Last updated: February 23, 2026
What is NDC 31722-0044?
NDC 31722-0044 refers to Balversa (erdafitinib), a targeted therapy approved by the FDA in June 2019 for the treatment of locally advanced or metastatic urothelial carcinoma with FGFR genetic alterations. It is marketed by Janssen Pharmaceuticals.
Market Size and Penetration
Current Market Landscape
- Indication: Primarily used for FGFR-driven bladder cancer.
- Patient Population: Estimated 81,000 new bladder cancer diagnoses annually in the U.S. (SEER, 2022).
- Reimbursement: Covered under Medicare and private insurers; cost-sharing varies.
- Market Penetration: Limited due to recent approval, with slow adoption reported in early years.
Competitors and Alternatives
| Drug Name |
Mechanism |
Approval Year |
Market Share (Estimate, 2023) |
| Erdafitinib (Balversa) |
FGFR inhibitor |
2019 |
~15% |
| Enfortumab Vedotin |
ADC for urothelial carcinoma |
2019 |
~35% |
| Pembrolizumab |
PD-1 inhibitor |
2017 |
~25% |
| Other FGFR inhibitors |
Multiple agents |
Varies |
~5-10% |
Market Trends
- Increasing approvals for targeted therapies in urothelial carcinoma
- Growing familiarity and adoption among oncologists
- Expansion into earlier lines of therapy pending ongoing trials
Price Analysis and Forecasts
Current Pricing Overview
- Wholesale Acquisition Cost (WAC): Approx. $14,000 per 30-day supply.
- Average Actual Acquisition Cost (AAC): Estimated at $12,500 due to discounts.
- Per-treatment Cost: $168,000 for a typical 12-month course, assuming continuous daily dosing.
Price Trends
| Year |
Average Price per 30-Day Supply |
Notes |
| 2019 |
$14,000 |
Launch year, initial pricing set |
| 2020 |
$13,800 |
Slight decline from discounts and coverage expansions |
| 2021 |
$13,600 |
Steady, slight decrease |
| 2022 |
$13,400 |
Market stabilization |
| 2023 |
$13,200 |
Slight downward adjustment, potential for further decrease |
Future Price Projections (2024-2028)
- Assumption: No significant price inflation; generic erosion unlikely due to patent protection until 2030.
- Projected Trend: Slight decline of 1-2% annually due to increased competition, volume discounts, and negotiated rebates.
- Estimated Price in 2028: Approximately $11,500—$12,000 per 30-day supply.
Regulatory and Pricing Influences
- Patent Status: Patent expires in 2030; biosimilar products may enter market thereafter, exerting downward pressure.
- Reimbursement Policies: CMS and private insurers' negotiation strategies influence net prices.
- Orphan Drug Designation: Provides market exclusivity until 2024, supporting higher initial prices.
Key Market Dynamics
- Clinical trial data supports expanded use; potential shift to earlier lines.
- Cost-effectiveness analyses are ongoing; payer willingness to reimburse influences access.
- Pricing strategies by Janssen may adapt based on competitive landscape and market uptake.
Summary Table of Market and Price Data
| Aspect |
Data Point or Projection |
| Current market size (U.S.) |
81,000 bladder cancer cases annually |
| Current market share |
~15% among FGFR-targeted therapies |
| 2023 average price |
$13,200 per 30-day supply |
| 2028 projected average price |
$11,500 - $12,000 |
| Patent expiration |
2030 |
Key Takeaways
- NDC 31722-0044 (Balversa) has a modest share in a competitive bladder cancer market.
- Pricing remains stable around $13,200, with slight decline expected through 2028.
- Market expansion depends on clinical trial outcomes and payer acceptance.
- Patent expiration in 2030 could lead to biosimilar entry, reducing price pressures.
- Providers' adoption rate influences overall revenue and future price dynamics.
FAQs
1. What factors influence Balversa’s pricing?
Pricing is affected by patent protection, market competition, reimbursement negotiations, and clinical efficacy data.
2. How does Balversa compare price-wise to its competitors?
Its current 30-day supply costs approximately $13,200, higher than some immunotherapies but comparable to other targeted therapies in urothelial carcinoma.
3. What is the projected market size for Balversa?
The initial addressable market in the U.S. is around 12,000-15,000 eligible patients annually with FGFR alterations.
4. Will the price decrease significantly after patent expiry?
Yes. Biosimilar or generic versions entering the market could reduce costs by 30-50% or more.
5. How does clinical adoption impact future revenues?
Increased physician awareness and approval for earlier lines of therapy will likely improve market share and revenue.
References
[1] Surveillance, Epidemiology, and End Results (SEER) Program. (2022). Cancer Stat Facts. http://seer.cancer.gov/statfacts/html/bladder.html
[2] FDA. (2019). FDA approves Balversa for bladder cancer with FGFR genetic alterations. https://www.fda.gov
[3] IQVIA. (2023). National Sale Data for Oncology Drugs.
[4] Russ, A. J., et al. (2022). "Targeted Therapies in Bladder Cancer." Journal of Clinical Oncology, 40(12), 1214-1224.
[5] US Patent and Trademark Office. (2022). Patent status for Erdafitinib. https://www.uspto.gov
