lytgobi Drug Patent Profile
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Which patents cover Lytgobi, and when can generic versions of Lytgobi launch?
Lytgobi is a drug marketed by Taiho Oncology and is included in one NDA. There are three patents protecting this drug.
This drug has sixty-nine patent family members in twenty-five countries.
The generic ingredient in LYTGOBI is futibatinib. One supplier is listed for this compound. Additional details are available on the futibatinib profile page.
DrugPatentWatch® Generic Entry Outlook for Lytgobi
Lytgobi will be eligible for patent challenges on September 30, 2026. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be September 30, 2029. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
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Summary for lytgobi
International Patents: | 69 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 32 |
Patent Applications: | 46 |
Drug Prices: | Drug price information for lytgobi |
What excipients (inactive ingredients) are in lytgobi? | lytgobi excipients list |
DailyMed Link: | lytgobi at DailyMed |
![lytgobi drug patent expirations Drug patent expirations by year for lytgobi](/p/graph/s/t/lytgobi-patent-expirations.png)
![Drug Prices for lytgobi](/p/graph/drug-price/lytgobi.png)
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for lytgobi
Generic Entry Date for lytgobi*:
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 NDA:
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 lytgobi
Drug Class | Kinase Inhibitor |
Mechanism of Action | Breast Cancer Resistance Protein Inhibitors Fibroblast Growth Factor Receptor Inhibitors P-Glycoprotein Inhibitors |
US Patents and Regulatory Information for lytgobi
lytgobi is protected by three US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of lytgobi is ⤷ Sign Up.
This potential generic entry date is based on 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.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting lytgobi
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING INTRAHEPATIC CHOLANGIOCARCINOMA
FDA Regulatory Exclusivity protecting lytgobi
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
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
Exclusivity Expiration: ⤷ Sign Up
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 | 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 | 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 | ||||
>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 lytgobi
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 lytgobi
See the table below for patents covering lytgobi around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 101623286 | ⤷ Sign Up | |
Brazil | 112017019809 | cristal de composto de benzeno alquinila 3,5-dissubstituído | ⤷ Sign Up |
Hungary | S2300043 | ⤷ Sign Up | |
South Korea | 102473372 | ⤷ Sign Up | |
European Patent Office | 3279202 | CRISTAL D'UN COMPOSÉ D'ALCYNYLE DE BENZÈNE 3,5-DISUBSTITUÉ (CRYSTAL OF 3,5-DISUBSTITUTED BENZENE ALKYNYL COMPOUND) | ⤷ Sign Up |
Portugal | 2657233 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for lytgobi
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2657233 | 2023C/548 | Belgium | ⤷ Sign Up | PRODUCT NAME: FUTIBATINIB OF EEN ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/23/1741 20230706 |
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 | 301254 | Netherlands | ⤷ Sign Up | PRODUCT NAME: FUTIBATINIB OF EEN ZOUT DAARVAN; REGISTRATION 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |