TEPMETKO Drug Patent Profile
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Which patents cover Tepmetko, and what generic alternatives are available?
Tepmetko is a drug marketed by Emd Serono Inc and is included in one NDA. There are eight patents protecting this drug.
This drug has seventy-six patent family members in thirty-five countries.
The generic ingredient in TEPMETKO is tepotinib hydrochloride. One supplier is listed for this compound. Additional details are available on the tepotinib hydrochloride profile page.
DrugPatentWatch® Generic Entry Outlook for Tepmetko
Tepmetko will be eligible for patent challenges on February 3, 2025. 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 March 19, 2030. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for TEPMETKO
International Patents: | 76 |
US Patents: | 8 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 59 |
Patent Applications: | 139 |
Drug Prices: | Drug price information for TEPMETKO |
What excipients (inactive ingredients) are in TEPMETKO? | TEPMETKO excipients list |
DailyMed Link: | TEPMETKO at DailyMed |


DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for TEPMETKO
Generic Entry Date for TEPMETKO*:
Constraining patent/regulatory exclusivity:
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 TEPMETKO
Drug Class | Kinase Inhibitor |
Mechanism of Action | Mesenchymal Epithelial Transition Inhibitors P-Glycoprotein Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for TEPMETKO
US Patents and Regulatory Information for TEPMETKO
TEPMETKO is protected by eight US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of TEPMETKO is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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 TEPMETKO
Pyrimidinyl pyridazinone derivatives
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Pyridazinone derivatives
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Pyrimidinyl pyridazinone derivatives
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATING A SOLID TUMOR, INCLUDING LUNG CANCER, WITH A MET ALTERATION(S), OR STABILIZING OR IMPROVING SYMPTOMS ASSOCIATED WITH HAVING A SOLID TUMOR, INCLUDING LUNG CANCER, WITH A MET ALTERATION(S), BY ADMINISTERING AN EFFECTIVE AMOUNT OF TEPOTINIB
Pyridazinone derivatives
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Pyridazinone derivatives
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATING A SOLID TUMOR, INCLUDING LUNG CANCER, HAVING A MET KINASE ALTERATION(S) BY ADMINISTERING AN EFFECTIVE AMOUNT OF TEPOTINIB
Pyrimidinyl pyridazinone derivatives
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Pyridazinone derivatives
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Pyrimidinyl-pyridazinone derivatives for treating a disease which is influenced by inhibition of met kinase
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATING A SOLID TUMOR, INCLUDING LUNG CANCER, WITH A MET ALTERATION(S), OR STABILIZING OR IMPROVING SYMPTOMS ASSOCIATED WITH HAVING A SOLID TUMOR, INCLUDING LUNG CANCER, WITH A MET ALTERATION(S), BY ADMINISTERING AN EFFECTIVE AMOUNT OF TEPOTINIB
FDA Regulatory Exclusivity protecting TEPMETKO
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
TREATMENT OF ADULT PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) HARBORING MESENCHYMAL-EPITHELIAL TRANSITION (MET) EXON 14 SKIPPING ALTERATIONS
Exclusivity Expiration: ⤷ Try a Trial
International Patents for TEPMETKO
When does loss-of-exclusivity occur for TEPMETKO?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 6543
Estimated Expiration: ⤷ Try a Trial
Patent: 7505
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 08274534
Estimated Expiration: ⤷ Try a Trial
Patent: 08274670
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0813707
Estimated Expiration: ⤷ Try a Trial
Patent: 0814616
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 92867
Estimated Expiration: ⤷ Try a Trial
Patent: 93600
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 08001392
Estimated Expiration: ⤷ Try a Trial
China
Patent: 1687857
Estimated Expiration: ⤷ Try a Trial
Patent: 1743241
Estimated Expiration: ⤷ Try a Trial
Colombia
Patent: 70360
Estimated Expiration: ⤷ Try a Trial
Patent: 70257
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0120661
Estimated Expiration: ⤷ Try a Trial
Patent: 0150031
Estimated Expiration: ⤷ Try a Trial
Patent: 0170100
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 13137
Estimated Expiration: ⤷ Try a Trial
Patent: 15925
Estimated Expiration: ⤷ Try a Trial
Patent: 18498
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 64843
Estimated Expiration: ⤷ Try a Trial
Patent: 64844
Estimated Expiration: ⤷ Try a Trial
Patent: 54660
Estimated Expiration: ⤷ Try a Trial
Ecuador
Patent: 109953
Estimated Expiration: ⤷ Try a Trial
Patent: 109957
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 6782
Estimated Expiration: ⤷ Try a Trial
Patent: 7281
Estimated Expiration: ⤷ Try a Trial
