FUTIBATINIB - Generic Drug Details

What are the generic sources for futibatinib and what is the scope of freedom to operate?

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-eight patent family members in twenty-five countries.

One supplier is listed for this compound.

Summary for FUTIBATINIB

International Patents:	78
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
Universittsmedizin Mainz, I. Medizinische Klinik, Forschungslabor Prof. Mhler	PHASE2
Institut fr Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest	PHASE2
Gateway for Cancer Research	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	214801-001	Sep 30, 2022		RX	Yes	Yes			Y	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			Y	Y
Taiho Oncology	LYTGOBI	futibatinib	TABLET;ORAL	214801-002	Jul 28, 2025		RX	Yes	No			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			Y	Y
Taiho Oncology	LYTGOBI	futibatinib	TABLET;ORAL	214801-002	Jul 28, 2025		RX	Yes	No

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
European Patent Office	3279202
South Korea	101623286
South Korea	20140080551	3,5-DISUBSTITUTED ALKYNYLBENZENE COMPOUND AND SALT THEREOF
Brazil	112014017749
Hungary	E051074
Japan	2017193581
Mexico	2014008605	COMPUESTO DE ALQUINILBENCENO 3,5-DISUSTITUIDO Y SALES DEL MISMO. (3,5-DISUBSTITUTED ALKYNYLBENZENE COMPOUND AND SALT THEREOF.)

Supplementary Protection Certificates for FUTIBATINIB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2657233	CR 2023 00036	Denmark		PRODUCT NAME: FUTIBATINIB ELLER ET SALT DERAF; REG. 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
2657233	C20230038	Finland
2657233	23C1050	France		PRODUCT NAME: FUTIBATINIB OU UN DE SES SELS; REGISTRATION 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	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	2390034-3	Sweden		PRODUCT NAME: FUTIBATINIB OR A SALT THEREOF; REG. NO/DATE: EU/1/23/1741 20230706

Market Dynamics and Financial Trajectory for FUTIBATINIB

Last updated: July 29, 2025

Introduction

Futibatinib, an irreversible pan-FGFR (fibroblast growth factor receptor) inhibitor, has garnered attention within oncology therapeutics owing to its targeted mechanism against FGFR-altered cancers. With a focus on its market potential, competitive landscape, and financial trajectory, this analysis offers a comprehensive view of Futibatinib's prospects amid evolving pharmaceutical trends.

Pharmacological Profile and Clinical Landscape

Futibatinib, developed by Taiho Pharmaceutical, exemplifies a precision medicine approach targeting tumors with FGFR aberrations. FGFR alterations, including mutations and gene amplifications, are implicated in multiple cancers such as cholangiocarcinoma, bladder cancer, and certain types of lung cancer [1]. The drug's irreversible binding offers a therapeutic advantage over reversible inhibitors, potentially addressing resistance mechanisms associated with FGFR-targeted therapies.

Currently, Futibatinib is under various stages of clinical development, notably in cholangiocarcinoma, where preliminary phase II data indicated encouraging efficacy—particularly in patients harboring FGFR2 fusions—leading to regulatory submissions and expedited review pathways.

Market Dynamics

1. Therapeutic Area Growth

The global FGFR inhibitor market is projected to expand significantly over the next decade, driven by the rising burden of FGFR-driven cancers. According to Market Research Future, the FGFR inhibitors market is expected to reach USD 4.92 billion by 2027, with a CAGR of around 7.8% [2]. Futibatinib's entry complements this growth trajectory, especially in niche indications where few approved therapies exist.

2. Competitive Landscape

Futibatinib enters a competitive arena comprising other FGFR inhibitors like Erdafitinib (JNJ), Pemazyre (pemigatinib), and Infigratinib. While Pemazyre has gained FDA approval for metastatic cholangiocarcinoma with FGFR2 fusion or rearrangement, others remain in clinical development. The differentiation lies in efficacy profiles, safety margins, and resistance management.

The competitive edge for Futibatinib hinges on its irreversible binding property, potentially offering sustained receptor inhibition and overcoming resistance seen with reversible inhibitors [3]. Nonetheless, its market penetration depends on clinical trial outcomes, regulatory approvals, and positioning against existing therapies.

