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. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the futibatinib profile page.
The generic ingredient in LYTGOBI is futibatinib. There is one drug master file entry for this compound. 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: | ⤷ Start Trial | Patent Expiration: | Mar 31, 2036 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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