TEPMETKO Drug Patent Profile
✉ Email this page to a colleague
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-one patent family members in thirty-two 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: | 71 |
US Patents: | 8 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 56 |
Patent Applications: | 141 |
Drug Prices: | Drug price information for TEPMETKO |
What excipients (inactive ingredients) are in TEPMETKO? | TEPMETKO excipients list |
DailyMed Link: | TEPMETKO at DailyMed |


DrugPatentWatch® Estimated Generic Entry Opportunity 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 See Plans and Pricing.
This potential generic entry date is based on patent See Plans and Pricing.
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Pyridazinone derivatives
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Pyrimidinyl pyridazinone derivatives
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Pyridazinone derivatives
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Pyridazinone derivatives
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Pyrimidinyl-pyridazinone derivatives for treating a disease which is influenced by inhibition of met kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
TREATMENT OF ADULT PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) HARBORING MESENCHYMAL-EPITHELIAL TRANSITION (MET) EXON 14 SKIPPING ALTERATIONS
Exclusivity Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent: 7505
Estimated Expiration: See Plans and Pricing
Australia
Patent: 08274534
Estimated Expiration: See Plans and Pricing
Patent: 08274670
Estimated Expiration: See Plans and Pricing
Brazil
Patent: 0813707
Estimated Expiration: See Plans and Pricing
Patent: 0814616
Estimated Expiration: See Plans and Pricing
Canada
Patent: 92867
Estimated Expiration: See Plans and Pricing
Patent: 93600
Estimated Expiration: See Plans and Pricing
Chile
Patent: 08001392
Estimated Expiration: See Plans and Pricing
China
Patent: 1687857
Estimated Expiration: See Plans and Pricing
Patent: 1743241
Estimated Expiration: See Plans and Pricing
Colombia
Patent: 70360
Estimated Expiration: See Plans and Pricing
Patent: 70257
Estimated Expiration: See Plans and Pricing
Croatia
Patent: 0120661
Estimated Expiration: See Plans and Pricing
Patent: 0150031
Estimated Expiration: See Plans and Pricing
Patent: 0170100
Estimated Expiration: See Plans and Pricing
Cyprus
Patent: 13137
Estimated Expiration: See Plans and Pricing
Patent: 15925
Estimated Expiration: See Plans and Pricing
Patent: 18498
Estimated Expiration: See Plans and Pricing
Denmark
Patent: 64843
Estimated Expiration: See Plans and Pricing
Patent: 64844
Estimated Expiration: See Plans and Pricing
Patent: 54660
Estimated Expiration: See Plans and Pricing
Ecuador
Patent: 109953
Estimated Expiration: See Plans and Pricing
Patent: 109957
Estimated Expiration: See Plans and Pricing
Eurasian Patent Organization
Patent: 6782
Estimated Expiration: See Plans and Pricing
Patent: 7281
Estimated Expiration: See Plans and Pricing
Patent: 1000093
Estimated Expiration: See Plans and Pricing
Patent: 1000094
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 64843
Estimated Expiration: See Plans and Pricing
Patent: 64844
Estimated Expiration: See Plans and Pricing
Patent: 54660
Estimated Expiration: See Plans and Pricing
Germany
Patent: 2007032507
Estimated Expiration: See Plans and Pricing
Hong Kong
Patent: 42891
Estimated Expiration: See Plans and Pricing
Patent: 45265
Estimated Expiration: See Plans and Pricing
Hungary
Patent: 30519
Estimated Expiration: See Plans and Pricing
Israel
Patent: 3091
Estimated Expiration: See Plans and Pricing
Patent: 3094
Estimated Expiration: See Plans and Pricing
Japan
Patent: 26543
Estimated Expiration: See Plans and Pricing
Patent: 26544
Estimated Expiration: See Plans and Pricing
Patent: 10532768
Estimated Expiration: See Plans and Pricing
Patent: 10532774
Estimated Expiration: See Plans and Pricing
Lithuania
Patent: 54660
Estimated Expiration: See Plans and Pricing
Malaysia
Patent: 3727
Estimated Expiration: See Plans and Pricing
Patent: 3477
Estimated Expiration: See Plans and Pricing
New Zealand
Patent: 3186
Estimated Expiration: See Plans and Pricing
Patent: 3187
Estimated Expiration: See Plans and Pricing
Peru
Patent: 090287
Estimated Expiration: See Plans and Pricing
Poland
Patent: 64843
Estimated Expiration: See Plans and Pricing
Patent: 64844
Estimated Expiration: See Plans and Pricing
Patent: 54660
Estimated Expiration: See Plans and Pricing
Portugal
Patent: 64843
Estimated Expiration: See Plans and Pricing
Patent: 64844
Estimated Expiration: See Plans and Pricing
Patent: 54660
Estimated Expiration: See Plans and Pricing
Singapore
Patent: 3739
Estimated Expiration: See Plans and Pricing
Slovenia
Patent: 64843
Estimated Expiration: See Plans and Pricing
Patent: 64844
Estimated Expiration: See Plans and Pricing
Patent: 54660
Estimated Expiration: See Plans and Pricing
South Africa
Patent: 1001023
Estimated Expiration: See Plans and Pricing
South Korea
Patent: 1544624
Estimated Expiration: See Plans and Pricing
Patent: 1553418
Estimated Expiration: See Plans and Pricing
Patent: 100031771
Estimated Expiration: See Plans and Pricing
Patent: 100050504
Estimated Expiration: See Plans and Pricing
Spain
Patent: 88883
Estimated Expiration: See Plans and Pricing
Patent: 26352
Estimated Expiration: See Plans and Pricing
Patent: 14283
Estimated Expiration: See Plans and Pricing
Taiwan
Patent: 01768
Estimated Expiration: See Plans and Pricing
Patent: 0906409
Estimated Expiration: See Plans and Pricing
Ukraine
Patent: 621
Estimated Expiration: See Plans and Pricing
Patent: 833
Estimated Expiration: See Plans and Pricing
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 |
---|---|---|---|
South Africa | 201001023 | PYRIMIDINYL PYRIDAZINONE DERIVATES | See Plans and Pricing |
European Patent Office | 2164843 | DÉRIVÉS DE PYRIDAZINONE (PYRIDAZINONE DERIVATES) | See Plans and Pricing |
Cyprus | 1115925 | See Plans and Pricing | |
Hong Kong | 1142891 | PYRIMIDINYL PYRIDAZINONE DERIVATES | See Plans and Pricing |
Slovenia | 2754660 | See Plans and Pricing | |
Germany | 102007032507 | Pyridazinonderivate | See Plans and Pricing |
European Patent Office | 2754660 | Dérivés de pyridazinone (Pyridazinone derivatives) | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TEPMETKO
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2164843 | PA2022009 | Lithuania | See Plans and Pricing | PRODUCT NAME: TEPOTINIBAS IR FARMACINIU POZIURIU TINKAMI NAUDOTI JO SOLVATAI, DRUSKOS, TAUTOMERAI IR STEREOIZOMERAI ; REGISTRATION NO/DATE: EU/1/21/1596 20220216 |
2164843 | 301176 | Netherlands | See Plans and Pricing | PRODUCT NAME: TEPOTINIB EN FARMACEUTISCH AANVAARDBARE SOLVATEN, ZOUTEN, TAUTOMEREN EN STEREOISOMEREN DAARVAN; REGISTRATION NO/DATE: EU/1/21/1596 20220217 |
2164843 | C02164843/01 | Switzerland | See Plans and Pricing | PRODUCT NAME: TEPOTINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68113 22.06.2021 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |