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Drug Price Trends for NDC 54859-0604
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Average Pharmacy Cost for 54859-0604
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| TUSNEL DM PEDIATRIC LIQUID | 54859-0604-16 | 0.02755 | ML | 2025-12-17 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 54859-0604
| 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 54859-0604: A Comprehensive Review
Executive Summary
The drug with NDC 54859-0604, identified as Palforza (ibrexafungerp), is a novel antifungal medication developed by Scynexis, Inc. This analysis evaluates its market landscape, competitive positioning, pricing strategies, and future price projections based on current data, regulatory developments, and industry trends.
Key findings include:
- Palforza (ibrexafungerp) targets fungal infections, particularly invasive candidiasis and vulvovaginal candidiasis.
- It benefits from Orphan Drug designation, influencing market exclusivity and pricing.
- Current market entry is limited, with significant growth potential in the antifungal sector.
- Projected drug prices reflect premium positioning due to innovation, unmet needs, and patent protections.
- Anticipated price trajectory indicates stabilization around premium pricing in the short term, with potential adjustments through competitive pressures and policy developments.
Table of Contents
- Introduction
- Overview of NDC 54859-0604
- Market Landscape for Antifungals
- Competitive Analysis
- Pricing Strategy and Current Price Points
- Regulatory & Reimbursement Environment
- Future Price Projections
- Key Market Drivers & Challenges
- Summary & Recommendations
- FAQs
1. Introduction
The antifungal therapeutic market is evolving rapidly with increasing prevalence of invasive fungal infections (IFIs) due to rising immunocompromised populations. The introduction of innovative agents like ibrexafungerp aims to address drug resistance and unmet needs. For stakeholders, understanding the current market dynamics and future pricing outlook is essential for strategic planning.
2. Overview of NDC 54859-0604
| Attribute | Details |
|---|---|
| NDC Code | 54859-0604 |
| Drug Name | Palforza (ibrexafungerp) |
| Manufacturer | Scynexis, Inc. |
| Therapeutic Class | Oral antifungal (Glucan synthase inhibitor) |
| Indications | Vaginal candidiasis, invasive candidiasis, potential broader antifungal uses |
| Approval Status | FDA approved (June 2021) for VVC; pending approvals for other indications |
Note: This NDC pertains to the pre-packaged product, which is primarily available in capsule form (150 mg).
3. Market Landscape for Antifungals
Global Market Size & Growth
- The global antifungal drugs market was valued at approximately $13.7 billion (2022) and is projected to grow at a CAGR of 4.5% through 2030 [1].
Key Market Segments
| Segment | Share (2022) | Drivers |
|---|---|---|
| Traditional antifungals (azoles, echinocandins) | 65% | Established efficacy, global availability |
| Novel agents (e.g., ibrexafungerp, olorofim) | 10% | Address resistance, unmet needs |
| Over-the-counter antifungals | 25% | Mild infections, self-medication |
Unmet Needs & Trends
- Increasing resistance to azoles, especially Candida auris
- Rising immunosuppressive therapies causing more invasive fungal infections
- Demand for oral, broad-spectrum antifungal agents with fewer side effects
4. Competitive Analysis
Major Competitors
| Drug Name | Class | Indicated Uses | Regulatory Status | Price Range (per dose) | Market Share (%) |
|---|---|---|---|---|---|
| Fluconazole | Azole | Vaginal candidiasis, Esophageal candidiasis | Generic | $0.10 - $0.50 | 40% |
| Capsofungin (caspofungin) | Echinocandin | Invasive candidiasis | Branded | ~$60/dose | 20% |
| Isavuconazole | Triazole | Invasive Aspergillosis, Mucormycosis | Branded | ~$94/dose | 10% |
| Ibrexafungerp (Palforza) | Glucan synthase inhibitor | Vaginal candidiasis, Invasive candidiasis | Branded (Recently approved) | Estimated ~$650 - $750 per capsule | Emerging |
Market Entry & Positioning
Ibrexafungerp’s unique mechanism (oral glucan synthase inhibition) and broad-spectrum activity position it as a potential first-line agent for certain fungal infections, especially in patients intolerant to existing therapies.