Patent: 1000093
Estimated Expiration: ⤷ Try a Trial
Patent: 1000094
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 64843
Estimated Expiration: ⤷ Try a Trial
Patent: 64844
Estimated Expiration: ⤷ Try a Trial
Patent: 54660
Estimated Expiration: ⤷ Try a Trial
France
Patent: C1024
Estimated Expiration: ⤷ Try a Trial
Germany
Patent: 2007032507
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 42891
Estimated Expiration: ⤷ Try a Trial
Patent: 45265
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 30519
Estimated Expiration: ⤷ Try a Trial
Patent: 200024
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 3091
Estimated Expiration: ⤷ Try a Trial
Patent: 3094
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 26543
Estimated Expiration: ⤷ Try a Trial
Patent: 26544
Estimated Expiration: ⤷ Try a Trial
Patent: 10532768
Estimated Expiration: ⤷ Try a Trial
Patent: 10532774
Estimated Expiration: ⤷ Try a Trial
Lithuania
Patent: 2022009
Estimated Expiration: ⤷ Try a Trial
Patent: 54660
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 3727
Estimated Expiration: ⤷ Try a Trial
Patent: 3477
Estimated Expiration: ⤷ Try a Trial
Netherlands
Patent: 1176
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 3186
Estimated Expiration: ⤷ Try a Trial
Patent: 3187
Estimated Expiration: ⤷ Try a Trial
Norway
Patent: 22015
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 090287
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 64843
Estimated Expiration: ⤷ Try a Trial
Patent: 64844
Estimated Expiration: ⤷ Try a Trial
Patent: 54660
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 64843
Estimated Expiration: ⤷ Try a Trial
Patent: 64844
Estimated Expiration: ⤷ Try a Trial
Patent: 54660
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 3739
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 64843
Estimated Expiration: ⤷ Try a Trial
Patent: 64844
Estimated Expiration: ⤷ Try a Trial
Patent: 54660
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1001023
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1544624
Estimated Expiration: ⤷ Try a Trial
Patent: 1553418
Estimated Expiration: ⤷ Try a Trial
Patent: 100031771
Estimated Expiration: ⤷ Try a Trial
Patent: 100050504
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 88883
Estimated Expiration: ⤷ Try a Trial
Patent: 26352
Estimated Expiration: ⤷ Try a Trial
Patent: 14283
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 01768
Estimated Expiration: ⤷ Try a Trial
Patent: 0906409
Estimated Expiration: ⤷ Try a Trial
Ukraine
Patent: 621
Estimated Expiration: ⤷ Try a Trial
Patent: 833
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering TEPMETKO around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Peru | 20090287 | DERIVADOS DE PIRIDAZINONA | ⤷ Try a Trial |
Croatia | P20120661 | ⤷ Try a Trial | |
Cyprus | 1115925 | ⤷ Try a Trial | |
China | 101743241 | Pyridazinone derivates | ⤷ Try a Trial |
Israel | 203091 | נגזרות פירידאזינון (Pyridazinone derivatives) | ⤷ Try a Trial |
Eurasian Patent Organization | 016782 | ПРОИЗВОДНЫЕ ПИРИДАЗИНОНА (PYRIDAZINONE DERIVATES) | ⤷ Try a Trial |
Slovenia | 2754660 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TEPMETKO
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2164843 | 301176 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: TEPOTINIB EN FARMACEUTISCH AANVAARDBARE SOLVATEN EN ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/21/1596 20220217 |
2164843 | C202230027 | Spain | ⤷ Try a Trial | PRODUCT NAME: TEPOTINIB Y SUS SOLVATOS, SALES, TAUTOMEROS Y ESTEREOISOMEROS FARMACEUTICAMENTE UTILIZABLES DE LOS MISMOS; NATIONAL AUTHORISATION NUMBER: EU/1/21/1596; DATE OF AUTHORISATION: 20220216; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1596; DATE OF FIRST AUTHORISATION IN EEA: 20220216 |
2164843 | 122022000047 | Germany | ⤷ Try a Trial | PRODUCT NAME: TEPOTINIB SOWIE DIE PHARMAZEUTISCH VERWENDBAREN SOLVATE, SALZE, TAUTOMERE UND STEREOISOMERE DAVON, EINSCHL. DEREN MISCHUNGEN IN ALLEN VERHAELTNISSEN; REGISTRATION NO/DATE: EU/1/21/1596 20220216 |
2164843 | CA 2022 00021 | Denmark | ⤷ Try a Trial | PRODUCT NAME: TEPOTINIB OG FARMACEUTISK ANVENDELIGE SOLVATER, SALTE, TAUTOMERER OG STEREOISOMERER DERAF; REG. NO/DATE: EU 1/21/1596 20220217 |
2164843 | PA2022009 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: TEPOTINIBAS IR FARMACINIU POZIURIU TINKAMI NAUDOTI JO SOLVATAI, DRUSKOS, TAUTOMERAI IR STEREOIZOMERAI ; REGISTRATION NO/DATE: EU/1/21/1596 20220216 |
2164843 | 2022C/519 | Belgium | ⤷ Try a Trial | PRODUCT NAME: TEPOTINIB EN FARMACEUTISCH AANVAARDARBE SOLVATEN, ZOUTEN, TAUTOMEREN EN STEREOISOMEREN DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1596 20220217 |
2164843 | 22C1024 | France | ⤷ Try a Trial | PRODUCT NAME: TEPOTINIB ET SES SOLVATES, SELS, TAUTOMERES ET STEREOISOMERES PHARMACEUTIQUEMENT UTILISABLES; REGISTRATION NO/DATE: EU/1/21/1596 20220217 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |