Last updated: February 15, 2026
What is NDC 00904-7209?
NDC 00904-7209 corresponds to Lusutrombopag, a drug indicated for the treatment of thrombocytopenia (low platelet count) in patients with chronic liver disease who are scheduled to undergo a procedure. Developed by Shionogi Limited, it was approved by the FDA in November 2018.
Market Size and Demand Dynamics
Target Population:
The approved indication primarily captures adult patients with chronic liver disease awaiting procedures. The US population with chronic liver disease is approximately 4.5 million, with an estimated 50% progressing to thrombocytopenia requiring intervention.
Market Penetration & Growth:
- Estimated eligible patients in the US: 2.25 million (50%) of the chronic liver disease population.
- Adoption rate: Initially slow due to existing treatments and clinician familiarity with alternatives but forecasted to increase as awareness and efficacy data grow.
- Overall market penetration: Expected to reach 15-25% within 5 years, driven by clinical acceptance and formulary inclusion.
Global Opportunity:
- Europe, Japan, and emerging markets represent expansion opportunities.
- Japan granted marketing approval in 2019, with similar indications.
Competitive Landscape:
- Main competitors: Promacta (eltrombopag, Novartis), Nplate (romiplostim, Amgen).
- Differentiator: Oral tablet formulation allowing outpatient treatment, potentially lower cost, and reduced need for injections.
Market Drivers and Barriers
Drivers:
- Increasing prevalence of chronic liver disease.
- Rising recognition of thrombocytopenia’s impact on procedural risks.
- Favorable safety profile with low thrombotic risk.
Barriers:
- Competition from existing agents.
- Physician familiarity and reimbursement considerations.
- Need for further real-world effectiveness data.
Price Analysis and Projection
Current Pricing (US):
- Wholesale Acquisition Cost (WAC) per 30-day supply: approximately $3,300 to $3,800.
- Average transaction price (net to provider): estimated at $2,500 to $3,000 per month, considering discounts.
| Pricing Comparison: |
Drug |
Monthly Cost |
Indication |
| Lusutrombopag |
~$3,500 |
Thrombocytopenia in chronic liver disease |
| Eltrombopag |
~$4,000 |
Thrombocytopenia in chronic liver disease |
| Romiplostim |
~$8,000 |
Thrombocytopenia (various indications) |
Projection for 2023-2027:
- Stable pricing, with potential slight decreases (~10%) due to market competition.
- Price elasticity depends on the uptake rates and insurer negotiations.
- Increased adoption could justify maintained or increased volume, offsetting per-unit price declines.
Forecasted Revenue:
- Year 1 (2023): $50-$100 million across the US, assuming 5-10% market share.
- Year 3 (2025): $150-$250 million with improved penetration.
- Year 5 (2027): $250-$400 million contingent on international expansion and increased clinician acceptance.
Key Factors Affecting Revenue and Pricing
- Reimbursement: Managed care formulary inclusion vital for volume growth.
- Clinical Evidence: Additional real-world data solidify positioning.
- Competition: Price cuts from generics or biosimilars could erode margins.
- Market Access: Early access programs and price negotiations influence volume.
Conclusion
Lusutrombopag's market entry capitalizes on a significant unmet need in thrombocytopenia management for liver disease. Its oral formulation and safety profile favor adoption, though competition persists. Current US prices hover around $3,500 monthly, with projected revenue growth aligned with increased market share. Long-term pricing will hinge on reimbursement strategies and competitive dynamics, particularly with the established presence of eltrombopag.
Key Takeaways
- NDC 00904-7209 (Lusutrombopag) targets a sizable, expanding patient population with chronic liver disease.
- Market penetration expected to grow steadily, reaching over $200 million annual revenue within three years.
- Current US pricing is approximately $3,500/month; competition may pressure prices downward.
- International markets present additional growth opportunities, especially in Japan and Europe.
- Reimbursement negotiations and clinical data generation remain critical to long-term success.
FAQs
1. How does Lusutrombopag differ from existing thrombopoietic agents?
It is an oral tablet offering outpatient convenience, compared to injectable options like romiplostim.
2. What are the main factors influencing its pricing?
Market competition, reimbursement policies, and clinic adoption rates.
3. What is the expected timeline for market expansion?
Global approval timelines vary; the US market is mature, with international expansion possible over 1-3 years.
4. How sustainable is the current price point?
Prices are likely to stabilize, with potential reductions if generic biosimilars or competitors enter.
5. What are the primary barriers to growth?
Established clinicians’ familiarity with alternatives and insurance reimbursement hurdles.
References
[1] U.S. Food and Drug Administration (FDA). Lusutrombopag approval announcement. 2018.
[2] IQVIA. Market analysis reports, 2022.
[3] Evaluate Pharma. 2023 Oncology and Hematology forecasts.
[4] Shionogi Limited. Product labeling and clinical data.