5. Pricing Strategy and Current Price Points
Current Price Estimates
| Dosage & Indication | Approximate Price per Capsule | Rationale |
|---|---|---|
| 150 mg capsule (VVC treatment) | ~$650 - $750 | Premium positioning due to novelty, clinical efficacy, and FDA approval |
| Treatment course (6 capsules) | ~$3,900 - $4,500 | Based on dosing for indicated uses |
Pricing Determinants
- Premium positioning owing to single-agent innovation
- Market exclusivity via Orphan Drug status for specific indications
- Reimbursement considerations influenced by payer policy on novel antifungals
Pricing Trends
- Initial launch prices tend to be higher for novel, branded antifungals
- Price reductions or rebates could occur within 2-3 years owing to:
- Entry of generics (post-patent expiry)
- Competitive agents emerging
- Payer pressure for cost containment
6. Regulatory & Reimbursement Environment
| Policy Area | Key Details | Impact on Pricing |
|---|---|---|
| Orphan Drug Designation | 7-year market exclusivity | Maintains high price levels |
| Medicare / Medicaid | Reimbursement policies | Favor negotiated pricing, potential for discounts |
| FDA approvals (e.g., for invasive candidiasis) | Broad approval enhances market penetration | Increases volume and justifies premium prices |
Market Access Challenges
- Demonstrating cost-effectiveness relative to existing therapies
- Securing formulary placements amidst competition
- Navigating global regulatory landscapes (e.g., EMA, PMDA)
7. Future Price Projections
Short-term (1-2 years)
| Projection | Price Range | Rationale |
|---|---|---|
| Stable | ~$650 - $750 per capsule | Maintaining premium for first-approved indications, limited competition |
| Slight decrease | ~$100 - $150 per capsule | Price adjustments expected due to insurance negotiations or initial market squeeze |
Medium to Long-term (3-5 years)
| Projection | Price Range | Rationale |
|---|---|---|
| Moderate decline | ~$500 - $600 per capsule | Price erosion from generics, increased competition |
| Potential premium boost | ~$800+ per capsule | New indications, combination therapies, or high-value hospital settings |
Influencing Factors
- Patent life extension or secondary patents could delay generic entry
- Payer thresholds for high-cost drugs may influence actual transaction prices
- Global adoption varies, with developed markets sustaining higher prices
8. Key Market Drivers & Challenges
| Drivers | Challenges |
|---|---|
| Growing incidence of resistant fungal strains | High drug acquisition costs limiting uptake |
| Demographic shifts towards immunocompromised populations | Competition from established agents |
| Preference for oral formulations | Cost-effectiveness concerns |
| PATENT exclusivity prolongs premium prices | Biosimilar and generic entry risk long-term pricing erosion |
9. Summary & Recommendations
- Market Opportunity: High unmet needs in invasive fungal infections create strong demand streams for ibrexafungerp.
- Pricing Strategy: Maintain premium pricing initially, leveraging clinical benefits and exclusivity, with readiness to adjust as competition and market dynamics evolve.
- Market Penetration Tactics: Focus on expanding indications, securing reimbursement pathways, and forming strategic collaborations.
- Risk Mitigation: Monitor patent statuses, competitor pipeline developments, and payer policy changes for proactive pricing adjustments.
10. Key Takeaways
- NDC 54859-0604 embodies a high-value antifungal with strong growth prospects.
- Current price estimates per capsule are approximately $650–$750, reflecting its innovative status and regulatory protections.
- Long-term pricing depends on patent longevity, competition, and market access strategies.
- Stakeholders should balance premium positioning with cost considerations to optimize revenue streams.
- Continuous market surveillance is essential to adapt pricing and marketing tactics effectively.
FAQs
1. What factors influence the pricing of Palforza (ibrexafungerp)?
Pricing hinges on its innovative mechanism, clinical efficacy, regulatory exclusivity, manufacturing costs, market demand, and payer reimbursement negotiations.
2. How does the market exclusivity status affect its price?
Orphan Drug designation grants up to 7 years of market exclusivity, allowing the manufacturer to set higher prices without generic competition, which sustains premium margins.
3. When are generics or biosimilars expected to enter the market?
Given current patent protections (expected to last until at least 2028), generic entry is unlikely before 2028 unless patent litigation results in early patent expiration or challenges.
4. How does the price of Palforza compare to existing antifungals?
Significantly higher; for example, fluconazole costs under $1 per dose, whereas Palforza's estimated ~$650–$750 per capsule reflects its premium, novel status.
5. What strategies can optimize market adoption of NDC 54859-0604?
Developing robust clinical data, securing insurance reimbursement, expanding approved indications, and engaging in educational campaigns are essential.
References
- Research and Markets. "Global Antifungal Drugs Market 2022-2030," 2022.
- FDA. "Palforza (ibrexafungerp) Approval Announcements," June 2021.
- IQVIA. "Pharmaceutical Market Data Analysis," 2022.
- EvaluatePharma. "Forecasting the Antifungal Market," 2022.
- SCYNEXIS. "Ibrexafungerp (Developments and Market Strategy)," 2022.
This analysis provides a data-driven, forward-looking perspective on the pricing and market dynamics of NDC 54859-0604, empowering stakeholders to make informed strategic decisions.
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