Last updated: February 23, 2026
What is the Drug with NDC 51672-4027?
NDC 51672-4027 identifies Futibatinib. It is an investigational kinase inhibitor developed by Taiho Oncology, primarily targeting cholangiocarcinoma and other solid tumors with FGFR gene alterations. FDA approval has not been granted; it remains in the clinical or early market phase.
Market Landscape
Indications and Unmet Medical Need
- Primary Indication: Advanced biliary tract cancers, specifically cholangiocarcinoma.
- Unmet Need: Limited effective options; median survival for untreated cases is approximately 3-6 months. Existing therapies include chemotherapy with modest efficacy. Targeted therapies like Futibatinib aim to improve outcomes for FGFR-positive tumors.
Competitive Landscape
Key competitors
| Drug Name |
Indications |
Approval Status |
Market Size (Estimated) |
Price (Approximate) |
| Infigratinib (Triasert) |
Cholangiocarcinoma (FGFR inhibitors) |
Approved |
$300M globally (2023 estimates) |
$13,500 per month |
| Pemigatinib (Pemazyre) |
FGFR2 fusion-positive cholangiocarcinoma |
Approved |
$250M globally (2023 estimates) |
$12,500 per month |
| Erdafitinib |
Urothelial carcinoma, FGFR-altered |
Approved |
$500M globally (2023 estimates) |
$14,000 per month |
Note: Futibatinib's future market share depends on trial results, regulatory approval, and competition.
Timing and FDA Status
- Current Status: Phase 2/3 trials completed; awaiting FDA decision (as of Q4 2023).
- Regulatory Milestones: Data readouts as of H1 2023 aim to support eventual NDA submission.
Pricing Projections
Factors Influencing Price
- Development costs: Estimated at $150M to $200M for Phase 1–3 trials.
- Market exclusivity: Likely 7-year patent rights if approved.
- Competitive prices: Similar FGFR inhibitors priced around $12,500 to $14,000 per month.
- Value-based pricing: Premium pricing possible if clinical benefits surpass existing therapies.
Price Range Estimates
| Scenario |
Price Per Month |
Rationale |
| Conservative |
$11,000 - $13,000 |
Comparable to current FGFR inhibitors |
| Moderate Premium |
$13,000 - $15,000 |
Slight advantage in efficacy or safety profile |
| Premium Launch |
$15,000+ |
Superior outcomes, limited competition |
Revenue Projections
Assuming a gradual adoption rate:
| Year |
Market Penetration |
Estimated Annual Revenue |
Commentary |
| Year 1 |
10% |
$50M - $75M |
Limited patient access, pending approval |
| Year 2 |
30% |
$150M - $225M |
Post-approval, expanding indications |
| Year 3 |
50% |
$250M - $375M |
Growing market share, new clinical data |
Key Market Risks
- Clinical failure: Any negative trial data could restrict market entry.
- Regulatory delays: Longer review periods could push revenue projections into later years.
- Competitive responses: Lower-priced or more effective FGFR inhibitors could suppress pricing power.
Key Takeaways
- Futibatinib remains investigational; commercial viability hinges on successful trial outcomes.
- The drug faces competition from established FGFR inhibitors with annual revenues exceeding $200M.
- Pricing in the $13,000 to $15,000 per month range is anticipated if approved.
- Market entry could occur in 2024–2025, with revenues scaling up in subsequent years.
- The therapy’s success depends on clinical outcomes, regulatory timelines, and competitive dynamics.
FAQs
Q1: When could Futibatinib reach the market?
A1: Pending FDA approval, likely in late 2024 or early 2025.
Q2: How does Futibatinib compare to existing FGFR inhibitors?
A2: It may offer improved specificity, safety, or efficacy, but definitive data is pending.
Q3: What are the key regulatory milestones?
A3: NDA submission anticipated after Phase 3 data analysis, possibly in 2024.
Q4: How vulnerable is the drug to competitive pricing pressure?
A4: High; existing drugs are priced around $12,500 to $14,000 monthly, limiting premium pricing.
Q5: What is the potential market size?
A5: Global revenue could reach $300M–$500M annually, contingent on approval and adoption rates.
Sources
- IQVIA. (2023). Pharmaceutical Market Data.
- FDA. (2023). Drug Approval Announcements.
- EvaluatePharma. (2023). Oncology Market Reports.
- Company filings and clinical trial registry data.
[1] APA citations omitted for brevity in this summary.
