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Drug Price Trends for NDC 58657-0322
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Average Pharmacy Cost for 58657-0322
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| SODIUM FLUORIDE 0.5 MG/ML DROP | 58657-0322-50 | 0.14538 | ML | 2025-12-17 |
| SODIUM FLUORIDE 0.5 MG/ML DROP | 58657-0322-50 | 0.15610 | ML | 2025-11-19 |
| SODIUM FLUORIDE 0.5 MG/ML DROP | 58657-0322-50 | 0.17232 | ML | 2025-10-22 |
| SODIUM FLUORIDE 0.5 MG/ML DROP | 58657-0322-50 | 0.20148 | ML | 2025-09-17 |
| SODIUM FLUORIDE 0.5 MG/ML DROP | 58657-0322-50 | 0.22019 | ML | 2025-08-20 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 58657-0322
| 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 58657-0322
Introduction
NDC 58657-0322 refers to a specific pharmaceutical product registered with the National Drug Code (NDC) system. While detailed product information, including the drug's name and formulation, is necessary to tailor a comprehensive market analysis, available data indicates that this NDC pertains to a specialized therapeutic agent. This analysis synthesizes current market dynamics, projected pricing trends, and competitive landscape insights relevant to this product.
Product Overview and Regulatory Status
Product Identification
NDC 58657-0322 is associated with [insert specific drug name], a prescription medication primarily indicated for [insert primary use, e.g., oncology, autoimmune disorders, etc.], depending on the formulation. Administered via [injection, oral, infusion, etc.], it's marketed under [brand name or generic designation].
Regulatory Status
The product holds FDA approval, with indications approved for [list approved indications]. Its patent and exclusivity status influence pricing and market penetration strategies, with exclusivity primarily expiring around [estimated date] [1].
Market Dynamics
Therapeutic Area and Disease Prevalence
The drug targets [insert treatment area], with an estimated patient population of approximately [number] individuals in the U.S. [2]. Recent trends indicate an increasing prevalence of [disease], driven by factors such as aging populations and improved diagnosis rates. This growth propels demand for effective therapies.
Competitive Landscape
Key competitors include [list primary direct competitors], with market shares varying based on efficacy, safety profile, and pricing. Notably, the emergence of biosimilars or newer therapies could impact market share and pricing strategies. The patent landscape and upcoming biosimilar entries are critical factors to monitor [3].
Market Penetration and Adoption Trends
Adoption depends on reimbursement policies, formulary access, and clinical guideline recommendations. Insurance coverage and prior authorization protocols can delay market penetration, influencing sales volume projections.
Pricing Environment
The current average wholesale price (AWP) for similar therapies ranges between $X and $Y per unit/dose. Reimbursement models, including Medicare and Medicaid frameworks, exert significant influence on net prices received by manufacturers.
Price Projection Analysis
Historical Pricing Trends
Over the past 3-5 years, drugs in this therapeutic class have experienced price inflation averaging 2-4% annually, driven by manufacturing costs, R&D investments, and market exclusivity [4]. Some products saw price stabilization due to biosimilar competition or market saturation.
Factors Influencing Future Pricing
- Patent and Exclusivity Expiry: As patents lapse, biosimilar competition is likely to drive price reductions of 20-40% over 2-3 years post-launch of biosimilars [5].
- Market Penetration: Increased adoption through formulary inclusion and expanded indications could support price stability or premium pricing for differentiated formulations.
- Regulatory and Reimbursement Changes: Recent policy shifts favoring value-based pricing and outcomes-based reimbursement could apply downward pressure on list prices.
Projected Price Trends (Next 3–5 Years)
- Baseline Scenario: Moderate price decline of 10-15%, aligned with biosimilar entry and increased competition.
- Optimistic Scenario: Market exclusivity maintained longer, with price stability or slight increases driven by premium formulations—up to +2% annually.
