Last updated: February 28, 2026
What is NDC 68180-0518?
NDC 68180-0518 refers to Dupilumab (brand name Dupixent). It is a monoclonal antibody approved for multiple indications including atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis. Manufactured by Sanofi and Regeneron Pharmaceuticals, Dupilumab accounts for a significant share in biologic therapeutics targeting immune-mediated diseases.
Market Overview
Indications and Patient Population
| Indication |
Estimated Patient Base |
U.S. Market Share (2022) |
| Atopic dermatitis |
10 million affected adults globally |
Dominates biologic treatments for eczema |
| Asthma (moderate to severe) |
25 million Americans with asthma |
Major player in severe asthma segment |
| Chronic rhinosinusitis with nasal polyposis |
2 million adults in U.S. |
Expanding indications in ENT markets |
Commercial Landscape
Dupilumab faces competition from other biologics:
| Product |
Indicated Uses |
Approximate Annual Sales (2022) |
Market Position |
| Mepolizumab (Nucala) |
Severe eosinophilic asthma |
$2.8 billion |
Second-line biologic |
| Omalizumab (Xolair) |
Allergic asthma, chronic urticaria |
$2.7 billion |
Leading in allergy treatments |
| Tralokinumab (Adbry) |
Atopic dermatitis |
$200 million |
Niche positioning |
Market Drivers
- Increased prevalence of eczema, asthma, and sinusitis.
- Growing acceptance of biologics as first-line treatments.
- Expansion of approved indications.
- Reimbursement policies increasingly favor biologics for severe cases.
Regulatory Trends
| Year |
Key Approvals |
Regions |
| 2017 |
U.S.: FDA approval for atopic dermatitis |
U.S. |
| 2018 |
EMA approval for eczema |
Europe |
| 2020 |
FDA approval for asthma |
U.S. |
| 2021 |
Approval for chronic rhinosinusitis |
U.S. and global markets |
Price Projection Analysis
Current Pricing
| Region |
Per-Patient Annual Cost |
Payment Model |
Notes |
| U.S. |
~$37,000 per year |
Commercial payers |
Price varies based on dosage and treatment duration |
| EU |
€18,000 - €25,000 annually |
National health systems |
Slightly lower due to negotiated pricing |
| Canada |
~$25,000 CAD annually |
Public insurance |
Similar to EU but varies by province |
Pricing Trends (2022–2025)
- Pricing Stabilization: Per-market prices have remained stable due to patent protection and market exclusivity.
- Potential Discounts: Payers seek discounts, influencing net prices; discounts up to 30% are common.
- Biosimilar Impact: No biosimilars are expected soon given the biologic's complex manufacturing; however, biosimilar competition for other biologics may affect overall biologics market dynamics.
Future Pricing Projections
| Year |
Estimated Cost (U.S.) |
Key Factors |
| 2023 |
~$37,000 |
Current pricing, no major regulation change |
| 2024 |
~$36,500 - $37,000 |
Slight decline expected due to payer pressure |
| 2025 |
~$36,000 |
Potential negotiations reduce list price |
Revenue Projections
- Global Sales (2023): Estimated $10.5 billion.
- Growth Rate: CAGR of 8% through 2027.
- Market Share Expansion: Growing approval for asthma and sinusitis indicates revenue increases of 10–12% annually post-2023.
Key Risks and Opportunities
Risks
- Patent cliffs may threaten exclusivity after 2028.
- Competitive biosimilar entries could reduce list prices.
- Reimbursement restrictions may limit access in some regions.
Opportunities
- Broadened indications, including pediatric uses.
- Combination therapies with other biologics.
- Geographic expansion into emerging markets.
Key Takeaways
- NDC 68180-0518 (Dupilumab) is a leading biologic in atopic dermatitis, asthma, and sinusitis.
- Current pricing in the U.S. averages around $37,000 annually per patient, with slight downward pressure expected.
- The global market generates over $10 billion annually, with a forecasted CAGR of approximately 8%.
- Competition from other biologics remains intense, but biosimilar entry is unlikely before 2028.
- Market growth is driven by increased prevalence, expanded indications, and ongoing adoption.
FAQs
Q1: How does Dupilumab's pricing compare to other biologics?
It is comparable to similar biologics like mepolizumab and omalizumab, which range from $25,000 to $40,000 annually per patient.
Q2: What factors could significantly alter price projections?
Introduction of biosimilars, regulatory changes impacting pricing policies, or notable clinical trial outcomes affecting indications.
Q3: Are there generic or biosimilar versions of Dupilumab?
No biosimilars are currently approved; complex manufacturing and patent protections delay biosimilar development.
Q4: How might expansion of indications influence revenue?
Broader approvals, especially for pediatric populations and additional conditions, could increase patient base and revenue streams.
Q5: What regional factors influence pricing and market adoption?
Reimbursement policies, healthcare infrastructure, and negotiated prices with health authorities vary, affecting access and price levels.
References
- Johnson, M., et al. (2022). Biologics in Atopic Dermatitis: Market Dynamics. Journal of Dermatological Treatment, 33(4), 325-332.
- Smith, A., et al. (2023). Global Trends in Biologic Therapies. International Journal of PharmacoEconomics, 45(2), 150-165.
- U.S. Food & Drug Administration. (2020). Dupilumab Approval History. www.fda.gov
- European Medicines Agency. (2021). Dupilumab Summary of Product Characteristics. www.ema.europa.eu
- IQVIA. (2022). Pharmaceutical Market Data.
[1] APA Citation: Johnson, M., et al. (2022). Biologics in atopic dermatitis: Market dynamics. Journal of Dermatological Treatment, 33(4), 325-332.
