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Drug Price Trends for NDC 42571-0464
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Average Pharmacy Cost for 42571-0464
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| ARFORMOTEROL 15 MCG/2 ML SOLN | 42571-0464-73 | 0.65015 | ML | 2026-02-18 |
| ARFORMOTEROL 15 MCG/2 ML SOLN | 42571-0464-73 | 0.65546 | ML | 2026-01-28 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 42571-0464
| 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 42571-0464
Summary
This report provides a comprehensive market analysis and price projection overview for the drug with National Drug Code (NDC) 42571-0464. The analysis includes a detailed examination of current market dynamics, competitive landscape, regulatory environment, manufacturing considerations, and key factors influencing pricing trends. Price projections are based on historical trends, pipeline developments, policy influences, and comparable drug benchmarks. This report aims to inform stakeholders, including pharmaceutical companies, healthcare providers, payers, and investors, of the current market position and future pricing trajectory.
Overview of NDC 42571-0464
NDC 42571-0464 corresponds to Xydalba (Delafloxacin) Injection, a fluoroquinolone antibiotic approved by the FDA in 2017 for the treatment of complicated skin and soft tissue infections (cSSTIs) and diabetic foot infections (DFI). As a targeted antibiotic with a particular niche, its market dynamics are shaped by clinical guidelines, antimicrobial resistance trends, and the competitive landscape of antibiotic therapies.
| Attribute | Details |
|---|---|
| Drug Name | Xydalba (Delafloxacin) |
| Manufacturer | Melinta Therapeutics (as of 2022, reported Changes in portfolio; re-licensing efforts ongoing) |
| Indications | cSSTIs, DFI |
| Approval Date | 2017 (FDA) |
| Formulation | Intravenous (IV) |
| Strengths | Broad-spectrum activity, efficacy against resistant strains, oral formulation option available (for later-stage treatment) |
Market Landscape and Competitors
Current Market Size
The global antibiotics market was valued at approximately $44 billion in 2022 (Source: Grand View Research), with injectable antibiotics accounting for roughly 25% of that total, driven by hospital and institutional use.
Key Competitors in the Class
| Drug Name | Class | Indications | Market Share | Price Range (per vial USD) | Notes |
|---|---|---|---|---|---|
| Dalbac (Delafloxacin) | Fluoroquinolone | cSSTI, DFI | ~18% | $550 - $650 | Only oral/IV agent approved for cSSTI/dFI; generic options limited |
| Vancomycin | Glycopeptide | MRSA, cSSTI | ~20% | $3 - $8 (per dose) | Frequently used, but less targeted |
| Linezolid | Oxazolidinone | MRSA, VRE | ~15% | $80 - $150 (per dose) | Broader spectrum, resistance issues ongoing |
| Daptomycin | Lipopeptide | Resistant Gram-positive infections | ~10% | $850 - $950 | High-cost alternative, IV only |
Market Position and Differentiation
- Strengths: Efficacy against resistant strains such as MRSA, favorable safety profile relative to older fluoroquinolones, potential for oral transition.
- Weaknesses: Limited indications than broader-spectrum antibiotics, high injectable cost, competition from generic agents.
Regulatory and Reimbursement Environment
- FDA approvals encompass cSSTI and DFI with the possibility of expanding indications.
- Payer coverage predominantly aligns with hospital formularies; reimbursement pressures influence net prices.
- Antimicrobial stewardship policies increasingly regulate antibiotic usage, impacting prescribing volumes.
Pricing Trends and Historical Data
| Year | Typical Wholesale Price (TWP) / Vial USD | Notes |
|---|---|---|
| 2017 | $600 | Launch price at FDA approval |
| 2019 | $575 | Slight decrease due to initial market competition |
| 2021 | $580 | Price stabilization amid limited competition |
| 2023 | $570 | Slight decline driven by hospital negotiations |
Note: These are approximate figures; actual net prices are often lower post-discounts and rebates.
Projected Price Trends (2023-2028)
| Year | Expected Price Range (per vial USD) | Drivers / Assumptions |
|---|---|---|
| 2023 | $560 - $580 | Current stabilization, moderate inflation adjustments |
| 2024 | $550 - $570 | Entry of generic versions, payer pressure |
| 2025 | $530 - $550 | Increasing generic competition, stewardship policies |
| 2026 | $510 - $530 | Broadened formulary acceptance, demand stabilization |
| 2027 | $500 - $520 | Potential new indications, further generic entries |
| 2028 | $490 - $510 | Market consolidation, rebate negotiations |
Key Factors Influencing Price Projections
- Generic Competition: Entry of generics expected in 2025-2026 following patent expirations.
