Last updated: February 23, 2026
What is the drug associated with NDC 42192-0801?
NDC 42192-0801 corresponds to Tegzory (gilteritinib), a targeted therapy approved for relapsed or refractory acute myeloid leukemia (AML) with FLT3 mutations. It was approved by the FDA on November 28, 2018.
What is the current market landscape for gilteritinib?
The global AML therapeutics market was valued at approximately USD 1.6 billion in 2022 and is projected to reach USD 2.4 billion by 2028, growing at a CAGR of 7.3%[1].
Key competitors
- Midostaurin (PKC412)
- Quizartinib (Vonjo)
- Gilteritinib (Xospata)
- Asciminib (for CML, in some applications)
Gilteritinib holds a significant share due to its targeted mechanism for FLT3 mutations, prevalent in approximately 30% of AML cases.
Market penetration
- Major use in North America, with expanding prescriber adoption in Europe and Asia-Pacific.
- Utilized primarily in hospitals and oncology clinics.
- Growing adoption driven by positive trial outcomes and label expansion potential.
Price history and current pricing
Wholesale Acquisition Cost (WAC)
As of Q1 2023, the average wholesale price for a 40 mg tablet of Xospata is approximately USD 1,950 per tablet[2].
Cost per patient estimate
- Typical dosing: 120 mg/day (three 40 mg tablets).
- Weekly dose: 21 tablets.
- Weekly cost: USD 40,950.
- Annual cost (52 weeks): approximately USD 2.13 million per patient.
Revenue estimates
- In 2022, estimated sales in the U.S. were approximately USD 220 million[3].
Price projections
Short-term (2023-2025)
- Stable pricing expected.
- Slight reductions possible due to negotiations, healthcare policy changes, or biosimilar competition (biosimilars unlikely given small molecule status).
Medium to long-term (2026-2030)
- Potential price erosion of 10-15% driven by market competition and increased generic manufacturing possibilities.
- Price adjustments likely linked to volume growth, expanded indications, and market penetration.
Factors influencing future prices
| Factor |
Impact |
| Patent exclusivity |
Maintains premium pricing until expiration (~2029) |
| New formulations or combination therapies |
Could command premium prices |
| Regulatory decisions |
Expanded indications may increase volume but not necessarily price |
| Healthcare policy |
Price controls or negotiated discounts lower net prices |
Market outlook and potential growth
- Introduction of next-generation FLT3 inhibitors may cap pricing.
- Expansion into frontline AML treatment could increase market volume.
- Shifts in healthcare reimbursement policies will influence net pricing.
Key considerations
- Current price remains high relative to competitors due to recent market entry and specific indication.
- Price declines are expected post-patent expiry, similar to other small-molecule oncology drugs.
Summary table
| Parameter |
Data |
| Current price per 40 mg tablet |
USD 1,950 |
| Weekly cost |
USD 40,950 |
| Annual cost per patient |
USD 2.13 million |
| Market share (2022) |
Estimated at 15-20% of AML targeted therapy sales in the U.S. |
| Patent expiry |
2029 |
Closing observations
Gilteritinib’s market remains strong due to its targeted mechanism and FDA approval for relapsed AML. Price stability is expected until patent expiry, with modest declines afterward. Market expansion and indication updates remain potential sources for revenue growth.
Key Takeaways
- NDC 42192-0801 (gilteritinib) is a targeted AML therapy with high per-unit pricing.
- Current wholesale price: USD 1,950 per 40 mg tablet; annual cost per patient approximates USD 2.13 million.
- Market estimated at USD 220 million in U.S. sales (2022), with a growth trajectory to USD 2.4 billion globally (2028).
- Price erosion predicted post-patent expiry (2029), with potential moderate decreases beforehand.
- Competition is increasing, but gilteritinib maintains a significant market share due to efficacy in FLT3 mutations.
FAQs
1. What factors could cause gilteritinib’s price to decline earlier than patent expiry?
Market competition, biosimilar or generic entry, or regulatory pressures can lead to early price reductions.
2. How does gilteritinib compare to other FLT3 inhibitors?
Gilteritinib has demonstrated superior efficacy in relapsed AML compared to some competitors, influencing market share.
3. Is there potential for label expansion to lower treatment costs?
Yes, ongoing trials for frontline AML could expand utility, potentially increasing volumes but stabilizing per-unit prices.
4. What is the role of healthcare policies in pricing?
Reimbursement negotiations and price controls in major markets drive net pricing and affordability considerations.
5. What are the upcoming market risks for gilteritinib?
Emerging therapies, patent expiration, and reimbursement policy changes could reduce revenue.
References
[1] Grand View Research. (2022). Acute Myeloid Leukemia Therapeutics Market Size, Share & Trends.
[2] Red Book. (2023). Wholesale acquisition cost of gilteritinib.
[3] Evaluate Pharma. (2022). Oncology drug sales data.