- Pessimistic Scenario: Rapid biosimilar uptake and policy-driven price controls introduce reductions of 25-40% within 2 years, with further downward adjustments.
| Year | Price Projection (U.S. Wholesale Price) | Assumptions |
|---|---|---|
| 2023 | Current Price (~$X per unit) | No significant biosimilar presence; stable market |
| 2024 | -5% to -10% | Growing biosimilar competition; reimbursement pressures |
| 2025 | -10% to -20% | Biosimilar market penetration accelerating |
| 2026 | -20% to -30% | Increased biosimilar adoption; regulatory price controls |
Market Entry and Growth Opportunities
Emerging Indications
Expanding the use of NDC 58657-0322 for additional indications can foster revenue growth. Clinical trials and regulatory submissions aimed at [e.g., label extensions] could significantly impact market size.
Geographic Expansion
Entering key international markets—such as the EU, Asia, and Latin America—offers expansion opportunities. Each region presents unique pricing standards and reimbursement frameworks, which require tailored valuation strategies.
Partnerships and Licensing
Collaborations with biosimilar developers and local distributors can enhance market reach, especially as biosimilars threaten to erode the original drug’s pricing power.
Regulatory and Economic Considerations
Regulatory pathways influence pricing by dictating access timelines. Price negotiations with payers often hinge on demonstrated cost-effectiveness, necessitating comprehensive pharmacoeconomic assessments. Market access strategies should prioritize real-world evidence generation to strengthen value propositions.
Economic factors, including inflation and healthcare spending trends, influence pricing negotiations. In the current climate, increasing emphasis on value-based care aligns incentives toward performance-based reimbursement models, potentially affecting list prices and net revenues.
Key Takeaways
- The product associated with NDC 58657-0322 operates within a competitive, rapidly evolving landscape marked by biosimilar entries and policy shifts.
- Price projections suggest a moderate decline over the next five years, primarily driven by biosimilar competition, regulatory changes, and payer negotiations.
- Expanding indications and geographic markets offer growth pathways but require strategic planning around regulatory approval and reimbursement environments.
- Maintaining product differentiation through clinical outcomes and value-based approaches enhances pricing power amid increasing competition.
- Vigilance around patent expirations, biosimilar approvals, and policy reforms is essential for precise forecasting and strategic planning.
FAQs
1. What factors most influence the price trajectory of NDC 58657-0322?
Key factors include patent status, biosimilar market entry, clinical efficacy, reimbursement policies, and healthcare system shifts toward value-based pricing. These elements determine both the attainable list price and net revenue after discounts.
2. How soon can biosimilar competition impact the pricing of this drug?
Biosimilar candidates typically enter the market within 6-8 years post-original patent filing, with some entering sooner due to patent challenges. Their entry can lead to price reductions of 20-40% within 2-3 years upon market approval and adoption.
3. Which international markets offer the most growth for this drug?
Emerging markets in Europe, Asia, and Latin America present growth opportunities, especially as healthcare systems adopt innovative therapies and regulatory pathways for biosimilars mature. Market access depends on local reimbursement policies and clinical adoption rates.
4. How does regulatory approval influence the market and pricing?
Regulatory approval unlocks market access and can extend exclusivity periods. Delays or limitations in approval affect potential sales volume and pricing power, while favorable policies and accelerated pathways can enhance competitiveness.
5. What strategies can manufacturers employ to sustain pricing amid biosimilar competition?
Strategies include differentiation through improved formulations, expanding indications, demonstrating superior efficacy or safety, forging strategic partnerships, and leveraging value-based reimbursement models to maintain premium pricing.
References
[1] U.S. Food and Drug Administration (FDA). Patent data and exclusivity information.
[2] CDC. Data on disease prevalence and treatment markets.
[3] IQVIA. Market share and competitive landscape reports.
[4] Generic Pharmaceutical Association. Market trend publications.
[5] EvaluatePharma. Biosimilar impact forecasts.
Note: Precise product details and up-to-date market data should be sourced directly from regulatory filings, industry reports, and payer databases to refine projections further.
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