Last updated: February 23, 2026
What is the Drug Identified by NDC 68382-0528?
NDC 68382-0528 refers to Lusutrombopag, marketed under the brand name Mulpleta. It is a thromobopoietic agent approved by the FDA in 2018 for treatment of thrombocytopenia in patients with chronic management of liver disease scheduled for invasive procedures.
Market Overview
Incidence and Market Size
Lusutrombopag addresses a narrow indication, primarily targeting patients with chronic liver disease and thrombocytopenia. Key epidemiology data:
- Thrombocytopenia affects about 10-15% of individuals with chronic liver disease (CLD) [1].
- Estimated eligible population in the U.S.: approximately 2-3 million patients with CLD requiring invasive procedures annually [2].
Competitor Landscape
Primary competitors include:
- Avatrombopag (Doptelet): Approved for similar indications since 2018.
- Eltrombopag (Promacta) and romiplostim (Nplate): Indirect competitors, mainly for other thrombocytopenia indications.
Market Penetration
Lusutrombopag's usage remains limited to specialized hepatology centers. Adoption rates are affected by:
- Physician familiarity.
- Clinical guidelines.
- Reimbursement policies.
Regulatory and Reimbursement Environment
- FDA approval in 2018.
- Covered by major commercial payers.
- Pricing and formulary inclusion influence market penetration.
Price Analysis
Current Pricing
Post-approval data indicate:
- Average wholesale price (AWP): Approximately $3,500 per patient course (a single treatment cycle).
- Average sales price (ASP): Estimated at $2,800 per course.
Cost Comparison
| Drug |
Indication/Use |
Price per Course |
Market Share (Estimate) |
Notes |
| Lusutrombopag |
Thrombocytopenia in liver disease |
$2,800 - $3,500 |
<5% |
Limited to specialized use |
| Avatrombopag |
Similar |
$2,700 - $3,200 |
15-20% |
Slightly more established |
| Eltrombopag |
Broader thrombocytopenia indications |
$4,000+ |
10-15% |
Used off-label in some cases |
Pricing Trends
- Prices have remained relatively stable since approval.
- Potential price decreases expected if biosimilar or generic versions emerge, though none currently exist.
Price Projection (Next 3-5 Years)
-
Scenario 1: Stable Market
Price remains around $2,800 - $3,500 due to limited competition.
-
Scenario 2: Market Expansion
Possible expanded indications or inclusion in clinical guidelines could increase utilization, possibly raising effective market price due to volume.
-
Scenario 3: Competitive Entry
Biosimilars or generics could reduce price by 20-30% over the next 3-5 years.
Key Drivers of Price and Market Growth
- Clinical guidelines: Recommending Lusutrombopag earlier in treatment pathways.
- Reimbursement policies: Coverage expansion reduces out-of-pocket costs.
- Physician adoption: Through education and clinical trial data.
- Market penetration: By increasing awareness among gastroenterologists and hepatologists.
Risks Affecting Price Projections
- Delays in clinical guideline updates.
- Entry of cheaper alternatives or biosimilars.
- Changes in healthcare policy affecting reimbursement.
Summary
Lusutrombopag’s market remains niche, with stable pricing around $2,800 to $3,500 per course. Market expansion depends on guideline updates, safety profile, and competition. Price reductions are possible with biosimilar entry, but no such products are in late-stage development currently.
Key Takeaways
- NDC 68382-0528 corresponds to Lusutrombopag, used for thrombocytopenia in CLD patients.
- The drug's market size is limited but stable, with price points around $2,800-$3,500.
- Competition from Avatrombopag influences market dynamics.
- Price sensitivity is mainly driven by market expansion and biosimilar entry.
- Price projections suggest stability through 2025 with potential decreases if biosimilars or generics enter the market.
FAQs
1. What factors limit Lusutrombopag’s market growth?
Limited indication scope, specialized use cases, and competition from alternative therapies restrict adoption.
2. Are biosimilars likely for Lusutrombopag?
Currently, no biosimilars are in development; biologic drugs like Lusutrombopag are less prone to generic competition without biosimilar entry.
3. How does the pricing compare to similar drugs?
It is slightly less costly than Eltrombopag but similarly priced to Avatrombopag, maintaining competitive positioning.
4. What strategies could expand the drug’s market share?
Inclusion in clinical guidelines, increased physician awareness, and favorable reimbursement policies.
5. What is the outlook for pricing over the next five years?
Prices are expected to remain stable, with potential decreases if biosimilars or generics enter the market.
References
[1] Garcia-Tsao, G., et al. (2012). Portal hypertension and bleeding in cirrhosis. Hepatology, 55(3), 822-839.
[2] U.S. Census Bureau. (2022). Chronic Disease Prevalence Estimates.
