Last updated: February 24, 2026
What is NDC 82009-0133?
NDC 82009-0133 is the National Drug Code for Gilteritinib, marketed under the brand name Xospata. It is an FDA-approved targeted therapy for relapsed or refractory acute myeloid leukemia (AML) that harbors FLT3 mutations.
Market Size and Adoption Trends
Current Market Landscape
- Prevalence of AML: Approximately 20,000 new cases annually in the U.S. (SEER, 2021).
- FLT3 Mutation Incidence: Present in 25-30% of AML cases, translating to about 5,000-6,000 eligible patients per year.
- Xospata's Sales Data: Estimated global sales of approximately $250 million in 2022, with the U.S. accounting for 70% of revenue (EvaluatePharma, 2023).
Competitive Positioning
- Key Competitors: Midostaurin (Rydapt), quizartinib (Vanflyta, investigational in many regions), and emerging FLT3 inhibitors.
- Market Entry: Launched in 2018 by Astellas Pharma after FDA approval in 2018.
Adoption Drivers
- Regulatory Approvals: Approved by FDA for FLT3-mutated AML in 2018.
- Clinical Efficacy: Demonstrates improved median overall survival (~9.2 months vs. 5.6 months with chemotherapy alone in trials).
- Prescribing Patterns: Increasing use in relapsed/refractory cases, with some expansion into frontline therapy in clinical trials.
Market Penetration
- Estimated Penetration: 25-30% in eligible patient population in 2022.
- Forecast for 2023-2027: Penetration expected to rise to 40-50% as awareness and clinical utilization expand.
Pricing Analysis
Current Pricing Structure
- Wholesale Acquisition Cost (WAC): Reported at approximately $14,250 per month per patient (GoodRx, 2023).
- Average Annual Cost: Approximately $170,000 per patient.
- Pricing versus Competitors: Slightly higher compared to midostaurin (~$13,000/month), justified by superior efficacy and targeted indication.
Reimbursement and Payer Trends
- Insurance Coverage: Generally broad, with majority of commercial payers and Medicare Part D covering Xospata.
- Out-of-Pocket Costs: Average patient copay ranges from $20 to $50 per month due to assistance programs.
Price Projection Factors
- Market Growth: Driven by increased adoption and expanded indications.
- Pricing Trends: Likely to experience stabilization or slight increase (~3-5% annually) owing to inflation and value-based pricing models.
- Regulatory Changes: Potential price negotiations or formulary restrictions could mildly influence net pricing.
Future Price and Market Projections (2023-2027)
| Year |
Estimated Market Penetration |
Projected Sales (USD millions) |
Pricing per Patient (USD) |
Notes |
| 2023 |
30% |
290 |
$14,250 |
Current pricing, increasing adoption |
| 2024 |
35% |
330 |
$14,400 |
Slight price increase aligned with inflation |
| 2025 |
40% |
370 |
$14,600 |
Broader indications could stabilize pricing |
| 2026 |
45% |
410 |
$14,750 |
Market saturation approaches |
| 2027 |
50% |
450 |
$14,850 |
Price stabilization with increased volume |
Assumptions: steady clinical adoption, no significant policy shifts, and consistent reimbursement patterns.
Key Takeaways
- Gilteritinib (NDC 82009-0133) has a growing market primarily driven by FLT3 mutation prevalence in AML.
- Annual market sales are projected to approach $400-500 million by 2027 with increased penetration.
- Current pricing at approximately $14,250/month is aligned with market expectations; slight increases are anticipated.
- Competition primarily centers on midostaurin, with future entrants potentially impacting pricing.
- Reimbursement trends favor broader coverage, supporting revenue stability.
FAQs
Q1: What patient population is most likely to benefit from Gilteritinib?
Patients with relapsed or refractory AML harboring FLT3 mutations.
Q2: How does the efficacy of Gilteritinib compare to competitors?
It demonstrates superior median overall survival (9.2 months) versus traditional chemotherapy, with targeted action offering better outcomes in FLT3-mutated AML.
Q3: What factors could influence future pricing?
Regulatory changes, market competition, reimbursement negotiations, and adoption rates.
Q4: Are there plans for expanding the approved indications?
Ongoing clinical trials are exploring frontline use and combination therapies, which could expand the market.
Q5: What is the primary driver for U.S. market penetration?
FDA approval and increasing clinician familiarity with targeted FLT3 therapies.
References
- SEER Cancer Statistics Review (2021). National Cancer Institute.
- EvaluatePharma (2023). Commercial Insights.
- GoodRx (2023). Medication Pricing Data.
