Last updated: April 3, 2026
What is NDC 00527-1311?
NDC 00527-1311 identifies Futibatinib, an experimental tyrosine kinase inhibitor developed primarily for treatment in certain cancers. As of the latest available data, Futibatinib is still under review or early-market phases in the U.S., pending regulatory approval or launch.
Market Landscape
Indications and Target Population
Futibatinib targets FGFR2 genetic alterations, predominantly in:
- Intrahepatic cholangiocarcinoma (iCCA)
- Other solid tumors with FGFR2 mutations
The total addressable market depends on the incidence of these cancers and the availability of competing therapies.
Competitive Environment
Key competitors include:
- Erdafitinib (JNJ-42756493)
- Pemigatinib (Incyte)
- Futibatinib's differentiator is its selectivity for FGFR2, which may influence positioning.
Market Size and Demand
Based on 2020 data:
- Cholangiocarcinoma annual incidence in the U.S.: approximately 2,800 cases.
- FGFR2 mutations present in roughly 10-15% of intrahepatic cholangiocarcinoma cases.
- Total potential U.S. patients: about 300-420 annually.
Global estimates project a broader market, with increasing detection and genetic testing expanding eligible patient pools.
Market Penetration Factors
- Regulatory approval status
- Clinical trial outcomes
- Competitive landscape and existing approvals
- Insurance reimbursement and coverage landscape
Price Projections
Current Pricing Benchmark
Approved drugs in similar niches exhibit wholesale acquisition costs (WAC):
| Drug |
Indication |
Annual Price (USD) |
| Erdafitinib |
FGFR-related urothelial carcinoma |
$90,000–$110,000 |
| Pemigatinib |
Cholangiocarcinoma |
~$100,000 |
Projected Price Range for Futibatinib
Considering its clinical data, regulatory status, and market competition, Futibatinib's initial annual treatment cost is expected to:
- Range from $90,000 to $115,000 in the U.S.
- Possibly lower or higher based on dosing, combination therapies, or pricing strategies.
Influencing Factors on Price
- Regulatory approval timeline: Delays could suppress early pricing premiums.
- Market exclusivity: Patent protections or orphan drug designation support higher prices initially.
- Reimbursement policies: Payers may negotiate discounts or formulary inclusion terms.
- Manufacturing costs: Scale and competition influence margins.
Future Price Trends
- Introduction of biosimilars or generic competitors could reduce prices within 3–5 years.
- Expansion into broader indications could support sustained pricing.
- Pricing adjustments are likely to be in line with those of similar targeted therapies in oncology.
Revenue Outlook
- First-year revenues could range from $50 million to $200 million if launched successfully, capturing early adoption in niche FGFR2-mutant cases.
- Growth depends on label expansions, clinical trial success, and competitive dynamics.
Regulatory and Policy Considerations
- FDA orphan drug designation grants market exclusivity until 7 years post-approval.
- The potential for accelerated approval based on Phase II data may influence early pricing strategies.
- Payer strategies will influence net pricing and access.
Summary Table: Market and Price Projections
| Aspect |
Details |
Range/Estimate |
| Target Patient Population |
U.S. intrahepatic cholangiocarcinoma FGFR2+ |
300–420 cases annually |
| Launch Year |
Pending regulatory approval, expected 2024-2025 |
N/A |
| Estimated Launch Price |
Comparable targeted kinase inhibitors |
$90,000–$115,000 per year |
| First-Year Revenue |
Based on initial uptake |
$50 million – $200 million |
| Long-Term Revenue Potential |
With label expansion |
Higher, depending on indications |
Key Takeaways
- NDC 00527-1311 (Futibatinib) is targeted at a niche cancer population, with limited current competition.
- Price points will align with existing FGFR inhibitors, around $90,000 to $115,000 annually.
- Market size is constrained by the incidence of FGFR2 mutations but could expand as genetic testing broadens.
- Rapid clinical trial results and regulatory milestones will significantly influence market entry and pricing.
- Long-term revenue depends on efficacy confirmation and indication expansion.
FAQs
1. When is Futibatinib expected to be FDA approved?
Typically, approval depends on clinical trial outcomes, with potential FDA decision in 2023-2024 based on ongoing data.
2. What is the key differentiation of Futibatinib from competitors?
Its selectivity for FGFR2 mutations may offer better efficacy and safety profiles, but comparative data is pending.
3. How does patent exclusivity impact pricing?
Patent protection can maintain higher prices for 7-12 years, depending on patent terms and regulatory exclusivities.
4. Are there existing biosimilars or generics for Futibatinib?
No, currently none on the market. Biosimilar competition generally appears 8-12 years post-approval.
5. What factors could lower the projected price?
Increased competition, market pressures, or reimbursement negotiations could lead to lower prices.
References
- Oncology Drug Pricing Comparatives (2022). PharmaPrice Index.
- Inc, Incyte Press Release (2022). Pemigatinib approval and sales data.
- U.S. Food & Drug Administration (FDA). Orphan Drug Designations and Market Exclusivities (2023).
- National Cancer Institute (2020). Incidence and prevalence data for cholangiocarcinoma.
- IQVIA. Global Oncology Market Reports (2022).
