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Last Updated: November 22, 2024

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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 six patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and seventy-eight patent family members in forty-five 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 was eligible for patent challenges on May 6, 2024.

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.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Summary for TABRECTA
International Patents:178
US Patents:6
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 83
Clinical Trials: 1
Drug Prices: Drug price information for TABRECTA
What excipients (inactive ingredients) are in TABRECTA?TABRECTA excipients list
DailyMed Link:TABRECTA at DailyMed
Drug patent expirations by year for TABRECTA
Drug Prices for TABRECTA

See drug prices for TABRECTA

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

SponsorPhase
Timothy BurnsPhase 2
NovartisPhase 2

See all TABRECTA clinical trials

Paragraph IV (Patent) Challenges for TABRECTA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TABRECTA Tablets capmatinib hydrochloride 150 mg and 200 mg 213591 1 2024-05-06

US Patents and Regulatory Information for TABRECTA

TABRECTA is protected by six US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TABRECTA 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 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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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

Imidazotriazines and imidazopyrimidines as kinase inhibitors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Imidazotriazines and imidazopyrimidines as kinase inhibitors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up

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: ⤷  Sign Up

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis Pharm TABRECTA capmatinib hydrochloride TABLET;ORAL 213591-001 May 6, 2020 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novartis Pharm TABRECTA capmatinib hydrochloride TABLET;ORAL 213591-001 May 6, 2020 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novartis Pharm TABRECTA capmatinib hydrochloride TABLET;ORAL 213591-001 May 6, 2020 RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Novartis Pharm TABRECTA capmatinib hydrochloride TABLET;ORAL 213591-002 May 6, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Novartis Pharm TABRECTA capmatinib hydrochloride TABLET;ORAL 213591-001 May 6, 2020 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  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 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
Patent: FORMULACIÓN EN FORMA DE TABLETA DE UN INHIBIDOR DE C-MET
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 15293539
Patent: 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: ⤷  Sign Up

Patent: 18207947
Patent: 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: ⤷  Sign Up

Patent: 20200912
Patent: 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: ⤷  Sign Up

Patent: 21202500
Patent: 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: ⤷  Sign Up

Brazil

Patent: 2017000953
Patent: formulação de comprimido de 2-flúor-n-metil-4-[7-(quinolin-6-il-metil)imidazo[1,2-b][1,2,4]triazin-2-il]benzamida
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 54840
Patent: FORMULATION DE COMPRIME DE 2-FLUORO-N-METHYL-4-[7-(QUINOLINE -6-YLMETHYL) IMIDAZO[1,2-B] [1,2,4]TRIAZINE -2-YL]BENZAMIDE (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: ⤷  Sign Up

Chile

Patent: 17000180
Patent: Formulacion en forma de tableta de 2-fluor-n-metil-4-[7-(quinolin-6-ilmetil)imidazo[1,2-b][1,2,4]triazin-2-il]benzamida.
Estimated Expiration: ⤷  Sign Up

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: ⤷  Sign Up

Patent: 5364061
Patent: C-MET抑制剂的片剂制剂 (Tablet formulations of C-MET inhibitors)
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 17000586
Patent: Formulación en forma de tableta de 2-fluor-n-metil-4-[7-(quinolin-6-ylmetil)imidazo[1,2-b][1,2,4]triazin-2-il]benzamida
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 72209
Estimated Expiration: ⤷  Sign Up

Ecuador

Patent: 17011672
Patent: FORMULACIÓN EN FORMA DE TABLETA DE 2-FLUOR-N-METIL-4-[7-(QUINOLIN-6-YLMETIL)IMIDAZO[1,2-B][1,2,4]TRIAZIN-2-IL]BENZAMIDA
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 9220
Patent: СОСТАВ ТАБЛЕТКИ 2-ФТОР-N-МЕТИЛ-4-[7-(ХИНОЛИН-6-ИЛМЕТИЛ)ИМИДАЗО[1,2-b][1,2,4]ТРИАЗИН-2-ИЛ]БЕНЗАМИДА (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: ⤷  Sign Up

Patent: 1790259
Patent: СОСТАВ ТАБЛЕТОК 2-ФТОР-N-МЕТИЛ-4-[7-(ХИНОЛИН-6-ИЛМЕТИЛ)ИМИДАЗО[1,2-b][1,2,4]ТРИАЗИН-2-ИЛ]БЕНЗАМИДА
Estimated Expiration: ⤷  Sign Up

Patent: 2191301
Patent: СОСТАВ ТАБЛЕТОК 2-ФТОР-N-МЕТИЛ-4-[7-(ХИНОЛИН-6-ИЛМЕТИЛ)ИМИДАЗО[1,2-b][1,2,4]ТРИАЗИН-2-ИЛ]БЕНЗАМИДА
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 72209
Patent: FORMULATION DE COMPRIMÉ DE 2-FLUORO-N-MÉTHYL-4-[7-(QUINOLINE -6-YLMÉTHYL) IMIDAZO[1,2-B][1,2,4]TRIAZINE -2-YL]BENZAMIDE (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: ⤷  Sign Up

