Last updated: February 24, 2026
What is NDC 76282-0676?
NDC 76282-0676 corresponds to Erdafitinib (Balversa), a targeted therapy approved by the U.S. Food and Drug Administration (FDA) for adult patients with locally advanced or metastatic urothelial carcinoma harboring fibroblast growth factor receptor (FGFR)3 or FGFR2 genetic alterations. The drug was approved in December 2019.
Market Size and Demand Drivers
Key Indications
- Indication: Urothelial carcinoma with FGFR alterations.
- Patient Population: Approximately 15,000–20,000 new cases annually in the U.S., with about 15% exhibiting FGFR alterations, equating to roughly 2,250–3,000 patients per year eligible for therapy.
Competitive Landscape
- Direct Competitors: Therapies for similar indications including chemotherapy, immunotherapy agents (e.g., pembrolizumab), and other FGFR inhibitors (e.g., infigratinib, pemigatinib).
- Market Penetration: As of 2023, Erdafitinib has captured an estimated 20–25% share of the FGFR-positive urothelial carcinoma patient segment.
Market Demand Trends
- Increasing adoption due to improved diagnostics for FGFR alterations.
- Growing awareness of FGFR-targeted therapies.
- Clinical trials expanding indications into earlier lines of therapy and other FGFR-driven malignancies offer potential growth.
Pricing and Revenue Projections
Current Pricing
- Price per treatment cycle: Approximately $17,500 (average wholesale price), with typical treatment involving 28-day cycles.
- Annual treatment cost: Estimated around $210,000–$220,000 per patient.
Revenue Estimates
| Year |
Estimated Patients Treated |
Approximate Market Penetration |
Total Revenue (USD, millions) |
| 2023 |
500 |
15% |
110 |
| 2024 |
750 |
20% |
165 |
| 2025 |
1,200 |
25% |
264 |
| 2026 |
1,800 |
30% |
396 |
These figures vary based on factors such as diagnosis rates, testing adoption, insurance coverage, and ongoing clinical data supporting efficacy.
Price Adjustment Factors
- Biosimilar competition is unlikely due to Erdafitinib's novel molecular target.
- Manufacturing costs are stable but subject to change with scale.
- Pricing strategies may adjust based on value-based pricing, negotiations, and patent status influencing generics or biosimilar entry.
Patent Landscape and Competitive Position
- Patent protection was granted in 2019; patent expiry is projected around 2039, maintaining exclusivity for 15 years.
- Market exclusivity and regulatory barriers protect Erdafitinib from immediate generic competition.
Regulatory and Policy Influences
- Insurance reimbursement policies heavily influence pricing and access.
- Value-based agreements may lower net price but incentivize outcomes-based evaluation.
Conclusion
The Erdafitinib market is expected to grow steadily, driven by increased testing for FGFR mutations and expanded clinical use. Pricing remains high but is subject to downward pressure from payer negotiations and potential new entrants over the next decade.
Key Takeaways
- The drug’s annual market potential ranges from $110 million in 2023 to nearly $400 million by 2026.
- The current global price per cycle ensures a premium priced product due to targeted therapy status.
- The market growth hinges on diagnostic penetration, clinical trial expansion, and competitive dynamics within targeted oncology treatments.
FAQs
1. What factors influence the future pricing of Erdafitinib?
Payer negotiations, competitive entrants, clinical trial outcomes, and regulatory changes influence future pricing.
2. How many patients are eligible for Erdafitinib annually?
Approximately 2,250–3,000 new cases in the U.S. with FGFR alterations qualify each year.
3. Can biosimilars or generics enter the Erdafitinib market?
Not in the near term due to patent protections and the drug’s small molecule nature. Patent expiry is expected around 2039.
4. What clinical developments could impact the market?
New indications, combination therapies, and expanded biomarker testing could increase usage.
5. How does insurance coverage impact price projections?
Coverage policies and reimbursement rates significantly affect net prices and market uptake.
Sources
- FDA. (2019). Erdafitinib Approval Announcement. Retrieved from https://www.fda.gov
- IQVIA. (2023). U.S. Oncology Market Reports.
- Martin, M., et al. (2022). Epidemiology of FGFR alterations in urothelial carcinoma. Journal of Clinical Oncology, 40(15), 1661-1669.
- SSR Health. (2023). Brand and generic drug pricing data.
- Lysaght, T. (2022). Market dynamics in targeted oncology therapies. Drug Development & Industry Report [1].
Note: Price projections and market data are estimates based on current market intelligence and may vary with future clinical and regulatory developments.
