Last updated: March 1, 2026
What is the drug associated with NDC 59676-0278?
NDC 59676-0278 corresponds to Erdafitinib (Balversa), a targeted therapy approved by the FDA in April 2019 for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma harboring FGFR mutations or gene fusions.
What is the current market landscape?
Market size and growth potential
- Prevalence: Urothelial carcinoma affects approximately 81,000 new cases annually in the U.S. (SEER, 2021).
- FGFR mutations: Present in approximately 15-20% of advanced urothelial carcinoma patients.
- Therapy adoption: As of 2023, Erdafitinib's penetration remains limited, primarily prescribed for second-line treatment post platinum-based chemotherapy failure.
Competitors
- Erdafitinib (Balversa): First FDA-approved FGFR inhibitor for this indication.
- Other FGFR inhibitors: In clinical development include infigratinib and futibatinib, with some receiving FDA breakthrough therapy designations.
Reimbursement landscape
- Coverage by major payers is generally favorable for approved indications.
- High drug acquisition costs are a barrier to access.
What are recent sales trends?
Revenue data
- Sales peaked at approximately $130 million in 2021.
- In 2022, revenue declined to around $100 million, reflecting market penetration limits and competitive dynamics.
Prescription volume
- Estimated 2,500 to 3,000 prescriptions annually in the U.S. (IQVIA, 2022).
Price analysis
Wholesale acquisition cost (WAC)
- The listed WAC for Erdafitinib is approximately $17,000 per month.
- Annual cost: around $204,000, assuming full adherence.
Comparative pricing
| Drug |
Indication |
Monthly Price |
Annual Price |
| Erdafitinib (Balversa) |
FGFR-mutated urothelial carcinoma |
$17,000 |
$204,000 |
| Infigratinib |
Similar FGFR inhibitor (clinical) |
$16,500 (est.) |
$198,000 (est.) |
| Futibatinib |
FGFR inhibitor (under review) |
Estimated lower |
Estimated lower |
Cost-effectiveness assessments
- Clinical trials show Erdafitinib achieves a median progression-free survival (PFS) of 5.4 months versus 2.7 months with chemotherapy.
- Cost per month of benefit: roughly $17,000, with incremental cost-effectiveness ratios (ICERs) under review due to emerging data.
Future price projections
Key factors influencing prices
- Market penetration growth: Increased adoption can lead to price stabilization or slight reductions.
- Pipeline competition: Next-generation FGFR inhibitors may exert downward pressure.
- Regulatory changes: Expansion of indications could increase demand, possibly sustaining current price levels.
Projections (2023-2027)
| Year |
Expected Market Penetration |
Predicted Revenue |
Price Trend |
| 2023 |
10% of eligible patients |
$125 million |
Stable to slight decrease |
| 2024 |
15% |
$195 million |
Slight decline possible |
| 2025 |
20% |
$260 million |
Potential decrease if new entrants emerge |
| 2026 |
25% |
$325 million |
Prices may stabilize |
| 2027 |
30% |
$390 million |
Possible reduction if generic or biosimilar options develop |
Summary of key drivers
- Clinical efficacy and safety profile support continued use.
- Market adoption remains moderate due to specificity and diagnostics requirements.
- Pricing remains high, consistent with other targeted oncology therapies, but may decline as competition consolidates.
Key Takeaways
- NDC 59676-0278, Erdafitinib, has limited but steady revenue growth driven by targeted patient populations.
- The drug’s price remains around $17,000/month, with potential marginal reductions as competition increases.
- Future market expansion depends on FDA label extensions and imaging diagnostic adoption.
- The competitive landscape is likely to intensify, influencing both pricing and sales volume.
FAQs
1. How does Erdafitinib compare in price to other FGFR inhibitors?
It is generally comparable; however, in clinical development, some agents are priced slightly lower, around $16,500 per month, depending on supplier and dosing.
2. What factors could lead to a decrease in Erdafitinib’s price?
Increased competition, availability of biosimilars or generics, or expanded indications reducing clinical exclusivity.
3. What is the primary patient population for Erdafitinib?
Patients with FGFR-mutated or FGFR gene fusion-positive locally advanced or metastatic urothelial carcinoma who have progressed on platinum-based therapy.
4. How significant is the market for this drug?
It targets a niche within urothelial carcinoma, representing a segment with approximately 12,000-16,000 annual new cases in the U.S.
5. What are the barriers to wider adoption?
Diagnostic testing for FGFR mutations, off-label use hesitance, and competition from other therapies.
References
[1] SEER Cancer Statistics Review, 2021. U.S. Cancer Statistics Working Group. National Cancer Institute.
[2] IQVIA. (2022). U.S. Prescriptions Data.
[3] FDA. (2019). FDA Approval of Erdafitinib (Balversa).
[4] ARK Data. (2022). Oncology Market Reports.
