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Last Updated: November 13, 2024

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*:
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

SponsorPhase
Cancer Research UK & UCL Cancer Trials CentrePhase 3
Accord Healthcare, Inc.Phase 3
Zymeworks Inc.Phase 3

See all FUTIBATINIB clinical trials

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 ⤷  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
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 ⤷  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

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

Country Patent Number Title Estimated Expiration
Mexico 351513 COMPUESTO DE ALQUINILBENCENO 3,5-DISUSTITUIDO Y SALES DEL MISMO. (3,5-DISUBSTITUTED ALKYNYLBENZENE COMPOUND AND SALT THEREOF.) ⤷  Sign Up
China 111867594 包含烷基硫酸钠的药物组合物 (PHARMACEUTICAL COMPOSITION INCLUDING SODIUM ALKYL SULFATE) ⤷  Sign Up
Malaysia 196077 CRYSTAL OF 3,5-DISUBSTITUTED BENZENE ALKYNYL COMPOUND ⤷  Sign Up
Finland C20230038 ⤷  Sign Up
Portugal 2657233 ⤷  Sign Up
Japan 2017193581 3,5−二置換ベンゼンアルキニル化合物の結晶 (CRYSTALS OF 3,5-DISUBSTITUTED BENZENE ALKYNYL COMPOUND) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for FUTIBATINIB

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
2657233 122023000066 Germany ⤷  Sign Up PRODUCT NAME: FUTIBATINIB ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1741 20230704
2657233 2023C/548 Belgium ⤷  Sign Up PRODUCT NAME: FUTIBATINIB OF EEN ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/23/1741 20230706
2657233 301254 Netherlands ⤷  Sign Up PRODUCT NAME: FUTIBATINIB OF EEN ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/23/1741 20230706
>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. 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.