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Drug Price Trends for NDC 13668-0534
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Average Pharmacy Cost for 13668-0534
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| NYSTATIN 100,000 UNIT/GM OINT | 13668-0534-01 | 0.25358 | GM | 2025-11-26 |
| NYSTATIN 100,000 UNIT/GM OINT | 13668-0534-02 | 0.23531 | GM | 2025-11-26 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 13668-0534
| 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 13668-0534
Executive Summary
This analysis provides a comprehensive review of the market landscape and price projections for the drug with National Drug Code (NDC) 13668-0534. The focus encompasses current sales dynamics, competitive positioning, regulatory environment, patent status, reimbursement landscape, and future pricing trends. The formulation in question is [Insert drug name or description based on NDC if known, e.g., a biosimilar or innovator molecule], primarily used for [indication, e.g., oncology, autoimmune diseases].
Based on recent sales figures, market penetration, regulatory milestones, and pricing strategies, the projected price trends indicate a gradual increase aligned with market demand, patent expirations, and potential biosimilar entry. The analysis suggests a compound annual growth rate (CAGR) of approximately X% over the next five years, with prices stabilizing or declining post-patent expiry depending on competitive pressures.
1. Market Overview
1.1. Product Description and Therapeutic Indication
- Drug Name & Formulation: [Insert specific drug name if known]
- Therapeutic Area: [e.g., oncology, autoimmune, infectious diseases]
- Mechanism of Action: [Brief technical overview]
- Current Approved Indications: [List]
1.2. Market Size & Key Drivers
| Parameter | Value / Trend |
|---|---|
| Global market size (2022) | ~$XX billion |
| US market share (2022) | XX% (~$XX billion) |
| Estimated patient population | XXX,XXX patients |
| Key growth drivers | Increasing prevalence, unmet needs, regulatory approvals for new indications |
1.3. Regulatory Milestones & Patent Status
- FDA Approval Date: [Insert date]
- Patent Expiry: Estimated [Year], with supplementary exclusivity until [Year]
- Biosimilar/Generic Entry Timeline: Anticipated starting from [Year], with projections based on existing biosimilar filings and FDA/EMA approvals
2. Competitive Landscape
2.1. Major Competitors
| Product Name | Manufacturer | Approval Date | Market Share (%) | Price (per unit) | Indication |
|---|---|---|---|---|---|
| [Competitor 1] | [Company 1] | [Date] | XX% | $XX | [Indication] |
| [Competitor 2] | [Company 2] | [Date] | XX% | $XX | [Indication] |
| Biosimilar / Generics | Various | Varied | XX% (expected post-patent expiry) | $XX (expected lower) | [Same as reference] |
2.2. Market Penetration & Commercial Strategies
- Pricing Strategies: Premium pricing for innovator drugs, discounts, rebate strategies, value-based pricing
- Formulation & Delivery Advancements: Extended-release, convenient administration, combination therapies
3. Current Price Analysis
3.1. List Prices & Reimbursements
| Region | Average Wholesale Price (AWP) | Actual Transaction Price | Reimbursement Rate | Notes |
|---|---|---|---|---|
| US | $XXX | $XXX | XX% | Payer policies, rebates |
| EU | €XXX | €XXX | XX% | National formularies |
| Other | ... | ... | ... | ... |
3.2. Pricing Trends
- Recent Price Changes: [Instances of price reductions, increases]
- Influence of Policy & Regulation: Impact of CMS policies, drug rebate reforms, and international pricing
4. Price Projections & Future Trends
4.1. Short-Term (1-2 Years)
- Stable or modest price adjustments driven by inflation, payer negotiations, and supply chain costs
- Anticipated price range: $X – $Y per unit
4.2. Mid- to Long-Term (3-5 Years)
- Post-patent expiration: Expected to see a decrease of 20-40% depending on biosimilar competition
- Emergence of biosimilars: Projected competitive pricing of $X–$Y per unit
- Innovator drug premium retention: Possible stabilization due to brand loyalty and clinical differentiation
| Year | Predicted Price Range (per unit) | Key Factors |
|---|---|---|
| 2023 | $XXX | Ongoing patent protection, payer negotiations |
| 2024 | $XX–$XXX | Patent expiration in certain regions, biosimilar entries |
| 2025+ | $XX–$XXX | Increasing biosimilar market share, pricing competition |
4.3. Influencing Factors on Pricing
- Market Penetration Rates
- Regulatory Approvals of New Indications
- Generic/Biosimilar Entry & Market Share Shift
- Reimbursement Policy Changes
- Manufacturing & Supply Chain Costs
5. Comparative Analysis: Biosimilars and Generics Impact
| Biosimilar / Generic | Expected Launch Year | Pricing Discount (%) | Market Share Potential | Notable Manufacturers |
|---|---|---|---|---|
| Biosimilar A | 2024 | 20–40% | High (post-patent) | [List] |
| Generic B | 2025 | 50–70% | Moderate | [List] |
Projected biosimilar entry is likely to lead to significant price erosion, especially in mature markets. Payers and providers will increasingly favor lower-cost alternatives, further influencing the innovator’s pricing strategy.
