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
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Summary for TEPMETKO
| International Patents: | 76 |
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 8 |
| Patent Applications: | 20 |
| 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
*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 |
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 ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Pyridazinone derivatives
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Pyrimidinyl pyridazinone derivatives
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Pyridazinone derivatives
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Pyridazinone derivatives
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Pyrimidinyl-pyridazinone derivatives for treating a disease which is influenced by inhibition of met kinase
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
TREATMENT OF ADULT PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) HARBORING MESENCHYMAL-EPITHELIAL TRANSITION (MET) EXON 14 SKIPPING ALTERATIONS
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Emd Serono Inc | TEPMETKO | tepotinib hydrochloride | TABLET;ORAL | 214096-001 | Feb 3, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Emd Serono Inc | TEPMETKO | tepotinib hydrochloride | TABLET;ORAL | 214096-001 | Feb 3, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Emd Serono Inc | TEPMETKO | tepotinib hydrochloride | TABLET;ORAL | 214096-001 | Feb 3, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Emd Serono Inc | TEPMETKO | tepotinib hydrochloride | TABLET;ORAL | 214096-001 | Feb 3, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | 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 |
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
Patent: DERIVADOS DE PIRIDAZINONA
Estimated Expiration: ⤷ Sign Up
Patent: 7505
Patent: DERIVADOS DE PIRIMIDINIL-PIRIDAZINONA
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 08274534
Patent: Pyrimidinyl pyridazinone derivates
Estimated Expiration: ⤷ Sign Up
Patent: 08274670
Patent: Pyridazinone derivates
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0813707
Patent: DERIVADOS DE PIRIMIDINIL-PIRIDAZINONA
Estimated Expiration: ⤷ Sign Up
Patent: 0814616
Patent: DERIVADOS DE PIRIDAZINONA
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 92867
Patent: DÉRIVÉS DE PYRIDAZINONE (Pyrimidinyl-pyridazinone derivatives.)
Estimated Expiration: ⤷ Sign Up
Patent: 93600
Patent: DERIVES DE PYRIDAZINONE (PYRIDAZINONE DERIVATES)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 08001392
Patent: Compuestos derivados de piridazinona, con actividad moduladora de quinasas; procedimiento de preparacion de dichos compuestos; composicion farmaceutica que comprende a dichos compuestos; kit farmaceutico; y uso para tratar un tumor solido.
Estimated Expiration: ⤷ Sign Up
China
Patent: 1687857
Patent: Pyridazinone derivates
Estimated Expiration: ⤷ Sign Up
Patent: 1743241
Patent: Pyridazinone derivates
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 70360
Patent: DERIVADOS DE PIRIMIDINIL - PIRIDAZINONA
Estimated Expiration: ⤷ Sign Up
Patent: 70257
Patent: DERIVADOS DE PIRIDAZINONA
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0120661
Estimated Expiration: ⤷ Sign Up
Patent: 0150031
Estimated Expiration: ⤷ Sign Up
Patent: 0170100
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 13137
Estimated Expiration: ⤷ Sign Up
Patent: 15925
Estimated Expiration: ⤷ Sign Up
Patent: 18498
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 64843
Estimated Expiration: ⤷ Sign Up
Patent: 64844
Estimated Expiration: ⤷ Sign Up
Patent: 54660
Estimated Expiration: ⤷ Sign Up
Ecuador
Patent: 109953
Patent: DERIVADOS DE PIRIDAZINONA
Estimated Expiration: ⤷ Sign Up
Patent: 109957
Patent: DERIVADOS DE PIRIMIDINIL-PIRIDAZINONA.
