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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 214801


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NDA 214801 describes LYTGOBI, which is a drug marketed by Taiho Oncology and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the LYTGOBI profile page.

The generic ingredient in LYTGOBI is futibatinib. One supplier is listed for this compound. Additional details are available on the futibatinib profile page.
Summary for 214801
Tradename:LYTGOBI
Applicant:Taiho Oncology
Ingredient:futibatinib
Patents:3
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 214801
Generic Entry Date for 214801*:
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.

Suppliers and Packaging for NDA: 214801
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LYTGOBI futibatinib TABLET;ORAL 214801 NDA TAIHO PHARMACEUTICAL CO., LTD. 64842-0120 64842-0120-4 1 BLISTER PACK in 1 CARTON (64842-0120-4) / 21 TABLET in 1 BLISTER PACK
LYTGOBI futibatinib TABLET;ORAL 214801 NDA TAIHO PHARMACEUTICAL CO., LTD. 64842-0120 64842-0120-5 1 BLISTER PACK in 1 CARTON (64842-0120-5) / 28 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength4MG
Approval Date:Sep 30, 2022TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 30, 2027
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Sep 30, 2029
Regulatory Exclusivity Use: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
Patent:⤷  SubscribePatent Expiration:Mar 31, 2036Product Flag?YSubstance Flag?YDelist Request?

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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.