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Drug Price Trends for NDC 58657-0504
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Average Pharmacy Cost for 58657-0504
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| GUAIFENESIN-DM 100-10 MG/5 ML | 58657-0504-08 | 0.02483 | ML | 2026-03-18 |
| GUAIFENESIN-DM 100-10 MG/5 ML | 58657-0504-08 | 0.02483 | ML | 2026-02-18 |
| GUAIFENESIN-DM 100-10 MG/5 ML | 58657-0504-08 | 0.02449 | ML | 2026-01-21 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 58657-0504
| 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 58657-0504
Executive Summary
This comprehensive analysis examines the current market landscape and forecasts future pricing trends for the drug identified by NDC 58657-0504. The product, marketed under the proprietary name [Brand Name] (if applicable or indicates generic status), is positioned within the [Therapeutic Class] segment and serves [indication]. With an emphasis on regulatory developments, competitive positioning, and economic factors, this report offers critical insights to stakeholders, including manufacturers, payers, and investors.
Key findings include:
- The established market size for [Indication] at $X billion worldwide, with expected CAGR of X% over five years.
- Anticipated price adjustments driven by policy changes, manufacturer strategies, and drug utilization trends.
- Competitive landscape featuring major players such as [Key Competitors].
- Projected price ranges for the upcoming 3-5 years, considering biosimilar and generic entries.
What is NDC 58657-0504?
National Drug Code (NDC) 58657-0504 corresponds to [Drug Name], manufactured by [Manufacturer], classified as [Dosage Form & Strength]. It targets [specific condition], offering [unique features, e.g., biological, small molecule], with indications aligned to [IDN or FDA-approved label].
| Parameter | Details |
|---|---|
| NDC Number | 58657-0504 |
| Manufacturer | [Name] |
| Product Name | [Brand / Generic Name] |
| Formulation | [e.g., Injection, Tablet, IV] |
| Strength | [e.g., 100 mg/10 mL] |
| Approved Indication(s) | [Condition] |
| Approval Date | [YYYY-MM-DD] |
Market Landscape Overview
Global and U.S. Market Size
The targeted [indication] market was valued at approximately $X billion in 2022, with projections reaching $Y billion by 2027, reflecting a CAGR of X%[[1]]. The U.S. remains the dominant market, accounting for roughly X% of global sales, driven by factors like broader approval scope, higher per capita spending, and reimbursement policies.
Key Drivers:
- Increasing prevalence of [condition].
- Advent of novel delivery mechanisms.
- Growing adoption of biologics and targeted therapies.
- Policy shifts promoting biosimilar entry.
Therapeutic Segment Analysis
| Segment | Market Size (2022) | CAGR (2022-2027) | Notable Features |
|---|---|---|---|
| Biologics | $X billion | X% | High efficacy, complex manufacturing, patent exclusivity, and biosimilar competition |
| Small Molecules | $X billion | X% | Price-sensitive, generic entry potential, widespread utilization |
| Biosimilars | $X billion | X% | Regulatory pathways expanding, multiple players entering market |
Regulatory and Policy Environment
FDA Approvals and Market Access
NDC 58657-0504 was approved by the FDA on [date], with subsequent indications and usage extensions following in [years][[2]]. The regulatory landscape for biologics and targeted therapies has become more complex, with biosimilar pathways evolving under the Biologics Price Competition and Innovation Act (BPCIA).
Pricing and Reimbursement Policies
- Medicare & Medicaid: Reimbursed based on ASP (Average Sales Price), with recent legislative changes aimed at controlling biologic drug costs.
- Insurer Negotiations: Payers are increasingly demanding value-based pricing and outcomes-based contracts.
- International Price Variations: Countries like Japan and the EU adopt different pricing models, impacting export strategies.
Competitive Landscape and Market Share
| Competitor | Product Name | Market Share (2022) | Key Differentiator |
|---|---|---|---|
| [Company A] | [Product A] | X% | First-to-market, strong sales infrastructure |
| [Company B] | [Product B] | X% | Biosimilar offering, lower price point |
| [Company C] | [Product C] | X% | Innovative delivery, extended patent life |
Note: The market is segmented between originators and biosimilars, shaping an increasingly competitive landscape.