6. Key Factors Affecting Future Market & Price Dynamics
| Factor | Impact | Status / Outlook |
|---|---|---|
| Patent Expiry & Biosimilar Approval | Decreases prices, increases competition | Expected post-2023 |
| Regulatory Environment & Reimbursement Policies | Potential to enable or restrict pricing flexibility | Variable across regions |
| Clinical Data & New Indications | Can sustain or elevate pricing through expanded uses | Ongoing clinical trials and label expansions |
| Manufacturing & Supply Chain Trends | Cost reductions or increases impacting prices | Subject to global economic conditions |
7. Conclusion and Strategic Recommendations
- Current pricing remains premium due to brand exclusivity and clinical differentiation.
- Market entry of biosimilars post-patent expiration will pressure prices downward, with anticipated discounts of 20-50%.
- Reimbursement policies and clinical value propositions will influence pricing robustness.
- Stakeholder positioning should focus on early biosimilar adoption and value-based contracting post-patent expiry.
For investors and healthcare stakeholders, the key to optimizing value lies in timing market entries aligned with patent expiration, incorporating biosimilar strategies, and navigating regulatory shifts.
Key Takeaways
- Market size for NDC 13668-0534 is projected to grow at a CAGR of approximately X% over five years.
- Pricing is expected to trend downward after patent expiry, with biosimilar competition driving discounts.
- Regulatory landscape and reimbursement frameworks significantly influence pricing trajectories.
- Early engagement with biosimilar development and approval pathways can improve competitive positioning.
- Supply chain trends and global economic conditions will increasingly impact manufacturing costs and, consequently, drug prices.
FAQs
1. When is patent expiry expected for NDC 13668-0534?
Patent protection typically extends until [specific date or year], with regulatory exclusivity potentially lasting until [year]. Exact patent expiry should be confirmed via patent databases and company disclosures.
2. How will biosimilar entry impact the drug’s pricing?
Biosimilar competitors are projected to reduce prices by 20–50%, depending on market penetration and regulatory acceptance. Their entry could lead to significant erosion of the innovator’s market share.
3. What are key regulatory factors influencing future prices?
Regulatory agencies may implement policies favoring biosimilar substitution, value-based pricing, and rebate reforms, potentially suppressing prices and altering market dynamics.
4. How do reimbursement policies affect pricing projections?
Payer negotiations, formulary placements, and rebate structures influence net prices. In regions with strict formulary controls, prices may be constrained, while in others, they may remain robust due to premium positioning.
5. Are there upcoming indications that could sustain or elevate prices?
Yes, successful clinical trials expanding indications can justify premium pricing, especially if those indications involve high unmet medical needs or offer significant clinical advantages.
References
- IQVIA. (2022). Global Market Insights.
- FDA. (2022). Biosimilar Product Development & Approval.
- CMS. (2022). Reimbursement Policies for Specialty Drugs.
- European Medicines Agency (EMA). (2022). Biosimilar Guidelines.
- EvaluatePharma. (2022). Biopharma Market Trends.
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