Last updated: March 8, 2026
What is NDC 52817-0610?
NDC 52817-0610 corresponds to a specific drug product approved by the FDA. Based on available data, this code describes Dupixent (dupilumab), an injectable monoclonal antibody indicated for atopic dermatitis, certain asthma types, and other inflammatory conditions.
Market Overview
Current Market Size
- The global atopic dermatitis market was valued at approximately $2.8 billion in 2022.
- Dupilumab accounts for around 60% of this market share, generating approximately $1.68 billion in 2022 (source: IQVIA).
Competitive Landscape
Key competitors include:
- Tralokinumab (AstraZeneca)
- Lebrikizumab (Eli Lilly, under development)
- Traditional therapies: topical corticosteroids, immunosuppressants
Dupilumab’s superiority in efficacy and safety keeps its market dominance stable despite emerging alternatives.
Key Trends
- Increasing prevalence of atopic dermatitis and asthma globally.
- Rising adoption of biologics over traditional therapies.
- Expanding approved indications, including eosinophilic esophagitis and chronic rhinosinusitis with nasal polyps.
Price Analysis
Current Pricing Structure
- List price per injection: approximately $5,000.
- Typical dosing (for atopic dermatitis): every two weeks, with an initial loading dose.
- Annual treatment cost (average patient): roughly $40,000–$60,000, depending on dosage adjustments.
Reimbursement and Market Access
- Most payers reimburse with few restrictions for approved indications.
- High reimbursement rates sustain revenue inflows for the manufacturer.
Pricing Trends
- Price increases have been minimal (0-3% annually) since market entry, primarily due to payer pushback.
- Some payers implement prior authorization and step therapy protocols to control costs.
Price Projections
Short-term (1-2 years)
- Stable or slight increase in list price: projected growth of 1-2% annually.
- Due to inflation and manufacturing cost increases, expect prices to hover around $5,100–$5,200 per injection by 2024.
Mid-term (3-5 years)
- Data suggests potential for a modest reduction in net prices due to increased biosimilar competition and payer negotiations.
- Price per injection could decrease to approximately $4,800–$5,000.
Long-term (5+ years)
- Patent expiry in emerging jurisdictions could lead to biosimilar entry.
- Biosimilar competition: prices could drop by 30-50%, leading to a treatment cost of $2,500–$3,500 per injection.
- Market share for biosimilars remains uncertain; uptake depends on regulatory and payer policies.
External Factors Impacting Price Dynamics
- Regulatory approvals for new indications could expand patient access, stabilizing prices.
- Patent protections last until 2026 in the U.S.; biosimilar entry may accelerate thereafter.
- Insurance policies and healthcare reforms will influence reimbursement rates and net prices.
Market Growth Drivers
- Increasing patient population.
- Broader acceptance of biologics.
- Continued development of new indications.
- Expansion into emerging markets.
Challenges and Risks
- Stringent payer controls.
- Biosimilar competition lowering net prices.
- Price sensitivity among healthcare providers and patients.
Summary Table: Price and Market Data
| Metric |
2022 Data |
Projected 2024 |
Projected 2027 |
| List price per injection |
$5,000 |
$5,100–$5,200 |
$4,800–$5,000 |
| Annual treatment cost |
$40,000–$60,000 |
$41,000–$62,400 |
$45,000–$70,000 |
| Market share (Dupilumab) |
~60% |
Stable |
Slight decline with bios German biosimilars |
| Biosimilar entry |
Not licensed |
Not available |
Possible 2026+ |
Key Takeaways
- NDC 52817-0610 corresponds to Dupilumab, a leading biologic in the atopic dermatitis market.
- The market is consolidating, with high adoption driven by efficacy and safety profiles.
- Price stability is expected in the short term, with potential reductions following patent expiry and biosimilar introduction.
- Payer negotiations and healthcare policies will remain primary influences on net prices.
- Market expansion into new indications and geographies will support revenue growth.
FAQs
1. When will biosimilars for Dupilumab likely enter the market?
Biosimilars could launch as early as 2026 in the U.S., following patent expiry in 2026 [1].
2. How will biosimilar competition impact the market?
Biosimilars typically reduce prices by 30-50%, leading to decreased revenue for originator biologics and increased market accessibility.
3. What are the main regulatory hurdles for biosimilar approval?
They include demonstrating equivalence in efficacy, safety, and immunogenicity; approval pathways differ by jurisdiction.
4. Will the price per injection continue to increase?
Short-term increases will likely be minimal; long-term trends depend on biosimilar market penetration and payer negotiations.
5. How does the expansion into new indications affect market size?
New approved indications expand the patient population, increasing overall revenue and possibly supporting higher prices initially.
References
[1] U.S. Food and Drug Administration. (2022). Biosimilar Approval and Regulatory Pathways. https://www.fda.gov/drugs/biosimilars/approval-biosimilar-products
