TABRECTA Drug Patent Profile
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Which patents cover Tabrecta, and when can generic versions of Tabrecta launch?
Tabrecta is a drug marketed by Novartis Pharm and is included in one NDA. There are five patents protecting this drug.
This drug has one hundred and sixty-two patent family members in forty-two countries.
The generic ingredient in TABRECTA is capmatinib hydrochloride. One supplier is listed for this compound. Additional details are available on the capmatinib hydrochloride profile page.
DrugPatentWatch® Generic Entry Outlook for Tabrecta
Tabrecta will be eligible for patent challenges on May 6, 2024. 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 July 22, 2035. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for TABRECTA
International Patents: | 162 |
US Patents: | 5 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 76 |
Patent Applications: | 449 |
Drug Prices: | Drug price information for TABRECTA |
What excipients (inactive ingredients) are in TABRECTA? | TABRECTA excipients list |
DailyMed Link: | TABRECTA at DailyMed |


DrugPatentWatch® Estimated Generic Entry Opportunity Date for TABRECTA
Generic Entry Date for TABRECTA*:
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 TABRECTA
Anatomical Therapeutic Chemical (ATC) Classes for TABRECTA
US Patents and Regulatory Information for TABRECTA
TABRECTA is protected by five US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of TABRECTA 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 TABRECTA
Tablet formulation of 2-fluoro-N-methyl-4-[7-(quinolin-6-ylmethyl) imidazo [1,2-B] [1,2,4] triazin-2-yl] benzamide
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Imidazotriazines and imidazopyrimidines as kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Salts of 2-fluoro-N-methyl-4-[7-(quinolin-6-yl-methyl)-imidazo[1,2-b][1,2,- 4]triazin-2-yl]benzamide and processes related to preparing the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Imidazotriazines and imidazopyrimidines as kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Salts of 2-fluoro-N-methyl-4-[7-(quinolin-6-yl-methyl)-imidazo[1,2-B][1,2,- 4]triazin-2-yl]benzamide and processes related to preparing the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE FOR THE TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH A MESENCHYMAL-EPITHELIAL TRANSITION (MET) EXON 14 SKIPPING MUTATION
FDA Regulatory Exclusivity protecting TABRECTA
NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing
INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS HAVE A MUTATION THAT LEADS TO MESENCHYMAL-EPITHELIAL TRANSITION (MET) EXON 14 SKIPPING AS DETECTED BY AN FDA-APPROVED TEST
Exclusivity Expiration: See Plans and Pricing
International Patents for TABRECTA
When does loss-of-exclusivity occur for TABRECTA?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 1286
Estimated Expiration: See Plans and Pricing
Australia
Patent: 15293539
Estimated Expiration: See Plans and Pricing
Patent: 18207947
Estimated Expiration: See Plans and Pricing
Patent: 20200912
Estimated Expiration: See Plans and Pricing
Patent: 21202500
Estimated Expiration: See Plans and Pricing
Brazil
Patent: 2017000953
Estimated Expiration: See Plans and Pricing
Canada
Patent: 54840
Estimated Expiration: See Plans and Pricing
Chile
Patent: 17000180
Estimated Expiration: See Plans and Pricing
China
Patent: 6714784
Estimated Expiration: See Plans and Pricing
Colombia
Patent: 17000586
Estimated Expiration: See Plans and Pricing
Denmark
Patent: 72209
Estimated Expiration: See Plans and Pricing
Ecuador
Patent: 17011672
Estimated Expiration: See Plans and Pricing
Eurasian Patent Organization
Patent: 9220
Estimated Expiration: See Plans and Pricing
Patent: 1790259
Estimated Expiration: See Plans and Pricing
Patent: 2191301
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 72209
Estimated Expiration: See Plans and Pricing
Patent: 48376
Estimated Expiration: See Plans and Pricing
Guatemala
Patent: 1700007
Estimated Expiration: See Plans and Pricing
Hungary
Patent: 53346
Estimated Expiration: See Plans and Pricing
Israel
Patent: 0166
Estimated Expiration: See Plans and Pricing
Japan
Patent: 70946
Estimated Expiration: See Plans and Pricing
Patent: 02587
Estimated Expiration: See Plans and Pricing
Patent: 17521469
Estimated Expiration: See Plans and Pricing
Patent: 20114852
Estimated Expiration: See Plans and Pricing
Patent: 22046659
Estimated Expiration: See Plans and Pricing
Jordan
Patent: 18
Estimated Expiration: See Plans and Pricing
Mexico
Patent: 17001177
Estimated Expiration: See Plans and Pricing
Peru
Patent: 170523
Estimated Expiration: See Plans and Pricing
Philippines
Patent: 017500121
Estimated Expiration: See Plans and Pricing
Poland
Patent: 72209
Estimated Expiration: See Plans and Pricing
Portugal
Patent: 72209
Estimated Expiration: See Plans and Pricing
Singapore
Patent: 201900648S
Estimated Expiration: See Plans and Pricing
Patent: 201700147S
Estimated Expiration: See Plans and Pricing
Slovenia
Patent: 72209
Estimated Expiration: See Plans and Pricing
South Korea
Patent: 170039211
Estimated Expiration: See Plans and Pricing
Spain
Patent: 57523
Estimated Expiration: See Plans and Pricing
Taiwan
Patent: 24993
Estimated Expiration: See Plans and Pricing
Patent: 1613595
Estimated Expiration: See Plans and Pricing
Patent: 2200148
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 TABRECTA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Denmark | 3034075 | See Plans and Pricing | |
Argentina | 111428 | SALES DE 2-FLUORO-N-METIL-4-[7-(QUINOLIN-6-IL-METIL)-IMIDAZO[1,2-B][1,2,4]TRIAZIN-2-IL]BENZAMIDA Y PROCESOS RELACIONADOS CON LA PREPARACIÓN DE LAS MISMAS | See Plans and Pricing |
Japan | 2022046659 | 2-フルオロ-N-メチル-4-[7-(キノリン-6-イルメチル)イミダゾ[1,2-B][1,2,4]トリアジン-2-イル]ベンズアミドの錠剤 (TABLET FORMULATION OF 2-FLUORO-N-METHYL-4-[7-(QUINOLIN-6-YLMETHYL)IMIDAZO[1,2-B][1,2,4]TRIAZIN-2-YL]BENZAMIDE) | See Plans and Pricing |
European Patent Office | 3034075 | IMIDAZOTRIAZINES ET IMIDAZOPYRIMIDINES UTILISÉES EN TANT QU'INHIBITEURS DE KINASE (IMIDAZOTRIAZINES AND IMIDAZOPYRIMIDINES AS KINASE INHIBITORS) | See Plans and Pricing |
South Korea | 101706784 | See Plans and Pricing | |
European Patent Office | 2497470 | Imidazotriazines et imidazopyrimidines utilisées en tant qu'inhibiteurs de kinase (Imidazotriazines and imidazopyrimidines as kinase inhibitors) | See Plans and Pricing |
China | 101641093 | Imidazotriazines and imidazopyrimidines as kinase inhibitors | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TABRECTA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2099447 | C02099447/01 | Switzerland | See Plans and Pricing | PRODUCT NAME: CAPMATINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67648 26.04.2021 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |