Last updated: February 21, 2026
What is the drug associated with NDC 55111-0447?
NDC 55111-0447 corresponds to Erdafitinib (Balversa), a targeted therapy approved by the FDA on April 12, 2019, for the treatment of locally advanced or metastatic urothelial carcinoma harboring FGFR3 or FGFR2 genetic alterations. Developed by Janssen, it is a small-molecule FGFR kinase inhibitor.
Market Size and Penetration
Current Market Landscape
-
The Urothelial carcinoma market in the U.S. (2019-2023) shows an annual incidence of approximately 81,000 cases, with around 45-50% of cases being advanced or metastatic at diagnosis.[1]
-
The target population for Erdafitinib includes patients with FGFR alterations, estimated at roughly 15-20% of urothelial carcinoma cases.[2]
-
Estimated eligible patients in the U.S. are 12,000–16,200 annually.
Competitive Environment
-
Erdafitinib competes primarily against immunotherapies (e.g., pembrolizumab) and chemotherapy agents.
-
Other FGFR inhibitors, such as Infigratinib and Pemigatinib, target similar patient populations, leading to a competitive landscape.
Market Penetration Metrics (2023)
| Metric |
Data |
| U.S. urothelial carcinoma incidence |
81,000 annually |
| FGFR-positive cases |
15–20% of total (12,000–16,200) |
| Estimated treated patients |
Approx. 8,000–10,000 in 2023 |
Prescription Trends
- Post-approval data indicates incremental uptake, with approximately 2,000–3,000 prescriptions annually in the U.S. as of 2022-2023,[3] representing roughly 20–30% of eligible patients.
Price Projections
Current Pricing
-
List price: Erdafitinib's wholesale acquisition cost (WAC) is approximately $12,000 per month.[4]
-
Annual treatment cost: Around $144,000.
Forecasted Trends (2024–2028)
-
Pricing stability: Given the lack of direct generic competition, price remains stable unless significant policy changes or biosimilar entries occur.
-
Potential for discounts: Payers may negotiate discounts of 10-20%, bringing effective prices down to $9,600–$10,800 per month.
-
Impact of biosimilar/alternative therapies: Limited for targeted small-molecule kinase inhibitors, reducing downward pressure.
Revenue Projections (U.S. Market)
| Year |
Prescriptions |
Revenue (USD) |
Assumptions |
| 2023 |
2,500 |
$30 million |
Existing demand, stable list pricing |
| 2024 |
3,000 |
$36 million |
Slight increase in prescriptions, stable prices |
| 2025 |
3,500 |
$42 million |
Market expansion, no price reduction |
| 2026 |
4,000 |
$48 million |
Continued growth |
| 2027 |
4,500 |
$54 million |
Saturation point approaching |
Note: These projections assume steady dosing and adherence, with minimal market share loss due to competitors.
Price Sensitivity and Market Dynamics
-
Payer negotiations could drive discounting, impacting revenue projections.
-
Competitive pressure from allosteric FGFR inhibitors and combination therapies may limit pricing power.
-
Expansion into additional indications or combination regimens could influence demand and pricing.
Regulatory and Policy Impacts
-
Upcoming formulary and reimbursement policy shifts in the U.S. could impact pricing:
-
International markets show lower prices, affecting global revenue potential.
Key Takeaways
-
Erdafitinib's market is firm domestically with limited competition, maintaining high price points.
-
The therapy targets a small subset of urothelial carcinoma patients, constraining total revenue.
-
Prescriptions are gradually increasing; revenues are projected to grow by 20–25% annually for the next five years if market share stabilizes.
-
Price discounts of up to 20% are possible through negotiations, but no significant pricing reductions are forecasted unless competitive or regulatory pressures increase.
-
Market expansion depends on broader indications or combination regimens; currently, growth is driven primarily by increased awareness and prescription rates.
FAQs
1. What factors influence Erdafitinib’s pricing?
Pricing is influenced by manufacturing costs, competition, payer negotiations, and regulatory policies. Lack of generic competition supports high prices, while negotiations and policy changes can reduce costs.
2. How does the market for FGFR inhibitors compare?
Multiple FGFR inhibitors exist (Infigratinib, Pemigatinib), each at similar price points. Competition is limited but growing, potentially affecting pricing strategies.
3. What is the potential for price reductions in the future?
Price reductions could reach 10-20% if payer negotiations intensify or if biosimilars or alternative therapies enter the market, though current patent protections limit immediate reductions.
4. How does the targeted patient population size affect revenue?
The small patient pool (12,000–16,200 in the U.S.) caps total revenue, regardless of high per-patient pricing. Market expansion into other indications can increase sales volume.
5. Are international markets likely to follow U.S. pricing?
International pricing is generally lower due to healthcare system policies and negotiations, reducing global revenue potential compared to the U.S.
References
[1] American Cancer Society. (2022). Cancer facts & figures 2022.
[2] Roberts, S., & Sharma, S. (2020). FGFR alterations in urothelial carcinoma: prevalence and implications. Oncology Reviews, 14(3), 456–463.
[3] IQVIA. (2023). U.S. Oncology Prescription Data.
[4] GoodRx. (2023). Erdafitinib pricing and discounts.
Note: Data estimates are based on publicly available sources and market analysis reports up to 2023. Actual market conditions may vary.
