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 seventy-two patent family members in forty-four 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: | 172 |
US Patents: | 5 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 83 |
Clinical Trials: | 1 |
Patent Applications: | 425 |
Drug Prices: | Drug price information for TABRECTA |
What excipients (inactive ingredients) are in TABRECTA? | TABRECTA excipients list |
DailyMed Link: | TABRECTA at DailyMed |


DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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.
Recent Clinical Trials for TABRECTA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Novartis | Phase 2 |
Timothy Burns | Phase 2 |
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 ⤷ 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 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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Imidazotriazines and imidazopyrimidines as kinase inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Imidazotriazines and imidazopyrimidines as kinase inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
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: ⤷ Try a Trial
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: ⤷ Try a Trial
Australia
Patent: 15293539
Estimated Expiration: ⤷ Try a Trial
Patent: 18207947
Estimated Expiration: ⤷ Try a Trial
Patent: 20200912
Estimated Expiration: ⤷ Try a Trial
Patent: 21202500
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2017000953
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 54840
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 17000180
Estimated Expiration: ⤷ Try a Trial
China
Patent: 6714784
Patent: 2‑氟‑N‑甲基‑4‑[7‑(喹啉‑6‑基甲基)咪唑并[1,2‑b][1,2,4]三嗪‑2‑基]苯甲酰胺的片剂制剂 (Tablet formulation of 2-fluoro-n-methyl-4-[7-(quinolin-6-ylmethyl)imidazo[1,2-b][1,2,4]triazin-2-yl]benzamide)
Estimated Expiration: ⤷ Try a Trial
Patent: 5364061
Estimated Expiration: ⤷ Try a Trial
Colombia
Patent: 17000586
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 72209
Estimated Expiration: ⤷ Try a Trial
Ecuador
Patent: 17011672
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 9220
Estimated Expiration: ⤷ Try a Trial
Patent: 1790259
Estimated Expiration: ⤷ Try a Trial
Patent: 2191301
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 72209
Estimated Expiration: ⤷ Try a Trial
Patent: 48376
Estimated Expiration: ⤷ Try a Trial
France
Patent: C1058
Estimated Expiration: ⤷ Try a Trial
Guatemala
Patent: 1700007
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 53346
Estimated Expiration: ⤷ Try a Trial
Patent: 200054
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 0166
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 70946
Estimated Expiration: ⤷ Try a Trial
Patent: 02587
Estimated Expiration: ⤷ Try a Trial
Patent: 17521469
Estimated Expiration: ⤷ Try a Trial
Patent: 20114852
Estimated Expiration: ⤷ Try a Trial
Patent: 22046659
Estimated Expiration: ⤷ Try a Trial
Jordan
Patent: 18
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 7276
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 17001177
Estimated Expiration: ⤷ Try a Trial
Patent: 21000595
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 170523
Estimated Expiration: ⤷ Try a Trial
Philippines
Patent: 017500121
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 72209
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 72209
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 201900648S
Estimated Expiration: ⤷ Try a Trial
Patent: 201700147S
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 72209
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 170039211
Patent: 2-플루오로-N-메틸-4-[7-이미다조[1,2-B][1,2,4]트리아진-2-일]벤즈아미드의 정제 제제 (2--N--4-[7--6-[12-B][124]-2-] TABLET FORMULATION OF 2-FLUORO-N-METHYL-4-[7-QUINOLIN-6-YLMETHYLIMIDAZO[12-B][124]TRIAZIN-2-YL]BENZAMIDE)
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 57523
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 24993
Estimated Expiration: ⤷ Try a Trial
Patent: 1613595
Estimated Expiration: ⤷ Try a Trial
Patent: 2200148
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 TABRECTA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Ukraine | 113716 | ІМІДАЗОТРИАЗИНИ І ІМІДАЗОПІРИМІДИНИ ЯК ІНГІБІТОРИ КІНАЗИ | ⤷ Try a Trial |
Ecuador | SP099400 | IMIDAZOTRIAZINAS E IMIDAZOPIRIMIDINAS COMO INHIBIDORES DE CINASA | ⤷ Try a Trial |
Japan | 2010510319 | ⤷ Try a Trial | |
World Intellectual Property Organization (WIPO) | 2009143211 | ⤷ Try a Trial | |
Portugal | 3172209 | ⤷ Try a Trial | |
China | 113248510 | 2-氟-N-甲基-4-[7-(喹啉-6-基甲基)咪唑并[1,2-b][1,2,4]三嗪-2-基]苯甲酰胺的盐及与其相关的制备方法 (Salts of 2-fluoro-n-methyl-4-[7-(quinolin-6-ylmethyl) imidazo [1, 2-b] [1, 2, 4] triazin-2-yl] benzamide and processes related thereto) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TABRECTA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2099447 | C20220044 00389 | Estonia | ⤷ Try a Trial | PRODUCT NAME: KAPMATINIIB;REG NO/DATE: EU/1/22/1650; 21.06.2022 |
2099447 | 53/2022 | Austria | ⤷ Try a Trial | PRODUCT NAME: CAPMATINIB ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/22/1650 (MITTEILUNG) 20220621 |
2099447 | CA 2022 00053 | Denmark | ⤷ Try a Trial | PRODUCT NAME: CAPMATINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/22/1650 20220621 |
2099447 | 2022C/557 | Belgium | ⤷ Try a Trial | PRODUCT NAME: CAPMATINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/22/1650 20220621 |
3172209 | 2022C/558 | Belgium | ⤷ Try a Trial | PRODUCT NAME: CAPMATINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; AUTHORISATION NUMBER AND DATE: EU/1/22/1650 20220621 |
3172209 | CA 2022 00056 | Denmark | ⤷ Try a Trial | PRODUCT NAME: CAPMATINIB ELER ET FARMACEUTISK ACCEPTABLET SALT DERAF; REG. NO/DATE: EU/1/22/1650 20220621 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |