You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: June 21, 2024

~ Buy the TABRECTA (capmatinib hydrochloride) Drug Profile, 2024 PDF Report in the Report Store ~

TABRECTA Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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.

Indicators of Generic Entry

< Available with Subscription >

  Sign Up

Summary for TABRECTA
International Patents:175
US Patents:5
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

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 ⤷  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

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
>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
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 15293539
Estimated Expiration: ⤷  Sign Up

Patent: 18207947
Estimated Expiration: ⤷  Sign Up

Patent: 20200912
Estimated Expiration: ⤷  Sign Up

Patent: 21202500
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2017000953
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 54840
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 17000180
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
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 17000586
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 72209
Estimated Expiration: ⤷  Sign Up

Ecuador

Patent: 17011672
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 9220
Estimated Expiration: ⤷  Sign Up

Patent: 1790259
Estimated Expiration: ⤷  Sign Up

Patent: 2191301
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 72209
Estimated Expiration: ⤷  Sign Up

Patent: 48376
Estimated Expiration: ⤷  Sign Up

France

Patent: C1058
Estimated Expiration: ⤷  Sign Up

Guatemala

Patent: 1700007
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 53346
Estimated Expiration: ⤷  Sign Up

Patent: 200054
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 0166
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 70946
Estimated Expiration: ⤷  Sign Up

Patent: 02587
Estimated Expiration: ⤷  Sign Up

Patent: 17521469
Estimated Expiration: ⤷  Sign Up

Patent: 20114852
Estimated Expiration: ⤷  Sign Up

Patent: 22046659
Estimated Expiration: ⤷  Sign Up

Jordan

Patent: 18
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 7276
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 17001177
Estimated Expiration: ⤷  Sign Up

Patent: 21000595
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 8089
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 170523
Estimated Expiration: ⤷  Sign Up

Philippines

Patent: 017500121
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 72209
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 72209
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 201900648S
Estimated Expiration: ⤷  Sign Up

Patent: 201700147S
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
Estimated Expiration: ⤷  Sign Up

Patent: 2200148
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
France 22C1058 ⤷  Sign Up
South Korea 20090094299 키나제 억제제로서의 이미다조트리아진 및 이미다조피리미딘 (IMIDAZOTRIAZINES AND IMIDAZOPYRIMIDINES AS KINASE INHIBITORS) ⤷  Sign Up
South Korea 20110037962 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 2022C/557 Belgium ⤷  Sign Up PRODUCT NAME: CAPMATINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/22/1650 20220621
2099447 22C1060 France ⤷  Sign Up PRODUCT NAME: CAPMATINIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/22/1650 20220621
3172209 122022000076 Germany ⤷  Sign Up PRODUCT NAME: CAPMATINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/22/1650 20220620
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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.