Last updated: February 23, 2026
What is NDC 51407-0812?
NDC 51407-0812 refers to Gilteritinib (brand name: Xospata), an oral tyrosine kinase inhibitor developed by Astellas Pharma. It is approved for treating relapsed or refractory acute myeloid leukemia (AML) with FLT3 mutations.
Market Overview
Current Market Size
The global AML therapeutics market was valued at approximately USD 1.3 billion in 2022, projected to grow at a CAGR of 8% through 2030. Gilteritinib accounts for a significant share within targeted AML therapies, especially following the FDA approval in November 2018.
Key Competitors
- Midostaurin (Rydapt): Approved for FLT3-mutated AML.
- Quizartinib (Vanflyta): Investigational, with ongoing trials.
- Gilteritinib: The only FLT3 inhibitor approved specifically for relapsed/refractory AML.
Usage Trends
In 2022, Gilteritinib's U.S. prescriptions were estimated at 30,000–40,000 units annually. Usage is expected to increase as adoption grows in second-line treatment protocols, especially amid the rising incidence of AML (approximately 21,000 new cases annually in the U.S.).
Regulatory Status & Approvals
- FDA (2018): Approved as monotherapy for relapsed or refractory FLT3-mutated AML.
- European Medicines Agency (EMA): Approved since 2019.
- Other markets: Approvals pending or in review, notably in Japan, Canada, and Australia.
Price Analysis
Current Pricing
- Average wholesale price (AWP) in the U.S.: approximately USD 13,000–15,000 per 30-count pack.
- Per treatment course: Estimated USD 150,000–200,000, based on dosing schedules (160 mg daily for 28 days per cycle).
Pricing Factors
- Market exclusivity: Patent expires in 2030, limiting generic competition.
- Cost of goods sold (COGS): Estimated at USD 1,500–2,500 per course.
- Reimbursement landscape: Insurers generally cover high-cost AML therapies, with copays determined by plan.
Price Trends
- Pre-approval: No market; price determined primarily by manufacturing costs.
- Post-approval: Prices stabilized at USD 14,000–15,000 per month due to limited competition.
- Forecast: Slight increases up to USD 16,000 per month projected through 2025, factoring inflation, investment in new formulations, and healthcare inflation.
Market Drivers and Limitations
Drivers
- Increasing AML incidence.
- Growing adoption of FLT3 testing to identify eligible patients.
- Expanding approval in additional territories.
- Positive clinical trial outcomes supporting broader use.
Limitations
- High cost limits access in low-income regions.
- Competition from emerging drugs and generics post-patent expiry.
- Market saturation in jurisdictions with established treatment protocols.
Price Projections (2023–2028)
| Year |
Estimated Price per 30-count pack |
Notes |
| 2023 |
USD 15,000 |
Stabilization at current levels. |
| 2024 |
USD 15,500 |
Slight inflationary increase. |
| 2025 |
USD 16,000 |
Introduction of enhanced formulations or dosing options. |
| 2026 |
USD 16,000 |
Market stabilization; potential competition impact. |
| 2027 |
USD 16,000 |
Patent protection intact; limited price pressure. |
| 2028 |
USD 16,000 |
Near patent expiry; generic entry possible. |
Key Market Opportunities
- Expanding to first-line AML treatment in eligibility for combination therapy.
- Developing biosimilars post-patent expiry.
- Penetration into emerging markets with rising healthcare coverage.
Risks
- Regulatory delays or safety concerns.
- Entry of competing FLT3 inhibitors.
- Pricing pressure due to increased competition or biosimilars.
Summary
Gilteritinib (NDC 51407-0812) commands a high per-unit market price driven by its targeted therapy status, AML treatment demand, and limited competition. Market growth hinges on rising AML incidence, expanding indications, and better market penetration. Prices are expected to remain stable through 2025, with marginal increases anticipated until patent expiration.
Key Takeaways
- Current U.S. market price: USD 14,000–15,000 per 30-count pack.
- Volume forecast: 30,000–40,000 prescriptions annually.
- Market value: approximately USD 450 million in 2022.
- Patent expiry expected in 2030, allowing for biosimilar competition.
- Growth driven by AML incidence and testing adoption; limited by high treatment cost and competition.
FAQs
1. How does Gilteritinib compare to other FLT3 inhibitors?
It is the only approved FLT3 inhibitor for relapsed/refractory AML in the U.S., with a favorable safety profile and targeted mechanism. Competitors are still in clinical development or approvals.
2. What is the expected timeline for generic versions?
Generic entry could occur post-2030, assuming patent expiry and regulatory approval processes.
3. How do pricing strategies impact market access?
High prices favor premium reimbursement for providers, but limit access in low-income markets. Payers may negotiate discounts or value-based agreements.
4. What new indications are under development?
Investigations include frontline AML therapy, combination treatments with hypomethylating agents, and broader hematologic malignancies.
5. What factors influence price projections in the next five years?
Patent lifecycle, emerging competitors, clinical guidelines, reimbursement policies, and healthcare inflation.
References
[1] MarketWatch. (2022). AML therapeutics market data.
[2] FDA. (2018). Approval of Gilteritinib.
[3] IQVIA. (2022). Prescription data on AML therapies.
[4] Astellas Pharma. (2022). Gilteritinib product overview.
