Last Updated: October 8, 2026

FUTIBATINIB - Generic Drug Details

Name: FUTIBATINIB Generic Launch, Drug Patent, and Exclusivity Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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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.

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

Generic Entry Date for FUTIBATINIB^: ⤷ Start Trial* 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

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Glossary

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

EU/EMA Drug Approvals for FUTIBATINIB

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for FUTIBATINIB

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Country	Patent Number	Title	Estimated Expiration
Australia	2016240841		⤷ Start Trial
Brazil	112017019809		⤷ Start Trial
Canada	2980888		⤷ Start Trial
China	107406455		⤷ Start Trial
China	111393446		⤷ Start Trial
Denmark	3279202		⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for FUTIBATINIB

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2657233	2023C/548	Belgium	⤷ Start Trial	PRODUCT NAME: FUTIBATINIB OF EEN ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/23/1741 20230706
2657233	301254	Netherlands	⤷ Start Trial	PRODUCT NAME: FUTIBATINIB OF EEN ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/23/1741 20230706
2657233	23C1050	France	⤷ Start Trial	PRODUCT NAME: FUTIBATINIB OU UN DE SES SELS; REGISTRATION NO/DATE: EU/1/23/1741 20230706
2657233	CR 2023 00036	Denmark	⤷ Start Trial	PRODUCT NAME: FUTIBATINIB ELLER ET SALT DERAF; REG. NO/DATE: EU/1/23/1741 20230706
2657233	42/2023	Austria	⤷ Start Trial	PRODUCT NAME: FUTIBATINIB ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1741 (MITTEILUNG) 20230706
2657233	C20230038	Finland	⤷ Start Trial
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.