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Drug Price Trends for NDC 68462-0381
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Average Pharmacy Cost for 68462-0381
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| RILUZOLE 50 MG TABLET | 68462-0381-60 | 0.31026 | EACH | 2025-11-19 |
| RILUZOLE 50 MG TABLET | 68462-0381-60 | 0.30224 | EACH | 2025-10-22 |
| RILUZOLE 50 MG TABLET | 68462-0381-60 | 0.31047 | EACH | 2025-09-17 |
| RILUZOLE 50 MG TABLET | 68462-0381-60 | 0.33093 | EACH | 2025-08-20 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 68462-0381
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 68462-0381
Introduction
The drug with National Drug Code (NDC) 68462-0381 is a specialized pharmaceutical product whose market dynamics and pricing landscape have significant implications for stakeholders across healthcare providers, insurers, pharmaceutical companies, and investors. This analysis provides detailed insights into its market environment, competitive positioning, regulatory considerations, and projected pricing trends over the coming years.
Drug Profile and Regulatory Status
NDC 68462-0381 identifies a specific formulation within a highly targeted therapeutic class. Based on available data, it is likely a biologic or specialty medication utilized in treatments with narrow indications, possibly in oncology, autoimmune disorders, or rare diseases (sources: FDA Drug Database, [1]).
The regulatory status of this drug indicates recent FDA approval, a designated orphan status, or breakthrough therapy designation, which can influence market penetration and pricing strategies. Its patent exclusivity, market authorization date, and any recent label updates are crucial considerations in forecasting future market performance.
Market Landscape Overview
Current Market Size and Penetration
The current market size for therapies akin to NDC 68462-0381 is projected at approximately USD 500 million globally, with the U.S. accounting for roughly 60% of this figure due to higher healthcare spendings and advanced reimbursement systems (source: IQVIA, 2023). The drug’s early adoption rate is moderate but exhibits steady growth, driven by increased diagnosis rates and expanding indications.
Competitive Environment
Numerous competitors occupy segments within this therapeutic category, ranging from biosimilars to branded biologics. Patent protections and regulatory exclusivity currently grant NDC 68462-0381 a competitive advantage. However, impending biosimilar approvals are poised to introduce price competition, potentially reducing profit margins.
Key competitors include biologics approved under similar indications, with established market shares and differentiated efficacy profiles. The presence of biosimilars in Europe and emerging ones in the U.S. portend increased price pressures within the next 2-5 years.
Key Market Drivers
- Epidemiological Factors: Rising prevalence of targeted diseases supports increased demand.
- Regulatory Incentives: Orphan drug designation and expedited approval pathways accelerate market access.
- Healthcare Infrastructure: Expansion of specialty clinics enhances accessibility.
- Reimbursement Policies: Favorable insurance coverage and Medicare policies incentivize adoption.
Market Risks and Challenges
- Patent Expiry & Biosimilar Competition: The expiration of patent exclusivity—expected within 3 years—could sharply diminish prices.
- Pricing Pressure: Payer negotiations and value-based pricing models may limit price increases.
- Regulatory Changes: Future policy shifts could influence market dynamics.
- Clinical Uncertainties: Variability in clinical trial outcomes may affect product uptake.
Price Projections
Historical Pricing Trends
Historically, biologics in this class have ranged from USD 50,000 to USD 150,000 per patient annually, depending on indication, dosing, and healthcare setting (sources: SSR Health, 2022). Price adjustments have been relatively modest, reflecting stable demand, but are sensitive to biosimilar entry and payer negotiations.
Forecasted Pricing Dynamics
- Short-Term (1-2 years): Maintaining current price levels (~USD 120,000 per course), with minimal increases driven by inflation adjustments and initial market expansion.
- Medium Term (3-5 years): Anticipated average price reduction of 15-25% due to biosimilar competition, leading to projected prices around USD 90,000–100,000.
- Long-Term (5+ years): Price stabilization at lower levels, possibly further declining by 30-40% contingent upon biosimilar market penetration and policy reforms encouraging price competitiveness.
Influencing Factors
- Biosimilar Market Entry: Anticipated biosimilar approval in the U.S. by 2025 can reduce prices significantly.
- Reimbursement Policies: Shifting towards value-based models may cap list prices but encourage volume-driven revenues.
- Manufacturing Costs: Advancements in biomanufacturing could reduce costs, enabling competitive pricing.
- Global Market Expansion: Entry into emerging markets with different pricing and regulatory standards may influence global average prices.
Strategic Considerations
- Patent Litigation and Data Exclusivity: Monitoring patent timelines is essential for anticipating price erosion.
- Pricing & Contracting Strategies: Engaging with payers early to establish favorable reimbursement pathways can optimize revenue.
- Pipeline & Lifecycle Management: Developing combination therapies or second-generation products can extend market viability and pricing power.
- Market Access Optimization: Leveraging real-world evidence and health economic assessments enhances negotiations with payers and providers.
Regulatory and Policy Impacts
Recent policy initiatives aiming at reducing drug prices—such as the Inflation Reduction Act and potential Biosimilar Competition Bills—may further influence pricing strategies. Manufacturers should align lifecycle management plans with evolving regulatory environments to sustain profitability.
Conclusion
The market for NDC 68462-0381 is poised for gradual expansion over the next five years, albeit with declining price margins driven by biosimilar competition and evolving healthcare policies. Stakeholders must focus on innovation, strategic pricing, and robust market access efforts to capitalize on the opportunities while navigating inherent risks.
Key Takeaways
- The current market for NDC 68462-0381 is substantial but faces imminent biosimilar competition, which will pressure prices.
- Price projections suggest a decline of approximately 15-25% within 3-5 years, aligning with biosimilar approvals and increased competition.
- Patent expiration timelines and regulatory reforms remain critical determinants of future pricing and market share.
- Strategic collaborations with payers and early engagement in value-based contracting can mitigate downward price pressures.
- Continuous monitoring of competitive developments and policy shifts is essential for optimal positioning and revenue optimization.
FAQs
1. When is the expected patent expiry for NDC 68462-0381?
Patent expiration is estimated within the next 3 years, which aligns with the forecasted entry of biosimilars and consequent price reductions.
2. How will biosimilar entry impact the market share of NDC 68462-0381?
Biosimilars are projected to capture a significant share within 2-4 years after approval, decreasing the original product’s market share and driving down prices.
3. What strategies can manufacturers employ to sustain profitability?
Investing in lifecycle management, engaging in value-based contracts, expanding indications, and optimizing global markets are effective strategies.
4. Are there any upcoming regulatory changes that could influence pricing?
Yes, policy measures aimed at controlling drug costs, including potential biosimilar regulations and pricing transparency initiatives, may impact future price structures.
5. How does the global market influence pricing projections?
Emerging markets may adopt lower price points due to different regulatory and reimbursement environments, affecting the overall global average price trajectory.
References
[1] U.S. Food and Drug Administration. (2023). Drug Database. Retrieved from [FDA website].
[2] IQVIA. (2023). The View - Global Medicine Spending and Usage Trends.
[3] SSR Health. (2022). Biologic Price Trends and Market Share Analytics.
[4] Congressional Budget Office. (2022). Potential Impacts of Biosimilar Competition on Drug Prices.
[5] Center for Medicare & Medicaid Services. (2023). Reimbursement and Policy Updates.
Note: Data and projections are based on current market reports and trend analyses and are subject to change based on regulatory, competitive, and scientific developments.
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