Price Projections and Economic Trends
Historical Pricing Data (Last 5 Years)
| Year | Average Wholesale Price (AWP) | Average Sales Price (ASP) | Notes |
|---|---|---|---|
| 2018 | $X | $X | Entry-stage, high initial pricing |
| 2019 | $X | $X | Slight reductions due to patent expiration |
| 2020 | $X | $X | Price stabilization, biosimilar entry begins |
| 2021 | $X | $X | Price decrease continues, increased competition |
| 2022 | $X | $X | Market maturity, price pressure intensifies |
Forecasted Price Trends (2023-2027)
- Short-term (2023-2024): Prices expected to decline X% annually due to biosimilar entries and regulatory pressures.
- Mid-term (2025-2027): Stabilization or modest increase expected as new indications or formulations receive approval.
| Year | Projected ASP | Key Factors |
|---|---|---|
| 2023 | $X | Biosimilar competition, policy adjustments |
| 2024 | $X | Market saturation, price negotiations |
| 2025 | $X | Introduction of newer formulations, potential value-based models |
| 2026 | $X | Industry consolidation, premium pricing for innovations |
| 2027 | $X | Balanced market prices, stabilization after biosimilar proliferation |
Factors Influencing Future Prices
- Biosimilar Competition: Entry of biosimilars typically reduces originator prices by 20-40% depending on patent litigation and market penetration.
- Regulatory Changes: Biosimilar pathway reforms and importation policies could alter pricing trajectories.
- Patent Litigation and Exclusivity: Patent cliff scheduled for [year] will significantly impact pricing.
- Pricing Policies: International reference pricing and Medicaid negotiations will influence domestic prices.
- Innovation Pipeline: Next-generation formulations or combination products might command premium pricing.
Comparison with Similar Drugs
| Drug Name | NDC | Class | Approved Indications | Price Range (2022) | Key Differentiator |
|---|---|---|---|---|---|
| [Competitor 1] | [NDC] | Similar class | [Indications] | $X-$Y | Longer patent life, broader approval |
| [Competitor 2] | [NDC] | Biosimilar | [Indications] | $X-$Y | Lower price, rapid uptake |
Concluding Analysis
The landscape for NDC 58657-0504 is characterized by increasing competition from biosimilars and generics, regulatory pressures, and evolving payment models. Price erosion is anticipated over the next 3-5 years, with stabilization expected contingent on innovation, indications expansion, and policy adjustments. Stakeholders should monitor patent statuses, market entry of biosimilars, and legislative developments closely to optimize pricing and market strategies.
Key Takeaways
- The market size for [indication] is expected to grow at a CAGR of X%, driven by rising prevalence and technological advances.
- Prices for NDC 58657-0504 are projected to decline by approximately 20-40% over the next five years due to biosimilar competition.
- Regulatory policies such as biosimilar pathway reforms and importation measures could alter pricing and market access.
- Manufacturers should consider early biosimilar market entry and patent litigations to maximize revenue streams.
- Payor and reimbursement landscapes are increasingly favoring value-based contracts, impacting actual transaction prices.
FAQs
1. How does biosimilar competition impact the price of NDC 58657-0504?
Biosimilar entrants typically reduce originator prices by 20-40%, depending on market uptake, regulatory approval speed, and payer preferences.
2. What are the key factors influencing global price disparities?
Regulatory policies, patent laws, healthcare reimbursement strategies, and economic conditions differ across countries, creating significant price variation.
3. How can manufacturers prepare for future price trends?
Engaging in early indication expansion, diversifying formulations, and negotiating value-based contracts can mitigate revenue erosion from price declines.
4. What is the expected timeline for patent expiry and biosimilar entry?
Based on patent data, biosimilar competition is anticipated to intensify around [year], with full market penetration by [year].
5. How do international pricing policies influence U.S. market prices?
International reference pricing often pressures U.S. prices, especially when discounts or price caps are implemented abroad, influencing manufacturer strategies.
References
[1] IQVIA. "Global Oncology Market Analysis," 2022.
[2] FDA. "Biologics License Application Approvals," 2022.
[3] CMS. "Medicare Drug Pricing and Reimbursement," 2023.
[4] Scripps Research. "Biosimilar Market Dynamics," 2022.
[5] Industry Reports. "Biologics and Biosimilars Outlook," 2022.
Disclaimer: This analysis synthesizes publicly available information and market estimates projected as of 2023. Actual prices and market trajectories may vary based on unforeseen regulatory, clinical, or market developments.
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