market share and pricing power.
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Are there upcoming regulatory or patent challenges for Sutent?
Patent litigation and regulatory approvals for biosimilars are ongoing; successful patent defenses can extend exclusivity, while approvals for biosimilars could accelerate price declines.
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What strategies can stakeholders adopt to navigate the evolving market?
Companies should invest in biosimilar development, optimize formulary placements, and explore novel indications or combination therapies to maintain market relevance amid pricing pressures.
References
[1] FDA. (2006). Sunitinib Malate Approval.
[2] EvaluatePharma. (2022). Oncology Market Data.
[3] IQVIA. (2023). Pharmaceutical Market Trends.
[4] Congressional Budget Office. (2020). Impact of Patent Expirations on Drug Prices.
[5] MarketsandMarkets. (2023). Biosimilars Market Analysis.
