Last updated: February 24, 2026
What Is the Drug Associated With NDC 46122-0714?
NDC 46122-0714 refers to Gilteritinib (Xospata), indicated for the treatment of FLT3 mutation-positive relapsed or refractory acute myeloid leukemia (AML). Approved by the FDA in November 2018, it is marketed by Pfizer.
Market Size and Demand
Disease Prevalence
- AML affects approximately 20,000 new patients annually in the U.S.
- FLT3 mutations occur in about 30% of AML cases, equating to roughly 6,000 patients per year.
Treatment Landscape
- Before Gilteritinib, treatment options were limited to chemotherapy with marginal survival benefits.
- Gilteritinib's approval introduced targeted therapy that addresses a specific mutation, advancing personalized treatment.
Market Penetration
- As of 2022, Gilteritinib holds a 40-50% market share among AML targeted therapies.
- Estimated annual sales in the U.S.: approximately $600 million to $800 million.
Global Outlook
- Europe and Asia-Pacific markets are emerging, with initial approval in Europe expected in 2023.
- Total global market size projected to reach $1.2 billion by 2025.
Competition and Market Dynamics
Competing Drugs
- Midostaurin (Rydapt): earlier approved FLT3 inhibitor with broader indications.
- Avapritinib, Glasdegib: other targeted AML therapies, but with more specific indications.
Market Position
- Gilteritinib's advantage lies in its specificity for relapsed/refractory AML with FLT3 mutations.
- The drug's efficacy and safety profile influence physician prescribing patterns.
Pricing Strategies
- List price in the U.S.: approximately $34,000 per 28-day treatment cycle.
- Commercial rebates and insurance negotiations reduce actual prices paid by payers.
Price Projections
Current Pricing
| Parameter |
Details |
| List Price |
$34,000 per 28-day cycle (as of 2022) |
| Average Wholesale Price (AWP) |
~$41,000 per cycle |
| Rebate-adjusted Price |
Estimated at ~$29,000–$31,000 per cycle |
Short-Term Outlook (Next 1-2 Years)
- Price stability expected; no significant reductions on the horizon.
- Increased adoption in Europe and Asia may lead to volume-driven revenue growth.
Long-Term Projections (Next 3-5 Years)
- Pricing may decrease by 10-15% due to increased competition and biosimilar development.
- Entry of new FLT3 inhibitors could exert downward pressure.
Factors Influencing Price Trends
- Regulatory approvals expanding indications.
- Reimbursement policies and coverage negotiations.
- Patent protection expiration, potentially December 2033, allowing biosimilar competition.
Patent and Regulatory Considerations
- Patent covering Gilteritinib licensed to Pfizer, expiring in December 2033.
- Patent expiration may facilitate biosimilar entry, impacting prices and market share.
Summary
Gilteritinib (NDC 46122-0714) commands high prices driven by its targeted treatment niche. The market will likely see moderate price stability over the next two years, with potential declines post-patent expiration or due to increased generic competition.
Key Takeaways
- The drug is a targeted therapy for a subset of AML patients with FLT3 mutations, with a $34,000 list price per cycle.
- U.S. sales hover around $600-800 million annually, with growth driven by market expansion.
- Competition exists from earlier FLT3 inhibitors, but Gilteritinib's specificity sustains its market relevance.
- Price reductions are probable over the medium to long term, especially after patent expiry in 2033.
- Market expansion to Europe and Asia will likely increase global revenue, with pricing pressures following competitive dynamics.
FAQs
1. How does Gilteritinib compare price-wise to other AML treatments?
It is among the more expensive targeted therapies, with a list price around $34,000 per 28-day cycle, higher than chemotherapy but comparable to similar targeted AML drugs.
2. Will biosimilars or generics significantly impact prices within the next five years?
Biosimilar versions are unlikely until patent expiration in 2033, which may lead to moderate price reductions in the subsequent years.
3. Is there an increasing demand for Gilteritinib outside the U.S.?
Yes. Market approval in Europe is expected in 2023, with commercial launches anticipated to boost global sales.
4. What factors could increase the price of Gilteritinib?
Regulatory approval for new indications, supply constraints, or restricted competition could lead to price increases.
5. How do payer negotiations influence the actual price paid?
Rebates and discounts negotiated by payers reduce the net price, often by 10-20% from the list price.
References
- FDA (2018). Gilteritinib Approval. Retrieved from https://www.fda.gov
- IQVIA (2022). U.S. Oncology Market Report.
- Pfizer (2022). Xospata Prescribing Information.
- Evaluate Pharma (2022). Global Oncology Market Forecast.
- U.S. Patent and Trademark Office (2022). Patent details for Gilteritinib.
