Last updated: March 9, 2026
What is NDC 00054-3730?
NDC 00054-3730 corresponds to Erdafitinib (Balversa), marketed by Janssen Pharmaceuticals. It is an oral FGFR inhibitor approved by the FDA for treating locally advanced or metastatic urothelial carcinoma with specific FGFR genetic alterations.
Market Landscape
Indications and Patient Population
Erdafitinib targets a niche patient population characterized by FGFR genetic alterations:
- Urothelial carcinoma diagnosis in approximately 80,470 new cases annually in the U.S. (2023)[1].
- FGFR alterations present in 15-20% of these cases[2].
Estimated eligible patients:
| Parameter |
Calculation |
Estimated Annual U.S. Patients |
| Total new urothelial carcinoma cases |
80,470 |
80,470 |
| FGFR alteration prevalence |
17.5% (average of 15-20%) |
14,077 |
| Eligible for erdafitinib |
Assumes 60% receive targeted therapy |
~8,446 |
Competitive Landscape
Primary competitors include other FGFR inhibitors such as:
- Infigratinib (INFI), approved for similar indications.
- Pemigatinib (PADCEV), marketed by Incyte for cholangiocarcinoma but investigated for urothelial carcinoma.
- Practical use depends on regulatory approvals, clinical outcomes, and access.
Current Market Penetration
- Initial adoption limited to FGFR-positive cases.
- Approximate market share in targeted therapy options: 20-30% of eligible patients.
- U.S. sales estimate for 2023: $190 million (Janssen's reported FGFR inhibitor sales)[3].
Global Perspective
- Markets in Europe, Japan, and Canada are smaller but expanding.
- Regulatory approval in European countries granted in 2022.
- Estimated global sales for 2023: $220 million.
Price Analysis
Current Pricing
- Wholesale Acquisition Cost (WAC): Approximately $15,000 per month.
- Average patient treatment duration: 12-18 months, influenced by disease progression and tolerability.
Cost Breakdown
| Parameter |
Details |
| Monthly WAC |
$15,000 |
| Annual treatment cost |
$180,000 (for 12 months) |
| Typical treatment length |
12-18 months |
| Total per patient (average) |
$180,000-$270,000 |
Price Trends & Adjustments
- Price reductions likely in response to increased competition.
- Payer pressures and biosimilar entry may reduce WAC over 3-5 years.
- Oncology drug prices exhibit slow declines; however, high growth expected due to expanding indications.
Projections
| Year |
Estimated Average Price (WAC) |
Market Penetration |
Total Sales Estimate |
| 2024 |
$14,500 |
25% of eligible patients |
~$275 million |
| 2025 |
$14,000 |
30% of eligible patients |
~$300 million |
| 2026 |
$13,500 |
35% of eligible patients |
~$330 million |
Assumptions include gradual price declines and increased market penetration with expanding indications and clinician familiarity.
Regulatory and Policy Impact
- Pending FDA approval for additional indications could expand markets.
- Reimbursement policies influence outpatient and specialty pharmacy pricing.
- Patent expiry expected around 2030; biosimilars may emerge thereafter, reducing prices.
Key Takeaways
- Erdafitinib addresses a small but high-value niche in oncology with a patient population of approximately 8,500 annually in the U.S.
- Current treatment cost averages $180,000 annually, with a projected slight decrease over the next three years.
- Market growth depends on regulatory approvals, clinical adoption, and competition from other FGFR inhibitors.
- Estimated global sales for 2023 stand at roughly $220 million, with potential to reach $330 million by 2026.
FAQs
What factors influence erdafitinib's price?
Pricing is affected by competition, manufacturer strategies, reimbursement policies, and clinical adoption.
How will biosimilars impact the market?
Patent expiration around 2030 could introduce biosimilars, potentially reducing prices and increasing access.
Is erdafitinib used outside the U.S.?
Yes, approvals in Europe and Japan exist, but market penetration varies depending on local regulatory and healthcare systems.
What are the prospects for expanding indications?
Further clinical trials could lead to approvals in other FGFR-driven cancers, increasing the patient pool.
How does the current market share compare to competitors?
Erdafitinib holds an estimated 20-30% share within FGFR inhibitor therapies for urothelial carcinoma, limited by recent market entry and competition.
References
[1] American Cancer Society. (2023). Cancer Facts & Figures 2023.
[2] Rosenberg, J. E., et al. (2020). FGFR alterations in urothelial carcinoma. Nature Reviews Urology, 17(8), 455–470.
[3] Janssen Pharmaceuticals. (2023). Annual report.
