Last updated: February 21, 2026
What is NDC 70748-0130?
NDC 70748-0130 corresponds to Xospata (gilteritinib), marketed by Astellas Pharma. It is a tyrosine kinase inhibitor approved by the FDA for relapsed or refractory acute myeloid leukemia (AML) with FLT3 mutations.
Market Overview
The global AML treatment market was valued at approximately USD 1.6 billion in 2022 and is projected to grow at a CAGR of 7% through 2030, driven by increased diagnosis, targeted therapies, and unmet clinical needs. Gilteritinib captures a significant portion of this market, particularly in the relapsed/refractory setting.
Competitive Landscape
| Drug Name |
Mechanism |
Approval Year |
Market Share (2022) |
Key Competitors |
| Gilteritinib (Xospata) |
FLT3 inhibitor |
2018 |
45% |
Midostaurin, Quizartinib, Glasdegib |
| Midostaurin |
Multi-kinase inhibitor |
2017 |
30% |
Gilteritinib, Quizartinib |
| Quizartinib |
FLT3 inhibitor (phase 3) |
2021 (approval in some markets) |
15% |
Gilteritinib |
| Glasdegib |
Hedgehog pathway inhibitor |
2018 |
5% |
Other targeted agents |
Sales predominantly in the U.S. and Europe, with emerging markets expanding as diagnostics improve.
Price Projections
List Price and Pricing Trends
| Year |
Wholesale Acquisition Cost (WAC) |
Estimated Net Price |
Comments |
| 2022 |
USD 26,000/month |
USD 19,000/month |
Based on wholesale price minus typical discounts |
| 2023 |
USD 26,500/month |
USD 19,500/month |
Slight increase reflecting inflation and market shifts |
| 2024 |
USD 27,000/month |
USD 20,000/month |
Expected small increase, reflecting ongoing market dynamics |
Price Drivers
- Market penetration: As awareness and diagnostics improve, volume increases may moderate pricing pressures.
- Reimbursement policies: Favorable coverage in major markets supports stable pricing.
- Competition: Quizartinib's approval and midostaurin's existing market hold influence on price stability.
Future Price Trends
Projected to increase modestly, with annual growth of 2–3% over the next five years, driven by inflation and estimated improvements in manufacturing efficiencies. Price erosion could occur if biosimilars or generics develop; however, as an oral targeted agent with patent exclusivity till approximately 2030, significant generic competition is unlikely before then.
Regulatory and Patent Landscape
- Patent protection extends until 2030.
- Regulatory exclusivity grants linkage to market dynamics.
- No approved biosimilars exist as of 2023, maintaining exclusivity.
Sales Forecasts
| Year |
Estimated Global Sales |
Key Factors |
| 2022 |
USD 600 million |
Primarily U.S. and Europe |
| 2025 |
USD 900 million |
Market expansion, increased diagnosis, new regional approvals |
| 2030 |
USD 1.2 billion |
Market penetration, wider indications, ongoing use in refractory AML |
Risks and Opportunities
Risks
- Price erosion due to potential biosimilar or generics, possibly after patent expiry.
- Competition from other targeted therapies, such as quizartinib.
- Regulatory hurdles in emerging markets affecting accessibility.
Opportunities
- Expanding indications, including earlier-line AML treatment.
- Combination therapy trials enhancing efficacy and market appeal.
- Increasing global diagnosis rates as personalized medicine advances.
Key Takeaways
- NDC 70748-0130 (Xospata) holds a primary position in AML treatment with a market share around 45%.
- Its list price has increased modestly, with projections indicating a 2–3% annual growth rate.
- Patent protection extends until approximately 2030, limiting generic competition.
- Market expansion depends on approved indications, diagnostics, and reimbursement policies.
- Competition from quizartinib and midostaurin remains significant; market share dynamics will depend on safety, efficacy, and regulatory approvals.
FAQs
1. What factors influence gilteritinib’s pricing?
Pricing is primarily influenced by market competition, manufacturing costs, reimbursement rates, and patent exclusivity.
2. How does the patent landscape affect future price projections?
Patent protection until 2030 restricts generic entry, supporting stable prices until expiry.
3. What market segments does gilteritinib target?
It targets relapsed or refractory AML patients with FLT3 mutations, predominantly in the U.S. and Europe.
4. Are there upcoming competitors that could impact pricing?
Yes, quizartinib’s approval in certain markets and potential biosimilars post-2030 could pressure prices.
5. How might expanding indications influence sales?
New indications, including earlier treatment lines and combination therapies, can significantly increase market size and sales volume.
References
[1] MarketsandMarkets. (2023). AML Market Global Forecast.
[2] FDA. (2018). Approval of Xospata for AML.
[3] IQVIA. (2022). Worldwide Oncology Specialty Drug Trends.
[4] Astellas Pharma. (2023). Gilteritinib Prescribing Information.
[5] EvaluatePharma. (2023). Oncology Drug Forecasts.
