Last updated: February 25, 2026
What Is the Drug Identified by NDC 44567-0235?
NDC 44567-0235 corresponds to Erdafitinib (Balversa), marketed by Janssen Pharmaceuticals. It is approved for the treatment of locally advanced or metastatic bladder cancer harboring specific FGFR genetic alterations.
Market Overview
Indications and Market Size
- Primary indication: Urothelial carcinoma with FGFR3 or FGFR2 genetic alterations.
- Market penetration: Limited to patients with specific genetic profiles; estimated to impact approximately 15,000 U.S. patients annually.
- Unmet need: Resistance to standard chemotherapy and immunotherapy in a subset of patients.
Competitive Landscape
- Recent approvals: Erdafitinib received FDA approval in April 2019.
- Key competitors:
- FGFR inhibitors: Infigratinib (approved), Pemigatinib (approved)
- Chemotherapy: Cisplatin-based regimens
- Immunotherapy: Atezolizumab, Durvalumab, and others
Market Drivers
- Increasing prevalence of bladder cancer, projected to reach 81,000 new cases in the U.S. (SEER, 2021).
- Shift toward personalized medicine targeting FGFR alterations.
- Growing adoption of targeted therapies in oncology.
Market Challenges
- Limited indication scope.
- Competition from other FGFR inhibitors.
- Cost and reimbursement hurdles.
Pricing Data
Current Price Approximate
- Wholesale acquisition cost (WAC): Approximately $11,200 per month per patient.
- Annual cost: Around $134,400, reflecting a 12-month treatment cycle.
- Pricing factors: Includes drug manufacturing, clinical testing, and market positioning strategies.
Comparison With Similar Agents
| Drug |
Approved Use |
WAC (per month) |
Approved Price Range |
| Erdafitinib |
FGFR-altered urothelial carcinoma |
$11,200 |
$10,800 – $12,000 |
| Infigratinib |
FGFR inhibitor (approved for cholangiocarcinoma, not bladder) |
$9,500 |
$9,200 – $10,200 |
| Pemigatinib |
Cholangiocarcinoma with FGFR2 fusion or rearrangement |
$8,900 |
$8,700 – $9,200 |
Price Trends and Projections
- Recent trend: Slight increase in WAC prices due to inflationary pressures and manufacturing costs.
- Projected 2023-2025 trend: WAC could rise by 3-5% annually if demand stabilizes and approvals expand.
- Influence factors: Potential for expanded indications, increased competition, or biosimilar entry.
Future Market and Price Projections
| Year |
Estimated Patient Population |
Expected Adoption Rate |
Projected Revenue |
Expected Price (WAC) |
| 2023 |
2,500 |
60% |
$33.5 million |
$11,200 |
| 2024 |
3,000 |
70% |
$45.2 million |
$11,600 |
| 2025 |
3,500 |
75% |
$58 million |
$12,000 |
Assumptions:
- Steady increase in FGFR testing rates.
- No significant price reductions due to competitive pressure.
- No major change in treatment guidelines restricting utilization.
Key Takeaways
- Erdafitinib (NDC 44567-0235) prices at approximately $11,200/month, reflecting its status as a targeted therapy for FGFR-altered bladder cancer.
- The market remains limited by indications but benefits from growth in personalized oncology.
- Future price increases may align with inflation and market expansion, projected at 3-5% annually.
- Competitive drugs could influence pricing strategies and market share.
- Commercial uptake depends on the prevalence of FGFR genetic alterations and testing rates.
FAQs
Q1: How often is Erdafitinib used in clinical practice?
It is prescribed for patients with FGFR3 or FGFR2 genetic alterations with advanced or metastatic bladder cancer after chemotherapy.
Q2: Are biosimilars or generics expected for Erdafitinib?
Currently, no biosimilars or generics are available. The drug’s patent protections limit competition until expiration, expected around 2035.
Q3: How does FGFR mutation prevalence influence market size?
FGFR mutations occur in approximately 15-20% of urothelial carcinomas, which limits the total patient population but targets a specific, responsive subset.
Q4: What factors could decrease the drug’s price?
Market entry of more affordable competitors, changes in patent law, or reimbursement policies favoring cost reductions may lower prices.
Q5: How critical are genetic testing costs to market adoption?
Genetic testing costs, typically $500-$2,000, influence patient identification and treatment decisions but are generally covered by insurance when indicated.
References
- Surveillance, Epidemiology, and End Results Program (SEER). (2021). Cancer stat facts: Bladder cancer. Retrieved from https://seer.cancer.gov/statfacts/html/bladder.html
- U.S. Food & Drug Administration (FDA). (2019). FDA Approves Erdafitinib for Bladder Cancer. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-approves-erdafitinib-bladder-cancer
- IQVIA. (2022). National Prescription Data.
- Pancer, K. (2021). FGFR inhibitors in urothelial carcinoma: A clinical review. Journal of Clinical Oncology.
- Drug Pricing Network Report. (2022). Oncology drug price trends.
