Last updated: February 28, 2026
What is the Drug NDC 60505-3111?
NDC 60505-3111 corresponds to Erdafitinib, a targeted therapy approved by the FDA for the treatment of locally advanced or metastatic urothelial carcinoma with FGFR3 or FGFR2 genetic alterations. It was approved on April 17, 2019. Erdafitinib is marketed by Janssen Pharmaceuticals.
Market Size and Demand Drivers
Current Market Overview
- Target Population: Approximately 13,000 new cases of advanced bladder cancer annually in the U.S. with FGFR alterations present in about 20-25% of cases.
- Treatment Landscape: Erdafitinib is indicated as a second-line treatment after platinum-based chemotherapy or immunotherapy failure.
Key Competitors
- Aflibercept (Eylea) and Ertugliflozin (Steglatro) are not directly comparable but illustrate reimbursement landscapes.
- Existing therapies lack targeted FGFR inhibition, giving Erdafitinib a niche.
Adoption Trends
- Increasing adoption correlates with expanded companion diagnostic use.
- About 3,500 to 4,500 patients per year in the U.S. qualify for FGFR-targeted treatment.
- Limited supply chain complexities; primarily paid through coverage with prior authorization.
Market Size Estimation
| Parameter |
Estimates |
| Total U.S. bladder cancer cases/year |
81,400 (SEER, 2021) |
| Percentage with FGFR alterations |
20-25% |
| Eligible patient pool per year |
16,280 – 20,350 |
| Expected treatment rate (after screening) |
80-90% |
| Potential annual treated patients |
13,000 – 18,000 |
The U.S. market for Erdafitinib is projected to be 12,000–15,000 patients annually, considering adoption rates and diagnostic availability.
Price Projections
Current Pricing
- List price (Wholesale Acquisition Cost, WAC): Approximately $17,000 per month.
- Average outpatient treatment duration: 6-12 months, leading to an approximate therapy cost of $102,000–$204,000 per patient annually.
Reimbursement and Net Price
- Insurance reimbursements typically range from 70-85%, resulting in net payer costs between $70,000 and $170,000 annually.
- Negotiated discounts and patient assistance programs lower net reimbursement.
Future Price Trends
- Price may stabilize or decrease marginally as biosimilar or generic competitors enter.
- Price adjustments tied to market penetration and negotiated payer contracts.
- Expected annual price change: 0-3%, aligning with inflation and market competition.
Market Penetration Impact on Revenue
| Scenario |
Patients Treated |
Average Price |
Revenue (USD, billions) |
| Conservative (50% uptake) |
6,500 |
$150,000 |
~$1.0 billion |
| Moderate (75% uptake) |
12,000 |
$150,000 |
~$1.8 billion |
| Aggressive (90% uptake) |
15,000 |
$150,000 |
~$2.2 billion |
Policy and Regulatory Influences
- FDA approval expands potential use, including expanding indications for other FGFR-related cancers.
- Reimbursement policies depend on coverage decisions by CMS and private insurers.
- Ongoing clinical trials may lead to label expansions, influencing pricing and market size.
Summary of Competitive Position
- Erdafitinib holds a unique position as a first FGFR inhibitor approved for urothelial carcinoma.
- Market expansion depends on diagnostic testing rates, clinical adoption, and payer coverage.
- Price stability possible due to limited direct competition but impacted by biosimilars or competition from other FGFR inhibitors in development.
Key Takeaways
- The U.S. market for Erdafitinib could reach $1.8–$2.2 billion annually at full adoption.
- List prices are around $17,000/month; net reimbursement varies.
- Market growth depends on increased diagnostic testing, clinician acceptance, and payer reimbursement strategies.
- Future price adjustments likely to be minimal unless new competitors emerge.
- Broader indications could further expand market potential.
FAQs
1. How large is the patient population eligible for Erdafitinib?
Approximately 13,000–15,000 patients annually in the U.S. have FGFR alterations and are eligible for treatment.
2. What is the current treatment cost per patient?
Around $102,000–$204,000 annually, based on a list price of $17,000 per month.
3. Are there any biosimilars or generics planned for Erdafitinib?
No biosimilars or generics are available yet; market entry depends on patent expiration and development pipeline progress.
4. How does payer coverage influence market size?
Prior authorization and diagnostic testing requirements can limit uptake, but broad coverage policies can substantially increase treatment rates.
5. What are the main factors influencing future price changes?
Market competition, patent status, payer negotiation, and clinical expansion efforts will shape pricing dynamics.
References
- U.S. Department of Health and Human Services, Surveillance, Epidemiology, and End Results Program (SEER). (2021). Cancer Stat Facts: Bladder Cancer.
- FDA. (2019). Erdafitinib approval letter.
- IQVIA. (2022). National Prescription Data Reports.
- Janssen Pharmaceuticals. (2019). Product labeling and prescribing information.
- Pharma Intelligence. (2022). Oncology Market Forecasts.
