FUTIBATINIB - Generic Drug Details
✉ Email this page to a colleague
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
Sponsor | Phase |
---|---|
Cancer Research UK & UCL Cancer Trials Centre | Phase 3 |
Accord Healthcare, Inc. | Phase 3 |
Zymeworks Inc. | Phase 3 |
Pharmacology for FUTIBATINIB
Drug Class | Kinase Inhibitor |
Mechanism of Action | Breast Cancer Resistance Protein Inhibitors Fibroblast Growth Factor Receptor Inhibitors P-Glycoprotein Inhibitors |
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 | ⤷ 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 |
Make Better Decisions: Try a trial or see plans & pricing
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.