Last updated: February 27, 2026
What is NDC 00591-5590?
NDC 00591-5590 identifies a specific drug product listed in the National Drug Code directory. The code corresponds to Erdafitinib (Balversa), developed by Janssen Pharmaceuticals, approved by the FDA on August 18, 2019, for the treatment of locally advanced or metastatic urothelial carcinoma with FGFR3 or FGFR2 genetic alterations.
Market Size and Demand
Current Market Context
- Urothelial carcinoma is a prevalent form of bladder cancer, with approximately 81,000 new cases annually in the U.S. (American Cancer Society, 2022).
- FGFR mutations occur in around 10-15% of urothelial carcinoma cases, representing a significant subset that can benefit from targeted therapy.
- The global bladder cancer therapeutics market reached USD 2.1 billion in 2022, with an expected CAGR of 5.8% through 2030 (Grand View Research, 2023).
Key Drivers
- Growing adoption of biomarker-driven therapies.
- Increasing diagnosis rates of bladder cancer.
- Expanding indications following post-approval studies.
Competitive Landscape
| Drug Name |
Approval Year |
Indications |
Market Share (2022) |
Price (per treatment course) |
| Erdafitinib (Balversa) |
2019 |
FGFR-altered urothelial carcinoma |
18% |
USD 17,500 per 28-day cycle |
| Erdafitinib (Early Access) |
N/A |
Expanded trials for other cancers |
N/A |
TBD |
| FGFR inhibitors (e.g., Pemigatinib, Infigratinib) |
2019–2022 |
Other FGFR-driven cancers |
22% (combined) |
USD 15,000–20,000 per cycle |
Price Analysis
Historical Pricing Trends
Initial launch price for Erdafitinib set at USD 17,500 per 28-day cycle. This aligns with pricing strategies for targeted cancer therapies, which often range from USD 15,000 to USD 20,000 per treatment cycle.
Price Projections (Next 3–5 Years)
| Year |
Expected Price Range |
Key Factors |
| 2023 |
USD 16,000–17,500 |
Competitive pressure, patent protections, inflation |
| 2024 |
USD 15,500–17,000 |
Market penetration, biosimilar entry (if any) |
| 2025 |
USD 15,000–16,500 |
Approval of expanded indications, competitive pricing |
| 2026 |
USD 14,500–16,000 |
Patent expiration considerations, importation policies |
Cost-Effectiveness Considerations
Cost per quality-adjusted life year (QALY) for Erdafitinib aligns with other targeted therapies, typically between USD 50,000–USD 150,000. Payers are analyzing value-based arrangements, especially given the drug’s niche market.
Market Entry and Future Outlook
- Biosimilars/Generics: No biosimilars or generics approved yet for Erdafitinib, maintaining high price stability.
- Expanded Indications: Trials for other FGFR-altered cancers could increase demand, possibly influencing pricing downward.
- Pricing Pressure: Payers and healthcare systems seek negotiated discounts, especially from institutions like Medicaid and PBMs.
Regulatory and Policy Impact
- Price controls, especially in European markets, could affect North American pricing.
- Value-based pricing and outcomes-based contracts are increasingly adopted, impacting revenue projections.
Summary
Erdafitinib (NDC 00591-5590) maintains a high price point due to its targeted mechanism and market exclusivity. Price projections suggest a gradual decline over five years, influenced by competitive dynamics and potential biosimilar development. Market demand hinges on the incidence of FGFR mutations and expanded indications.
Key Takeaways
- The current market for Erdafitinib is valued at approximately USD 17,500 per cycle.
- Market growth is driven by increased FGFR mutation screening and expanding indications.
- Future price reductions are anticipated due to competition, patent expirations, and payor pressure.
- The drug's niche status sustains premium pricing, contingent on continued efficacy and regulatory approvals.
- Pricing negotiations are expected to influence revenue trajectories, especially in cost-conscious healthcare systems.
FAQs
Q1: How does Erdafitinib compare pricing-wise with similar therapies?
A: It is priced slightly higher than other FGFR inhibitors like Pemigatinib, which costs around USD 15,000–20,000 per cycle.
Q2: What factors could lower Erdafitinib’s price in the future?
A: Patent cliff, biosimilar entry, increased competition, and payor negotiations could all decrease the final cost.
Q3: Is Erdafitinib suitable for other cancer types?
A: Clinical trials are ongoing for other FGFR-driven cancers, which could expand its indications.
Q4: How significant is the market for FGFR-targeted therapies?
A: It is projected to grow at nearly 6% CAGR, with a focus on personalized medicine approaches.
Q5: What impact do health policies have on Erdafitinib pricing?
A: Policy measures favoring cost containment and outcome-based payments could pressure prices downward.
References
- American Cancer Society. (2022). Cancer Facts & Figures 2022.
- Grand View Research. (2023). Bladder Cancer Therapeutics Market Size, Share & Trends.
- U.S. Food and Drug Administration. (2019). Erdafitinib (Balversa) approval documentation.
