Details for New Drug Application (NDA): 214801
✉ Email this page to a colleague
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.
Pharmacology for NDA: 214801
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: | RX | Dosage: | TABLET;ORAL | Strength | 4MG | ||||
Approval Date: | Sep 30, 2022 | TE: | 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: | ⤷ Sign Up | Patent Expiration: | Mar 31, 2036 | Product Flag? | Y | Substance Flag? | Y | Delist Request? |
Complete Access Available with Subscription