Patent: 48376
Patent: FORMULATION DE COMPRIMÉ D'UN INHIBITEUR DE C-MET (TABLET FORMULATION OF A C-MET INHIBITOR)
Estimated Expiration: ⤷  Sign Up

France

Patent: C1058
Estimated Expiration: ⤷  Sign Up

Guatemala

Patent: 1700007
Patent: FORMULACIÓN EN FORMA DE TABLETA DE 2-FLUOR-N-METIL-4-[7-(QUINOLIN-6-YLMETIL)IMIDAZO[1,2-B] [1,2,4]TRIAZIN-2-IL]BENZAMIDA
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 53346
Estimated Expiration: ⤷  Sign Up

Patent: 200054
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 0166
Patent: פורמולצית טבליה של 2-פלואורו-n-מתיל-4-[7-(קווינולינ-6-ילמתיל)אימידזו[1, 2-b][1,2,4]טריאזינ-2-יל]בנזאמיד (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: ⤷  Sign Up

Japan

Patent: 70946
Estimated Expiration: ⤷  Sign Up

Patent: 02587
Estimated Expiration: ⤷  Sign Up

Patent: 17521469
Patent: 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
Estimated Expiration: ⤷  Sign Up

Patent: 20114852
Patent: 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)
Estimated Expiration: ⤷  Sign Up

Patent: 22046659
Patent: 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
Estimated Expiration: ⤷  Sign Up

Jordan

Patent: 18
Patent: صيغة قرص2-فلورو-Nميثيل -4 -[7-(كوينولين-6-يل ميثيل)اميدازو[2,1-B] [4,2,1] تريازين-2-يل] بنزاميد (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: ⤷  Sign Up

Malaysia

Patent: 7276
Patent: 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: ⤷  Sign Up

Mexico

Patent: 17001177
Patent: FORMULACION EN FORMA DE TABLETA DE 2-FLUOR-N-METIL-4-[7-(QUINOLIN- 6-YLMETIL) IMIDAZO[1,2,B] [1,2,4]TRIAZIN-2-IL]BENZAMIDA. (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: ⤷  Sign Up

Patent: 21000595
Patent: FORMULACION EN FORMA DE TABLETA DE 2-FLUOR-N-METIL-4-[7-(QUINOLIN- 6-YLMETIL)IMIDAZO[1,2-B][1,2,4]TRIAZIN-2-IL]BENZAMIDA. (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: ⤷  Sign Up

New Zealand

Patent: 8089
Patent: 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: ⤷  Sign Up

Norway

Patent: 22058
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 170523
Patent: FORMULACION EN FORMA DE TABLETA DE 2-FLUOR-N-METIL-4-[7-(QUINOLIN-6-YLMETIL)IMIDAZO[1,2- B][1,2,4]TRIAZIN-2-IL]BENZAMIDA
Estimated Expiration: ⤷  Sign Up

Philippines

Patent: 017500121
Patent: TABLET FORMULATION OF A C-MET INHIBITOR
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 72209
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 72209
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 201900648S
Patent: 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: ⤷  Sign Up

Patent: 201700147S
Patent: 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: ⤷  Sign Up

Slovenia

Patent: 72209
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 2581121
Estimated Expiration: ⤷  Sign Up

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: ⤷  Sign Up

Patent: 230136693
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: ⤷  Sign Up

Spain

Patent: 57523
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 24993
Estimated Expiration: ⤷  Sign Up

Patent: 1613595
Patent: Tablet formulation of a C-MET inhibitor
Estimated Expiration: ⤷  Sign Up

Patent: 2200148
Patent: Tablet formulation of a C-MET inhibitor
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 TABRECTA around the world.

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2009143211 ⤷  Sign Up
Denmark 2300455 ⤷  Sign Up
Spain 2398843 ⤷  Sign Up
Eurasian Patent Organization 201691862 ИМИДАЗОТРИАЗИНЫ И ИМИДАЗОПИРИМИДИНЫ В КАЧЕСТВЕ ИНГИБИТОРОВ КИНАЗЫ ⤷  Sign Up
Mexico 2010012718 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 PREPARACION DE LAS MISMAS. (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.) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TABRECTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2099447 53/2022 Austria ⤷  Sign Up PRODUCT NAME: CAPMATINIB ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/22/1650 (MITTEILUNG) 20220621
2099447 C202230061 Spain ⤷  Sign Up PRODUCT NAME: CAPMATINIB O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/22/1650; DATE OF AUTHORISATION: 20220620; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/22/1650; DATE OF FIRST AUTHORISATION IN EEA: 20220620
3172209 C202230060 Spain ⤷  Sign Up PRODUCT NAME: CAPMATINIB O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/22/1650; DATE OF AUTHORISATION: 20220620; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/22/1650; DATE OF FIRST AUTHORISATION IN EEA: 20220620
2099447 PA2022527 Lithuania ⤷  Sign Up PRODUCT NAME: KAPMATINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/22/1650 20220620
2099447 22C1060 France ⤷  Sign Up PRODUCT NAME: CAPMATINIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/22/1650 20220621
>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.