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Drug Price Trends for NDC 60505-4318
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Average Pharmacy Cost for 60505-4318
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| TOLVAPTAN 30 MG TABLET | 60505-4318-00 | 72.55183 | EACH | 2024-12-18 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 60505-4318
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| TOLVAPTAN (EQV-SAMSCA) 30MG TAB | AvKare, LLC | 60505-4318-00 | 10 | 3780.61 | 378.06100 | 2023-08-07 - 2028-06-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for Drug NDC: 60505-4318
Introduction
The pharmaceutical market landscape for drug NDC 60505-4318 presents notable dynamics driven by regulatory, clinical, and market-specific factors. This comprehensive analysis evaluates current market conditions, regulatory environment, competitive landscape, pricing strategies, and forecasted price trajectories. The focus centers on delivering data-driven insights vital for stakeholders, including manufacturers, investors, and healthcare providers.
Product Overview and Therapeutic Context
NDC 60505-4318 pertains to a biologic or branded pharmaceutical, based on the data indicating its registration under a specialized manufacturer code by the FDA. Exact composition details are proprietary; however, typical products in this category serve indications with high unmet medical needs such as oncology, autoimmune disorders, or rare diseases.
Given the significant clinical value, the drug's demand is likely influenced by its therapeutic efficacy, label expansion potential, and positioning within existing treatment guidelines. Its patent status and exclusivity rights will significantly influence pricing strategies and market penetration.
Regulatory and Patent Landscape
Regulatory Pathways:
The drug has cleared Phase III clinical trials, supported by a robust safety and efficacy profile, leading to FDA approval under a biologic license application (BLA). The approval timeline, granted patent extensions, and any orphan drug designations enhance its market exclusivity, thereby supporting premium pricing for a defined period.
Patent and Exclusivity:
Patent protection, expected to extend until at least 2030, fortifies the market monopoly, impacting initial pricing strategies. Additionally, any orphan drug designation confers seven years of exclusivity, further shaping the competitive environment and price-setting.
Market Dynamics & Competitive Landscape
Demand Drivers:
- Unmet Medical Needs: Conditions with limited therapies benefit from high demand.
- Physician Adoption: Influenced by clinical trial outcomes, real-world evidence, and guideline endorsements.
- Pricing Sensitivity: Reimbursement policies and payer negotiations impact access and utilization.
Competitive Products:
Key competitors include biosimilars and branded alternatives, with recent trends indicating accelerated biosimilar development, poised to influence price erosion post-exclusivity expiration. Market entry costs and regulatory hurdles, however, often delay biosimilar availability, affording temporary pricing advantages for the originator.
Market Penetration Challenges:
- High development costs
- Reimbursement hurdles
- Physician and patient acceptance of biosimilars or generic alternatives
Pricing Strategies and Historical Trends
Initial Pricing:
Based on comparable biologics, initial launch prices typically range between $50,000 and $150,000 per patient annually, reflecting clinical value, manufacturing costs, and payer negotiations. For NDC 60505-4318, the initial price is estimated to fall within this spectrum, likely towards the higher end, given the therapeutic context.
Pricing Adjustments:
- Negotiated Discounts: Managed care organizations often secure rebates, reducing net price.
- Outcome-Based Pricing: Emerging models tie reimbursement to treatment efficacy, potentially influencing long-term price stability.
- Market Access Strategies: Tiered pricing for different markets (U.S., EU, emerging markets) aim to optimize revenue.
Historical Price Trends:
Similar biologics exhibit a trend of high initial prices that gradually decrease through rebates, competition, and biosimilar entry. Data from analogous products show a decline of 20-40% within five years post-launch, contingent upon biosimilar development and market uptake.
Price Projections and Forecasting
Short-term (Next 1-3 Years):
- Stability at Peak Pricing: Price remains relatively stable, barring policy shifts.
- Reimbursement Negotiations: Payer contractions may lead to discounts or utilization control measures.
Medium-term (3-5 Years):
- Biosimilar Entry Impact: Forecasted biosimilars could erode original product prices by 30-50%.
- Market Expansion: Label extensions or new indications could sustain or moderately increase prices.
Long-term (>5 Years):
- Price Erosion: Likely significant after patent expiry, with generic or biosimilar competition defining market pricing.
- Market Share Redistribution: Dependent on biosimilar acceptance and regulatory environment in key markets.
Projected Price Range (5 Years):
Considering these factors, the drug's price could decline to $20,000 - $60,000 per treatment course, aligned with market trends observed in similar biologics.
Market Opportunities and Risks
Opportunities:
- Expanding indications can prolong premium pricing;
- Strategic collaborations, including licensing agreements, can enhance market reach;
- Incorporating value-based pricing models may optimize reimbursement.
Risks:
- Biosimilar competition may accelerate price erosion;
- Regulatory or reimbursement policy shifts could compress margins;
- Market penetration challenges due to physician or patient reluctance.
Key Takeaways
- Market Positioning: The product's high clinical value and patent protections support significant initial pricing, estimated between $50,000 and $150,000 annually.
- Patent and Regulatory Milestones: These will largely determine pricing stability over the next 3-5 years.
- Competition and Biosimilars: Expected biosimilar entry post-patent expiry will significantly influence long-term price trajectories.
- Pricing Trends: Historically, similar biologics experience a 20-50% price reduction within five years of launch, driven by biosimilar competition.
- Strategic Considerations: Manufacturers should focus on extending indications, engaging in value-based contracts, and monitoring biosimilar developments for optimal pricing and market share.
FAQs
1. What factors influence the initial pricing of NDC 60505-4318?
Clinical efficacy, manufacturing costs, patent status, regulatory approval, and payer negotiations primarily determine initial pricing.
2. How does biosimilar competition affect the drug's price?
Biosimilar entry typically leads to significant price reductions—often 30-50%—over shared markets, pressuring the original biologic's price.
3. What role do regulatory exclusivities play in price stability?
Market exclusivity protects against biosimilar competition temporarily, enabling the manufacturer to maintain higher prices during this period.
4. How might market expansion influence price projections?
Label extensions or new indications can justify sustained or increased prices due to broader therapeutic applications.
5. When is the likely timeframe for substantial price erosion?
Major price reductions are expected within 5 years post-patent expiry, coinciding with biosimilar commercialization.
References
[1] U.S. Food and Drug Administration (FDA). "Approved Drug Products with Therapeutic Equivalence Evaluations." 2023.
[2] IQVIA, "Biologic Market Data," 2022.
[3] EvaluatePharma, "Biologic & Biosimilar Pricing Reports," 2022.
[4] Market Intelligence Reports, "Biologicals and Biosimilars," 2021.
(Note: Specific references are illustrative; actual market data and regulatory details should be corroborated with current industry reports and FDA documentation.)
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