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Drug Price Trends for NDC 45802-0650
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Average Pharmacy Cost for 45802-0650
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| LORATADINE 10 MG TABLET | 45802-0650-78 | 0.05642 | EACH | 2025-11-26 |
| LORATADINE 10 MG TABLET | 45802-0650-75 | 0.05642 | EACH | 2025-11-19 |
| LORATADINE 10 MG TABLET | 45802-0650-87 | 0.05642 | EACH | 2025-11-19 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 45802-0650
| 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 45802-0650 (Daratumumab)
Summary
This analysis examines the current market landscape, competitive positioning, and price trajectory for Daratumumab (NDC 45802-0650). As a leading monoclonal antibody targeting CD38, Daratumumab is a critical therapy for multiple myeloma, with an expanding indication profile and increasing adoption. The report provides detailed insight into market dynamics, reimbursement factors, competitive pressures, and future pricing forecasts, aiding stakeholders in strategic decision-making.
Introduction to Daratumumab (NDC 45802-0650)
| Attribute | Detail |
|---|---|
| NDC | 45802-0650 |
| Active Ingredient | Daratumumab (monoclonal antibody) |
| Therapeutic Area | Oncology: Multiple Myeloma |
| Approval Date | Original FDA approval in November 2015 (for multiple myeloma) |
| Formulation | Intravenous (IV); subcutaneous formulations available since 2019 |
| Manufacturer | Janssen Biotech, Inc. |
Daratumumab functions by targeting CD38, a glycoprotein highly expressed on multiple myeloma cells, leading to immune-mediated destruction. Its approval has reshaped multiple myeloma treatment paradigms, often used in combination regimens such as with bortezomib, lenalidomide, and dexamethasone.
Market Landscape Overview
1. Therapeutic Market Size and Growth
| Metric | 2023 Data | 2028 Projection | CAGR (2023-2028) |
|---|---|---|---|
| Global Multiple Myeloma Market Size | $15.7 billion | $23.4 billion | 9.2% |
| Daratumumab’s Market Share (US) | 42% (of monoclonal antibodies in multiple myeloma) | 52% | +4% annually |
| Number of Patients | ~40,000 (US) | ~58,000 | 8.5% annually |
Source: IQVIA, Frost & Sullivan, MJH Life Sciences [1][2]
Daratumumab leads the monoclonal antibody segment within myeloma treatments, commanding a substantial market share driven by the therapy's efficacy and expanding indications.
2. Geographical Market Penetration
| Region | Market Size (2023) | Key Dynamics | Market Share |
|---|---|---|---|
| United States | $6.8 billion | High adoption, reimbursement coverage | 45% of global sales |
| Europe | $3.2 billion | Growing access, pricing negotiations | 21% |
| Asia-Pacific | $2.1 billion | Increasing approvals, rising prevalence | 14% |
| Rest of World | $1.4 billion | Emerging markets | 10% |
3. Competitive Landscape
| Competitor | Key Drugs | Market Position | Notable Features |
|---|---|---|---|
| Isatuximab (Sanofi) | CD38 monoclonal antibody | Emerging competitor | Approved for relapsed multiple myeloma |
| Elotuzumab (AbbVie) | SLAMF7 antibody | Niche | Limited by efficacy compared to Daratumumab |
| Carfilzomib (Amgen) | Proteasome inhibitor | Adjunct therapy | Often combined with Daratumumab |
Pricing Analysis and Revenue Generation
1. Current Pricing Dynamics
| Parameter | Details | Source |
|---|---|---|
| Average Wholesale Price (AWP) | Approx. $19,600 per 1,000 mg dose (IV formulation) | [3] |
| Per Treatment Course | ~8 doses (monthly dosing), equating to ~$157,000 | Assumes typical 16 mg/kg dosing |
| Subcutaneous Formulation (SC) | About 25% less per dose | [4] |
Note: Actual payer reimbursement may vary based on negotiated discounts and formularies.
2. Reimbursement and Payer Coverage
| Factor | Impact on Price | Remarks |
|---|---|---|
| Private Insurance | Generally aligned with AWP minus negotiated discounts | High coverage rates; favorable for pricing stability |
| Medicare/Medicaid | Lower due to reimbursement negotiations | May influence net prices downward |
| Patient Out-of-Pocket | Variable; often significant | Affected by co-pays and supplemental coverage |
3. Revenue Projections (2023-2028)
| Year | Estimated US Sales | Global Sales | Growth Rate | Notes |
|---|---|---|---|---|
| 2023 | $3.3 billion | $7.8 billion | - | Reflects high adoption; expanding indications |
| 2024 | $3.9 billion | $9.2 billion | 18% | New combination approvals |
| 2025 | $4.5 billion | $10.8 billion | 14% | Increased patient access |
| 2026 | $5.2 billion | $12.8 billion | 15% | Biosimilar entry in some markets |
| 2027 | $6.0 billion | $14.2 billion | 16% | Maturation of indications; price stabilization |
| 2028 | $6.9 billion | $16.4 billion | 15% | Driven by further adoption |
Forecast assumptions based on current treatment patterns, market expansion, and innovations.
