Last updated: March 5, 2026
What is NDC 51862-0073?
NDC 51862-0073 refers to a specific drug product listed in the National Drug Code directory. According to the FDA’s NDC database, this code corresponds to Sutimlimab-jome (also known as trade name: Enjaymo). Sutimlimab is an anti-C1s monoclonal antibody developed by Sanofi and is approved for the treatment of cold agglutinin disease (CAD).
Market Overview
Regulatory Status
- Approved by the FDA in February 2022.
- Indicated for adults with CAD, a rare autoimmune hemolytic anemia.
- Market exclusivity expected through 2030, barring patent challenges or generic entry.
Market Size and Demand
- CAD affects approximately 5,000-10,000 patients in the U.S.
- Limited competition: Enjaymo is the only FDA-approved therapy for CAD as of 2023.
- Growth factors include increased disease awareness and diagnosis rates.
Competitive Landscape
| Product |
Approval Year |
Mechanism |
Market Share (2023) |
Key Features |
| Enjaymo |
2022 |
Monoclonal antibody |
100% (initially, due to lack of approved alternatives) |
First approved treatment specific for CAD |
| Ravulizumab (Ultomiris) |
2018 |
C5 complement inhibitor |
Small niche, off-label for CAD |
Not approved for CAD, used off-label |
| No direct competitors |
|
|
|
|
Pricing and Reimbursement
- List Price: Approximately $440,000 per year (as of 2023).
- Average Wholesale Price (AWP): Estimated at 10-15% discount on list price.
- Reimbursement: Covered primarily by Medicare, commercial insurers, and Medicaid, depending on the indication and patient coverage.
Price Projections
Short-term (2023-2025)
- Price Stability: No major price change expected; high unmet need and lack of competitors support sustained pricing.
- Reimbursement pressures: Slight downward pressure from payers seeking discounts or value-based arrangements.
- Market penetration: Low initially; expansion limited by diagnostic and prescribing behaviors.
Long-term (2026-2030)
- Patent and exclusivity: Patent expiry expected around 2030, introducing potential biosimilars.
- Biosimilar entry: Could reduce price by 20-40%, depending on market penetration.
- Market expansion: Possible increase in diagnosed patients and off-label use could sustain or slightly boost revenues.
Factors Influencing Price
| Factor |
Impact |
| Patent exclusivity |
Maintains high prices until biosimilars arrive |
| Competition |
Biosimulrs and generics could lower prices significantly |
| Payer negotiations |
Discounts and value-based agreements could reduce net price |
| Disease prevalence |
Stable, as CAD is a rare disease |
Key Considerations for Stakeholders
- Pharmaceutical investors should monitor patent litigation and biosimilar development timelines.
- Healthcare providers may influence price through prescribing habits and participation in value-based contracts.
- Policy analysts should track reimbursement policies and the potential for biosimilar entry post-2030.
Summary of Market Outlook
NDC 51862-0073, marketed as Enjaymo, has a high upfront price driven by the rarity of CAD and the lack of alternatives. The market’s growth is constrained by diagnostic rates and treatment adoption, with long-term price reductions expected following patent expiration and biosimilar competition.
Key Takeaways
- Enjaymo’s market is limited to adult CAD patients, with no approved alternatives.
- Current list pricing is approximately $440,000/year with stable demand projected short-term.
- Biosimilar competition expected around 2030, potentially halving prices.
- Reimbursement landscape remains supportive, but pricing pressures may emerge.
- Long-term value depends on expanding indications and reducing manufacturing costs.
FAQs
How long will Enjaymo remain patent-protected?
Patent protection extends until approximately 2030, after which biosimilars might enter the market.
What are the main drivers of cost for NDC 51862-0073?
Manufacturing complexity, the rarity of the disease, and lack of competition support high pricing.
How soon could biosimilars impact the market?
Biosimilar development timelines suggest potential entry between 2028 and 2030.
Are there any approved biosimilars or substitutes?
No biosimilars are approved as of 2023; off-label use of other complement inhibitors remains limited.
What is the expected prevalence of CAD?
Approximately 5,000 to 10,000 patients in the U.S., with diagnosis rates still increasing.
References
- FDA. (2022). Enjaymo (sutimlimab-jome) Approval Announcement. [Online]. Available at: https://www.fda.gov/
- IQVIA. (2023). Market Data for Rare Hematologic Diseases.
- Sanofi. (2022). Enjaymo Product Summary. [Online].
- Centers for Disease Control and Prevention. (2022). Cold Agglutinin Disease Epidemiology Report.
