Futibatinib - Generic Drug Details
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What are the generic sources for futibatinib and what is the scope of patent protection?
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
| Sponsor | Phase |
|---|---|
| Cancer Research UK | Phase 3 |
| Servier | Phase 3 |
| GlaxoSmithKline Research & Development Limited | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for futibatinib
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Taiho Oncology | LYTGOBI | futibatinib | TABLET;ORAL | 214801-001 | Sep 30, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Taiho Oncology | LYTGOBI | futibatinib | TABLET;ORAL | 214801-001 | Sep 30, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Taiho Oncology | LYTGOBI | futibatinib | TABLET;ORAL | 214801-001 | Sep 30, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >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 |
|---|---|---|---|
| Singapore | 11202008435S | PHARMACEUTICAL COMPOSITION INCLUDING SODIUM ALKYL SULFATE | ⤷ Try a Trial |
| Japan | 5355825 | ⤷ Try a Trial | |
| Russian Federation | 2672563 | КРИСТАЛЛЫ 3,5-ДИЗАМЕЩЕННОГО БЕНЗОЛАЛКИНИЛЬНОГО СОЕДИНЕНИЯ (CRYSTALS OF 3,5-DISUBSTITUTED BENZOLALKYNYL COMPOUND) | ⤷ Try a Trial |
| Netherlands | 301254 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for futibatinib
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2657233 | 301254 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: FUTIBATINIB OF EEN ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/23/1741 20230706 |
| 2657233 | 122023000066 | Germany | ⤷ Try a Trial | PRODUCT NAME: FUTIBATINIB ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1741 20230704 |
| 2657233 | CA 2023 00036 | Denmark | ⤷ Try a Trial | PRODUCT NAME: FUTIBATINIB ELLER ET SALT DERAF; REG. NO/DATE: EU/1/23/1741 20230706 |
| 2657233 | 2023C/548 | Belgium | ⤷ Try a Trial | PRODUCT NAME: FUTIBATINIB OF EEN ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/23/1741 20230706 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
