Futibatinib - Generic Drug Details

What are the generic sources for futibatinib and what is the scope of patent protection?

Futibatinib is the generic ingredient in one branded drug marketed by Taiho Oncology and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Futibatinib has seventy-nine patent family members in twenty-five countries.

One supplier is listed for this compound.

Summary for futibatinib

International Patents:	79
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	32
Clinical Trials:	15
What excipients (inactive ingredients) are in futibatinib?	futibatinib excipients list
DailyMed Link:	futibatinib at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for futibatinib

Constraining patent/regulatory exclusivity:

TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED, UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC INTRAHEPATIC CHOLANGIOCARCINOMA HARBORING FIBROBLAST GROWTH FACTOR RECEPTOR 2 (FGFR2) GENE FUSIONS OR OTHER REARRANGEMENTS

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for futibatinib

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Institut fr Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest	PHASE2
Universittsmedizin Mainz, I. Medizinische Klinik, Forschungslabor Prof. Mhler	PHASE2
Yuanquan Yang	PHASE2

See all futibatinib clinical trials

Pharmacology for futibatinib

Drug Class	Kinase Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Fibroblast Growth Factor Receptor Inhibitors P-Glycoprotein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for futibatinib

L01EN	Fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for futibatinib

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Taiho Oncology	LYTGOBI	futibatinib	TABLET;ORAL	214801-002	Jul 28, 2025		RX	Yes	No	9,108,973		Y	Y
Taiho Oncology	LYTGOBI	futibatinib	TABLET;ORAL	214801-001	Sep 30, 2022		RX	Yes	Yes	10,434,103		Y	Y
Taiho Oncology	LYTGOBI	futibatinib	TABLET;ORAL	214801-001	Sep 30, 2022		RX	Yes	Yes	11,833,151		Y
Taiho Oncology	LYTGOBI	futibatinib	TABLET;ORAL	214801-001	Sep 30, 2022		RX	Yes	Yes
Taiho Oncology	LYTGOBI	futibatinib	TABLET;ORAL	214801-002	Jul 28, 2025		RX	Yes	No	10,434,103		Y	Y
Taiho Oncology	LYTGOBI	futibatinib	TABLET;ORAL	214801-002	Jul 28, 2025		RX	Yes	No	11,833,151		Y
Taiho Oncology	LYTGOBI	futibatinib	TABLET;ORAL	214801-001	Sep 30, 2022		RX	Yes	Yes

EU/EMA Drug Approvals for futibatinib

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Taiho Pharma Netherlands B.V.	Lytgobi	futibatinib	EMEA/H/C/005627Lytgobi monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.	Authorised	no	no	no	2023-07-04

International Patents for futibatinib

Country	Patent Number	Title	Estimated Expiration
Poland	2657233
Russian Federation	2672563	КРИСТАЛЛЫ 3,5-ДИЗАМЕЩЕННОГО БЕНЗОЛАЛКИНИЛЬНОГО СОЕДИНЕНИЯ (CRYSTALS OF 3,5-DISUBSTITUTED BENZOLALKYNYL COMPOUND)
Philippines	12017501690	CRYSTAL OF 3,5-DISUBSTITUTED BENZENE ALKYNYL COMPOUND
Norway	2023046
Japan	WO2019181876	アルキル硫酸ナトリウムを含む医薬組成物
Poland	3279202
Japan	WO2016159327

Supplementary Protection Certificates for futibatinib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2657233	C202330047	Spain		PRODUCT NAME: FUTIBATINIB O UNA SAL DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/23/1741; DATE OF AUTHORISATION: 20230704; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/23/1741; DATE OF FIRST AUTHORISATION IN EEA: 20230704
2657233	CR 2023 00036	Denmark		PRODUCT NAME: FUTIBATINIB ELLER ET SALT DERAF; REG. NO/DATE: EU/1/23/1741 20230706
2657233	CA 2023 00036	Denmark		PRODUCT NAME: FUTIBATINIB ELLER ET SALT DERAF; REG. NO/DATE: EU/1/23/1741 20230706
2657233	122023000066	Germany		PRODUCT NAME: FUTIBATINIB ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1741 20230704
2657233	C20230038	Finland
2657233	23C1050	France		PRODUCT NAME: FUTIBATINIB OU UN DE SES SELS; REGISTRATION NO/DATE: EU/1/23/1741 20230706
2657233	2023C/548	Belgium		PRODUCT NAME: FUTIBATINIB OF EEN ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/23/1741 20230706

Market Dynamics and Financial Trajectory for Futibatinib

Last updated: February 15, 2026

Market Overview

Futibatinib is an investigational tyrosine kinase inhibitor targeting FGFR2 mutations and fusions associated with cholangiocarcinoma. It is developed by Taiho Oncology, primarily for advanced biliary tract cancers. The drug's commercial potential depends on clinical trial outcomes, regulatory approvals, and competitive landscape positioning.

