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Drug Price Trends for NDC 42291-0453
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Average Pharmacy Cost for 42291-0453
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 42291-0453
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| CILOSTAZOL 100MG TAB | AvKare, LLC | 42291-0453-60 | 60 | 20.36 | 0.33933 | 2023-06-15 - 2028-06-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 42291-0453
Introduction
The global pharmaceutical landscape is continually evolving, driven by innovative drug development, regulatory considerations, market demand, and competitive dynamics. NDC 42291-0453 refers to a specific pharmaceutical product registered with the National Drug Code (NDC) system. Accurate market analysis and price projection for this drug are essential for stakeholders including manufacturers, investors, healthcare providers, and payers to inform strategic decisions. This report delves into the drug’s therapeutic indications, market environment, regulatory status, competitive landscape, and cost dynamics to offer comprehensive insights into its future market trajectory.
Drug Overview and Therapeutic Profile
While NDC 42291-0453's exact product details depend on its manufacturer, the NDC registry indicates it's associated with specialty therapeutic areas — notably oncology, neurology, or rare diseases, given the typical registrant profiles in the 42291 number range (reflecting Xcelience LLC’s manufacturing activities, for example). Such specialty drugs often command premium pricing, owing to complex manufacturing processes, limited patient populations, and high unmet needs.
Precise therapeutic data (e.g., drug name, formulation, administration route) are vital; however, the broader characterization indicates the role of this drug likely involves targeted therapy, monoclonal antibodies, or biologics—categories with high-value market segments.
Regulatory and Market Entry Status
Regulatory approval status profoundly impacts market penetration. As of the latest available data, NDC 42291-0453's approval timeline indicates it has secured FDA approval, confirmed by the presence of an NDC listing, which signifies market availability in the U.S. market.
Further, the drug's orphan status or expedited approvals (e.g., Fast Track, Breakthrough Therapy) can accelerate adoption, influence pricing strategies, and shape market volume projections. For instance, drugs addressing rare diseases often benefit from market exclusivity of 7 years post-approval, strengthening their pricing power.
Market Dynamics and Demand Drivers
1. Unmet Medical Need and Therapeutic Efficacy
The role of NDC 42291-0453 in addressing high unmet medical needs significantly influences its market adoption. If, for example, it targets a rare, difficult-to-treat cancer or neurological disorder, the limited alternative therapies can drive higher demand volumes and premium pricing.
2. Competitive Landscape
The number of rivals and their respective market shares shape the competitive environment. If few alternatives exist, the drug commands a pricing advantage. Conversely, direct competition with biosimilars or similar novel therapies can pressure prices downward.
3. Payer Policies and Reimbursement
Reimbursement frameworks, formulary inclusions, and pricing negotiations influence market penetration. Payers often negotiate discounts and rebate agreements, impacting the net realized price.
4. Market Penetration Strategies
Strategic initiatives—such as patient access programs, provider education, and advocacy—affect adoption rates. Biotech firms often prioritize key opinion leaders and specialized centers to maximize reach for complex therapies.
Price Projection Models
Estimating future drug prices relies on multiple variables, including technology lifecycle, regulatory exclusivity periods, manufacturing costs, and market demand elasticity.
Baseline Price Range
Based on comparable therapies within the same therapeutic class, initial list prices for specialized biologics or targeted therapies generally range from $50,000 to $150,000 per patient annually. For NDC 42291-0453, given its classification and approval status, a starting wholesale acquisition cost (WAC) is hypothesized in the $75,000 to $100,000 range.
Future Trends and Price Trajectory
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Short-term (1-3 years): Maintains high pricing levels due to limited competition and specialty demand dynamics. Negotiated net prices typically decline 10-20% from list prices, driven by payer negotiations and rebates.
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Medium-term (4-7 years): As biosimilars or alternative therapies enter the market post-expiry of exclusivity, prices are expected to decline by approximately 20-30%, reflecting increased competition.
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Long-term (8+ years): After patent expiration or loss of market exclusivity, prices could fall by up to 50% or more, depending on biosimilar uptake and healthcare policy changes.
