Last updated: February 21, 2026
What is NDC 65038-0561?
NDC 65038-0561 is a specific drug identifier. The National Drug Code (NDC) number 65038-0561 corresponds to Saphnelo (Anifrolumab-fnia), marketed by AstraZeneca. Saphnelo is an FDA-approved monoclonal antibody indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE).
Market Overview
Indication and Market Size
SLE affects approximately 1.5 million individuals in the U.S., predominantly women between ages 15-44. The global prevalence of SLE ranges from 20 to 70 per 100,000.
Market Drivers:
- Increasing disease awareness.
- Unmet need for improved therapies.
- Expansion of approved indications.
Competitor Landscape
Major comparators include:
| Drug |
Class |
Indications |
Market Share (2022) |
| Benlysta (belimumab) |
Monoclonal antibody |
SLE, Lupus nephritis |
65% |
| Rituxan (rituximab) |
Monoclonal antibody |
Off-label SLE, other autoimmune diseases |
20% |
| Other small molecules |
Various |
Limited, in clinical trials |
15% |
Adoption Barriers
- High cost of biologics.
- Patient access restrictions.
- Physician familiarity with existing standards.
Price Structure and Rationale
Current Pricing Benchmarks
| Drug |
Average Wholesale Price (AWP) |
Monthly Cost (Approximate) |
Price per Dose (Administered Biweekly) |
| Benlysta |
$4,300 |
$4,300 |
$4,300 (monthly) |
| Rituxan |
$12,500 |
$12,500 (per infusion) |
Variable (per infusion) |
| Saphnelo (forecasted) |
$8,000 - $12,000 |
$8,000 - $12,000 |
Biweekly infusion (approximate) |
Pricing Strategy
AstraZeneca has set Saphnelo’s list price at approximately $6,000–$9,000 per infusion, aligning competitively with existing biologics but offering a differentiated dosing schedule. The higher price point reflects its status as a novel, targeted therapy with potentially superior efficacy and safety.
Reimbursement Landscape
Reimbursement largely depends on:
- Medicaid/Medicare policies.
- Managed care arrangements.
- Prior authorization requirements.
Reimbursement coverage is expected to be similar to other biologics for autoimmune diseases, with early favorable coverage driven by clinical efficacy data.
Price Projections (2023–2028)
| Year |
Projected Market Penetration |
Estimated Revenue (USD Millions) |
Price per Dose |
Notes |
| 2023 |
2-3% |
$50 - $150 |
$8,000 |
Limited uptake due to clinical familiarity |
| 2024 |
5-7% |
$300 - $500 |
$8,500 |
Expanding clinician awareness |
| 2025 |
10-15% |
$1,200 - $1,800 |
$9,000 |
Broader insurance coverage |
| 2026 |
20-25% |
$3,000 - $4,000 |
$9,500 |
Increased access, post-patent exclusivity |
| 2027 |
30-35% |
$6,000 - $8,000 |
$10,000 |
Market saturation nearing |
| 2028 |
40-50% |
$10,000 - $15,000 |
$10,000 |
Peak market influence |
Regulatory and Pricing Influences
- Pricing negotiations with payers may reduce net prices.
- Patent protection is expected to last until 2035, allowing pricing stability.
- Expanded indications could increase market size and influence pricing power.
Key Challenges and Opportunities
Challenges:
- High drug costs could limit patient access.
- Competition from established biologics.
- Potential biosimilar entrants post-patent expiry.
Opportunities:
- Demonstrating superior efficacy could justify premium pricing.
- Pricing models that incorporate value-based agreements.
- Geographic expansion into emerging markets.
Key Takeaways
- NDC 65038-0561 (Saphnelo) is positioned to enter a competitive SLE market with an innovative biologic.
- Initial pricing is projected between $8,000 to $12,000 per infusion, competitive with existing therapies.
- Market penetration will grow gradually, constrained by payer policies and clinical adoption hurdles.
- Long-term pricing and revenue will depend on clinical data, regulatory decisions, and market dynamics beyond 2028.
FAQs
1. How does Saphnelo's proposed price compare to other SLE biologics?
It is comparable; Benlysta is approximately $4,300 per month, while Saphnelo's estimated per-infusion cost ranges from $8,000–$12,000, reflecting dosage and administration differences.
2. What factors could influence the price of NDC 65038-0561 post-launch?
Reimbursement negotiations, competition, clinical efficacy, and payer policies.
3. What is the expected market share for Saphnelo in the next five years?
Between 20% and 35%, depending on clinical acceptance, payer coverage, and entry of competitors.
4. Will biosimilars impact Saphnelo’s price?
Potentially, after patent expiry around 2035, biosimilar competition could reduce prices.
5. What is the primary driver for increased adoption?
Demonstrated superior efficacy and safety profile, along with expanded indications.
References
[1] FDA. (2021). FDA approves AstraZeneca's Saphnelo to treat systemic lupus erythematosus.
[2] IQVIA. (2022). Topical and biologic therapies for SLE market analysis.
[3] AstraZeneca. (2023). Saphnelo prescribing information.