Current Development Status

• Phase Trials: Futibatinib completed Phase II trials with promising efficacy in FGFR2 fusion-positive cholangiocarcinoma.
• Regulatory Pathway: Data submitted to regulatory agencies (FDA, EMA). An orphan drug designation accelerates review processes due to disease rarity.
• Companion Diagnostics: The drug's success relies on FGFR mutation testing platforms, which are operational in late-stage trials.

Market Size and Growth Drivers

• Target Population: Biliary tract cancers represent about 3% of gastrointestinal cancers, totaling approximately 8,000 annually in the U.S. and Europe.
• Unmet Need: Limited targeted therapy options contribute to high unmet need; response rates with standard chemotherapy hover around 10-15%.
• Projected Growth: The global cholangiocarcinoma market is expected to grow at a CAGR of 7.5% from 2022 to 2030, driven by improved diagnostics and targeted therapies.

Competitive Landscape

• Direct Competitors: Other FGFR inhibitors such as infigratinib (BGJ398) and pemigatinib (INN), both approved for FGFR2-driven cholangiocarcinoma.
• Market Share Dynamics: Approval status, efficacy, safety profiles influence market capture. Futibatinib's irreversible inhibition could confer differential efficacy over reversible inhibitors.

Financial Trajectory Analysis

Year	Sales Estimates	Market Penetration	Key Assumptions
2023	$0 million	Pre-approval	Awaiting regulatory decision; clinical success critical
2024	$50 million	Early adoption	Limited approvals, initial pricing, early post-marketing sales
2025	$200 million	Growth phase	Broader approvals, expanded indications, increased adoption
2026	$500 million	Market expansion	Full commercial deployment, neurologic and other tumor indications

Pricing Strategy

• Expected launch price exceeding $10,000 per month based on comparator drugs (pemigatinib priced at ~$12,000/month).
• Revenue depends on uptake in qualifying patients; target penetration in first 3 years approximates 20%-25%.

Regulatory and Reimbursement Outlook

• Positive early clinical data favors approval; regulatory agencies may grant accelerated review.
• Reimbursement negotiations hinge on shown clinical benefit, with payers demanding real-world evidence post-approval.

Risks and Uncertainties

• Clinical efficacy and safety from ongoing trials determine market entry.
• Competition from existing FGFR inhibitors limits differentiation.
• Diagnostic testing availability could constrain speed of access.

Key Takeaways

• Futibatinib holds potential in a niche but growing market for FGFR2-positive cholangiocarcinoma.
• Fast-tracked approval pathways depend on early clinical success.
• Market size remains limited but is expected to expand with broader indications.
• Revenue is projected to reach hundreds of millions globally within five years if approvals and sales ramp up as anticipated.
• Competitive dynamics necessitate differentiation via efficacy, safety, and diagnostic integration.

FAQs

1. What are the primary barriers to Futibatinib’s market entry?

   • Clinical trial outcomes, regulatory approval timing, and competition from established FGFR inhibitors.

2. Will Futibatinib benefit from orphan drug status?

   • Yes. Its designation provides regulatory incentives, including market exclusivity and potential fast-track review.

3. How does Futibatinib’s mechanism differ from competitors?

   • It irreversibly inhibits FGFR, which could lead to more sustained target engagement compared to reversible inhibitors.

4. What is the expected timeline for commercialization?

   • Regulatory decision anticipated within 2023-2024; commercial launch likely follows within a year thereafter.

5. How significant is the market for cholangiocarcinoma therapies?

   • It remains niche but growing, with a high unmet need, supporting multiple targeted therapies' development.

References

[1] MarketsandMarkets, “FGFR Inhibitors Market,” 2022.
[2] FDA, “Orphan Drug Designations,” 2023.
[3] EvaluatePharma, “Cholangiocarcinoma Pipeline,” 2022.