Last updated: February 28, 2026
What is NDC 69367-0397?
NDC 69367-0397 refers to a specific drug identified in the National Drug Code (NDC) system. The NDC indicates the product's manufacturer, formulation, strength, and package size. This code corresponds to Xospata (gilteritinib), a FLT3 inhibitor approved by the FDA for treatment of relapsed or refractory acute myeloid leukemia (AML) with FLT3 mutations.
Market Overview
FDA Approval and Indication
- Approval Date: November 2018.
- Indication: Treatment of adult patients with relapsed or refractory AML with FLT3 mutations.
- Mechanism: Inhibits FLT3 receptor tyrosine kinase, blocking proliferation of leukemia cells.
Market Size
- AML represents approximately 20,000 new cases annually in the United States.
- Approximately 30-40% of AML cases have FLT3 mutations.
- Estimated target population: 6,000-8,000 patients in the U.S. per year.
Competitive Landscape
- Existing FLT3 inhibitors include Midostaurin (approved 2017) and Quizartinib (under review or in early market phases).
- Xospata entered a niche with limited direct competition but faces pricing and reimbursement challenges.
Key Industry Players
- AbbVie (manufacturer).
- Collaborates with healthcare providers and payers for coverage.
Pricing Analysis
Current Price Points
- Average wholesale price (AWP): Approximately $29,000 per month.
- Per treatment cycle: Typically 1-3 months, depending on the patient response.
- Annual treatment cost: Estimated at $87,000 – $290,000.
Pricing Benchmark Comparison
| Drug |
Indication |
Monthly Price |
Approximate Annual Price |
| Gilteritinib (NDC 69367-0397) |
AML FLT3+ (refractory/relapsed) |
$29,000 |
$87,000 |
| Midostaurin |
AML FLT3+ (newly diagnosed) |
$25,000 |
$250,000 |
| Quizartinib |
AML FLT3+ (in development) |
$\sim$ $30,000 |
Under review |
Price Trends and Projections
- Currently stable, with potential for reduction as biosimilars or generics are developed.
- Possible discounts for bulk or specialty pharmacy agreements.
- Price adjustments may follow reimbursement policies, particularly if new competitors enter.
Market Dynamics and Cost Factors
Insurance and Reimbursement
- Majority of costs supported via Medicare, Medicaid, private insurers.
- Reimbursement policies influence net prices significantly.
- Cost-effectiveness analyses favor targeted therapies like Xospata, enhancing coverage prospects.
Patent and Patent Expiry
- Patent protection until approximately 2030.
- No generic approvals yet; potential generic entry post-2030 could reduce prices by up to 80%.
Future Market Growth
- Increased awareness and genetic testing for FLT3 mutations.
- Expansion into earlier treatment lines remains under exploration.
- Market growth projected at a compound annual growth rate (CAGR) of 7-10% over next five years.
Strategic Considerations
- Launching biosimilars or generics before patent expiry could substantially reduce prices.
- Drug pricing strategies should align with value-based care initiatives.
- Expansion into international markets may influence global price levels, often lower than U.S. benchmarks.
Key Takeaways
- The current U.S. average price of NDC 69367-0397 (gilteritinib) is approximately $29,000 per month.
- The target patient population is about 6,000-8,000 annually, with significant growth prospects.
- Compound annual growth rate for the market is projected at 7-10%.
- Price reductions are likely post-patent expiry, especially with biosimilars.
- Reimbursement and insurance policies greatly influence net market penetration.
FAQs
Q1: When is patent expiry expected for gilteritinib?
A1: Patent protection is expected until around 2030, after which biosimilar competition could emerge.
Q2: Are there approved biosimilars or generics for gilteritinib?
A2: No biosimilars or generics are approved currently; potential entry could occur post-2030.
Q3: What is the main driver for future price reductions?
A3: Entry of biosimilars or generics and market competition will drive prices downward.
Q4: How does insurance reimbursement impact drug pricing?
A4: Insurance policies influence net prices through negotiated discounts, coverage criteria, and formulary placement.
Q5: Are any new indications or line-of-therapy approvals expected?
A5: Clinical trials are exploring extending gilteritinib’s use to earlier lines of AML treatment, which could impact market size and pricing.
References
[1] U.S. Food and Drug Administration. (2018). FDA approves Xospata for AML with FLT3 mutation.
[2] IQVIA. (2022). Prescription Drug Market Data.
[3] Evaluate Pharma. (2022). Oncology drug market forecasts.
[4] Centers for Disease Control and Prevention. (2021). Leukemia Statistics.
[5] Kaiser Family Foundation. (2022). Reimbursement and Insurance Coverage Data.
