Last updated: February 24, 2026
What is the approved indication and formulation of NDc 60687-0820?
NDC 60687-0820 corresponds to Futibatinib, an oral kinase inhibitor indicated for the treatment of locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or rearrangement.
- Formulation: 20 mg capsules
- Approved by the FDA in September 2022 under the accelerated approval pathway.
- Mechanism: Selectively inhibits fibroblast growth factor receptor (FGFR) 1, 2, 3, 4.
What is the current market size and key competitive landscape?
Market Size
- Cholangiocarcinoma incidence: approximately 8,000–10,000 new cases annually in the U.S.
- FGFR2 alterations present in roughly 10%-15% of intrahepatic cholangiocarcinoma cases, translating to an estimated 800–1,500 eligible patients annually.
- Total market for FGFR inhibitors targeting cholangiocarcinoma: projected at $300–400 million in the U.S. for 2023.
Key Competitors
| Drug |
Indication |
Market Launch |
Price (Per 30-Day Supply) |
Notes |
| Pemigatinib |
Cholangiocarcinoma, FGFR2+ |
2020 |
$17,500 |
Approved for FGFR2+ cholangiocarcinoma; first FGFR inhibitor |
| Infigratinib |
Cholangiocarcinoma, FGFR+ |
2021 |
$16,000 |
Approved via accelerated pathway; dosing optimized |
| Erdafitinib |
Urothelial carcinoma, FGFR+ |
2019 |
$23,000 |
Broader indication; off-label use in cholangiocarcinoma |
Market Dynamics
- Market entry barriers include need for biomarker testing.
- Clinical preference leans toward oral agents with manageable toxicity.
- Competition is primarily driven by the strength of clinical data, pricing, and indication breadth.
What are the pricing and reimbursement considerations?
Pricing Trends
- FGFR inhibitors typically retail at $16,000–$23,000 monthly.
- SmPC (Summary of Product Characteristics) and real-world prescriber preferences favor slightly lower prices to improve uptake.
Reimbursement Landscape
- Covered by Medicare, Medicaid, and commercial insurers with prior authorization.
- Cost-effectiveness evaluations are ongoing; incremental cost per quality-adjusted life year (QALY) for FGFR inhibitors ranges from $75,000 to $150,000.
Price Projections
| Year |
Estimated Average Monthly Price |
Unknown Factor |
Rationale |
| 2023 |
$18,000 |
Launch volume |
Competitive pricing with Pemigatinib, initial uptake high. |
| 2024 |
$17,500 |
Market competition |
Slight reduction reflects payer pressure and biosimilar entry. |
| 2025 |
$16,500 |
Pricing negotiations |
Potential discounts to expand coverage and uptake. |
What are the key factors influencing future market development?
Clinical Data
- Ongoing trials evaluating efficacy in broader FGFR+ tumors.
- Data on durability of response and tolerability influence physician prescribing.
Regulatory Pathway
- Potential for accelerated approval continuation hinges on confirmatory trial results.
- Expanded indications could broaden market share.
Manufacturing and Supply
- Proprietary manufacturing processes could impact pricing flexibility.
- Supply chain stability influences availability and costs.
Policy & Reimbursement
- Healthcare payers' acceptance depends on cost-benefit analyses.
- Price negotiations and value-based pricing models will shape future pricing.
What are the potential price trajectories?
- Handling of biosimilar or generic entries unlikely due to small molecule patent protections and bespoke manufacturing.
- Pricing will largely hinge on clinical value, competition, and reimbursement negotiations.
- Price reductions of 10–15% over two years are likely as market competition intensifies.
Summary of key projections
| Year |
Projected Market Revenue |
Average Monthly Price |
Market Penetration |
Key Drivers |
| 2023 |
$50–70 million |
$18,000 |
40–50% |
Initial clinical adoption, reimbursement pathways. |
| 2024 |
$70–100 million |
$17,500 |
50–60% |
Increased competition, expanded biomarker testing. |
| 2025 |
$100–150 million |
$16,500 |
60–70% |
Further market expansion, formulary acceptance. |
Key Takeaways
- NDc 60687-0820 (Futibatinib) entered the U.S. market in September 2022 with an indication for FGFR2+ cholangiocarcinoma.
- The market size is limited but growing, driven by the prevalence of FGFR2 alterations.
- Competitive landscape centers on Pemigatinib and Infigratinib, with pricing in the $16,000–$23,000 monthly range.
- Future pricing will depend heavily on clinical outcomes, market competition, and payer negotiations.
- Market potential can reach $100–150 million in revenue by 2025 if uptake and indications expand.
FAQs
1. What distinguishes Futibatinib from other FGFR inhibitors?
Futibatinib is a selective irreversible FGFR inhibitor. It binds covalently, potentially offering more sustained inhibition compared to reversible inhibitors.
2. How does pricing compare to competitors?
Futibatinib's initial pricing aligns with Pemigatinib and Infigratinib, at approximately $17,500–$18,000 per month.
3. What barriers exist for market expansion?
Limited by the prevalence of FGFR2 alterations and the need for biomarker testing. Clinical trial results and safety profile will influence growth.
4. Are biosimilars or generics expected?
Unlikely in the near term due to proprietary chemistry and manufacturing; patents typically extend 10–12 years from launch.
5. How will reimbursement trends affect pricing?
Payer pressure may necessitate price reductions; value-based agreements could influence net prices.
References
- U.S. Food and Drug Administration. (2022). FDA approves futibatinib for cholangiocarcinoma. https://www.fda.gov/
- MarketScope Insights. (2023). FGFR inhibitors: Market analysis and competitive landscape.
- IQVIA. (2023). Pharmaceutical pricing and reimbursement forecasts.
- National Cancer Institute. (2022). Cholangiocarcinoma statistics.
- EvaluatePharma. (2023). Oncology drug market forecasts.
[1] U.S. Food and Drug Administration. (2022). FDA approves futibatinib for cholangiocarcinoma.
[2] MarketScope Insights. (2023). FGFR inhibitors: Market analysis and competitive landscape.
[3] IQVIA. (2023). Pharmaceutical pricing and reimbursement forecasts.
[4] National Cancer Institute. (2022). Cholangiocarcinoma statistics.
[5] EvaluatePharma. (2023). Oncology drug market forecasts.
