Last updated: February 12, 2026
Overview of NDC 24208-0410
The drug identified by National Drug Code (NDC) 24208-0410 is Gilteritinib, marketed under the brand name Xospata. It is an oral kinase inhibitor indicated primarily for the treatment of relapsed or refractory acute myeloid leukemia (AML) with FLT3 mutations.
Product Profile
- Manufacturer: Astellas Pharma Inc.
- Formulation: 80 mg and 120 mg tablets
- Approved since: November 2018 (FDA)
- Indications: Treatment of FLT3-mutated AML in adult patients
Market Dynamics and Competitive Landscape
Market Size
The AML drug market is projected to reach approximately USD 2.6 billion by 2027, growing at a Compound Annual Growth Rate (CAGR) of 6.2% [1].
Key Market Players
- Gilteritinib (Xospata): First-in-class FLT3 inhibitor approved for AML.
- Competitive Agents:
- Midostaurin (Rydapt)
- Quizartinib (under review/approval in some regions)
- Other investigational FLT3 inhibitors in clinical trials
Prescriber Base
- AML treatment involves hematology/oncology specialists.
- Predominant in the US, Europe, and Japan, where AML incidence is higher.
- Estimated number of new AML cases annually: 20,000 in the US, with about 30% harboring FLT3 mutations [2].
Market Penetration & Adoption
Gilteritinib demonstrates increasing prescription rates, driven by:
- The unmet need for FLT3-targeted therapies.
- Regulatory approval expanding to second-line treatment.
- Emerging combination therapy trials.
Pricing History
- Initial Wholesale Acquisition Cost (WAC): Approximately $27,250 per 30-day supply at launch (2018).
- Current WAC: Around $28,500–$30,000 per month, adjusting for inflation and market factors.
Prices are comparable to similar targeted therapies but face pressure from biosimilars and generics in the future.
Price Projections
Short-term (1-2 years)
- Slight increases of 2-3% per year.
- Influenced by inflation, reimbursement policies, and manufacturer negotiations.
- Limited price erosion expected unless new generic competitors emerge or biosimilar versions are approved.
Mid to Long-term (3-5 years)
- Potential stabilization or marginal decrease due to market saturation.
- Price declines may occur if biosimilars or alternative FLT3 inhibitors gain market share.
- The introduction of combination regimens could shift demand patterns, impacting unit sales and pricing.
Impact of Biosimilars and Generics
- No biosimilars or generics are currently available.
- Potential entry after patent exclusivity expires, likely around 2030.
- Price reductions projected at 20-40% upon biosimilar entry.
Regulatory & Policy Factors
- Reimbursement: Coverage by Medicare, Medicaid, and private insurers influences pricing stability.
- Pricing Trends: US prices are higher compared to Europe and Asia, with limited discounts unless tied to value-based arrangements.
- Orphan Drug Designation: AML treatments often qualify, which can extend exclusivity and influence pricing.
Revenue Forecasts
| Year |
Estimated Global Sales |
Notes |
| 2023 |
USD 400 million |
Growing adoption, expanding indications |
| 2024 |
USD 430 million |
Continued market penetration |
| 2025 |
USD 440 million |
Potential plateau unless new indications or combinations emerge |
| 2026 |
USD 415 million |
Price stability expected, possible slight decline |
Risks and Opportunities
-
Risks:
- Emergence of competitive FLT3 inhibitors.
- Patent challenges or litigation.
- Reimbursement restrictions.
-
Opportunities:
- Combination therapy approvals.
- Expansion into earlier lines of AML therapy.
- Global market expansion, especially in Asia.
Summary
Gilteritinib (NDC 24208-0410) maintains a strong position in the AML targeted therapy market. Its current price levels are influenced by patent exclusivity, regulatory environment, and market adoption. Short-term prospects suggest modest price increases, with potential for decline pending biosimilar entry and competitive pressures over the next five years.
Key Takeaways
- Gilteritinib’s market growth is driven by its targeted mechanism of action and the unmet needs in FLT3-mutated AML.
- Price stability is expected with slight increases in the near term, with potential declines post-biosimilar entry.
- The total addressable market will expand as indications broaden, but competitive threats remain.
- Reimbursement policies and drug pricing regulations will significantly influence revenue trajectories.
- The evolution of combination therapies could alter demand and pricing patterns.
FAQs
Q1: When are biosimilars or generics expected to enter the market for gilteritinib?
A1: Likely around 2030, contingent upon patent expiration and regulatory approval processes.
Q2: How does gilteritinib compare economically to other AML treatments?
A2: It is priced similarly to other targeted therapies, with WAC ranging from USD 28,000 to USD 30,000 per month, prices comparable to midostaurin.
Q3: What factors could accelerate price declines?
A3: Entry of biosimilars, new competitive FLT3 inhibitors, or regulatory changes affecting pricing policies.
Q4: How does reimbursement impact gilteritinib’s market penetration?
A4: Favorable reimbursement facilitates broader access and higher sales, while restrictions can suppress demand and affect pricing power.
Q5: What is the outlook for gilteritinib’s global sales?
A5: It is expected to grow modestly in the next few years, with potential for expansion as approvals for additional indications are secured internationally.
References
[1] MarketsandMarkets. AML Therapeutics Market Forecast, 2022–2027.
[2] American Cancer Society. AML Incidence & Demographics, 2022.
[3] FDA. Drug Approvals and Labeling for Xospata (Gilteritinib), 2018.
