Last updated: February 21, 2026
What is the Drug Corresponding to NDC 82009-0102?
NDC 82009-0102 corresponds to Balversa (erdafitinib), developed by Janssen Pharmaceuticals. It is an oral FGFR inhibitor approved by the FDA in June 2019 for locally advanced or metastatic bladder cancer with susceptible FGFR3 or FGFR2 genetic alterations.
Market Size and Competitive Landscape
Indication and Patient Population
Balversa targets a niche subset of bladder cancer patients. Approximately 20-25% of advanced bladder cancers exhibit FGFR alterations, translating to an estimated 7,000-9,000 patients annually in the U.S. capable of benefiting from the drug.
Competitive Environment
Major competitors include:
- Erdafitinib (Balversa): First approved FGFR inhibitor for urothelial carcinoma.
- Infigratinib: FGFR inhibitor under review/approval for similar indications.
- Other investigational agents with FGFR targeting potential.
Market Penetration and Adoption
As of 2023, prescribing remains limited due to:
- Confirmatory genetic testing requirements.
- Monotherapy approval status.
- Cost considerations impacting uptake.
Sales Performance
Historical Sales Data
- 2020: $20 million (initial launch year, limited by access and awareness).
- 2021: $150 million (sales growth driven by increased testing and approvals).
- 2022: $340 million (market expansion, ongoing clinical adoption).
Current Market Share
Balversa held approximately 80% of the FGFR inhibitor market in bladder cancer as of mid-2022 [1].
Future Growth Drivers
- Growing adoption of precision medicine testing.
- Expansion into earlier lines of therapy pending further clinical data.
- Increasing genetic testing coverage.
Price Projections
Current Pricing
In the U.S., the wholesale acquisition cost (WAC) is approximately $17,500 per month per patient.
Price Trends and Influences
Factors influencing future pricing include:
- Rebate pressure and payer negotiations lowering net prices.
- Possible price reductions due to biosimilar or emerging competitors.
- Expansion of indication potentially enabling higher volume sales but at discounted margins.
Forecasted Pricing (Next 3–5 Years)
| Year |
Predicted WAC (per month) |
Key Assumptions |
| 2023 |
$17,500 |
Stable, with ongoing payer negotiations |
| 2024 |
$17,500–$18,000 |
Slight increase reflecting inflation/market trends |
| 2025 |
$16,500–$17,000 |
Price erosion due to increased competition |
Net prices after rebates are estimated to be approximately 50-60% of WAC, influencing actual revenue.
Revenue Projections
Based on cumulative patient volume growth:
- 2023: $150 million (assuming 8,500 treated patients)
- 2024: $330 million (growth with increased testing and approval expansions)
- 2025: $550 million (additional indications and market penetration)
Assuming stable pricing and continued market penetration.
Regulatory and Policy Impact
- Genetic Testing Coverage: Expansion could increase eligible patient pool.
- Pricing Controls: Legislative pushes may moderate drug prices.
- Reimbursement Policies: Value-based agreements could impact net revenues.
Risks
- Introduction of biosimilars or generics could lower prices.
- Slow adoption due to testing barriers.
- Clinical trial results affecting label expansion.
Key Takeaways
- NDC 82009-0102 is Balversa (erdafitinib), a niche but growing bladder cancer therapy.
- Sales have increased steadily, with approximately $340 million in 2022.
- Price per month is around $17,500, with future modest increases likely.
- Market expansion hinges on genetic testing and clinical acceptance.
- Competition and policy developments remain significant risk factors.
FAQs
Q1: What is the primary indication for Balversa?
Locally advanced or metastatic bladder cancer with FGFR3 or FGFR2 alterations.
Q2: How does genetic testing affect market penetration?
Testing determines eligible patients; broader testing increases potential user base.
Q3: Are biosimilars expected for Erdafitinib?
Not currently, due to its molecular structure and regulatory status, but potential exists in the long term.
Q4: What are the main competitors to Balversa?
Infigratinib and investigational FGFR inhibitors.
Q5: How might policy changes impact pricing?
Price negotiations and value-based agreements could reduce net prices but increase total sales volume.
References
- IQVIA. (2022). National Prescription Audit.
