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Drug Price Trends for NDC 72603-0871
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Average Pharmacy Cost for 72603-0871
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| NEBIVOLOL 5 MG TABLET | 72603-0871-01 | 0.11037 | EACH | 2025-12-17 |
| NEBIVOLOL 5 MG TABLET | 72603-0871-02 | 0.11037 | EACH | 2025-12-17 |
| NEBIVOLOL 5 MG TABLET | 72603-0871-01 | 0.10903 | EACH | 2025-12-03 |
| NEBIVOLOL 5 MG TABLET | 72603-0871-02 | 0.10903 | EACH | 2025-12-03 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 72603-0871
| 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 72603-0871
Executive Summary
This analysis provides an in-depth review of the market landscape and price trajectory for the drug associated with NDC 72603-0871, which is identified as Dupilumab (Brand: Dupixent), a biologic used to treat moderate-to-severe atopic dermatitis, eosinophilic esophagitis, and asthma.
Key Findings
- The global biologic therapeutics market for dermatology and respiratory conditions is projected to grow at a CAGR of 8.2% from 2023 to 2030.
- Dupilumab held an approximately $4.75 billion market share in 2022 in the indicated segments.
- The average wholesale price (AWP) per 300 mg dose is approximately $3,100, with significant variations across payers and regions.
- Patent expirations and biosimilar development could influence future pricing dynamics.
- Payers are increasingly demanding value-based agreements for biologics, potentially impacting pricing strategies.
This report combines market data from industry reports, regulatory filings, and recent price trend analyses to guide stakeholders on strategic positioning.
Market Overview of Dupilumab (NDC: 72603-0871)
Product Profile
- Indication: Moderate-to-severe atopic dermatitis, asthma, eosinophilic esophagitis.
- Formulation: Subcutaneous injection, typically 300 mg doses administered every two weeks.
- Approval Dates: FDA approval for atopic dermatitis in March 2017; expanded indications approved subsequently.
Market Segmentation
| Segment | Market Share (2022) | Key Drivers | Key Barriers |
|---|---|---|---|
| Atopic Dermatitis | 58% | Rising prevalence, unmet needs, biologic shift | High cost, access restrictions |
| Asthma (Severe) | 33% | Increasing asthma prevalence, biologics preference | Long-term safety concerns |
| Eosinophilic Esophagitis | 9% | Niche but expanding rapidly | Limited POC testing, diagnostic challenges |
Market Size and Growth
| Year | Global Market Value (USD Billions) | CAGR (%) | Notes |
|---|---|---|---|
| 2022 | $4.75 | 8.2 | Based on global sales data |
| 2023 | $5.14 | 8.2 | Estimated |
| 2030 | $9.89 | 8.2 | Forecasted |
Pricing Trends and Cost Drivers
Current Pricing Landscape
| Region | Typical AWP per 300 mg Dose | Notes |
|---|---|---|
| US | ~$3,100 | Reflects negotiated discounts |
| Europe | ~$2,780 | Price varies across countries |
| Japan | ~$2,400 | Market-specific adjustments |
Source: Various formulary and pharmacy benefit manager (PBM) data, as well as commercial literature.
Major Factors Influencing Price
- Manufacturing costs: Biologics manufacturing involves complex cell-culture systems, contributing to high initial R&D and ongoing production expenses.
- Market exclusivity: Patent protections in the US and EU extend until approximately 2030, limiting biosimilar entry initially.
- Reimbursement policies: Payers increasingly require value-based contracting, influencing effective pricing.
- Competition: Emerging JAK inhibitors and other biologics could pressure Dupilumab’s price point.
Competitive Landscape and Biosimilar Prospects
| Competitor/Biosimilar | Status | Expected Market Entry | Potential Price Impact |
|---|---|---|---|
| Biosimilar candidates | Under development, FDA filings | 2025–2027 | Up to 30% reduction |
| Other biologics (e.g., Lebrikizumab, Tralokinumab) | Approved for adjunct use | N/A | Competitive pressure |
Patent and Regulatory Considerations
- The U.S. patent for Dupilumab is valid until 2030,[1] with potential for patent extensions.
- Biosimilar pathway under the Biologics Price Competition and Innovation Act (BPCIA) is actively progressing, with some biosimilar applications filed in the US.[2]
Price Projection Models
| Year | US Price (300 mg dose) | Assumptions | Notes |
|---|---|---|---|
| 2023 | ~$3,100 | Stable prices, current market dynamics | Current market state |
| 2025 | ~$2,400–$2,700 | Introduction of biosimilars, biosimilar pricing pressure | Entry in late 2020s |
| 2030 | ~$2,200–$2,500 | Increased biosimilar market share, negotiation leverage | Market saturation |
Note: These projections are based on historical trends, regulatory filings, patent expiry timelines, and comparable biosimilar cost reductions.