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 6782
Patent: ПРОИЗВОДНЫЕ ПИРИДАЗИНОНА (PYRIDAZINONE DERIVATES)
Estimated Expiration: ⤷ Sign Up
Patent: 7281
Patent: ПРОИЗВОДНЫЕ ПИРИМИДИНИЛПИРИДАЗИНОНА (PYRIMIDINYL PYRIDAZINONE DERIVATES)
Estimated Expiration: ⤷ Sign Up
Patent: 1000093
Patent: ПРОИЗВОДНЫЕ ПИРИДАЗИНОНА
Estimated Expiration: ⤷ Sign Up
Patent: 1000094
Patent: ПРОИЗВОДНЫЕ ПИРИМИДИНИЛ-ПИРИДАЗИНОНА
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 64843
Patent: DÉRIVÉS DE PYRIDAZINONE (PYRIDAZINONE DERIVATES)
Estimated Expiration: ⤷ Sign Up
Patent: 64844
Patent: DÉRIVÉS DE PYRIMIDINYLPYRIDAZINONE (PYRIMIDINYL PYRIDAZINONE DERIVATES)
Estimated Expiration: ⤷ Sign Up
Patent: 54660
Patent: Dérivés de pyridazinone (Pyridazinone derivatives)
Estimated Expiration: ⤷ Sign Up
France
Patent: C1024
Estimated Expiration: ⤷ Sign Up
Germany
Patent: 2007032507
Patent: Pyridazinonderivate
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 42891
Patent: PYRIMIDINYL PYRIDAZINONE DERIVATES
Estimated Expiration: ⤷ Sign Up
Patent: 45265
Patent: PYRIDAZINONE DERIVATES
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 30519
Estimated Expiration: ⤷ Sign Up
Patent: 200024
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 3091
Patent: נגזרות פירידאזינון (Pyridazinone derivatives)
Estimated Expiration: ⤷ Sign Up
Patent: 3094
Patent: נגזרות פירימידיניל-פירידאזינון (Pyrimidinyl-pyridazinone derivatives)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 26543
Estimated Expiration: ⤷ Sign Up
Patent: 26544
Estimated Expiration: ⤷ Sign Up
Patent: 10532768
Estimated Expiration: ⤷ Sign Up
Patent: 10532774
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 2022009
Estimated Expiration: ⤷ Sign Up
Patent: 54660
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 3727
Patent: PYRIDAZINONE DERIVATIVES
Estimated Expiration: ⤷ Sign Up
Patent: 3477
Patent: PYRIMIDINYL-PYRIDAZINONE DERIVATIVES
Estimated Expiration: ⤷ Sign Up
Netherlands
Patent: 1176
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 3186
Patent: PYRIMIDINYL-PYRIDAZINONE DERIVATIVES
Estimated Expiration: ⤷ Sign Up
Patent: 3187
Patent: PYRIDAZINONE DERIVATIVES
Estimated Expiration: ⤷ Sign Up
Norway
Patent: 22015
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 090287
Patent: DERIVADOS DE PIRIDAZINONA
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 64843
Estimated Expiration: ⤷ Sign Up
Patent: 64844
Estimated Expiration: ⤷ Sign Up
Patent: 54660
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 64843
Estimated Expiration: ⤷ Sign Up
Patent: 64844
Estimated Expiration: ⤷ Sign Up
Patent: 54660
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 3739
Patent: PYRIDAZINONE DERIVATES
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 64843
Estimated Expiration: ⤷ Sign Up
Patent: 64844
Estimated Expiration: ⤷ Sign Up
Patent: 54660
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1001023
Patent: PYRIMIDINYL PYRIDAZINONE DERIVATES
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1544624
Estimated Expiration: ⤷ Sign Up
Patent: 1553418
Estimated Expiration: ⤷ Sign Up
Patent: 100031771
Patent: PYRIMIDINYL PYRIDAZINONE DERIVATIVES
Estimated Expiration: ⤷ Sign Up
Patent: 100050504
Patent: PYRIDAZINONE DERIVATES
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 88883
Estimated Expiration: ⤷ Sign Up
Patent: 26352
Estimated Expiration: ⤷ Sign Up
Patent: 14283
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 01768
Estimated Expiration: ⤷ Sign Up
Patent: 0906409
Patent: Pyridazinone derivatives
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 621
Patent: ПОХІДНІ ПІРИДАЗИНОНУ[ПРОИЗВОДНЫЕ ПИРИДАЗИНОНА (PYRIDAZINONE DERIVATES)
Estimated Expiration: ⤷ Sign Up
Patent: 833
Patent: ПОХІДНІ ПІРИМІДИНІЛ-ПІРИДАЗИНОНУ[ПРОИЗВОДНЫЕ ПИРИМИДИНИЛ-ПИРИДАЗИНОНА (PYRIMIDINYL PYRIDAZINONE DERIVATES)
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| Japan | 2010532768 | ⤷ Sign Up | |
| Slovenia | 2754660 | ⤷ Sign Up | |
| Japan | 2010532774 | ⤷ Sign Up | |
| South Korea | 101544624 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TEPMETKO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2164843 | CA 2022 00021 | Denmark | ⤷ Sign Up | PRODUCT NAME: TEPOTINIB OG FARMACEUTISK ANVENDELIGE SOLVATER, SALTE, TAUTOMERER OG STEREOISOMERER DERAF; REG. NO/DATE: EU 1/21/1596 20220217 |
| 2164843 | 301176 | Netherlands | ⤷ Sign Up | PRODUCT NAME: TEPOTINIB EN FARMACEUTISCH AANVAARDBARE SOLVATEN EN ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/21/1596 20220217 |
| 2164843 | PA2022009 | Lithuania | ⤷ Sign Up | PRODUCT NAME: TEPOTINIBAS IR FARMACINIU POZIURIU TINKAMI NAUDOTI JO SOLVATAI, DRUSKOS, TAUTOMERAI IR STEREOIZOMERAI ; REGISTRATION NO/DATE: EU/1/21/1596 20220216 |
| 2164843 | C202230027 | Spain | ⤷ Sign Up | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
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