3. Regulatory and Reimbursement Environment

Futibatinib is pursuing accelerated approval pathways, leveraging robust phase II data, especially in FGFR2-fusion cholangiocarcinoma. Reimbursement strategies will be critical, particularly within healthcare systems emphasizing targeted biologics with demonstrated clinical benefits and manageable safety profiles.

4. Market Entry Timing

Considering clinical trial advancements, regulatory milestones, and strategic partnerships, Futibatinib's commercial launch is anticipated within 1-3 years, contingent on successful trials and approval timelines. Early market entry could favor rapid adoption among oncologists seeking novel options for FGFR-altered cancers.

Financial Trajectory

1. Revenue Outlook

Forecasts indicate that Futibatinib's revenue will be primarily driven by its approvals for cholangiocarcinoma and additional indications as evidence accrues. Considering that the global cholangiocarcinoma market was valued at USD 243 million in 2020 and anticipated to grow with novel therapeutics [4], Futibatinib could capture a notable segment, especially in geographies with supportive reimbursement frameworks.

2. Pricing Strategy

Targeted oncology drugs often command premium pricing, averaging USD 10,000–20,000 per month per patient based on efficacy and compared to the standard of care. The irreversible mechanism and potential to overcome resistance could justify a higher price point, subject to payer acceptance and regional pricing regulations.

3. Market Penetration and Adoption

Adoption will depend on clinical efficacy, safety profiles, physician familiarity, and health policy environments. Early access programs and strategic alliances with oncology centers can facilitate rapid uptake, elevating revenue trajectories over the medium term.

4. Cost Structure and Investment

Significant R&D investments continue through clinical trials, regulatory submissions, and post-market surveillance. While initial costs are high, successful approval and market penetration promise revenue growth, with profitability materializing as sales compound and manufacturing efficiencies improve.

5. Risks and Opportunities

Key risks include regulatory delays, unfavorable trial outcomes, and competitive pressures. Conversely, unmet clinical needs and the unique irreversible mechanism present opportunities for market dominance in specific indications.

Conclusion

Futibatinib's market trajectory is poised for promising growth within the precision oncology segment. Its differentiating features, ongoing clinical development, and strategic positioning are favorable factors. However, its ultimate financial success hinges on regulatory approvals, demonstration of superiority or non-inferiority against competitors, and effective commercialization strategies.

Key Takeaways

• Futibatinib targets FGFR-driven cancers, with a focus on cholangiocarcinoma, where unmet needs remain significant.
• Its irreversible binding mechanism offers potential clinical advantages, positioning it favorably against reversible FGFR inhibitors.
• Market growth is robust, driven by increasing FGFR alterations in cancers and expanding indications.
• Early regulatory approval and licensing agreements will be decisive in shaping its imminent revenue prospects.
• Pricing strategies and reimbursement pathways will critically influence market penetration and financial performance.

FAQs

Q1: What distinguishes Futibatinib from other FGFR inhibitors?
A1: Its irreversible binding mechanism confers prolonged receptor inhibition and may overcome resistance associated with reversible inhibitors, enhancing its therapeutic potential.

Q2: In which cancer types is Futibatinib primarily tested?
A2: Currently, it is under clinical evaluation mainly for cholangiocarcinoma with FGFR alterations, but broader applications in bladder, lung, and other FGFR-driven cancers are under exploration.

Q3: When is Futibatinib expected to reach the market?
A3: Pending successful clinical outcomes and regulatory reviews, commercialization could occur within 1-3 years.

Q4: How does the competitive landscape impact Futibatinib’s market prospects?
A4: Competition from existing FGFR inhibitors like Pemigatinib and Erdafitinib may limit initial market share but differentiation through efficacy and safety can provide strategic advantages.

Q5: What are the main risks associated with Futibatinib’s financial trajectory?
A5: Risks include regulatory delays, clinical trial failures, unfavorable safety profiles, and challenges in reimbursement negotiations.

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References

1. McDermott, R., & Chen, Y. (2022). FGFR inhibitors in cancer therapy: Targeting FGFR-driven malignancies. Oncogene, 41(12), 1849-1860.
2. Market Research Future. (2021). FGFR inhibitors market forecast. Retrieved from [marketresearchfuture.com].
3. Smith, J. et al. (2022). Comparative efficacy of irreversible versus reversible FGFR inhibitors. Cancer Treatment Reviews, 102, 102295.
4. Grand View Research. (2021). Cholangiocarcinoma market size and opportunities. Retrieved from [grandviewresearch.com].