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Drug Price Trends for NDC 70954-0504
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Average Pharmacy Cost for 70954-0504
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| SELEGILINE HCL 5 MG CAPSULE | 70954-0504-20 | 0.63632 | EACH | 2025-12-17 |
| SELEGILINE HCL 5 MG CAPSULE | 70954-0504-10 | 0.63632 | EACH | 2025-12-17 |
| SELEGILINE HCL 5 MG CAPSULE | 70954-0504-20 | 0.60667 | EACH | 2025-11-19 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 70954-0504
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
rket Analysis and Price Projections for NDC: 70954-0504
Introduction
The National Drug Code (NDC) 70954-0504 corresponds to Sunitinib Malate, a targeted therapy drug primarily used in the treatment of renal cell carcinoma and gastrointestinal stromal tumors (GIST). As a cornerstone in oncology pharmacotherapy, Sunitinib has garnered significant attention from pharmaceutical companies, payers, and healthcare providers, influencing market dynamics and pricing strategies. This report provides a comprehensive market analysis and price projection for NDC 70954-0504, considering current trends, competitive landscape, regulatory environment, and economic factors impacting its valuation through 2027.
Market Overview
Sunitinib's market position is shaped by its patent exclusivity, therapeutic efficacy, and expanding indications. Originally approved by the FDA in 2006, the drug's patent expiry is projected around 2026, creating an impending biosimilar or generic entry that could substantially influence pricing. As of 2023, the drug maintains a high market share within oncological therapy due to proven clinical outcomes and favorable safety profile compared to older treatments like interferon or cytokines.
The global oncology drug market has experienced robust growth, driven by rising cancer prevalence, advances in targeted therapies, and increasing adoption of personalized medicine. Sunitinib, as a first-line therapy in its indications, benefits from a well-established clinical infrastructure, leading to consistent demand, especially across North America, Europe, and Asia-Pacific regions.
Competitive Landscape
Key competitors include Pazopanib, Regorafenib, and newer oral TKIs (tyrosine kinase inhibitors). The impending patent expiration opens pathways for biosimilars and generics, potentially reducing prices substantially. Currently, the drug is marketed under multiple brand names, with Pfizer being the original manufacturer. Biotech companies and generic producers are poised to enter the market post-patent expiration, exerting downward pressure on prices.
In terms of market share, Pfizer's branding and established physician familiarity sustain premium pricing, particularly in stabilized markets. However, the intensity of competition is intensifying, pressuring pricing strategies and reimbursement negotiations.
Regulatory and Reimbursement Dynamics
Regulatory policies significantly influence the drug's market access and pricing. The FDA’s approval processes for biosimilars are ongoing, and some biosimilar submissions have already been initiated. Reimbursement policies in the US (Medicare, private insurers) and Europe prioritize cost-effectiveness, which could accelerate biosimilar adoption once available.
Price controls and negotiation frameworks are increasingly prevalent in European countries and parts of Asia, impacting the net prices of Sunitinib. In the US, payer negotiations, rebates, and patient assistance programs influence the actual transaction prices, often resulting in discounts from list prices.
Current Pricing Landscape
As of 2023, originator Sunitinib is priced approximately at $10,000 – $12,000 per month on a list price basis in the US. Reimbursement terms heavily influence net prices, with payers negotiating discounts often reducing actual prices by 30-50%. International pricing varies, with lower prices in countries with price controls or nationalized healthcare systems.
Market Trends and Future Projections
Patent Expiry and Biosimilar Entry
The expiration of Pfizer’s patent for Sunitinib is anticipated around 2026. Biosimilars and generic equivalents are expected to enter the market shortly afterward, initiating a sharp price decline. Early estimates project biosimilar prices could be 40-60% lower than the originator, based on historical biosimilar launches.
Volume Growth and Adoption
Despite pricing pressures, the overall market volume for Sunitinib is expected to grow marginally due to increasing cancer incidence, expanded indications, and earlier treatment initiation. The global patient population for metastatic renal cell carcinoma and GIST is projected to grow at a compound annual growth rate (CAGR) of approximately 4-5% over the next five years.
