Last updated: February 13, 2026
What is the Drug NDC 65862-0937?
NDC 65862-0937 corresponds to Sarclisa (isatuximab-irfc), a monoclonal antibody approved by the FDA in 2020 for multiple myeloma. It is typically used in combination with other therapies for relapsed or refractory multiple myeloma (RRMM). Sarclisa is marketed by Sanofi.
Current Market Landscape
Market Size and Patient Population
The multiple myeloma market is expanding with increasing diagnosis rates. Several factors influence the market size for Sarclisa:
- Prevalence: Approximately 35,000 new cases annually in the U.S. (per American Cancer Society, 2022).
- Treatment landscape: Multiple targeted therapies, including proteasome inhibitors and immunomodulatory drugs.
- Line of therapy: Sarclisa is approved for use in relapsed/refractory settings, primarily second-line and beyond.
Key Competitors
Major drugs competing with Sarclisa include:
- Darzalex (daratumumab) by Janssen
- Empliciti (elotuzumab) by Bristol-Myers Squibb
- Revilimid (carfilzomib) by Amgen
Market penetration is influenced by efficacy, safety profiles, administration routes, and approval scope. Darzalex remains the dominant monoclonal antibody, with an estimated 65% market share in monoclonal antibody therapy for MM.
Market Penetration and Adoption
Since launching in 2020, Sarclisa has seen gradual uptake:
- U.S. sales estimates: Approximate $100 million in 2022.
- Physician adoption: Limited to specialist oncologists due to target patient profile and reimbursement pathways.
Pricing and Reimbursement Status
- List price (2022): Around $11,000 per 20 mg vial.
- Cost per treatment cycle: Approximately $60,000, assuming standard dosing regimens.
- Reimbursement: Covered by Medicare and private insurers, with negotiated discounts impacting net pricing.
Pricing Trends and Projections
Current Price Point
The average wholesale price (AWP) per vial stands at $11,000, with variations depending on negotiated reimbursements, discounts, and patient assistance programs. Typical treatment involves multiple vials per cycle.
Future Price Trajectory
Price projections depend on multiple factors:
- Market penetration: As adoption increases, pricing could stabilize or slightly decline due to competitive pressure.
- Patents and exclusivity: Patent expiration unlikely before 2030, maintaining patent exclusivity until then.
- Reimbursement policies: Potential price negotiations with payers could influence net prices.
Pricing in the Next 3 Years
- Conservative estimate: Slight decrease (~5%) in list prices due to increased competition.
- Aggressive estimate: Stable pricing with small inflation adjustments (~2%) annually, driven by inflation and demand.
| Year |
Estimated List Price per Vial |
Comments |
| 2023 |
$11,000 |
Baseline |
| 2024 |
$10,780 (3% decline) |
Competitive pressure |
| 2025 |
$10,560 (2% increase) |
Market stabilization |
Net prices and adoption rates could differ based on health policy changes, patent status, and clinical trial results.
Market Growth and Revenue Forecasts
Revenue Projections (U.S. Market)
| Year |
Estimated Revenue |
Notes |
| 2023 |
$150 million |
Increasing market penetration |
| 2024 |
$200 million |
Broader adoption |
| 2025 |
$250 million |
Competitive saturation, price stabilization |
total revenue depends on the number of patients treated, dosing regimens, and payer contracts encountered.
Global Market Outlook
- Limited initial global distribution; expansion expected in Europe and Asia starting 2024.
- Pricing strategies in other markets may differ due to local reimbursement policies.
Key Drivers and Risks
Drivers
- Efficacy demonstrated in multiple myeloma treatment lines.
- Increasing diagnosis rates.
- Combination therapy growth.
Risks
- Expiry of patents and biosimilar entry post-2030.
- Market share erosion by competing monoclonal antibodies.
- Reimbursement restrictions.
Summary
| Aspect |
Details |
| Current Price |
Approximate list price of $11,000 per vial |
| Market Size |
U.S. multiple myeloma treatment market, approx. $5 billion |
| Market Growth |
Expected 20-30% CAGR for monoclonal antibody segment |
| Price Trend |
Slight decrease (~5%) over the next three years |
Key Takeaways
- Sarclisa (NDC 65862-0937) is a relatively new entrant in multiple myeloma therapy, with increasing adoption.
- Current pricing remains high with anticipated slight decreases due to market competition.
- Revenue growth depends significantly on treatment uptake, reimbursement landscape, and competitor dynamics.
- Key risks include patent expiration and biosimilar competition, potentially reducing prices after 2030.
FAQs
Q1: When does Sarclisa's patent expire?
A1: Patents are expected to extend until at least 2030, with potential for extension based on patent strategies.
Q2: How does Sarclisa compare price-wise to Darzalex?
A2: Darzalex's list price is around $14,000 per vial, making Sarclisa slightly less expensive but similar in overall costs per treatment cycle.
Q3: What is the main driver for Sarclisa's revenue growth?
A3: Increasing adoption in relapsed multiple myeloma patients and expanding combination therapy approvals.
Q4: How might biosimilars impact Sarclisa's future pricing?
A4: Biosimilar entry post-2030 could lead to significant price reductions, possibly 20-30% below current levels.
Q5: Which regions are the focus for Sarclisa expansion?
A5: Europe and Asia are primary targets, with regulatory approvals expected from 2024 onward.
Sources
[1] American Cancer Society. "Cancer Facts & Figures 2022."
[2] FDA. "Sarclisa (isatuximab-irfc) Approval Details."
[3] IQVIA. "Pharmaceutical Market Data 2022."
[4] Sanofi. "Sarclisa Prescribing Information."
