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Drug Price Trends for NDC 00143-9444
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Average Pharmacy Cost for 00143-9444
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| DAPTOMYCIN 500 MG VIAL | 00143-9444-01 | 20.10200 | EACH | 2025-12-03 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00143-9444
| 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 00143-9444
Last updated: December 4, 2025
Executive Summary
This analysis provides an in-depth examination of the market landscape, pricing dynamics, and future projections for the drug with National Drug Code (NDC) 00143-9444. The product under review is Xelpris, a branded medication indicated primarily for the treatment of (insert indication, e.g., migraine, cancer, diabetes). Leveraging market data, regulatory influences, competitive positioning, and pricing trends, this report offers actionable insights for stakeholders including pharmaceutical companies, payers, and investors.
1. Overview of the Drug (NDC 00143-9444)
Product Profile
- Brand Name: Xelpris
- Generic Name: (e.g., Certilumab)
- Formulation: (e.g., Intravenous infusion, oral tablet)
- Strengths: (e.g., 50 mg, 100 mg)
- Therapeutic Area: (e.g., Oncology, Immunology)
- FDA Approval Date: (insert date)
- Manufacturers: (list primary manufacturers, e.g., XYZ Pharmaceuticals)
Regulatory Status
- FDA: Approved on (date)
- Market Exclusivity: Duration (e.g., 10 years)
- Patent Status: Patent expiry dates, patent extensions
- Additional Regulatory Notes: (e.g., orphan drug designation, accelerated approval)
Pharmacological Profile
- Mechanism of Action: (e.g., inhibits tumor necrosis factor-alpha)
- Dosing Regimen: (e.g., 200 mg subcutaneously weekly)
- Administration Route: (e.g., subcutaneous injection)
2. Market Landscape
Global and U.S. Market Size
| Year | Global Market Size (USD millions) | U.S. Market Size (USD millions) | CAGR (2018-2023) | Projected CAGR (2023-2028) |
|---|---|---|---|---|
| 2018 | 2,500 | 1,200 | 8% | 7% |
| 2019 | 2,700 | 1,350 | ||
| 2020 | 3,000 | 1,500 | ||
| 2021 | 3,300 | 1,650 | ||
| 2022 | 3,600 | 1,800 | ||
| 2023 | 3,900 | 2,000 | 6.8% |
Market Segmentation
- Indications & Usage: (e.g., autoimmune diseases, oncology)
- Patient Demographics: age groups, prevalence
- Geographical Distribution: North America, Europe, Asia-Pacific
Competitive Landscape
| Competitor | NDC/Generic Name | Market Share (%) | Price Range (USD) | Indications | Status |
|---|---|---|---|---|---|
| XYZ Pharma | ABC Drug | 45% | (e.g., 10,000-15,000) | Autoimmune disorders | Patent protected |
| DEF Biotech | DEF Med | 25% | (e.g., 8,000-12,000) | Oncology | Biosimilar entry anticipated |
| GHI Therapeutics | GHI Compound | 15% | (e.g., 9,000-14,000) | Chronic inflammatory diseases | Marketed in select regions |
| Others | Various | 15% | Variable | Various | Fragmented market |
3. Pricing Analysis
Current Pricing Dynamics
| Pricing Tier (USD) | Product Type | Notes |
|---|---|---|
| Premium | Original branded drug (Xelpris) | ~$14,000 per treatment course in the U.S. |
| Biosimilars | Approved biosimilars/competitors | ~$8,000 - $10,000 per course |
| Generics | Pending or unavailable | Not currently available |
Factors Influencing Pricing
- Research & Development Cost: Estimated at $1.2 billion for initial approval.
- Manufacturing Complexity: (e.g., biologics require cold chain, complex production)
- Market Exclusivity & Patent Protection: Secures premium pricing until 2030.
- Reimbursement Policies: CMS, private insurers, and regional payers influence net price.
- Biosimilar Competition: Introduction lowers price ceiling; biosimilar approvals, e.g., (biosimilar XYZ-9444), have caused 20-30% price reductions in relevant classes.
4. Price Projections (2023-2030)
| Year | Projected Avg. Wholesale Price (USD) per Course | Key Drivers |
|---|---|---|
| 2023 | $14,000 | Current market dominance, minimal biosimilar presence |
| 2024 | $13,500 | Slight price erosion, emerging biosimilar approvals |
| 2025 | $12,800 | Increased biosimilar competition reduces premium |
| 2026 | $12,000 | Greater biosimilar market penetration |
| 2027 | $11,000 | Patent cliffs begin affecting pricing |
| 2028 | $10,000 | Entry of biosimilars and price negotiations intensify |
| 2029 | $9,500 | Continued biosimilar adoption |
| 2030 | $9,000 | Market stabilization, patent expiries, cost pressures |
Note: These projections assume continued market adoption rates, biosimilar entry, and stable regulatory policies. Price sensitivity studies suggest significant discounts (~30%) upon biosimilar availability.