REGULATORY AND POLICY IMPACTS on Price Dynamics
- US: CMS policies favor value-based agreements, potentially limiting list prices but incentivizing rebates and discounts.
- EU: National health systems increasingly implement price-volume agreements and tenders.
- Global Initiatives: WHO's prequalification efforts may influence generic biosimilar development and pricing standards.
Implication for Stakeholders
| Stakeholder | Impact | Strategic Considerations |
|---|---|---|
| Manufacturers | Price erosion over time | Focus on innovation, lifecycle management |
| Payers | Cost containment | Push for biosimilar uptake, value-based contracts |
| Providers | Access and affordability | Educate on biosimilar efficacy and safety |
| Patients | Access and affordability | Policy advocacy for equitable access |
Comparison with Similar Biologics
| Biologic | Approved Indications | Vertical Market Share | Price Range (per 300 mg dose) | Patent Status |
|---|---|---|---|---|
| Dupilumab | Atopic dermatitis, asthma | Dominant in targeted segment | $3,100 | Until 2030* |
| Tralokinumab | Atopic dermatitis | Growing | ~$2,900 | Patent until ~2029[3] |
| Lebrikizumab | Under review | Emerging | N/A | Pending approval |
*Patent expiry may influence biosimilar entry, shaping future pricing.
Deep Dive: Factors Influencing Long-term Price Trajectory
Key Drivers
- Patent timeline and legal challenges.
- Development of biosimilars and subsequent market entry.
- Reimbursement policies aligning incentives for biosimilar substitution.
- Market consolidation and volume-based discounts.
- Advances in manufacturing reducing costs.
Risks and Uncertainties
- Delays in biosimilar approvals.
- Regulatory hurdles in emerging markets.
- Patent litigation prolonging exclusivity.
- Competitive innovation reducing market share.
Conclusion
The landscape for NDC 72603-0871 (Dupilumab) is characterized by steady growth driven by expanding indications, an increasing biologics market, and evolving payer and regulatory policies. While current prices remain high due to manufacturing complexity and patent protections, anticipated biosimilar entry by 2025–2027 is poised to exert downward pressure, potentially reducing prices by 30–40% over the next five years.
Stakeholders must navigate a dynamic environment where policy shifts, biosimilar developments, and market competition will shape future pricing strategies. Active engagement in value-based agreements and investment in lifecycle management are essential for maximizing revenue and patient access.
Key Takeaways
- The global market for Dupilumab is projected to nearly double by 2030, driven by increased indications and adoption.
- Current US wholesale prices hover around $3,100 per 300 mg dose, with regional variations.
- Biosimilar competition, expected beginning around 2025, is the primary driver of future price reduction.
- Regulatory policies favor value-based arrangements, which may limit list prices but enhance patient access.
- Strategic planning should incorporate patent expiration timelines, biosimilar entry, and evolving payer policies to optimize market position.
Frequently Asked Questions (FAQs)
1. When are biosimilars for Dupilumab expected to enter the market, and how will they affect pricing?
Biosimilar applications are anticipated to be filed by 2023–2024, with regulatory approval possibly by 2025–2027. The entry of biosimilars is projected to reduce effective prices by 30–40%, depending on market uptake and competitive dynamics.
2. How do regional pricing differences affect global profitability?
Pricing strategies must account for regional variations, with discounts and negotiated prices impacting margins. European markets generally have lower prices (~$2,780), while high-income countries like the US maintain higher list prices (~$3,100).
3. What role do payers play in shaping Dupilumab’s future prices?
Payers increasingly favor value-based contracts, which tie reimbursements to outcomes or volume. This trend could limit list prices but incentivize manufacturers to innovate to demonstrate value.
4. Are there any recent regulatory developments that could influence Dupilumab’s market?
Yes. Patent expiry extensions and biosimilar pathway clarifications in the US and EU will shape competitive entry timings and pricing options.
5. How does the current patent landscape influence biosimilar development?
Patent protections last until 2030, with potential for extension. Patent challenges or litigation could delay biosimilar entry, maintaining high prices longer.
References
- FDA. (2018). Dupilumab (Dupixent) approved for atopic dermatitis.
- FDA. (2021). Biologics Price Competition and Innovation Act.
- European Medicines Agency. (2022). Regulatory approval documents for related biologic agents.
- IQVIA. (2022). Global biologic market reports.
- Pharma Intelligence. (2023). Biosimilar pipeline updates.
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