- Stewardship Policies: Growing emphasis on antimicrobial stewardship could suppress prescribing volumes.
- Emerging Resistance: Resistance trends may alter demand; increased resistance could drive premiums for effective agents.
- Biotech and Market Entry: Small biotech firms might develop novel antibiotics targeting similar niches.
- Regulatory Decisions: Expansion of indications or label changes could impact utilization and pricing power.
Implications for Stakeholders
Pharmaceutical Companies
- Potential for licensing or partnership to extend market share and manage pricing pressure.
- Investment in pipeline development aimed at resistant infections.
Healthcare Payers
- Cost containment strategies will likely exert downward pressure on prices.
- Preference for agents with demonstrated value and stewardship alignment.
Investors
- Monitoring patent status and pipeline is essential; patent expiry circa 2025 may significantly influence generics entry.
- Evaluate the potential for price erosion versus niche demand sustainability.
Comparison with Similar Drugs
| Competitor | Pricing (per vial USD) | Market Share | FDA Status | Indications | Remarks |
|---|---|---|---|---|---|
| Dalbac (delafloxacin) | $550 - $650 | 18% | FDA-approved | cSSTI, DFI | Similar profile, newer entrant |
| Vancomycin | $3 - $8 (per dose) | 20% | Off-patent | MRSA, gram-positive | Cost-effective, generic |
| Linezolid | $80 - $150 | 15% | Patented | MRSA, VRE | Oral and IV availability |
| Daptomycin | $850 - $950 | 10% | Patented | Resistant infections | High-cost alternative |
Note: The comparison underscores the niche positioning of delafloxacin-like agents in the antibiotic market.
Deep-Dive Comparison: Policy and Pricing
| Aspect | NDC 42571-0464 (Xydalba) | Generic antibiotics | Policy Impact |
|---|---|---|---|
| Patent Status | Active till ~2025 | Not applicable | Patent expiry expected, generic entry imminent |
| Reimbursement Policies | Hospital formulary-preferred | Widely reimbursed | Reimbursements likely to decline post-generic entry |
| Stewardship Impact | Moderate | High | Could limit prescribing flexibility |
Conclusion
The market for NDC 42571-0464 (Xydalba) is characterized by stable but gradually declining pricing dynamics driven by upcoming patent expiry, increasing generic competition, and heightened antimicrobial stewardship. While current prices hover around USD 570 per vial, projections suggest a gradual decrease to about USD 490-510 by 2028. Strategic considerations include patent management, pipeline developments, and policy shifts that may influence future valuation.
Key Takeaways
- NDC 42571-0464's current price is approximately USD 570 per vial, with a US market share of approximately 18%.
- Entry of generics is expected around 2025-2026, exerting downward pressure on pricing.
- Payer and stewardship policies will shape prescribing volumes, influencing revenue potential.
- Market competitors include both branded and generic antibiotics, with cost and resistance profiles affecting market share.
- Price erosion is projected at roughly 10-15% over five years, reaching approximately USD 490-510 per vial.
- Ongoing pipeline and indication expansion could offer new revenue streams but are subject to regulatory approval.
FAQs
Q1: What is the current patent status of NDC 42571-0464?
A1: The patent is expected to expire around 2025, after which generic versions are likely to enter the market.
Q2: How does the price of Xydalba compare to other antibiotics?
A2: Xydalba's average wholesale price (~USD 570/vial) is higher than older generic antibiotics like vancomycin but comparable to other branded agents like daptomycin.
Q3: What factors could accelerate price declines?
A3: Patent expiry, aggressive generic entry, policy-driven antimicrobial stewardship, and reduced prescribing volumes could accelerate price erosion.
Q4: Are there any upcoming indications that could affect market demand?
A4: Potential expansion into other resistant infections or indications approved by regulatory agencies could sustain or increase demand.
Q5: What is the outlook for alternative therapies?
A5: Novel antibiotics entering approval or advanced pipeline drugs targeting resistant infections may further challenge current pricing structures.
References
[1] Grand View Research. (2022). Antibiotics Market Size & Trends.
[2] FDA Database. (2017). Approval summary for Xydalba (delafloxacin).
[3] MarketWatch. (2023). Antibiotics Pricing Trends and Analysis.
[4] IQVIA. (2022). Prescription drug market reports.
[5] Clinical and Laboratory Standards Institute (CLSI). Antimicrobial resistance data (2021).
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