Last updated: March 13, 2026
What is NDC 51407-0272?
NDC 51407-0272 refers to a specific drug product, assigned by the National Drug Code (NDC) number. According to publicly available data, this code corresponds to Xospata (gilteritinib) manufactured by Pfizer, approved by the FDA for the treatment of relapsed or refractory acute myeloid leukemia (AML) with FLT3 mutations.
Market Overview
Indication and Patient Population
Gilteritinib is indicated for patients with FLT3-mutated AML. The primary patient population is estimated at approximately 10,000-12,000 patients in the US annually, based on AML incidence data and mutation prevalence (Source: American Cancer Society, 2022).
Competitive Landscape
- Key competitors: Midostaurin (PKC412, approved for newly diagnosed AML with FLT3 mutations), Quizartinib, and Crenolanib.
- Other therapies: Standard chemotherapy agents with or without stem cell transplant.
Market Penetration
The drug entered the market in November 2018, with Pfizer holding a market share of approximately 40% in the FLT3-targeted AML segment as of 2022. Adoption varies based on patient suitability and clinician familiarity.
Reimbursement and Access
Reimbursement is primarily through commercial insurers and Medicare. Average wholesale price (AWP) reflects the tiered pricing structure, with cost sharing dependent on insurance plans.
Price Analysis
Current Pricing
- List Price: Approximately $31,200 per month, translating to about $374,400 annually (Source: Red Book, 2022).
- Average Wholesale Price (AWP): Ranges between $30,000 and $32,000 per month.
- Net Price: Estimated to be 20-30% lower than list price due to discounts and rebates.
Pricing Trends
Since FDA approval in 2018, the price has increased marginally by about 3-5% annually, consistent with inflation and market adjustments. No significant price erosion detected due to limited generic competition yet.
Cost-Effectiveness Considerations
Cost per quality-adjusted life year (QALY) gained is estimated at $150,000-$200,000 based on clinical efficacy data, positioning gilteritinib as a high-cost but targeted therapy.
Market and Price Projections (2023-2028)
Market Growth Forecast
- Compound annual growth rate (CAGR) in the FLT3 AML segment is projected at 4-6%, driven by increased diagnosis and expanding use in earlier lines.
- Market value for FLT3 inhibitors is expected to reach approximately $2 billion globally by 2028.
Price Projection Outlook
- Short term (2023-2024): Pricing likely remains stable in the $30,000-$32,000 range per month. Pfizer may introduce modest price increases aligned with inflation.
- Medium term (2025-2028): Potential for slight discounts due to market competition or biosimilar entry upon patent expiry (~2030). Prices could decrease by 10-15% in this period.
- Long term: Patent expiration could lead to generics or biosimilar entry, reducing prices by 50% or more.
Key Factors Influencing Price Trajectory
- Market competition from emerging FLT3 inhibitors.
- Negotiations with payers and healthcare systems.
- Regulatory changes, including potential price controls.
- Patent status and biosimilar availability.
Policy and Regulatory Environment
- The Biden administration has proposed drug price reforms aimed at controlling drug costs for high-cost medicines.
- Price transparency initiatives may impact reimbursement negotiations.
- Patent extensions and exclusivity periods will influence generic entry.
Summary Table
| Parameter |
Current Data |
Future Projections |
| List Price per Month |
~$31,200 |
Stable or modest increase (~5%) |
| Patient Population (US) |
~11,000 |
Slight growth due to early detection |
| Market Share (2022) |
40% |
Stable, with potential increase |
| Price Erosion (2025-2028) |
N/A |
10-15% reduction possible |
| Patent Expiry |
~2030 |
Entry of biosimilars possible |
Key Takeaways
- NDC 51407-0272 (gilteritinib) serves a niche but expanding AML market with targeted therapy.
- Current pricing approximates $31,200 per month; stable since launch.
- Market growth projected at 4-6% CAGR, with prices expected to remain stable short-term.
- Patent expiration and market competition could significantly reduce prices post-2030.
- Reimbursement policies and payer negotiations will influence actual net prices.
FAQs
Q1: How competitive is the FLT3 inhibitor market?
The market is moderately competitive, with Pfizer holding a leading position. Other drugs like Quizartinib are in late-stage development or approved, but Pfizer’s market share remains dominant.
Q2: What factors could influence a price decrease in the coming years?
Patent expiry, biosimilar approvals, increased market competition, and healthcare policies targeting drug affordability.
Q3: Are biosimilars expected for gilteritinib?
Biosimilar entry is unlikely until after patent expiry (~2030), due to the nature of biologics manufacturing and regulatory pathways.
Q4: How does the current list price compare internationally?
US prices are higher than many other countries due to different pricing policies; European and Asian markets typically have lower prices.
Q5: What is the potential impact of value-based payment models?
Such models may result in price adjustments based on treatment outcomes, possibly reducing per-patient costs or aligning reimbursement with efficacy.
References
- American Cancer Society. (2022). Cancer facts & figures 2022. https://www.cancer.org/cancer/myeloid-leukemia.html
- Red Book Online. (2022). Drug pricing data. Wolters Kluwer.
- FDA. (2018). Gilteritinib (Xospata) approval notice.
- IQVIA. (2022). Pharmaceutical Market Report.
- U.S. Patent Office. (2022). Patent status for gilteritinib.
