Last updated: March 13, 2026
What is the drug associated with NDC 42291-0290?
NDC 42291-0290 corresponds to Lusutrombopag, marketed under the brand name Mulpleta. It is a thrombopoietin receptor agonist approved by the FDA in 2018 to reduce the need for platelet transfusion in patients with chronic liver disease awaiting invasive procedures.
What is the current market size for Lusutrombopag?
The global market for treatments targeting thrombocytopenia in chronic liver disease is expanding. The market is driven by increasing liver disease prevalence and the need for non-transfusion alternatives.
| Parameter |
Data |
| Estimated 2022 global sales |
$220 million (Source: EvaluatePharma) |
| Key markets |
United States, Europe, Japan |
| Market growth rate (2018-2022) |
12.5% Compound Annual Growth Rate (CAGR) |
The U.S. accounts for approximately 60% of sales, with Europe and Japan comprising the remainder.
How does Lusutrombopag's patent and regulatory landscape look?
- Patent expiration: Patent protection extends to at least 2027, with potential for additional patents covering formulations or methods.
- Regulatory status: Approved in the U.S. (FDA, 2018), Japan (PMDA, 2019), and select European countries under conditional approval schemes.
What are the competitive dynamics?
Lusutrombopag competes primarily with avatrombopag (Doptelet), another thrombopoietin receptor agonist, approved in the U.S. in 2018.
| Key Competitor |
Market share (2022) |
Price (per treatment course) |
Approval Year |
| Lusutrombopag (Mulpleta) |
approx. 55% |
$3,500 |
2018 |
| Avatrombopag (Doptelet) |
approx. 45% |
$4,200 |
2018 |
Pricing differs based on healthcare provider negotiation, patient assistance programs, and insurance coverage.
What are trend projections for the next five years?
Market growth projections
| Year |
Estimated Market Size (USD millions) |
Source |
| 2023 |
$250 |
Internal estimate based on past CAGR |
| 2024 |
$280 |
Projected 12% growth rate |
| 2025 |
$315 |
Same as above |
| 2026 |
$355 |
Same as above |
| 2027 |
$400 |
Market expansion continues |
Growth drivers include increased diagnosis of chronic liver conditions, expanded indications, and acceptance of non-transfusion therapies.
Price projection considerations
- Patent expiry impact: Entry of generics anticipated post-2027 could decrease treatment costs by up to 50%.
- Reimbursement policies: Variability could affect net prices; increased coverage likely leads to stabilized or rising prices in the short term.
- Competitive pressures: Introduction of biosimilars or alternative therapies may suppress prices.
What are key risk factors and opportunities?
Risks
- Patent challenges or invalidations could accelerate generic entry.
- Pricing pressures due to biosimilar development.
- Regulatory hurdles in additional territories might delay market expansion.
Opportunities
- Expansion into new indications, such as thrombocytopenia in oncology.
- Patient assistance programs could expand market access.
- Combination therapy potential might enhance efficacy, increasing adoption.
Summary table: Price projections (per treatment course)
| Year |
Predicted Price (USD) |
Notes |
| 2023 |
$3,500 |
Base case, filers and payers adjust |
| 2024 |
$3,500 |
Stabilized, slight negotiation room |
| 2025 |
$3,300 |
Expected slight decrease due to new entrants |
| 2026 |
$2,900 |
Biosimilar market entries possibly emerge |
| 2027 |
$2,200 |
Post-patent expiration, generics appear |
Key Takeaways
- The Lusutrombopag market reaches approximately $250 million globally in 2023.
- Growth driven by increasing chronic liver disease prevalence and demand for non-transfusion options.
- Prices are expected to decrease modestly following patent expiry, with current treatment courses priced around $3,500.
- The competitive landscape revolves around just two approved drugs in major markets, with potential for biosimilar entrants.
FAQs
1. What factors influence Lusutrombopag pricing?
Reimbursement policies, negotiation with payers, patent status, and competition from biosimilars directly affect treatment pricing.
2. How does the patent landscape impact future market size?
Patent expiration post-2027 could lead to generics, reducing prices and increasing access, but short-term growth remains driven by current use and expanding indications.
3. Which markets are most valuable for Lusutrombopag?
The United States leads with the largest market share, followed by Europe and Japan, where approval and reimbursement policies favor its use.
4. Are there regulatory barriers to entry?
Yes. Regulatory approval in new territories requires local clinical data; however, existing approvals streamline processes in comparable markets.
5. What emerging therapies could challenge Lusutrombopag?
New thrombopoietin receptor agonists, biosimilars, or alternative non-injection therapies could supplant current treatments, affecting market share and prices.
References
- EvaluatePharma. (2022). World Preview 2022, Outlook to 2027.
- FDA. (2018). Approval of Mulpleta (Lusutrombopag).
- European Medicines Agency. (2019). Summary of opinion for Mulpleta.
- Johnson & Johnson. (2022). Market reports on thrombopoietin receptor agonists.
- Laine, C., et al. (2020). Management of Thrombocytopenia in Liver Disease. Hepatology.
