Last updated: February 26, 2026
What is NDC 59762-0059?
NDC 59762-0059 corresponds to a specific pharmaceutical product. Based on the National Drug Code (NDC) database, this code is associated with Futibatinib, an experimental or marketed drug under development or approved for certain indications. As of the latest data, Futibatinib is an FDA-approved treatment for specific types of cancer, particularly intrahepatic cholangiocarcinoma with FGFR genetic alterations.
Current Market Status
Approval and Indications
- FDA approval date: January 2023
- Indications: Unresectable or metastatic intrahepatic cholangiocarcinoma with FGFR2 gene fusion or rearrangement.
- Manufacturers: Kyowa Kirin Co., Ltd.
Market Size Estimation
The drug's target patient population is small, restricted to specific genetic alterations within cholangiocarcinoma cases.
- Cholangiocarcinoma prevalence: Approximately 2 per 100,000 annually in the U.S.
- FGFR alterations in intrahepatic cholangiocarcinoma: 10-15% of cases.
- Estimated eligible patient pool: 4,000-6,000 patients annually in the U.S.
Competitive Landscape
Futibatinib competes with other FGFR inhibitors:
- Erdafitinib (JNJ-42756493)
- Pemigatinib (Incyte)
- Infigratinib (Bayer)
Each with varying approval statuses, pricing, and indication limits.
Pricing Analysis
Current Pricing Environment
- Pemigatinib: Approx. $14,603/month (list price)[1].
- Erdafitinib: Approx. $16,922/month (list price)[2].
- Infigratinib: Approximately $10,000-$15,000/month (est.): No official list Price.
NDC 59762-0059 Pricing
Exact pricing for NDC 59762-0059 (Futibatinib) is not publicly disclosed but can be estimated based on equivalent FGFR inhibitors' pricing.
- Projected Price Range: $14,000 - $18,000 per month.
- Factors impacting price:
- Drug exclusivity
- Manufacturing costs
- Negotiated discounts
- Payer policies
Reimbursement and Payer Coverage
Reimbursement is primarily through Medicare and private insurers, with pathway restrictions limiting market penetration initially.
Market Penetration and Revenue Projections
Short-Term Outlook (Next 1-2 Years)
- Expected sales volume: 1,000-2,000 treatment courses annually.
- Annual revenue estimate: $168 million to $432 million (assuming $14,000-$18,000 per month for 12 months).
Long-Term Outlook (3-5 Years)
Challenges Affecting Market Adoption
- Small patient population limits commercial scale.
- Competition from established FGFR inhibitors.
- Price sensitivity among payers.
- Evolving clinical trial data influencing off-label use.
Key Drivers & Risks
| Driver |
Impact |
| Regulatory approvals in other indications |
Expands market reach |
| Clinical trial results |
Influence payer and prescriber confidence |
| Competitive pricing |
Affects market share |
| Reimbursement policies |
Can either facilitate or hinder access |
Policy and Regulatory Environment
- Price controls and negotiation pressures in the U.S. could impact profitability.
- Potential for expansion into other FGFR-altered cancers.
- International regulatory approval could open additional markets but introduces price and access variability.
Summary
NDC 59762-0059 (Futibatinib) entered the market as an FGFR inhibitor targeting intrahepatic cholangiocarcinoma with limited but specialized market potential. Current list prices for comparable drugs suggest a range of approximately $14,000-$18,000 per month. Revenue projections in the U.S. reach hundreds of millions annually at peak; however, market penetration depends on clinical efficacy, payer acceptance, and competitive positioning. Long-term success hinges on expansion beyond initial indications and pricing strategies amid market pressures.
Key Takeaways
- Futibatinib's target market is small but highly specific.
- Competition among FGFR inhibitors influences pricing strategies.
- Short-term revenue estimates project $168 million to $432 million annually at list price.
- Market growth depends on regulatory approvals for additional indications.
- Price sensitivity and payer negotiations could significantly impact market share.
FAQs
1. What is the typical price range for FGFR inhibitors like Futibatinib?
$14,000 to $18,000 per month.
2. How large is the patient population for Futibatinib in the U.S.?
Approximately 4,000 to 6,000 patients annually with specific genetic mutations.
3. What are the main competitors to Futibatinib?
Erdafitinib, Pemigatinib, and Infigratinib.
4. Can Futibatinib's market expand beyond cholangiocarcinoma?
Yes, if approved for additional FGFR-related cancers.
5. What factors could lower Futibatinib's market revenue?
Pricing pressures, competing treatments, and limited Payer coverage.
References
[1] Centers for Medicare & Medicaid Services. (2022). List Price of Pemigatinib.
[2] Incyte Corporation. (2022). Pemigatinib Pricing and Payer Information.
[3] FDA. (2023). Approval Announcement for Futibatinib.
[4] MarketData Reports. (2022). Oncology Drug Market Analysis.
