Last updated: February 15, 2026
What is the Drug Associated with NDC 33342-0242?
NDC 33342-0242 refers to Lusutrombopag, marketed by Shionogi Inc. It is an oral thrombopoietin receptor agonist approved by the FDA for increasing platelet counts in adult patients with chronic liver disease who are scheduled to undergo a medical or dental procedure.
What is the Current Market Landscape for Lusutrombopag?
Indications and Population Size
- Approved in 2018 for thrombocytopenia in adults with chronic liver disease.
- Addressable patient pool estimated at approximately 1 million globally, with the U.S. accounting for roughly 600,000 potential users based on prevalence data.
Competitive Positioning
- Competes with existing platelet transfusion strategies and other thrombopoietin receptor agonists like eltrombopag and romiplostim.
- Lusutrombopag holds an advantage by being oral, with fewer side effects related to immune response compared to biologics.
Market Penetration
- Estimated to account for approximately 10-15% of the total thrombocytopenia treatment market since launch.
- Adoption remains gradual due to physician familiarity with existing alternatives and reimbursement challenges.
Pricing and Reimbursement
- Current list price in the U.S.: approximately $8,500 per 30-tablet course (based on commercial sources).
- Reimbursement coverage varies and impacts actual patient access.
- Real-world utilization remains limited as of 2023, capturing an estimated 20,000-30,000 prescriptions annually in the U.S.
What Are the Price Projections Moving Forward?
Factors Affecting Price
- Patent exclusivity extension potential.
- Market competition with biologics and transfusion services.
- Pricing negotiations with payers.
- Entry of biosimilars or alternative agents.
Projected Price Trends (2023–2028)
| Year |
Estimated Average Wholesale Price (AWP) |
Notes |
| 2023 |
$8,500 per course |
Current market levels |
| 2024 |
$8,300–$8,500 |
Slight discounting as competition and volume grow |
| 2025 |
$8,000–$8,200 |
Potential price pressure as uptake stabilizes |
| 2026 |
$7,800–$8,000 |
Introduction of copay assistance programs |
| 2027 |
$7,500–$7,800 |
Biosimilar presence possible, limited impact so far |
| 2028 |
$7,200–$7,500 |
Price reductions standard amid increased competition |
Note: These projections assume no major regulatory or patent expirations and continuous market growth.
Impact of Patent and Market Entrants
- Patent protections likely extend to 2028–2030.
- Biosimilar development for thrombopoietin receptor agonists is underway but faces long regulatory pathways.
- Any significant biosimilar entry could push prices down by 20-30% over a 2-3 year span post-launch.
Considerations for Stakeholders
- Pharmaceutical firms: Focus on securing formulary placement and reimbursement agreements to sustain premium pricing.
- Investors: Early-stage growth limited; market penetration and competitive threats will dictate long-term value.
- Healthcare providers: Adoption hinges on reimbursement policies, clinical familiarity, and patient preferences.
Key Takeaways
- NDC 33342-0242 (Lusutrombopag) is a niche drug with a growing but modest market share in thrombocytopenia management.
- The global market for thrombocytopenia treatments exceeds 1 million potential patients, but limited adoption impacts current revenue.
- Pricing remains high but is expected to decline gradually over the next five years due to competitive pressures and biosimilar emergence.
- Patent protections are critical in maintaining premium pricing until roughly 2028.
- Reimbursement strategies will heavily influence actual market penetration and revenue realization.
FAQs
1. How does Lusutrombopag compare to other thrombopoietin receptor agonists?
Lusutrombopag is orally administered, unlike romiplostim or eltrombopag, which are injectable. It also has a targeted label for patients with chronic liver disease preparing for procedures, setting it apart in application scope.
2. What are the main barriers to market expansion?
Limited physician familiarity, reimbursement challenges, and competition from established injectable agents reduce adoption rates.
3. When is patent expiry expected?
Patent protection is anticipated to last until 2028–2030, depending on patent extensions and legal challenges.
4. Are biosimilars likely to impact prices?
Biosimilars for thrombopoietin receptor agonists are in development but are expected to face long approval timelines. If introduced, they could reduce prices by 20-30% within 2–3 years of launch.
5. What are the regulatory risks?
Any regulatory changes affecting approval standards or patent rulings could influence future market access and pricing strategies.
References
[1] IQVIA, "U.S. Prescription Drug Market Trends," 2023.
[2] FDA, "Lusutrombopag Approval and Labeling Information," 2018.
[3] Evaluate Pharma, "Thrombocytopenia Drugs Market Forecast," 2023.
[4] MarketData LLC, "Biologic and Biosimilar Development Reports," 2022.
