Last updated: February 24, 2026
What is NDC 72305-0150?
NDC 72305-0150 is the National Drug Code associated with a specific pharmaceutical product. Based on available data, this code corresponds to gilteritinib (brand name Xospata), a targeted therapy for specific types of acute myeloid leukemia (AML). It was approved by the FDA in November 2018 for adults with relapsed or refractory AML with an FLT3 mutation.
Market Landscape
Market Size and Patient Population
- The AML market in the U.S. was valued at approximately $1.2 billion in 2022.
- The relapsed/refractory AML segment accounts for roughly 25-30% of the AML population.
- The total number of AML cases estimated annually in the U.S. is around 20,000, with about 5,000-6,000 patients fitting the relapsed/refractory profile eligible for gilteritinib therapy.
Competition
Primary competitors include:
- Midostaurin (Rydapt): Approved since 2017 for newly diagnosed FLT3-mutated AML.
- Quizartinib (Vanflyta): Approved in Japan, awaiting broader approval outside.
- Other experimental agents and combination therapies undergoing clinical trials.
Market Share Trends
- Gilteritinib captured approximately 40% of the relapsed/refractory AML market segment as of 2022.
- Key factors influencing market share include clinical efficacy, safety profile, physician familiarity, and access.
Regulatory Environment
- FDA approval focuses on relapsed/refractory FLT3-mutated AML.
- Pending or recent approvals in Europe and Asia could influence global market dynamics.
Price Analysis
Current Pricing Strategy
- Gilteritinib's average wholesale price (AWP): approximately $23,000 to $25,000 per month.
- Typical treatment duration: 3 to 6 months depending on patient response.
- Total treatment cost: around $69,000 to $150,000 per patient.
Reimbursement Landscape
- Reimbursed largely through commercial insurance, Medicaid, and Medicare.
- Reimbursement rates vary regionally; coding guidelines (e.g., HCPCS, J-codes) support reimbursement.
Price Competitiveness
- The drug's price positions it as a mid-to-high-tier targeted AML therapy.
- Price adjustments are possible through negotiations with payers, especially for new market entrants or volume guarantees.
Future Price Projections
Key Market Drivers
- Increased adoption due to clinical trial data demonstrating improved outcomes.
- Expansion of indications and potential label updates.
- Biosimilar or generic competitors unlikely within the next 5 years due to the nature of the original compound and patent protections.
Projected Pricing Trends (2023-2028)
| Year |
Expected Average Monthly Price |
Notes |
| 2023 |
$23,000 - $25,000 |
Stable, pending market uptake |
| 2024 |
$22,000 - $24,000 |
Slight reduction predicted through payer negotiations |
| 2025 |
$21,000 - $23,000 |
Volume-based discounts may influence price |
| 2026 |
$20,000 - $22,000 |
Possible price pressure from new entrants |
| 2027 |
$19,000 - $21,000 |
Further competition and market saturation |
| 2028 |
$18,000 - $20,000 |
Long-term decline unless new indications are approved |
caveats
- Payer repricing strategies, policy changes, and market entry of competitors will modify these projections.
- Price adjustments may also occur due to inflation, drug manufacturing costs, or novel formulations.
Key Takeaways
- NDC 72305-0150 corresponds to gilteritinib, a key drug for FLT3-mutated AML.
- The drug’s market is approximately $1.2 billion in the U.S., with a steady growth trajectory driven by increasing diagnosis and improved treatment protocols.
- Current list prices are around $23,000-$25,000 per month, with total treatment costs reaching up to $150,000.
- Future prices are likely to decline gradually over the next 5 years, influenced by payer negotiations, market competition, and clinical developments.
FAQs
Q1: How does gilteritinib compare with other FLT3 inhibitors?
It shows comparable efficacy to quizartinib but has different safety and tolerability profiles, influencing physician choice.
Q2: Are biosimilars or generics expected for gilteritinib?
No. Protections related to patent rights and brand exclusivity make biosimilars unlikely within the next 5 years.
Q3: What impact will new approvals have on current pricing?
New indications or label updates can increase demand and potentially stabilize or elevate prices.
Q4: How does reimbursement impact the actual cost to patients?
Reimbursement negotiations often reduce out-of-pocket costs, but high list prices may result in significant patient co-pays unless subsidized.
Q5: Will price reductions affect market share?
Potentially, as payer-driven discounts and generics influence competitiveness, particularly if new therapies gain approval.
References
[1] IQVIA. (2022). The Global Use of Medicine in 2022. IQVIA Reports.
[2] FDA. (2018). FDA approves Xospata for AML. Food and Drug Administration.
[3] MarketWatch. (2023). AML therapeutics market analysis.
[4] GlobalData. (2022). Oncology drug forecast report.
[5] CMS. (2023). HCPCS and reimbursement guidelines. Centers for Medicare & Medicaid Services.
