You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 22, 2024

CAPMATINIB HYDROCHLORIDE - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic sources for capmatinib hydrochloride and what is the scope of freedom to operate?

Capmatinib hydrochloride is the generic ingredient in one branded drug marketed by Novartis Pharm and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Capmatinib hydrochloride has one hundred and seventy-eight patent family members in forty-five countries.

One supplier is listed for this compound.

Summary for CAPMATINIB HYDROCHLORIDE
International Patents:178
US Patents:6
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 25
DailyMed Link:CAPMATINIB HYDROCHLORIDE at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for CAPMATINIB HYDROCHLORIDE
Generic Entry Date for CAPMATINIB HYDROCHLORIDE*:
Constraining patent/regulatory exclusivity:
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 CAPMATINIB HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Sun Yat-sen UniversityPhase 2
Yonsei UniversityPhase 2
Southwest Oncology GroupPhase 2

See all CAPMATINIB HYDROCHLORIDE clinical trials

Paragraph IV (Patent) Challenges for CAPMATINIB HYDROCHLORIDE
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 CAPMATINIB HYDROCHLORIDE

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 213591-002 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 Y Y ⤷  Sign Up
Novartis Pharm TABRECTA capmatinib hydrochloride TABLET;ORAL 213591-002 May 6, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  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 213591-002 May 6, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novartis Pharm TABRECTA capmatinib hydrochloride TABLET;ORAL 213591-002 May 6, 2020 RX Yes Yes ⤷  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 CAPMATINIB HYDROCHLORIDE

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
China 115364061 C-MET抑制剂的片剂制剂 (Tablet formulations of C-MET inhibitors) ⤷  Sign Up
Malaysia 188335 IMIDAZOTRIAZINES AND IMIDAZOPYRIMIDINES AS KINASE INHIBITORS ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for CAPMATINIB HYDROCHLORIDE

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
3172209 51/2022 Austria ⤷  Sign Up PRODUCT NAME: CAPMATINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/22/1650 (MITTEILUNG) 20220621
2099447 122022000083 Germany ⤷  Sign Up PRODUCT NAME: CAPMATINIB ODER EIN PHARMAZEUTISCH UNBEDENKLICHES 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.