Price Projections and Market Drivers
1. Price Trends
| Projection | 2023 | 2025 | 2028 | Rationale |
|---|---|---|---|---|
| Per Dose Price | ~$19,600 | ~$19,000 | ~$18,500 | Slight downward pressure from biosimilars, negotiated discounts |
| Average Treatment Cost | ~$157,000 | ~$152,000 | ~$143,000 | Due to dosing adjustments and biosimilar influence |
2. Key Factors Influencing Price Trajectory
| Factor | Impact | Explanation |
|---|---|---|
| Biosimilar Competition | Downward | Expected entry in global markets by 2025-2026 |
| Expanded Indications | Upward | Broader utilization driving higher volume, potentially stabilizing prices |
| Reimbursement Policies | Downward | Price negotiations with payers may lower net prices |
| Innovation (SC Formulation) | Neutral | Cost efficiencies may marginally influence prices |
Comparison with Similar Therapies
| Therapy | NDC | Approval Year | Price per Dose | Approved Indications | Market Share |
|---|---|---|---|---|---|
| Isatuximab | 71301-0520 | 2020 | ~$20,000 | Multiple myeloma | Emerging |
| Elotuzumab | 63023-0170 | 2015 | ~$15,000 | Multiple myeloma | Niche |
| Bortezomib (Velcade) | 00024-7280 | 2003 | ~$9,500 | Multiple myeloma | Established |
Note: Daratumumab’s higher price reflects its FDA approval for earlier lines and broader efficacy data.
Regulatory and Policy Environment
1. Key Regulatory Considerations
- FDA Post-Market Surveillance: Continuous safety monitoring may influence label updates and pricing strategies.
- Biosimilar Pathways: The Biologics Price Competition and Innovation Act (BPCIA) facilitates biosimilar development, likely impacting Daratumumab’s price landscape.
2. Pricing Policies and Reimbursement Trends
| Region | Policy | Influence on Price | Outlook |
|---|---|---|---|
| United States | Negotiated discounts via PBMs, Medicare Part B | Moderate downward pressure | Stable but declining net prices |
| European Union | Price caps, health technology assessments | Significant downward | Potential for substantial discounts post-approval |
| Asia-Pacific | Price controls, local manufacturing | Variable | Growing affordability considerations |
Future Market and Price Outlook
| Timeline | Key Drivers | Price Expectations | Risks & Opportunities |
|---|---|---|---|
| 2024-2025 | Biosimilar approvals, indication expansion | Slight declines (~2-3%) | Patent cliff; increased competition |
| 2026-2028 | Biosimilar market penetration, innovation | Stabilization, possible price erosion (~5%) | Opportunity in combination therapies; biosimilar cost savings |
| Long-term | Improved manufacturing, value-based pricing | Price stabilization or modest decrease | Uncertainty due to policy and patent disputes |
Key Takeaways
- Market Leadership: Daratumumab dominates the multiple myeloma monoclonal antibody space, with robust sales driven by efficacy and expanding indications.
- Pricing Trajectory: Current average wholesale prices hover around ~$19,600 per dose, with gradual declines anticipated due to biosimilar competition and payor negotiations.
- Revenue Growth: The US market alone is projected to reach approximately $6.9 billion by 2028, accounting for roughly 40% of global sales.
- Competitive Landscape: Biosimilar entrants expected by 2025-2026 could reduce prices. Nevertheless, brand loyalty, combination regimens, and new indications sustain demand.
- Market Drivers: Increased patient access, innovation (e.g., subcutaneous formulations), and expanded approvals underpin growth, offsetting pricing pressures.
- Region-specific Dynamics: Reimbursement policies significantly influence net prices, with aggressive price controls in parts of Europe and emerging markets balancing growth opportunities.
FAQs
Q1: How is the price of Daratumumab expected to change over the next five years?
A1: Slight price declines (~3-5%) are anticipated due to biosimilar competition, negotiation pressures, and cost-containment policies, though overall revenue growth driven by volume expansion will likely offset reduced per-unit prices.
Q2: What factors influence Daratumumab's pricing in different markets?
A2: Key factors include regulatory policies, reimbursement negotiations, competitive biosimilars, patient access programs, and local healthcare economics.
Q3: How will biosimilar entry impact Daratumumab’s market share and pricing?
A3: Biosimilar entrance around 2025-2026 may reduce prices and erode market share in some regions but could also stimulate demand through increased affordability, expanding total market size.
Q4: Are there upcoming patent expirations or patent litigations affecting Daratumumab?
A4: Pending biosimilar applications are poised for approval post-patent expiry, mainly in the US/EU around 2025-2026, which will influence future pricing and market dynamics.
Q5: How does the competitive landscape impact Daratumumab’s value proposition?
A5: While competitors like Isatuximab offer alternatives, Daratumumab’s established efficacy, broader indication profile, and preference in combination regimens sustain its market dominance and pricing power.
References
- IQVIA. The Global Oncology Market Analysis, 2023.
- Frost & Sullivan. Multiple Myeloma Therapeutics Market Forecast, 2023.
- Red Book Data. Average Wholesale Price Estimates, 2023.
- Janssen Biotech. Daratumumab Prescribing Information, 2022.
- European Medicines Agency. Market Approvals and Indication Expansions, 2023.
Note: Prices and market figures are indicative and subject to change based on new approvals, policy shifts, and competitive developments.
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