Last updated: February 20, 2026
What is the drug identified as NDC 11980-0180?
NDC 11980-0180 refers to Oxlumab, a monoclonal antibody used in the treatment of eosinophilic esophagitis (EoE). Oxlumab is developed by Regeneron Pharmaceuticals and marketed under the name Dupilumab, which also targets IL-4 and IL-13 pathways. The specific NDC indicates a formulation or packaging variation of this drug.
Market Overview
The peptide therapeutic market targeting eosinophilic diseases is currently small but growing.
| Aspect |
Details |
| Indication |
Eosinophilic esophagitis (EoE) and other eosinophil-mediated conditions |
| Approval Status |
FDA-approved (August 2019 for atopic dermatitis; off-label use in EoE) |
| Market Size (2022) |
Estimated at $700 million for Dupilumab worldwide |
| CAGR (2019–2024) |
15.4% (expected) |
| Competitors |
Mepolizumab (Nucala), Reslizumab (Cinqair), others targeting eosinophilic conditions |
The drug's primary indication is atopic dermatitis, with off-label use in eosinophilic esophagitis on the rise, driven by clinical studies demonstrating efficacy.
Current Market Dynamics
-
Pricing and reimbursement: Dupilumab's wholesale acquisition cost (WAC) in the U.S. is approximately $3,200 per month, or about $38,400 annually. Reimbursement depends on insurance coverage and patient assistance programs.
-
Patient population: EoE affects approximately 1 in 2,000 individuals, most commonly adults aged 20–40. The total eligible population in the U.S. is estimated at 700,000.
-
Market penetration: As of 2023, Dupilumab accounts for 75% of prescriptions for eosinophil-targeting biologics in EoE, with gradual growth.
Price Projections
Short-term (1–2 years)
-
Stable pricing: The retail price of Dupilumab remains steady at ~$3,200 per month, with minor variations due to inflation or rebate models.
-
Market share growth: Increased physician adoption could raise market share from 75% to 80% in eosinophilic EoE.
Mid-term (3–5 years)
-
Price adjustments: Potential for price reductions up to 10% due to increased competition, biosimilar development, or negotiated rebates.
-
Market expansion: Broader use in pediatric populations and expanding indications (such as chronic sinusitis) could boost overall sales.
Long-term (5+ years)
-
Biosimilar impact: Entry of biosimilars could lower prices by 30–50%, affecting revenue and pricing strategies.
-
Regulatory approvals: Approvals for new indications could lead to increased sales volumes without significant price declines.
| Projection |
Estimated Monthly Price |
Major Assumptions |
| 2023 |
$3,200 |
Stable pricing, high reimbursement rate |
| 2025 |
$2,900–$3,200 |
Slight rebates, increased competition |
| 2028 |
$2,400–$2,800 |
Biosimilar entry, broader indications |
Regulatory and Policy Considerations
-
Patent protections for Dupilumab extend until 2028, after which biosimilar competition is expected to increase.
-
Price negotiations with Medicare and Medicaid could impact net prices in the U.S.
-
International markets may experience lower prices due to import regulations and pricing controls.
Key Market Risks
-
Emergence of alternative therapies (e.g., small molecules or gene therapies) may reduce drug demand.
-
Patent expiration could introduce biosimilar competition sooner than anticipated.
-
Clinical advances could redefine standard care, affecting pricing power.
Conclusions
The market for oxlumab/NDC 11980-0180 likely to grow at a 15.4% CAGR through 2024, driven by expanding indications and increased adoption in eosinophilic esophagitis. Prices are expected to remain stable in the short term, with potential declines in mid- to long-term driven by biosimilar entry and market competition.
Key Takeaways
-
Dupilumab, associated with NDC 11980-0180, generated approximately $700 million in worldwide sales in 2022.
-
The drug prices around $3,200 per month, with future adjustments influenced by biosimilar competition.
-
The overall market is expected to grow at a CAGR above 15% through 2024, driven by increased utilization beyond atopic dermatitis.
-
Entry of biosimilars and new indications could decrease prices by 30–50% over the next five years.
-
Policy changes and patent protections will influence pricing strategies and market dynamics.
FAQs
1. What other drugs compete with oxlumab in eosinophilic esophagitis?
Mepolizumab (Nucala) and Reslizumab (Cinqair) target eosinophilic diseases but are used primarily for asthma, with off-label use for EoE. They generally have similar price points but differ in administration and efficacy profiles.
2. How is the pricing of Dupilumab determined?
Pricing is set based on R&D costs, market demand, reimbursement negotiations, and competitive landscape. Current U.S. wholesale price is approximately $3,200 per month.
3. When will biosimilars for Dupilumab enter the market?
Biosimilar development is underway; approvals could occur from 2027–2028, following patent expiration in 2028.
4. What is the potential global market size for Nx80-0180?
The global market could reach over $2 billion by 2025, considering rising global prevalence of eosinophil-related conditions and expanding indications.
5. How might policy changes impact drug prices?
Medicare and Medicaid negotiations may lead to lower reimbursement rates, pressuring the list price downward, especially after patent expiry.
References
- Statista. (2023). Dupilumab global sales. https://www.statista.com/
- FDA. (2019). Dupilumab approval details. https://www.fda.gov/
- IQVIA. (2022). Global biologics market report.
- Centers for Disease Control and Prevention. (2020). Eosinophilic esophagitis prevalence estimates.
- US Patent and Trademark Office. (2022). Patent expiration data for Dupilumab.
