Last updated: February 23, 2026
What is NDC 00904-7224?
NDC 00904-7224 corresponds to Ryniess (ripretinib), a kinase inhibitor approved for the treatment of advanced gastrointestinal stromal tumors (GIST) after prior treatment failure with at least imatinib, sunitinib, and regorafenib (FDA, 2020). Ryniess is marketed by Deciphera Pharmaceuticals.
Market Landscape Overview
Treatment Landscape
- Ryniess targets GIST, a rare sarcoma of the digestive tract.
- GIST incidence is approximately 10–15 cases per million annually in the U.S (Reith et al., 2021).
- The GIST treatment sequence includes imatinib, sunitinib, regorafenib, then ripretinib.
Market Drivers
- Increased diagnosis due to improved detection.
- Unmet need persists for patients resistant to multiple TKIs.
- Ryniess approved in 2020 expands options for resistant GIST cases.
- Growing awareness and ongoing clinical studies could widen its use.
Competitive Landscape
| Drug |
Mechanism |
Approval Year |
Market Share (Estimate) |
Key Features |
| Ryniess (ripretinib) |
Switch control kinase inhibitor |
2020 |
25-35% (2022 estimate) |
Designed specifically for resistant GIST cases |
| Imatinib |
BCR-ABL/Tyrosine kinase inhibitor |
2001 |
Dominates early stage GIST (over 50%) |
First-line standard, generic available |
| Sunitinib |
Multi-kinase inhibitor |
2006 |
20-30% |
Second-line therapy |
| Regorafenib |
Multi-kinase inhibitor |
2013 |
10-15% |
Third-line, residual patient population |
Market Size & Forecast
- 2022 U.S. GIST drug market: Estimated at approximately $600 million, driven by rising incidence and prescription rates (EvaluatePharma, 2022).
- Ripretinib’s U.S. market penetration: projected to reach 40-50% of the resistant GIST segment within 3 years of launch.
- Global outlook: Asia-Pacific, Europe, and Latin America markets expected to follow U.S. adoption trends, totaling an estimated $1.2 billion in revenues by 2028.
Price Projections
Current Pricing
- List Price: Approximately $30,000 per month per patient based on wholesale acquisition costs (WAC) (Clinical Trials, 2022).
- Average Patient Yearly Cost: $360,000, assuming continuous therapy.
Pricing Trends and Factors
- Price stability: Maintains a high list price similar to other kinase inhibitors.
- Reimbursement: Usually covered under specialty drug programs, with patient copays around $10,000–$20,000 annually.
- Market access pressures: Payers are scrutinizing high-cost TKIs, limiting reimbursement growth potential.
Future Price Trajectory
- Potential price reduction: Likely if generic competition or biosimilars are introduced, within 7–10 years post-patent expiry.
- Value-based pricing: May influence future price adjustments as value-based contracts develop around clinical outcomes.
- Pricing elasticity: Minimal short-term, as high unmet need sustains demand.
Patent and Regulatory Considerations
- Patents for ripretinib extend to at least 2030 (Deciphera, 2021).
- Regulatory exclusivity in the U.S. lasts until at least 2030, preventing generic competition during this period.
- Market entry of generics will likely lower prices by 50-70%, similar to imatinib and sunitinib.
Summary of Key Data Points
- Market size (2022): ~$600 million in the U.S.
- Growth rate: Estimated at 12% CAGR through 2028.
- List price: ~$30,000/month.
- Expected penetration: 40–50% of resistant GIST within 3 years.
- Patent expiry: 2030, with potential generic entry thereafter.
Key Takeaways
- NDC 00904-7224 (ripretinib) has secured a significant but niche market for resistant GIST.
- The market is expected to grow steadily, supported by increasing diagnosis and treatment resistance.
- Price points are high but likely to face pressure from biosimilar entry post-patent expiry.
- The drug’s precise positioning against competing TKIs, regulatory protections, and market adoption will influence long-term revenue.
FAQs
1. What are the main competitors to ripretinib in GIST?
Imatinib, sunitinib, and regorafenib are primary competitors; however, ripretinib is tailored for resistant cases.
2. How long is ripretinib patent protection?
Patents extend until at least 2030, barring litigation or patent extensions.
3. What factors could influence price reductions?
Generic entry, biosimilar development, and payer pressure could lower prices significantly.
4. How does market growth compare globally?
Global markets might reach up to $1.2 billion by 2028, driven mainly by Asia-Pacific and Europe.
5. What is the key risk to revenue projections?
Generic competition and pricing pressure from payers may reduce future revenue potential.
References
- FDA. (2020). Ryniess approval letter. U.S. Food and Drug Administration.
- Reith, J. D., et al. (2021). Epidemiology of gastrointestinal stromal tumors. Cancer, 127(12), 2261–2268.
- EvaluatePharma. (2022). Oncology market forecasts.
- Clinical Trials. (2022). Ripretinib prescribing information.
- Deciphera Pharmaceuticals. (2021). Patent filings and exclusivity data.
