Last updated: February 13, 2026
What is NDC 64380-0200?
NDC 64380-0200 refers to a specific pharmaceutical product registered in the National Drug Code system. It is identified as a vial of Ublituximab-xiik (brand name: Briumvi), marketed for the treatment of multiple sclerosis (MS) and other autoimmune diseases. Ublituximab is a chimeric monoclonal antibody targeting CD20 on B cells.
Market Landscape
Product Status:
- Ublituximab received FDA approval on December 30, 2022, for relapsing forms of multiple sclerosis.
- It was developed by TG Therapeutics, Inc.
- The product entered the MS treatment space alongside established therapies like ocrelizumab (Ocrevus), rituximab, and ofatumumab.
Competitive Position:
- Ublituximab is positioned as a potentially differentiated B-cell depleting therapy, with a dosing regimen of every six months, which is less frequent than some competitors.
- Its efficacy data shows comparable or improved disease control, leading to early adoption and licensing in major markets.
Market Size:
- Global MS market was valued at approximately USD 21.4 billion in 2022, projected to grow annually at 3.8% through 2030 [1].
- The US accounts for 50% of global sales, with an estimated 1 million MS patients in the US as of 2022 [2].
- Estimated Ublituximab sales could reach USD 500 million annualized within the first 3 years post-commercialization, contingent on prescriber uptake and formulary access.
Pricing Trends:
- Benchmarking against ocrelizumab (Ocrevus), which has a list price of USD 65,000 per year [3], Ublituximab’s initial pricing is projected at USD 62,000 to USD 68,000 annually.
- The price could decline over time with biosimilar competition or payer negotiations.
Price Projections
Initial Year (2023-2024):
- Launch price set at USD 65,000 per year, aligning with existing high-efficacy MS therapies.
- Wholesale Acquisition Cost (WAC) for a typical 20 mg vial (NDC 64380-0200) is projected around USD 2,200 based on comparable monoclonal antibody pricing.
Volume and Revenue Assumptions:
- First-year prescriptions: 8,000 to 10,000 courses.
- Average patient treatment duration: 12-24 months.
- Revenue forecast: USD 130 million to USD 250 million in the first fiscal year.
Long-term Trends (2025-2030):
- Dosing schedule, efficacy, and safety profile influence clinician adoption.
- Price reductions are expected as biosimilars and competitors penetrate the market.
Pricing Sensitivity Factors:
- Payer negotiations may reduce prices by 10-20%.
- Biosimilar entrants could lower prices by 15-30% within 5 years.
- Patient assistance programs could impact net pricing.
Key Drivers and Risks
Drivers:
- Unique dosing schedule (semi-annual infusion).
- Favorable efficacy and safety profile.
- Growing MS patient population.
Risks:
- Market share dilution due to biosimilar competition.
- Delays or limitations in insurance reimbursement.
- Emerging clinical data favoring alternative agents.
Summary of Price Forecast
| Year |
Expected WAC per vial |
Projected Annual Revenue |
Assumptions |
| 2023 |
USD 2,200 |
USD 130-150 million |
Launch in initial markets, limited competition |
| 2024 |
USD 2,200 - 2,000 |
USD 150-200 million |
Increasing market penetration |
| 2025-2027 |
USD 1,800 - 2,000 |
USD 200-250 million |
Biosimilars enter, price pressure increases |
Conclusion
NDC 64380-0200 (Ublituximab-xiik) has entered a competitive MS treatment market with an initial pricing aligned to high-efficacy monoclonal antibodies. Revenue and price trajectories depend tightly on prescriber acceptance, payer coverage, and biosimilar market entry. Prices are expected to stabilize or decline marginally over the next 3-5 years.
Key Takeaways
- The drug is positioned as a semi-annual MS monoclonal antibody, targeting a growing market.
- Initial pricing is comparable to existing high-efficacy MS therapies, with a WAC of USD 2,200 per vial.
- Total revenue projections for 2023-2024 estimate USD 130-200 million, influenced by market access.
- Biosimilar competition could generate a 15-30% price reduction within 5 years.
- Market growth depends on clinical data, adoption rate, and insurance reimbursement strategies.
FAQs
1. How does Ublituximab compare to existing MS therapies in price?
It is priced similarly to Ocrevus, with a WAC around USD 2,200 per vial, translating to about USD 65,000 annually per patient.
2. What factors could influence the price decline over the next few years?
Biosimilar competition, payer negotiations, and market saturation are primary drivers of price reduction.
3. What is the estimated market share for Ublituximab in the initial years?
It could capture 10-15% of the relapsing MS market within the first 2 years, depending on clinician and payer acceptance.
4. Are there any regulatory or patent issues influencing pricing?
Patent protections extend at least 10 years, but biosimilars are expected to enter sooner, putting downward pressure on seal prices.
5. What is the potential for international expansion?
High; with regulatory approvals, markets like Europe and Asia could adopt Ublituximab, expanding revenue streams.
References
[1] Persistence Market Research, “Multiple Sclerosis Market Analysis,” 2022.
[2] National Multiple Sclerosis Society, “MS in the U.S.,” 2022.
[3] GoodRX, “Ocrevus Price,” 2022.
