Last updated: February 15, 2026
Market Analysis and Price Projections for NDC 00955-1722
Description of the Drug
NDC 00955-1722 is identified as Lusutrombopag. It is marketed under the brand name Mulpleta and approved by the FDA for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.
Market Landscape
Indication and Patient Population
Lusutrombopag targets a niche segment of patients with chronic liver disease, specifically those with thrombocytopenia requiring invasive procedures. In the U.S., approximately 3 million people have chronic liver disease, with an estimated 40% experiencing thrombocytopenia, a condition that complicates surgical procedures.
Market Size and Trends
The global thrombocytopenia treatment market was valued at an estimated USD 1 billion in 2022. The segment including TPO receptor agonists like lusutrombopag represents a sizable but competitive niche. The market is projected to grow at a compound annual growth rate (CAGR) of 6-8% over the next five years, driven by increased diagnosis and procedural interventions.
Key Competitors
- Eltrombopag (Promacta, Revgam): FDA approved for similar uses but indicated for aplastic anemia and chronic immune thrombocytopenic purpura.
- Avatrombopag (Doptelet): FDA approved for thrombocytopenia associated with chronic liver disease in preparation for procedures.
- Romiplostim (Nplate): For immune thrombocytopenic purpura.
Lusutrombopag’s primary competitors are avatrombopag and eltrombopag, with the latter having broader indications but less specific for liver-related thrombocytopenia.
Regulatory Status
Approved by the FDA in 2018 for thrombocytopenia in chronic liver disease. It has also received approval in Japan and the European Union, broadening its access and potential sales.
Pricing Dynamics and Projections
Current Pricing
Pricing varies significantly by healthcare system, insurer contracts, and geographic region. In the U.S., a typical course of lusutrombopag (typically a 7-day treatment course) costs approximately USD 5,000 to USD 7,000 per treatment episode.
- Price per dose/episode: Approximately USD 700 to USD 1,000.
- Reimbursement rate: Medicare and commercial payers often reimburse at or near list price, with discounts applied.
Price Trends and Influences
- Market Competition: Slight price erosion is expected due to competitive offerings like avatrombopag, which has similar indications and pricing.
- Patent and Exclusivity: U.S. patent protection extends until 2024, with potential for extension or new patents, influencing pricing strategies.
- Manufacturing Costs: Production costs are stable, with no significant cost reduction forecasts.
Price Projection (2023-2028)
- 2023: $5,000-$7,000 per treatment course.
- 2024: Slight decline to $4,800-$6,800 due to increased competition and patent expiry.
- 2025-2028: Stabilization around $4,500-$6,500; premium pricing persists in tightly regulated markets like the U.S. and EU, with discounts in cost-sensitive markets.
Market Penetration and Revenue Projections
| Year |
Estimated Units Sold |
Revenue (USD millions) |
Notes |
| 2023 |
10,000 |
50-70 |
Established sales, initial growth |
| 2024 |
12,000 |
58-81 |
Price decline, expanded use in new regions |
| 2025 |
15,000 |
68-103 |
Broadened adoption, increased competition |
| 2026 |
18,000 |
81-117 |
Market stabilization |
| 2027 |
20,000 |
90-130 |
Mature market, steady growth |
Key Factors Affecting Future Market and Price
- Regulatory changes: New approvals or off-label use restrictions could alter demand.
- Generic development: Patent expiry may lead to generics, drastically reducing prices.
- Healthcare policies: Reimbursement reforms could impact market share.
- Adoption rates: Presentation of clinical data supporting superior efficacy or safety could increase penetration.
Key Takeaways
- NDC 00955-1722 (Lusutrombopag) is a niche, high-cost therapeutic for thrombocytopenia in chronic liver disease.
- The domestic market is competitive with close rival drugs (avatrombopag, eltrombopag), influencing price and volume.
- Current treatment costs are around USD 5,000 to USD 7,000 per episode, with gradual price erosion expected after patent expiry.
- Revenue projections suggest sales will grow modestly from USD 50 million in 2023 to over USD 100 million by 2026, barring market or regulatory shifts.
- Patent expiration in 2024 may introduce generics, significantly impacting pricing and market share.
FAQs
1. What factors could accelerate lusutrombopag’s market adoption?
Clinical data demonstrating superior safety or efficacy, expanded indications, or reimbursement policy shifts can improve adoption rates.
2. How does patent expiration impact pricing?
Patent expiry often leads to generic entry, reducing prices potentially by 60-80%, thereby decreasing revenue per unit.
3. Are there significant regional differences in pricing?
Yes. The U.S. typically has higher prices due to less price regulation, whereas European and Asian markets tend to have more government negotiation, reducing costs.
4. What are the main competitive advantages of lusutrombopag?
It offers a dosing schedule optimized for procedural timing and has a strong safety profile, especially in patients with liver impairment.
5. How might future pharmaceutical developments impact this market?
Advances in alternative thrombocytopenia treatments, gene therapies, or new mechanistic drugs could reduce demand for TPO receptor agonists.
References
- FDA Drug Approval Package for Mulpleta (Lusutrombopag) [1]
- Market Research Future, "Thrombocytopenia Market Analysis," 2022 [2]
- IQVIA, "Pharmaceutical Sales Data," 2022 [3]
- U.S. Patent and Trademark Office, patent filings related to lusutrombopag [4]
- Centers for Medicare & Medicaid Services, reimbursement policies [5]
