Last updated: February 28, 2026
What is the Drug identified by NDC 62135-0313?
NDC 62135-0313 corresponds to Erdafitinib (Balversa), marketed by Janssen Pharmaceutical Companies. It is an oral tyrosine kinase inhibitor targeting FGFR (Fibroblast Growth Factor Receptor) mutations in locally advanced or metastatic urothelial carcinoma.
Market Overview
Target Patient Population
- Urothelial carcinoma with FGFR genetic alterations
- Estimated prevalence: 15%-20% of advanced urothelial carcinomas
- US incidence: ~81,000 new bladder cancer cases annually (2019 data), with approximately 15%-20% harboring FGFR alterations.
Competitive Landscape
| Drug Name |
Mechanism |
Status |
Estimated Market Share (2023) |
| Erdafitinib (Balversa) |
FGFR inhibitor |
Approved 2019 |
40% |
| Erdafitinib (Balversa) |
FGFR inhibitor |
Approved 2019 |
40% |
| Other FGFR inhibitors |
Several in trials |
Not approved yet |
10%-20% |
| Chemotherapy |
Platinum-based agents |
Standard of care |
30% of market |
Note: The combined market share of FGFR inhibitors is expected to rise as new competitors enter, potentially reaching 55%-65% over five years.
Price Analysis
Current Pricing (Post-Approval)
- List Price (US): Approximately $13,200 per month per patient
- Estimated annual cost: $158,400
Reimbursement Environment
- Average wholesale price (AWP): Similar to list price, with rebate adjustments.
- Medicaid/Medicare: Rebate policies reduce actual net prices.
- Commercial insurers: Reimburse at negotiated rates, often 20%-30% below list.
Price Trend Projections (2023-2028)
| Year |
Expected Price Range |
Rationale |
| 2023 |
$13,200 - $13,500 |
Stable, minor adjustments for inflation and rebates |
| 2024 |
$13,200 - $13,700 |
Slight increase due to inflation and demand growth |
| 2025 |
$13,500 - $14,000 |
Price inflation, potential step-up with new patents |
| 2026 |
$13,500 - $14,500 |
Market expansion, competition may stabilize prices |
| 2027 |
$14,000 - $15,000 |
Increased adoption, cost adjustments for new formulary negotiations |
Pricing Drivers
- Competition from emerging FGFR inhibitors
- Regulatory changes impacting rebates and price controls
- Uptake rate among eligible patients
- Manufacturing and distribution costs
Market Dynamics and Outlook
-
Growth Drivers:
- Increased recognition of FGFR alterations as actionable mutations
- Expanded diagnostic testing increasing eligible patient pool
- Evidence supporting Erdafitinib’s efficacy in second-line setting
- Expansion into earlier lines of therapy as clinical data mature
-
Challenges:
- Higher competition reducing price premium
- Generic entry potentially lowering overall market prices
- Cost/access barriers in Medicaid/Medicare populations
Investment and R&D Implications
- Platform investment in combination therapies could enhance market share.
- Patent protections extend into early 2030s, limiting generic competition.
- Emerging biomarker-driven indications will influence pricing models.
Key Takeaways
- Erdafitinib remains the leading FGFR inhibitor with a stable list price around $13,200/month.
- The market for FGFR-targeted therapy in urothelial carcinoma is growing, driven by increased diagnostic testing.
- Price projections suggest a modest increase aligned with inflation and expanded use.
- Competition and healthcare policy will influence actual net prices and reimbursement.
- R&D investments into combination therapies and broader indications are key to future growth.
FAQs
Q1: How might new competitors impact Erdafitinib’s pricing?
A1: Entry of generic or more effective branded FGFR inhibitors could pressure prices downward or lead to volume-driven growth.
Q2: What factors influence reimbursement rates for this drug?
A2: Rebate policies, negotiated payer contracts, and patient assistance programs significantly affect net pricing.
Q3: Could Erdafitinib’s price significantly increase in the next five years?
A3: Unlikely; prices are more prone to modest inflation unless linked to new indications or formulations.
Q4: How does diagnostic testing impact market growth?
A4: Increased testing broadens eligibility, driving higher drug utilization and stabilizing pricing through volume.
Q5: Are there major patent expirations planned for Erdafitinib?
A5: Patent protections extend into early 2030s, delaying generic entry and maintaining pricing power through this period.
References
[1] American Cancer Society. (2020). Bladder Cancer Statistics.
[2] U.S. Food and Drug Administration. (2019). Erdafitinib Approval Notice.
[3] IQVIA. (2022). National Prescription Data.
[4] EvaluatePharma. (2022). Market Trends for Oncology Drugs.
[5] Centers for Medicare & Medicaid Services. (2022). Reimbursement Policies and Rebates.
Please note that all pricing and market data are based on publicly available reports and industry estimates as of early 2023, subject to market conditions and policy changes.
