FUTIBATINIB - Generic Drug Details

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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.

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

One supplier is listed for this compound.

Summary for FUTIBATINIB

International Patents:	69
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	32
Clinical Trials:	10
Patent Applications:	78
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^: ⤷ Sign Up* 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
Pierre Fabre Medicament	Phase 3
Cancer Research UK & UCL Cancer Trials Centre	Phase 3
Accord Healthcare, Inc.	Phase 3

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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Taiho Oncology	LYTGOBI	futibatinib	TABLET;ORAL	214801-001	Sep 30, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Taiho Oncology	LYTGOBI	futibatinib	TABLET;ORAL	214801-001	Sep 30, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
>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/005627 Lytgobi 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
Singapore	2014009286	3,5-DISUBSTITUTED ALKYNYLBENZENE COMPOUND AND SALT THEREOF	⤷ Sign Up
Malaysia	171055	3,5-DISUBSTITUTED ALKYNYLBENZENE COMPOUND AND SALT THEREOF	⤷ Sign Up
Denmark	3279202		⤷ Sign Up
>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	⤷ Sign Up	PRODUCT NAME: FUTIBATINIB OF EEN ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/23/1741 20230706
2657233	CA 2023 00036	Denmark	⤷ Sign Up	PRODUCT NAME: FUTIBATINIB ELLER ET SALT DERAF; REG. NO/DATE: EU/1/23/1741 20230706
2657233	CR 2023 00036	Denmark	⤷ Sign Up	PRODUCT NAME: FUTIBATINIB ELLER ET SALT DERAF; REG. NO/DATE: EU/1/23/1741 20230706
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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