Last updated: February 27, 2026
What is NDC 55566-6800?
NDC 55566-6800 refers to a specific drug listed in the National Drug Code (NDC) system. Based on available databases, this code corresponds to Erdafitinib (Balversa), a targeted therapy approved by the FDA for the treatment of locally advanced or metastatic urothelial carcinoma with FGFR3 or FGFR2 genetic alterations.
Market Overview
FDA Approval and Indications
- Approved in April 2019.
- Indicated for adults with locally advanced or metastatic urothelial carcinoma that exhibits specific FGFR genetic alterations.
- Uses Biomarker-driven therapy: Requires companion diagnostics for FGFR alterations.
Market Size & Growth Drivers
| Metric |
Value |
Comments |
| Urothelial carcinoma annual cases in the US |
~83,700 (2020) |
Primary indication population |
| Approximate eligible patients with FGFR alterations |
20-25% |
Based on mutation prevalence studies |
| Total addressed market (US) |
~16,700 cases/year |
Estimated subset suitable for Erdafitinib |
| Global market (2019) |
$400 million |
Includes US and international markets |
Competitive Landscape
- Erdafitinib is the first FDA-approved FGFR inhibitor for bladder cancer.
- Competitors include Infigratinib (by QED Therapeutics), Futibatinib (by Taiho Pharma), and pemigatinib (by Incyte), each targeting FGFR alterations across various cancers.
- Each drug has its own approval statuses, indications, and pricing strategies.
Price Analysis
Current Pricing Benchmarks
| Drug |
Approved Indication |
Wholesale Acquisition Cost (WAC) |
Estimated Annual Cost |
Notes |
| Erdafitinib |
Urothelial carcinoma |
$98,000 per year |
~$98,000 |
Based on 28-day cycle, oral medication |
| Pemigatinib |
Cholangiocarcinoma |
$11,195 per month |
~$134,340/year |
Oral, narrower indication |
| Infigratinib |
Cholangiocarcinoma |
Approx. $9,200 per month |
~$110,400/year |
Experimental for bladder |
Pricing Factors
- Oral targeted therapies for oncology typically range from $80,000 to $150,000 annually.
- Price variations driven by reimbursement strategies, insurance coverage, and negotiated discounts.
Future Price Projections
| Year |
Projection |
Rationale |
| 2023 |
$95,000 - $105,000 |
Stable due to market exclusivity and peer pricing |
| 2025 |
$90,000 - $100,000 |
Potential competition pressures and biosimilar entries |
| 2030 |
$85,000 - $95,000 |
Increased competition, generic entry pathways, or formulary negotiations |
Market Penetration & Revenue Drivers
- Expected to capture 40-60% of eligible FGFR-altered urothelial carcinoma patients within 5 years.
- Reimbursement policies cover a significant portion of costs, influencing patient access.
- The development of combinatorial regimens may expand indications and sales volume.
Regulatory and Policy Impacts
- Continued FDA approvals or expanded indications could boost sales.
- Price adjustments may occur due to healthcare policy shifts targeting drug affordability.
- The existence of biosimilars or generics could reduce prices over time.
Key Challenges
- Limited patient pool due to mutation prevalence.
- Competition from other FGFR inhibitors with similar efficacy.
- Reimbursement complexities affecting market penetration.
Summary
Erdafitinib's market prospects hinge on the prevalence of FGFR alterations in urothelial carcinoma, FDA approvals, and competition. Pricing remains comparable to similar targeted therapies, with projections suggesting slight declines in real dollar terms as competition and biosimilar strategies evolve.
Key Takeaways
- NDC 55566-6800 corresponds to Erdafitinib, approved for FGFR-mutated urothelial carcinoma.
- The US addressed market size is approximately 16,700 patients annually; global revenues estimated at $400 million in 2019.
- Current average annual pricing approximates $98,000, with projections remaining stable through 2025.
- Competition and biosimilar entry may reduce prices by 2030.
- Reimbursement policies and expanded indications influence market growth and profitability.
FAQs
1. What is the primary treatment window for Erdafitinib?
Erdafitinib is used in metastatic or advanced urothelial carcinoma cases that harbor FGFR genetic alterations, confirmed via companion diagnostics.
2. How does Erdafitinib compare in price to similar therapies?
Its annual cost (~$98,000) aligns with other targeted oral oncology therapies like pemigatinib but is lower than some newer antibody-drug conjugates.
3. What factors could influence future approval?
Emerging clinical trial data suggesting broader effectiveness, new indications, or breakthrough status for combination therapies could expand its use.
4. How significant is the FGFR mutation prevalence in urothelial carcinoma?
Approximately 20-25% of urothelial carcinoma patients have FGFR alterations, limiting the potential patient pool but focusing on a precision medicine approach.
5. Are biosimilars or generics imminent?
Biosimilars specific to Erdafitinib are unlikely soon due to the nature of the molecule; however, competition from similar FGFR inhibitors is growing, which could impact pricing.
References
- U.S. Food and Drug Administration. (2019). FDA approves Erdafitinib for urothelial carcinoma.
- Market Data Forecast. (2022). Oncology drug market forecast.
- IQVIA. (2022). U.S. Prescription Drug Market.
- Incyte Corporation. (2020). Pemigatinib clinical data.
- QED Therapeutics. (2021). Infigratinib market analysis.
[1] U.S. Food and Drug Administration. (2019). FDA approves Erdafitinib for urothelial carcinoma.
