Last updated: March 3, 2026
What is the drug associated with NDC 42291-0498?
The National Drug Code (NDC) 42291-0498 corresponds to Ublituximab, a monoclonal antibody developed by TG Therapeutics, indicated for relapsing forms of multiple sclerosis (RMS). It received FDA approval in December 2022 for adult RMS patients.
Market Overview
Indication and Demographics
Ublituximab is used in the treatment of relapsing multiple sclerosis. The global multiple sclerosis market was valued at approximately $20.3 billion in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 4.5% through 2028[1].
Competitive Landscape
Ublituximab faces competition from established therapies such as:
- Ocrelizumab (Ocrevus) — the current market leader for RMS.
- Natalizumab (Tysabri)
- Alemtuzumab (Lemtrada)
- Ofatumumab (Kesimpta)
These agents vary in mechanism, dosing regimen, and approval status, influencing market share dynamics.
Adoption Factors
Market penetration relies on:
- Efficacy profile
- Safety and tolerability
- Dosing convenience
- Pricing strategies
- Insurance coverage
Ublituximab’s differentiation as an anti-CD20 monoclonal antibody with a shorter infusion time may impact its uptake.
Price Projections
Current Pricing
Initial wholesale acquisition cost (WAC) for Ublituximab is estimated at approximately $12,000 per 300 mg vial, with typical induction doses requiring multiple vials per infusion. Standard MS dosing schedules involve intravenous infusions every six months after initial loading.
Projected Pricing Trends
- Year 1–2: With limited market penetration, pricing is expected to stabilize around $12,000 per dose.
- Year 3–5: Entry of biosimilars or improved pricing negotiations could reduce the cost by 10–20%, bringing prices down to approximately $9,600–10,800 per dose.
- Long-term (5+ years): Competitive pressures and volume growth may further lower per-dose costs to approximately $8,000–9,000.
Market Share Impact on Revenue
Assuming a conservative adoption rate of 10% of RMS patients (~100,000 globally), with an average dosing of 2 doses annually, potential revenues could reach:
| Year |
Market Share |
Patients (000s) |
Doses per Patient |
Price per Dose |
Revenue (USD millions) |
| 2023 |
1% |
1 |
2 |
$12,000 |
$24 |
| 2024 |
3% |
3 |
2 |
$12,000 |
$72 |
| 2025 |
6% |
6 |
2 |
$12,000 |
$144 |
| 2026 |
10% |
10 |
2 |
$12,000 |
$240 |
Growth assumptions depend on clinical data, positioning, and payer acceptance.
Price Sensitivity and Payer Negotiations
Health plans may push for discounts, especially with broader MS portfolios. Rebates and formularies could influence achievable net prices, potentially reducing profit margins.
Policy and Regulatory Considerations
- Pricing regulations: No caps currently. Future legislative moves could affect pricing strategies.
- Biosimilar development: Ongoing biosimilar research could impact market share and pricing.
Key Takeaways
- Ublituximab’s initial price likely around $12,000 per dose.
- Long-term prices may decrease to approximately $8,000–10,000 due to market forces.
- Revenue depends heavily on market penetration, competitive landscape, and payer negotiations.
- Competitive advantages such as infusion time and safety profile could influence adoption.
- Overall market growth supports potential for increased sales, but pricing pressures may limit margins over time.
FAQs
-
When did FDA approve Ublituximab?
December 2022.
-
What is the primary indication?
Relapsing multiple sclerosis.
-
What are the main competitors?
Ocrelizumab, natalizumab, alemtuzumab, ofatumumab.
-
What is the approximate initial price?
Around $12,000 per dose.
-
How might prices change in the next five years?
They could decrease to about $8,000–10,000 due to biosimilar entry and market competition.
References
[1] Global Market Insights. (2022). Multiple sclerosis treatment market size and forecast. Retrieved from https://www.gminsights.com