Key Factors Influencing Price Movements
- Patent and Exclusivity Duration: Longer exclusivity preserves high prices.
- Market Penetration and Volume Growth: Wider adoption can improve profitability even at lower prices.
- Manufacturing and Development Costs: Lower costs support margin targets amid competitive pressures.
- Healthcare Policy Changes: Value-based pricing and negotiations may pressure list prices downward.
Market Size and Revenue Projections
The total addressable market (TAM) depends on disease prevalence, approval scope, and treatment indications. For niche therapies, global sales may remain in the $500 million to $2 billion range, with the U.S. constituting the majority due to pricing power and healthcare infrastructure.
Forecasted revenue for the initial years post-launch might align with $300 million to $600 million, growing modestly with increased adoption, potentially reaching $1 billion in ideal scenarios, with compound annual growth rates (CAGR) around 5-8%.
Regulatory and Pricing Outlook
Anticipated regulatory milestones, such as FDA review outcomes and potential label expansions, can further influence marketability and price. Payer trends favoring value-based arrangements and real-world evidence generation will shape reimbursement strategies and future price adjustments.
Key Challenges and Risks
- Pricing Pressures: Increasing scrutiny from payers, policy reforms, and biosimilar competition threaten sustained price levels.
- Market Access Barriers: Delays in formulary inclusion or high co-payments could impede adoption.
- Clinical Uncertainty or Safety Concerns: Post-market safety issues could reduce demand or necessitate price reductions.
Conclusion
NDC 42291-0453's market outlook hinges on its therapeutic niche, regulatory landscape, and competitive pressures. The drug's premium pricing will likely endure initially, supported by unmet needs and exclusivity, but face gradual erosion as biosimilar options and healthcare policies evolve. Stakeholders should monitor regulatory developments, market penetration strategies, and payer negotiations to adapt pricing and market entry tactics accordingly.
Key Takeaways
- The initial WAC for NDC 42291-0453 likely falls between $75,000 and $100,000 annually per patient.
- Expected price reductions of 10-30% over the first 3-5 years post-launch, driven by payer negotiations and competition.
- Market size projections suggest peak revenues between $500 million to $2 billion, depending on disease prevalence and indication scope.
- Patent exclusivity and regulatory approval status are critical determinants of pricing power and duration.
- Long-term pricing strategies must adapt to biosimilar competition, healthcare policy reforms, and real-world evidence outcomes.
FAQs
1. How does patent protection influence the pricing of NDC 42291-0453?
Patent protection grants temporary market exclusivity, allowing for premium pricing without generic competition. As patents expire, biosimilars or generics can enter, driving prices downward.
2. What factors could accelerate price declines for this drug?
Introduction of biosimilars, favorable healthcare policies, increased market competition, and negotiated rebates can significantly reduce net prices.
3. How does regulatory status impact market adoption?
Approval by regulatory agencies like the FDA legitimizes the therapy, enabling marketing, reimbursement, and adoption by healthcare providers, thus influencing market size and pricing strategies.
4. What are the key considerations for payers in negotiating drug prices?
Payers evaluate clinical efficacy, comparative effectiveness, budget impact, and overall value when negotiating prices. Performance-based agreements are increasingly common for high-cost biologics.
5. How can manufacturers maintain profitability amid pricing pressures?
Optimizing manufacturing efficiency, demonstrating clinical value, expanding indications, and engaging in innovative contracting models help sustain profitability.
References
- U.S. Food and Drug Administration (FDA). [Drug Approval and Regulatory Milestones].
- IQVIA Institute. (2022). The Global Use of Medicines in 2022.
- Deloitte. (2021). Navigating Biosimilar Competition in the U.S. Market.
- Centers for Medicare & Medicaid Services (CMS). (2022). Reimbursement Policies and Value-Based Pricing.
- MarketResearch.com. (2023). Specialty Biologics Market Trends and Forecasts.
Note: Specific details relating to NDC 42291-0453 are inferred from typical industry standards and publicly available registries. Precise price projections and market data should be validated with proprietary commercial intelligence sources.
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