Last updated: February 22, 2026
What is NDC 61748-0301?
NDC 61748-0301 refers to a specific drug product, identified by the National Drug Code (NDC). It corresponds to Uplizna (inebilizumab-cibget), a monoclonal antibody indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults. Approved by the FDA in 2020, Uplizna targets CD19-positive B cells, reducing relapse frequency in NMOSD patients.
Market Landscape
Existing Competition
Uplizna faces competition in the NMOSD space primarily from:
- Soliris (eculizumab) by Alexion/AstraZeneca, approved in 2019, with an estimated 90% market share in NMOSD.
- Enspryng (satralizumab) by Genentech, approved in 2020, capturing approximately 10% of the market.
- Other emerging therapies focus on complement inhibition or B-cell modulation.
Patient Population
- Estimated prevalence of NMOSD is approximately 1-10 per 100,000 globally.
- In the U.S., roughly 20,000 individuals potentially eligible.
- The typical treatment course involves administration every four weeks.
Market Size & Growth
| Year |
Estimated U.S. NMOSD Patients |
Market Value |
Growth Rate |
| 2021 |
20,000 |
$400 million |
- |
| 2025 (projected) |
22,000 |
$600 million |
10% CAGR |
The growth reflects increasing diagnosis, approval of new drugs, and broader insurance coverage.
Pricing and Reimbursement
- Uplizna is priced at approximately $37,000 per infusion.
- The treatment typically involves 12 infusions per year, leading to an annual cost of roughly $444,000 per patient.
- Reimbursement depends heavily on payer policies; private insurers and CMS have begun covering Uplizna, but with prior authorization requirements.
Price Projections and Potential Trends
Short-term (Next 1-2 Years)
- Price stability around current levels is expected.
- Manufacturers may offer rebates or discounts to accelerate market penetration.
- Payer negotiations could influence final patient costs; discounts of 10-20% are possible.
Mid-term (3-5 Years)
- Introduction of biosimilars or generic formulations is unlikely due to complexity.
- Market forces may push for price adjustments based on comparative efficacy and safety.
- As the patient pool expands, economies of scale could slightly lower per-unit costs, but overall prices may remain high.
Long-term (5+ Years)
- Competition from novel therapies may pressure prices downward.
- Potential for value-based pricing models, contingent on real-world effectiveness data.
- Price reductions of 10-30% feasible if multiple players enter or patents expire.
Regulatory and Policy Impact
- Changes in drug pricing regulations, especially in the U.S., could influence net prices.
- Policies incentivizing biosimilar development could eventually impact Uplizna’s pricing structure.
- Medicare Part D negotiations may alter reimbursement rates and patient out-of-pocket costs.
Key Drivers and Risks
| Drivers |
Risks |
| Growing NMOSD diagnosis |
Entry of biosimilars or new competitors |
| Increasing insurance coverage |
Regulatory restrictions on pricing |
| Expanded indications |
Patent challenges or legal barriers |
Summary
Uplizna (NDC 61748-0301) operates in a niche yet growing segment of immunology-focused therapeutics. Its high price point remains justified by the rarity of NMOSD and the complexity of monoclonal antibody manufacturing. Price projections suggest marginal reductions in subsequent years driven by market competition and policy changes, but significant price erosion is unlikely in the near term.
Key Takeaways
- Uplizna faces limited direct competition but dominates a niche global market.
- Annual treatment costs hover around $444,000; payer negotiations could influence net prices.
- Market expansion and policy shifts could lead to 10-30% price reductions over 5+ years.
- Biosimilars are unlikely within the short-term horizon.
- Efficacy, safety, and reimbursement policies primarily influence market penetration and pricing dynamics.
Frequently Asked Questions
Q1: How does Uplizna compare in price to its competitors?
A1: Soliris costs approximately $50,000 per infusion, totaling about $600,000 annually. Enspryng is priced similarly but with fewer infusions per year, leading to approximately $270,000 annually.
Q2: What factors could significantly alter Uplizna’s market share?
A2: Addition of new therapies, biosimilar entry, changes in reimbursement policies, and new clinical data demonstrating superior efficacy.
Q3: Are biosimilars likely for Uplizna?
A3: Biosimilar development is challenging due to the complexity of monoclonal antibodies. It is unlikely within the next 5 years.
Q4: How does insurance coverage impact patient access?
A4: Insurance policies, especially Medicare and private plans, heavily influence patient out-of-pocket costs and access. Reimbursement policies are evolving.
Q5: What are the main risks to Uplizna’s pricing power?
A5: Market entry of competitors, patent challenges, regulatory policies, and shifts toward value-based pricing models.
Citations
- U.S. Food and Drug Administration. (2020). FDA approves first treatment for neuromyelitis optica spectrum disorder.
- MarketWatch. (2022). NMOSD therapeutics market analysis.
- IBISWorld. (2023). Monoclonal antibody manufacturing industry report.
- IQVIA. (2022). U.S. pharmaceutical pricing report.
- FDA. (2021). Biosimilar development guidance.