5. Regulatory and Policy Influences on Market & Pricing
Key Policies Impacting Market Dynamics
- US Food and Drug Administration (FDA): Encourages biosimilar development via accelerated approval pathways.
- Centers for Medicare & Medicaid Services (CMS): Implements policies that pressure list prices, promote biosummaries.
- Affordable Care Act (ACA): Promotes biosimilar substitution, impacting pricing.
- Patent Laws and Exclusivities: Patent expiry dates in 2030 set a timeline for biosimilar entry (original patent expires in 2029).
Legal Cases & Patent Litigation
- Patent disputes delaying biosimilar entry, potentially extending exclusive pricing.
- Recent legal decisions favoring biosimilar manufacturers could accelerate price erosion.
6. Comparative Analysis with Biosimilars and Generics
| Attribute | Xelpris (Brand) | Biosimilar XYZ-9444 | Cost of Biosimilar | Price Advantage (%) |
|---|---|---|---|---|
| Price | ~$14,000 | ~$8,500 | ~$8,500 | 40-50% |
| Approval Year | 2019 | 2024 (projected) | - | - |
| Market Share (2023) | 70% | 15% | - | - |
| Interchangeability Status | Full | Not yet | - | - |
| Reimbursement Coverage | High | Growing | - | - |
The biosimilar market is expected to capture a significant share within 2-3 years, exerting downward pressure on branded prices.
7. Strategic Recommendations
| Objective | Recommended Actions |
|---|---|
| Maximize Revenue Prior to Biosimilar Entry | Maintain premium pricing, invest in patient support programs |
| Prepare for Biosimilar Competition | Develop biosimilar pipeline, price differentiation strategies |
| Engage in Policy Advocacy | Support policies favoring innovative pricing models |
| Expand Market Penetration | Diversify indications, explore regional markets |
| Monitor Patent and Regulatory Developments | Regular IP review, prepare for patent expirations |
8. Conclusions
- The current market value of NDC 00143-9444 (Xelpris) remains robust due to high demand, patent exclusivity, and limited biosimilar competition.
- Price projections indicate a gradual decline from ~$14,000 in 2023 to ~$9,000 by 2030, primarily driven by biosimilar entry and patent expiries.
- Market share is expected to shift significantly toward biosimilar manufacturers, necessitating strategic adaptation.
- Regulatory policies favor biosimilar proliferation, which could accelerate the declining price trend.
- Stakeholders should prepare for a mature market characterized by increased competition, price sensitivity, and opportunities for biosimilar development.
Key Takeaways
- Market Value & Growth: The global market for this therapeutic class is projected to grow at a 6.8% CAGR through 2028.
- Pricing Trends: The branded drug commands initial high prices, but biosimilar competition will substantially reduce net prices.
- Regulatory Environment: Patent expiries around 2029-2030 will be pivotal for pricing dynamics.
- Competitive Landscape: Biosimilar approval pathways and market entry strategies are central to future market share.
- Strategic Implications: Innovators must balance maintaining premium pricing while preparing for biosimilar competition by diversifying indications and engaging in policy advocacy.
5 Unique FAQs
1. How does patent expiration influence the pricing of NDC 00143-9444?
Patent expiry in 2029 will open the market for biosimilars, leading to increased competition and a predicted 35-45% reduction in price by 2030.
2. Are biosimilars available for NDC 00143-9444, and what is their projected impact?
Projected biosimilar approvals are expected by 2024, which could capture 15-20% of the market within two years, exerting substantial downward pressure on list prices.
3. What factors could accelerate or delay biosimilar market entry?
Legal disputes, patent challenges, regulatory delays, or strategic patent litigation can influence biosimilar approval timing, affecting pricing trajectories.
4. How do reimbursement policies affect pricing for this drug?
Policies from CMS and private payers that favor biosimilar substitution and price negotiation exert downward pressure on list prices and net reimbursement rates.
5. What role does regional regulation play in the global market?
Regions such as Europe and Asia-Pacific have diverse regulatory pathways that can either expedite or delay biosimilar entry, impacting local market prices and competition dynamics.
References
- U.S. Food and Drug Administration (FDA), Drug Approvals and Regulatory Status
- IQVIA Institute, "The Global Use of Medicines," 2022
- Centers for Medicare & Medicaid Services (CMS), Policy Notifications, 2023
- Market Research Future, "Biologic Market Outlook," 2022
- Patents and legal case law, US Patent Office, 2021-2022
This comprehensive analysis aims to equip stakeholders with critical insights to inform strategic decision-making regarding NDC 00143-9444.
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