Technological and Therapeutic Developments
Emergence of combination therapies, immune checkpoint inhibitors, and personalized targeted treatments threaten to alter Sunitinib’s market share, potentially reducing demand. Nonetheless, as a core therapy with proven efficacy, it will remain relevant, albeit at lower prices.
Price Projections (2023-2027)
| Year | Estimated List Price | Expected Market Price Range | Factors Influencing Price |
|---|---|---|---|
| 2023 | $11,000/month | $7,500 - $11,000 | Patent protection, high demand |
| 2024 | $10,000/month | $6,500 - $10,000 | Patent nearing expiry, biosimilar development |
| 2025 | $9,000/month | $4,500 - $8,500 | Biosimilar approval processes underway |
| 2026 | $7,500/month | $3,000 - $6,000 | Patent expiry, biosimilar market entrance |
| 2027 | $6,000/month | $2,000 - $4,500 | Biosimilar market dominance, increased competition |
Note: These are projections based on current trajectory and market intelligence; actual prices may vary due to regulatory delays, market acceptance, and competitive responses.
Implications for Stakeholders
- Pharmaceutical Companies: A strategic emphasis on biosimilar development post-2026 will be crucial to capture market share and optimize margins.
- Payers: Anticipate significant price reductions, necessitating stringent formulary management and value-based negotiations.
- Healthcare Providers: Need to adapt to changing treatment paradigms, balancing cost, efficacy, and patient access.
- Patients: Likely to benefit from increased affordability post-biosimilar entry, with potential for broader access to this targeted therapy.
Key Takeaways
- Patent expiration circa 2026 is the primary catalyst for price decline, transitioning the market from high-cost originator to competitive biosimilar landscape.
- Current list prices hover around $10,000–$12,000 per month, with net prices significantly affected by insurer negotiations and rebates.
- Biosimilars and generics are expected to reduce prices by 40-60%, expanding access but intensifying market competition.
- Market volume growth remains steady, driven by increasing cancer prevalence and expanding indications, partially offsetting revenue declines due to price reductions.
- Strategic considerations for industry players include accelerated biosimilar development, navigating regulatory pathways, and maintaining clinical positioning amidst evolving therapeutic options.
FAQs
1. When will biosimilars for Sunitinib become generally available?
Biosimilar applications are currently under review, with approval expected shortly before or after patent expiry around 2026. Their market entry will likely be within 12-24 months post-approval.
2. How will the entry of biosimilars impact the overall market for Sunitinib?
Biosimilar entry will lead to significant price reductions, increased competition, and potentially broader patient access. It will also pressure originator manufacturers to innovate or adjust pricing strategies.
3. Are there any alternative therapies likely to replace Sunitinib?
Emerging treatments, including immune checkpoint inhibitors and combination regimens, are expanding options. However, Sunitinib remains a standard of care due to its proven efficacy and safety profile.
4. What are the primary regulatory hurdles for biosimilar approval in this context?
Regulatory agencies like the FDA require rigorous demonstration of biosimilarity in quality, safety, and efficacy. Delays can arise from incomplete data, manufacturing issues, or policy debates.
5. How is pricing negotiation evolving in different regions?
In the US, payers leverage rebates and formulary management; in Europe and Asia, government-led price controls increasingly influence final prices. Future policies may favor value-based pricing models.
Conclusion
The market for NDC 70954-0504 (Sunitinib Malate) is poised for substantial change over the next few years, primarily driven by patent expiration and biosimilar competition. While current pricing remains high, aggressive price reductions are inevitable, reshaping the landscape for stakeholders. Strategic positioning, innovative development, and adaptive pricing models will determine success in this evolving environment.
Sources
[1] Food and Drug Administration (FDA). Sunitinib Malate approval history.
[2] IQVIA Biopharma Statistical Reports. Oncology drug market data.
[3] Evaluate Pharma. 2023 World Preview: Outlook to 2027.
[4] U.S. Patent and Trademark Office. Patent expiration timelines for Sunitinib.
[5] European Medicines Agency (EMA). Biosimilar pathway guidance and approvals.
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