Last updated: February 20, 2026
What is the Drug NDC 00480-7068?
NDC 00480-7068 refers to a specific drug product listed in the National Drug Code directory. It corresponds to Rydapt (midostaurin), a kinase inhibitor approved by the U.S. Food and Drug Administration (FDA) in April 2017. It is indicated for the treatment of newly diagnosed acute myeloid leukemia (AML) with FLT3 mutations and systemic mastocytosis.
Market Size and Key Drivers
Current Market Landscape
- Global AML Treatment Market (2022): Estimated at $1.4 billion, projected to grow at 6.2% CAGR through 2028.
- Systemic Mastocytosis Market: Smaller, but with high unmet needs; approximated at $150 million globally.
- Major Competitors: Gilteritinib (Xospata), quizartinib, and other FLT3 inhibitors.
Market Growth Factors
- Rising incidence of AML (~20,000 new cases annually in the U.S.).
- Advances in precision medicine targeting FLT3 mutations.
- Expanding indications, including potential use in other hematologic malignancies.
- Potential for combination therapies increasing treatment options.
Regulatory and Reimbursement Environment
- FDA approval facilitates market entry.
- Medicaid and private payers cover Rydapt at negotiated rates.
- Price optimization tied to patent protection until 2036.
Price Analysis and Projection
Current Pricing (2023)
- Wholesale Acquisition Cost (WAC): Approximately $22,500 per 30-day supply.
- Average Selling Price (ASP): Around $24,500 due to discounts.
- Patient Cost: With insurance, co-pays generally range between $50-$200 per month.
Price Trends and Influences
- Patent Expansion: Patent protects until 2036, limiting generic competition.
- Market Penetration: Increasing adoption in eligible AML patients.
- Reimbursement Policies: Influence final patient costs; price inflation tends to lag behind list prices due to rebates.
Price Projection (2024-2028)
| Year |
Estimated Average Price (WAC) |
Notes |
| 2024 |
$22,700 |
Slight inflation based on healthcare inflation trends. |
| 2025 |
$23,000 |
Market penetration stabilizes; prices maintained. |
| 2026 |
$23,500 |
Potential for price increases due to demand growth. |
| 2027 |
$24,000 |
Competition from biosimilars unlikely; patent still active. |
| 2028 |
$24,500 |
Slight inflation, assuming no major market disruptions. |
Price Adjustment Factors
- Market competition: No immediate generic or biosimilar competition expected before patent expiry.
- Regulatory changes: Potential policy shifts could influence drug prices.
- R&D pipeline: Emergence of new FLT3 inhibitors could pressure pricing.
Strategic Considerations
- Market Expansion: Monitoring off-label uses could expand market size.
- Pricing negotiations: Engage with payers to optimize reimbursement.
- Patent and Exclusivity: Maintain patent protections; consider additional formulation patents.
Conclusion
NDC 00480-7068 (Rydapt) maintains a stable market position driven by its receptor-specific indications and patent protections. Its price remains around $22,500–$24,500 per month, with minimal downside pressure expected before patent expiration. The market outlook remains positive, supported by growing incidence rates and limited competition.
Key Takeaways
- Rydapt's current price is approximately $22,500 per 30-day supply.
- Market growth is driven by rising AML incidence and targeted therapies.
- Patent protection until 2036 limits generic competition.
- Price projections increase gradually, reflecting inflation and stable demand.
- Competition from biosimilars or generics is unlikely within the next few years.
FAQs
1. How does patent expiry impact Rydapt prices?
Patent expiry around 2036 could introduce generics, likely causing significant price reductions.
2. What are the primary competitors to Rydapt?
Gilteritinib (Xospata) and quizartinib are main competitors, with similar indications for AML.
3. Is Rydapt approved for other indications?
Yes, it is officially approved for systemic mastocytosis and certain AML subtypes with FLT3 mutations.
4. How do reimbursement policies influence the actual patient price?
Reimbursement negotiations and rebate programs typically reduce actual patient out-of-pocket costs.
5. What trends could affect future pricing?
Emergence of alternative therapies, FDA policy changes, and market competition could impact prices.
References
- U.S. Food and Drug Administration. (2017). FDA approves new targeted therapy for AML with FLT3 mutations. https://www.fda.gov
- MarketWatch. (2022). Global AML market size and forecast. https://www.marketwatch.com
- IQVIA. (2023). Pharmaceutical pricing and reimbursement report. https://www.iqvia.com
- NADDI. (2021). Systemic mastocytosis treatment data. https://naddi.org
- FDA. (2023). Patent and exclusivity data for Rydapt. https://www.fda.gov
