Last updated: February 22, 2026
What is the drug associated with NDC 00641-6056?
NDC 00641-6056 corresponds to Rydapt (midostaurin), an oral kinase inhibitor approved by the FDA for treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) with FLT3 mutations and for systemic mastocytosis.
What is the current market landscape for midostaurin?
Market Size and Patient Population
- Target indications: AML with FLT3 mutations, systemic mastocytosis.
- Estimated diagnosed patients:
- AML with FLT3 mutation: approximately 15-20% of AML cases, translating into around 7,500 to 10,000 U.S. patients annually.
- Systemic mastocytosis: approximately 150-300 cases in the U.S. annually.
- Market penetration:
- AML: majority of potentially eligible patients may receive midostaurin as part of standard care, with current utilization rates around 70-80%.
- Systemic mastocytosis: lower utilization due to rarity and off-label use.
Competitive Landscape
- Main competitors:
- Gilteritinib (Xospata): approved for relapsed/refractory FLT3-mutated AML.
- Quizartinib (Vanflyta): under clinical development.
- Other therapies targeting AML and systemic mastocytosis, including chemotherapy and supportive care agents.
- Market dynamics:
- Midostaurin remains a first-line treatment for newly diagnosed AML with FLT3 mutations.
- The drug's unique positioning and FDA approval solidify its market share among kinase inhibitors.
Pricing and Reimbursement Environment
- Average Wholesale Price (AWP): Approximately $30,000 to $35,000 per month for a typical treatment course.
- Reimbursement:
- Covered primarily under hospital outpatient (OPPS) and specialty pharmacy channels.
- Insurance coverage rates exceed 85%, with co-pays averaging $200-$500 per month for insured patients.
What are the price projections looking like for midostaurin?
Short-term (Next 1-2 years)
- Price stability: Current list prices are unlikely to change significantly barring new competition.
- Pricing pressures:
- Payor negotiations and formulary exclusions could reduce net pricing by 5-10%.
- Increased adoption may offset discounts, maintaining revenue per patient.
Mid-term (3-5 years)
- Potential price increases:
- If approved for additional indications, prices could rise by 10-15%, aligning with broader oncology growth trends.
- Launch of biosimilars or generics is unlikely in the near term due to patent exclusivity, which extends until at least 2028.
- Market expansion:
- Growing awareness and guideline inclusion may improve utilization, supporting revenue growth.
Long-term (over 5 years)
- Price erosion:
- Introduction of generics or biosimilars would substantially reduce prices, potentially by 50% or more.
- Market evolution:
- Development of newer, more effective FLT3 inhibitors may limit midostaurin’s market share.
- While patent protections provide revenue stability in the near term, patent cliffs will eventually pressure pricing.
What are the key factors influencing drug prices?
| Factor |
Impact |
| Patent protections |
Maintain exclusivity; delay generic competition |
| Clinical efficacy and safety profiles |
Strong data support higher prices; adverse data can suppress prices |
| Competition from similar drugs |
Binds pricing; increased competitors often drive prices down |
| Payer negotiations |
Can reduce net sales; formulary inclusion influences revenue |
| Indication breadth |
Broader approved uses support higher prices |
Synthesis
Midostaurin's current market is stable with high penetration in its approved indications. Price points remain company-controlled and are supported by clinical positioning and reimbursement. Future revenue hinges on indications expansion, market growth, and patent protections, but face erosion from biosimilar entry expected after 2028.
Key Takeaways
- NDC 00641-6056 (midostaurin) targets AML with FLT3 mutations and systemic mastocytosis.
- The U.S. market size approximates 7,500-10,000 AML patients annually.
- Current treatment courses cost approximately $30,000-$35,000 per month.
- Price projections suggest stability in the short term, potential increases with new indications, and eventual decline post-patent expiration.
- Competitive pressures, patent status, and healthcare reimbursement strategies are critical determinants of future pricing.
FAQs
Q1: How long will patent protections last for midostaurin?
A1: Patent protections extend until at least 2028, with some patents potentially expiring earlier or later depending on jurisdictions and patent extensions.
Q2: What is the expected impact of biosimilars or generics?
A2: The entry of biosimilars or generics could reduce prices by 50% or more, significantly impacting revenue.
Q3: Are there upcoming indications that could expand the market?
A3: Yes. Trials are exploring midostaurin in other hematologic malignancies, which could broaden use if approved.
Q4: How does midostaurin compare price-wise to similar kinase inhibitors?
A4: It is comparable, priced around $30,000-$35,000 per month, similar to gilteritinib, with some variance based on negotiations.
Q5: What are the main factors limiting price increases?
A5: Competition, biosimilar entry, payor pressure, and regulatory limitations restrict upward pricing movement.
References
- U.S. Food and Drug Administration. (2017). FDA Approves Rydapt for Newly Diagnosed Acute Myeloid Leukemia. https://www.fda.gov
- IQVIA. (2022). National Prescription Audit Data.
- Price Transparency Files, Centers for Medicare & Medicaid Services. (2022).
- EvaluatePharma. (2022). Oncology Market Report.
- FDA. (2020). Summary of new drug applications and approvals.
